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Feasibility of a Transition Diabetes Team to discharge patients with type 2 diabetes starting injectable therapies
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583
Article Type: Research
Date Submitted by the Author: 04-May-2018
Complete List of Authors: Pyrlis, Felicity; Austin Health, Endocrinology Ogrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research Institute Arthur, Sonja; University of Melbourne, Medicine Zhai, Cathy; University of Melbourne, Medicine Churilov, Leonid; University of Melbourne, Medicine Baqar, Sara; Austin Health, Endocrinology Zajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne,
Medicine Ekinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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Feasibility of a Transition Diabetes Team to discharge patients with type 2 diabetes
starting injectable therapies
Pyrlis F1, Ogrin R
2,3,, Arthur S³, Zhai B
3, Churilov L³, Baqar S
1, Zajac JD
1,3, Ekinci E I
1,3
1 Endocrinology Department, Austin Health, Heidelberg, Australia
2 Bolton Clarke Research Institute, Melbourne, Australia
3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
Corresponding Author:
Dr Felicity Pyrlis
Endocrinology Department, Austin Health
300 Waterdale Road, Heidelberg, VIC 3081
Australia
Email: [email protected]
Word count: 2496
Keywords: diabetes, inpatient, insulin, injectable, discharge
Ethical Approval: HREC Austin Health, Victoria, Australia
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Abstract
Objectives: This study aimed to investigate if the use of a transition team was feasible for
patients with diabetes being discharged from hospital on injectable diabetes therapies.
Design, Setting, Participants: This pilot, randomised controlled trial was conducted between
2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider. Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to
transition team or standard care.
Interventions: The transition team received in-home diabetes education 24-48 hours post-
discharge, with endocrinologist review 2-4 weeks and 16 weeks post-discharge.
Main outcome measures: The primary outcome was feasibility, defined by percentage of
patients successfully receiving the intervention. Secondary outcomes included safety, defined
by hospital readmission and emergency department presentations within 16 weeks post-
randomization, and treatment satisfaction, measured using Diabetes Treatment Satisfaction
Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS), and change in
HbA1c throughout the study.
Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in
safety between groups was detected. No difference in change in HbA1c between groups was
detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team
median HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a significant improvement
in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5, 16);
transition team DTSQc median 15 (IQR 10, 17.5), p=0.047), although interpretability is
limited by missing data.
Conclusion: This study demonstrated that the use of a novel transition diabetes team is a
feasible alternative model of care.
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Article Summary: Strengths and Limitations in this Study
• A strength of this study was the successful collaboration of two large organisations
providing support for the transition of care from hospital to home. Daily challenges
in coordinating team members across organisations to achieve the same goals was evident throughout the trial. Despite this, the current study recruited a large number
of patients.
• We acknowledge the limitations of the study. Eight patients in each group did not
have follow-up HbA1c measurements, despite active encouragement.
• The number of missing DTSQc questionnaires may have limited interpretability of
DTSQc results. The follow-up DTSQc was completed by 40 (16.7% missing) of the
standard care patients and 36 (34.5% missing) of the transition team patients, despite the best efforts of investigators to obtain completed DTSQc questionnaires. We
believe the non-random nature of missing data was largely due to factors related to
the transition team group, particularly difficulties involved in attending appointments at hospital. However, it may be that patients failing to complete the DTSQc were less
satisfied with treatment, suggesting that this was more likely in the transition team
group. A significantly higher number of male participants failed to complete the
DTSQc, and missing data were higher in those patients with hypertension and
dyslipidaemia. The difficulty in obtaining this data raises concerns about the
feasibility of using this method to assess treatment satisfaction in patients recently
hospitalised with acute illness.
• Withdrawal of participants from the transition team in hospital prior to the
intervention may reflect reluctance in hospitalized patients to accept health providers
entering their home, which may be a limitation of this model.
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Introduction
Despite relative stability or a slight decline in diabetes-related mortality (1), global prevalence
of diabetes is rising (2). Consequently, health care costs related to diabetes continue to
increase over time (3).
It has been demonstrated that 34% of hospital inpatients aged over 54 attending a tertiary hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type
2 diabetes have longer hospital length of stay and higher mortality rates compared to those
without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemic control at the time of hospital admission, often result in the need for intensification with
injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an
opportunity to identify those with poor glycaemic control and optimise diabetes management
(8). However, commencement of injectable therapies can be difficult in the context of
concurrent acute illness.
Guidelines recommend that patients are required to demonstrate self-management with
injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling
patients to effectively self-manage, and assists in optimising glycaemic control post-discharge
(10). However, diabetes education in the hospital setting is subject to a number of limitations
including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes education may prove more effective based on understanding a patient’s life context and
allowing adaptation of self-management routines such as timing of injection, sharps disposal
and medication storage to suit the patient’s home environment (12).
This pilot study developed and evaluated the use of a transition team comprising in-home
diabetes education by a credentialed diabetes educator (CDE), and early post-discharge
assessment by an endocrinologist. We hypothesized that the proposed intervention would be
feasible and would not negatively affect patient satisfaction when compared to standard care.
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Methods
Design
This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in
metropolitan Melbourne and a community-based healthcare provider. Study participants were
recruited during inpatient admissions between March 2014 and November 2015 and follow-up continued until March 2016. SQUIRE Reporting guidelines adhered to (13).
Participants
Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, were screened for the study, and randomised to receive the intervention or standard care after
providing informed consent.
Participant inclusion criteria:
• Type 2 diabetes,
• Age greater than 18 years,
• Need to start or change insulin or other injectable therapy, therefore requiring a
credentialed diabetes educator (CDE) to provide education prior to discharge,
• Ability to be contactable by telephone,
• Medically stable and awaiting diabetes education,
• Reside within a 30-minute travel radius of the hospital. This initial criterion was later
abandoned and the decision to provide home care in the patient’s residence was
placed at discretion of the CDE,
• Ability to attend hospital for outpatient follow-up,
• Stable glycaemia defined as blood glucose levels between 5-15 mmol/L in the 24
hours prior to randomisation.
Participant exclusion criteria:
• Participants who did not fulfil inclusion criteria,
• Participants unable to provide informed consent.
Randomisation
Participants were randomised in a 1:1 ratio using permuted block randomisation, by an
investigator without patient contact. Group allocations were concealed by writing allocations
on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant given their allocation after informed consent was obtained. Due to the difference in treatment
protocols, the study was open label to the participants and investigators.
Patient and Public Involvement
Changes in diabetes management, including initiation of new injectable medications, are often
required during hospitalisation, and good glycaemic control is important during admission and post-discharge. Patients must be actively involved in changes to diabetes management,
and require education regarding therapy changes and administration of injectable medications.
Effective education of patients can be difficult in the hospital setting, particularly in the
setting of concurrent acute illness. It is subject to a number of limitations including acute
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illness, pain and a sense of being overwhelmed in hospital. These clinical observations
contributed to the formulation of our research questions, however there was no direct patient
involvment in this.
Patients were not involved in the original study design, and involvement of patients in
recruitment was impractical as patients were hospitalised at the time of recruitment. However, during participation in the trial some intervention group patients expressed
difficulty keeping their hospital appointment for endocrinologist follow-up. In response, a
protocol for following up these patients using “telehealth” was established towards the end of the study. In this respect, patients had an influence on the study design and conduct of the
study. A qualitative analysis of these patients’ experiences and their perceptions of the
intervention was performed, and this will be reported separately.
Following publication of our findings, the paper outlining study results will be sent to the
study participants.
Interventions
Standard Care
Participants randomised to standard care were educated by hospital credentialed diabetes
educators (CDEs) prior to discharge. This comprised education regarding injectable therapy, storage, injection technique, and sharps disposal, and provision of additional resources when
required. Additional resources included National Diabetes Services Scheme (NDSS)
registration, supply of glucometer if required, written patient information regarding diabetes,
and outpatient follow-up. Participants were discharged when medically appropriate and the
inpatient team were satisfied that the participant could safely administer the injectable
therapy. Prior to discharge, appropriate follow-up was organised. General Practitioners (GPs)
were notified that participants had commenced or changed treatment.
Transition Team (intervention)
The transition team group participants received in-home education to start injectable therapy by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided
with an appropriate glucometer in addition to education regarding medication, storage,
injection technique, sharps disposal, NDSS registration, an education package in the relevant language, and CDE contact details.
Further contact with participants was based on CDE evaluation of the participant’s capacity to
self-manage injectable therapy. Once the CDE ascertained that participants were able to self-manage without further intervention, the endocrinologist was notified. Participants were then
linked with community CDE services, if necessary, for ongoing monitoring of self-
management.
Follow-up with the same endocrinologist was provided within four weeks and at 16 weeks
post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist
liaised with the participant’s GP regarding changes to management and plans for ongoing
follow-up after the 16-week visit.
Data collection
Baseline demographic, medication and medical data were collected and participants
completed the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at
enrolment. Follow-up data were collected at 16 weeks post-randomization, including rates of hospital readmissions and emergency presentations, length of hospital stay (LOS), glycaemic
control as measured by HbA1c and treatment satisfaction using the DTSQ change version
(DTSQc). Initial attempts to collect DTSQc questionnaires in the standard care group was by
reply-paid mail, however after a limited response rate using this method, patients were
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contacted by phone. Study participation ceased at the 16-week endocrinology appointment,
and final data collection occurred. Further follow-up for ongoing diabetes management was
arranged at conclusion of the study.
Ethics
Ethics approval was obtained from the Austin hopsital human ethics committee and the
community healthcare provider ethics committee. Each participant provided written informed
consent.
Outcomes
The primary outcome measured was feasibility (proportion of participants in the transition
team group completing the intervention as per protocol). Secondary outcomes were safety, as
defined by hospital readmission and emergency department presentations within 16 weeks
post-randomization, and patient satisfaction with care (measured by DTSQ). Exploratory
outcomes were change in HbA1c and length of hospital stay.
Sample size determination
Due to the pilot nature of the study, the sample size estimation was based on precision arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of
participants randomized into transition team group would be able to complete the intervention
as per protocol), the sample of 55 participants randomized to the transition team group
provides the precision (desired half-width of the 95% confidence interval) of 0.08.
The same number of participants was to be randomized to the standard care group, thus
ensuring 80% power to detect potential medium-to-large effects of transition team
intervention compared to the standard care (Cohen’s d=0.55) assuming the settings of
alpha=0.05. Thus, the total sample size for this study was proposed as 110 participants.
Statistical methods
The demographic and clinical characteristics of participants were summarized as medians
(interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical variables.
The feasibility of the intervention was estimated as a proportion of participants in the
transition team group completing the intervention as per protocol with corresponding 95% confidence interval (95% CI).
The difference in safety profiles (diabetes related hospital presentation or admission) between
two groups was investigated using Fisher's exact test.
DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression
model with the DTSQ score at 16 weeks post-randomization as an output and treatment group
and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the
auxillary variables demonstrating significant association with the DTSQ data being missing,
into the median regression model.
Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon rank-sum test.
Statistical analysis was performed using STATA software (StataCorp, College Station, TX,
USA).
All statistical tests were two sided and were performed at a significance level of α = 0.05.
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Statistical analysis was performed on both intention to treat and per protocol bases. Per
protocol analysis was deemed necessary to account for the patients who were initially
assigned to transition team but withdrew prior to intervention; in this situation they received
standard care.
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Results
One hundred and five participants were randomised to transition team or standard care.
Following initial drop outs, 103 participants received the intervention or standard care (Figure
1). 55 participants randomised to the transition team and 48 participants randomised to
receive standard care were included in the per protocol analysis (Figure 1). Participants randomised to the transition team withdrew for a variety of reasons such as decisions to
change treatment, change of discharge destination, and changes to clinical status. For the
purposes of the per protocol analysis, these participants crossed over to the standard care group.
Five participants withdrew following the home visit by the CDE but prior to completing the
endocrinologist component of the intervention as they did not wish to participate.
One participant in the transition team group was unable to be followed up as they were being
actively palliated for terminal malignancy, and one died before completion of the trial, for
reasons unrelated to diabetes. One participant withdrew from the standard care group and one
died before final data analysis in this group.
Baseline characteristics of participants are outlined in Table 1. No differences between groups
at baseline were identified
Feasibility
Forty seven out of 55 participants in the TDT group completed the study as per protocol
(85%, 95%CI: 73%, 94%).
Safety
There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard
care) and one for inability to cope with insulin management at home due to change in social
circumstances (transition team). Neither participant was admitted.
Patient satisfaction
A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0)
Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline
DTSQs value, the transition team median DTSQc value was 4 points higher than the standard care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40
(16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team
patients, thus the “missingness” of the data was not likely to be random. On the sensitivity analysis adjusted for the variables significantly associated with the missing DTSQc data at 16
weeks, the results remained qualitatively similar.
HbA1c
No statistically significant difference in change in HbA1c (standard care median HbA1c -
1.5% (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -
0.2%), p = 0.83) was observed, Figure 3, Table 2.
Length of Stay
There was a trend towards a reduced length of stay in the transition team group when
analysed on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team median 6 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3.
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Discussion
Key findings
The most important finding in this trial was that a transition team to initiate injectable diabetes therapies following discharge is a feasible model of care. These data suggest that a
transition team is safe and acceptable with a trend towards reduced length of hospital stay.
Moreover, patients randomized to the transition team group had greater treatment satisfaction as demonstrated by a greater difference in DTSQc score.
Relationship with previous studies
The results pertaining to the quality of this intervention are supported by results from other
studies examining home-based care in diabetes. The quality markers of this intervention
include feasibility and objective measures of medical indices, including readmission and
emergency presentation rates, change in HbA1c from baseline and length of stay, and patient-
reported outcomes.
We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when
analysed on a per protocol basis. Future studies with greater numbers may demonstrate
statistically significant reductions in length of hospital stay.
We demonstrated significant improvements in treatment satisfaction in the transition team
group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical
trials and validated in several languages. The status version (DTSQs) evaluates baseline
satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of an intervention on satisfaction with treatment (14, 15, 16). Interpretability of this parameter is
limited by missing data, discussed below.
Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with
HbA1c reduction of over 2% in both groups. Importantly, there was no difference detected
between the reduction in HbA1c in the transition team and the standard care group.
Other quality outcomes assessed included emergency department presentations and hospital
readmissions. There were no significant differences in our study. This suggests that patient
safety is unlikely to be compromised by delivery of home-based education. However, given
the limited literature in this field, further studies with greater numbers would be necessary to
validate these findings.
Strengths and limitations of this study:
A strength of this study was the successful collaboration of two large organisations providing support for the transition of care from hospital to home. Daily challenges in coordinating
team members across organisations to achieve the same goals was evident throughout the
trial. Despite this, the current study recruited a large number of patients.
We acknowledge the limitations of the study. Eight patients in each group did not have
follow-up HbA1c measurements, despite active encouragement.
The number of missing DTSQc questionnaires may have limited interpretability of DTSQc
results. The follow-up DTSQc was completed by 40 (16.7% missing) of the standard care
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patients and 36 (34.5% missing) of the transition team patients, despite the best efforts of
investigators to obtain completed DTSQc questionnaires. We believe the non-random nature
of missing data was largely due to factors related to the transition team group, particularly
difficulties involved in attending appointments at hospital. However, it may be that patients
failing to complete the DTSQc were less satisfied with treatment, suggesting that this was more likely in the transition team group. A significantly higher number of male participants
failed to complete the DTSQc, and missing data were higher in those patients with
hypertension and dyslipidaemia. The difficulty in obtaining this data raises concerns about the feasibility of using this method to assess treatment satisfaction in patients recently
hospitalised with acute illness.
Withdrawal of participants from the transition team in hospital prior to the intervention may
reflect reluctance in hospitalized patients to accept health providers entering their home,
which may be a limitation of this model.
Study implications
Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to
improve outcomes over the course of disease. Escalating rates of diabetes necessitates the
development of feasible alternative models of care, with the potential to improve clinical
outcomes and health care costs. This study has investigated one such option, and has
demonstrated feasibility, improved treatment satisfaction, and a trend to reduced length of
stay, with no safety concerns detected.
Conclusion
The results of this novel pilot study suggest that use of a transition team provides a feasible
alternative model of care for patients with type 2 diabetes requiring initiation of injectable therapies. More research is necessary to validate these findings in larger populations, and to
ascertain whether it may lead to reduced length of stay and healthcare costs.
Funding
The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who
funded this project. A/Prof Ekinci was supported by Australian National Health and Medical
Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship,
Royal Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop
Medical Research Foundation research grant.
Acknowledgements
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned by Prof Clare Bradley) and sourced from HPR Ltd.
The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes education for the intervention group.
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Competing Interests statement
We have read and understood BMJ policy on declaration of interests and declare that we have
no competing interests.
Author Contributions
F Pyrlis - involved in development of trial, clinical management of participants, performed
final write up
R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
S Arthur - recruitment of participants and management of logistics of trial (research assistant),
data collection and analysis
B Zhai - logistics of trial (research assistant), final data collection and statistical analysis
S Baqar - recruitment of participants, data collection and analysis
L Churilov - statistical analysis
JD Zajac - supervisory/ advisory role
EI Ekinci - development of protocol, supervisory and advisory role during trial, assisted with
statistical analysis and final write up
Data Statement: Dataset is restricted but can be provided upon reasonable request.
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References
1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010.
http://www.aihw.gov.au/diabetes-indicators/deaths)
2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes
prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103:137-149
3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children
and young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. No. CVD 53; Diabetes Series No 21,)
http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359
4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient
HbA1c testing: a prospective observational study. BMJ open diabetes research &
care. 2015;3(1):e000113
5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for
coronary artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9
6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and
new hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3
7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of
diabetes self-management education in the hospital setting. Primary Care Diabetes.
2014;8(3):187-94.
8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al.
Strategies for Improving Participation in Diabetes Education. A Qualitative Study.
PLoS One. 2014; 9(4)
9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult
inpatients with diabetes. October 2015
10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact
of inpatient diabetes management, education, and improved discharge transition on
glycemic control 12 months after discharge. Diabetes Research and Clinical Practice.
2012;98:249-56
11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of
diabetes self-management education in the hospital setting. Primary Care Diabetes.
2014;8(3):187-94.
12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an
educational health strategy for self-care in diabetes. Visita domiciliária: estratégia
educativa em saúde para o autocuidado em diabetes. 2014;27(1):23
13. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0
(Standards for QUality Improvement Reporting Excellence): revised publication
guidelines from a detailed consensus process
14. Bradley C, Lewis KS. Measures of psychological well-being and treatment
satisfaction developed from the responses of people with tablet-treated diabetes.
Diabetic Medicine. 1990; 7:445-451.
15. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
16. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change
version for use alongside status version provides appropriate solution where ceiling
effects occur. Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J,
Valentine J and Witthaus E (2007) The Diabetes Treatment Satisfaction
Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health and Quality
of Life Outcomes. 1999; 5 (5) 57
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Figure 1 : Recruitment and participation flowchart
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Table 1: Comparison of baseline clinical and biochemical characteristics between in the
control and TDT groups by initial randomization/ intention to treat)
Characteristic Control group
(n=48)
Transitions group
(n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (34.4) 22 (61.1)
Median type 2 diabetes (SD) 7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and
Fisher Exact tests used for binary variables
Table 2: Results by intention to treat analysis. Differences in hospital readmission rates,
change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Control group (n=48) Transitions group
(n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median,
IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -
0.2%)
0.83
Length of stay (days)
(median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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Table 3: Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group
(n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median,
IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days)
(median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
Figure 2: Change in treatment satisfaction (DTSQ)
Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c
(%) per protocol analysis
Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length
of hospital stay (days) per protocol analysis
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Reporting checklist for quality improvement study.
Based on the SQUIRE guidelines.
Instructions to authors
Complete this checklist by entering the page numbers from your manuscript where readers will find
each of the items listed below.
Your article may not currently address all the items on the checklist. Please modify your text to
include the missing information. If you are certain that an item does not apply, please write "n/a" and
provide a short explanation.
Upload your completed checklist as an extra file when you submit to a journal.
In your methods section, say that you used the SQUIRE reporting guidelines, and cite them as:
Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for
QUality Improvement Reporting Excellence): revised publication guidelines from a detailed
consensus process
Reporting Item
Page
Number
#1 Indicate that the manuscript concerns an initiative to improve
healthcare (broadly defined to include the quality, safety,
effectiveness, patientcenteredness, timeliness, cost, efficiency,
and equity of healthcare)
1
#02a Provide adequate information to aid in searching and indexing 2
#02b Summarize all key information from various sections of the text
using the abstract format of the intended publication or a
structured summary such as: background, local problem,
methods, interventions, results, conclusions
2
Problem
description
#3 Nature and significance of the local problem 4
Available
knowledge
#4 Summary of what is currently known about the problem,
including relevant previous studies
4
Rationale #5 Informal or formal frameworks, models, concepts, and / or
theories used to explain the problem, any reasons or
4
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assumptions that were used to develop the intervention(s), and
reasons why the intervention(s) was expected to work
Specific aims #6 Purpose of the project and of this report 4
Context #7 Contextual elements considered important at the outset of
introducing the intervention(s)
5
Intervention(s) #08a Description of the intervention(s) in sufficient detail that others
could reproduce it
5-6
#08b Specifics of the team involved in the work 5-6
Study of the
Intervention(s)
#09a Approach chosen for assessing the impact of the intervention(s) 6-7
#09b Approach used to establish whether the observed outcomes
were due to the intervention(s)
6-7
Measures #10a Measures chosen for studying processes and outcomes of the
intervention(s), including rationale for choosing them, their
operational definitions, and their validity and reliability
6-7
#10b Description of the approach to the ongoing assessment of
contextual elements that contributed to the success, failure,
efficiency, and cost
7
#10c Methods employed for assessing completeness and accuracy
of data
7
Analysis #11a Qualitative and quantitative methods used to draw inferences
from the data
7
#11b Methods for understanding variation within the data, including
the effects of time as a variable
7
Ethical
considerations
#12 Ethical aspects of implementing and studying the intervention(s)
and how they were addressed, including, but not limited to,
formal ethics review and potential conflict(s) of interest
6
#13a Initial steps of the intervention(s) and their evolution over time
(e.g., time-line diagram, flow chart, or table), including
modifications made to the intervention during the project
8.10
#13b Details of the process measures and outcome 8.10
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#13c Contextual elements that interacted with the intervention(s) 10
#13d Observed associations between outcomes, interventions, and
relevant contextual elements
10
#13e Unintended consequences such as unexpected benefits,
problems, failures, or costs associated with the intervention(s).
10
#13f Details about missing data 9
Summary #14a Key findings, including relevance to the rationale and specific
aims
9
#14b Particular strengths of the project 9
Interpretation #15a Nature of the association between the intervention(s) and the
outcomes
9
#15b Comparison of results with findings from other publications 9
#15c Impact of the project on people and systems 10
#15d Reasons for any differences between observed and anticipated
outcomes, including the influence of context
9-10
#15e Costs and strategic trade-offs, including opportunity costs 10
Limitations #16a Limits to the generalizability of the work 9-10
#16b Factors that might have limited internal validity such as
confounding, bias, or imprecision in the design, methods,
measurement, or analysis
9-10
#16c Efforts made to minimize and adjust for limitations 9-10
Conclusion #17a Usefulness of the work 10
#17b Sustainability 10
#17c Potential for spread to other contexts 10
#17d Implications for practice and for further study in the field 10
#17e Suggested next steps 10
Funding #18 Sources of funding that supported this work. Role, if any, of the
funding organization in the design, implementation,
10
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interpretation, and reporting
The SQUIRE 2.0 checklist is distributed under the terms of the Creative Commons Attribution License
CC BY-NC 4.0. This checklist was completed on 12. April 2018 using http://www.goodreports.org/, a
tool made by the EQUATOR Network in collaboration with Penelope.ai
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Figure 1 : Recruitment and participation flowchart
373x341mm (150 x 150 DPI)
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Figure 2: Change in treatment satisfaction (DTSQ)
401x555mm (96 x 96 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
725x555mm (96 x 96 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis
794x555mm (96 x 96 DPI)
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For peer review onlyFeasibility of using a transition diabetes team to commence injectable therapies post discharge from a tertiary hospital
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583.R1
Article Type: Original research
Date Submitted by the Author: 24-Oct-2018
Complete List of Authors: Pyrlis, Felicity; Austin Health, EndocrinologyOgrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research InstituteArthur, Sonja; University of Melbourne, MedicineZhai, Cathy; University of Melbourne, MedicineChurilov, Leonid; University of Melbourne, MedicineBaqar, Sara; Austin Health, EndocrinologyZajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne, MedicineEkinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
<b>Primary Subject Heading</b>: Diabetes and endocrinology
Secondary Subject Heading: Patient-centred medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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1 Feasibility of using a transition diabetes team to commence injectable therapies post discharge 2 from a tertiary hospital
3
4 Pyrlis, F1, Ogrin, R2,3, Arthur, S³, Zhai, C3, Churilov, L³, Baqar, S1, Zajac, J D1,3, Ekinci, E. I. 1,3
5 1 Endocrinology Department, Austin Health, Heidelberg, Australia
6 2 Royal District Nursing Service, Melbourne, Australia
7 3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
8
9 Corresponding Author: 10 Dr Felicity Pyrlis11 Endocrinology Department, Austin Health12 300 Waterdale Road, Heidelberg, VIC 308113 Australia 14 Email: [email protected]
15
16 Word count: 2426
17 Keywords: diabetes, inpatient, insulin, injectable, discharge
18 Ethical Approval: HREC Austin Health, Victoria, Australia (LNR_13_Austin_179)
1920
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21 Article Summary:
2223 This study aimed to investigate if the use of a transition team was feasible for patients 24 with diabetes being discharged from hospital on injectable diabetes therapies.25 This pilot, randomised controlled trial was conducted between 2014 and 2016 conjointly 26 by a tertiary referral hospital and a community healthcare provider.27 Hospital inpatients (n=105) on new injectable diabetes therapies were randomised to 28 transition team (receiving in-home diabetes education 24-48 hours post-discharge, with 29 endocrinologist review 2-4 weeks and 16 weeks post-discharge) or standard care.30 The primary outcome was feasibility, defined by percentage of patients successfully 31 receiving the intervention.32 This study demonstrated that the use of a novel transition diabetes team is a feasible 33 alternative model of care.
34
35 Strengths and limitations of the study:
36 A strength of this study was the successful collaboration of two large organisations providing 37 support for the transition of care from hospital to home.
38 We acknowledge the limitations of the study.
39 Eight patients in each group did not have follow-up HbA1c measurements, despite active 40 encouragement.
41 The follow-up DTSQc was completed by 40 (16.7% missing) of the standard care patients and 36 42 (34.5% missing) of the transition team patients,and the number of missing DTSQc questionnaires 43 may have limited interpretability of DTSQc results. .
44 Withdrawal of participants from the transition team in hospital prior to the intervention may 45 reflect reluctance in hospitalized patients to accept health providers entering their home, which 46 may be a limitation of this model.
47
48
49
50
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52 Abstract
53 Objectives: This study aimed to investigate if the use of a transition team was feasible for patients 54 with diabetes being discharged from hospital on injectable diabetes therapies.
55
56 Design, Setting, Participants: This pilot, randomised controlled trial was conducted between 2014 57 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider. Hospital 58 inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to transition team or 59 standard care. The transition team received in-home diabetes education 24-48 hours post-60 discharge, with endocrinologist review 2-4 weeks and 16 weeks post-discharge.
61
62 Main outcome measures: The primary outcome was feasibility, defined by percentage of patients 63 successfully receiving the intervention. Secondary outcomes included safety, defined by hospital 64 readmission and emergency department presentations within 16 weeks post-randomization, and 65 treatment satisfaction, measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ). 66 Exploratory outcomes included length of stay (LOS), and change in HbA1c throughout the study.67
68 Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in 69 safety between groups was detected. No difference in change in HbA1c between groups was 70 detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team median 71 HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a significant improvement in patient 72 satisfaction in the transition team (standard care median 10.5 (IQR 8.5, 16); transition team 73 DTSQc median 15 (IQR 10, 17.5), p=0.047), although interpretability is limited by missing data.
74 Conclusion: This study demonstrated that the use of a novel transition diabetes team is a feasible 75 alternative model of care.
76
77
78
79
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80 Introduction
81 Despite stability in diabetes-related mortality (1), global prevalence of diabetes is rising (2). 82 Consequently, health care costs related to diabetes continue to increase over time (3).
83 It has been demonstrated that 34% of hospital inpatients aged over 54 attending a tertiary hospital 84 have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 2 diabetes 85 have longer hospital length of stay and higher mortality rates compared to those without (5, 6). 86 Factors such as stress hyperglycaemia, medications, and inadequate glycaemic control at the time 87 of hospital admission, often result in the need for intensification with injectable diabetes therapies 88 (7). Furthermore, the hospitalisation period provides an opportunity to identify those with poor 89 glycaemic control and optimise diabetes management (8). However, commencement of 90 injectable therapies can be difficult in the context of concurrent acute illness.
91 Guidelines recommend that patients are required to demonstrate self-management with injectable 92 therapies prior to hospital discharge (9). Diabetes education is crucial in enabling patients to 93 effectively self-manage, and assists in optimising glycaemic control post-discharge (10). 94 However, diabetes education in the hospital setting is subject to a number of limitations including 95 acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes education may 96 prove more effective based on understanding a patient’s life context and allowing adaptation of 97 self-management routines such as timing of injection, sharps disposal and medication storage to 98 suit the patient’s home environment (12).
99 This pilot study developed and evaluated the use of a transition team comprising in-home 100 diabetes education by a credentialed diabetes educator (CDE), and early post-discharge 101 assessment by an endocrinologist. We hypothesized that the proposed intervention would be 102 feasible and would not negatively affect patient satisfaction when compared to standard care.
103
104
105 Methods
106 Design
107 This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in 108 metropolitan Melbourne and a community-based healthcare provider. Study participants were 109 recruited during inpatient admissions between March 2014 and November 2015 and follow-up 110 continued until March 2016. The trial was stopped after funding was exhausted and sufficient 111 participants were recruited.
112 Participants
113 Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, 114 were screened for the study, and randomised to receive the intervention or standard care after 115 providing informed consent. Participant inclusion criteria were the ability to provide informed 116 consent, the presence of type 2 diabetes, age > 18 years, requirement to commence or change 117 injectable therapies, therefore requiring a credentialed diabetes educator (CDE) to provide 118 education prior to discharge, medically stable and awaiting diabetes education, reside within a 119 30-minute travel radius of the hospital, ability to attend hospital for outpatient follow-up and 120 stable glycaemia defined as blood glucose levels between 5-15 mmol/L in the 24 hours prior to 121 randomisation. 122
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123 Randomisation
124 Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 125 investigator without patient contact. Group allocations were concealed by writing allocations on 126 a card, and placing in sealed, unlabelled envelopes, with each consecutive participant given their 127 allocation by a research assistant after informed consent was obtained. Due to the difference in 128 treatment protocols, the study was open label to the participants and investigators.
129 Intervention
130 Standard Care
131 Participants randomised to standard care were educated by hospital credentialed diabetes 132 educators (CDEs) prior to discharge. Diabetes education regarding injectable therapies in our 133 institution complies with guidelines of the Australian Diabetes Educators Association (13). This 134 comprised education regarding injectable therapy, storage, injection technique, and sharps 135 disposal, and provision of additional resources when required. Additional resources included 136 National Diabetes Services Scheme (NDSS) registration, supply of glucometer if required, 137 written patient information regarding diabetes, and outpatient follow-up. Participants were 138 discharged when medically appropriate and the inpatient team were satisfied that the participant 139 could safely administer the injectable therapy. Prior to discharge, appropriate follow-up was 140 organised. General Practitioners (GPs) were notified that participants had commenced or changed 141 treatment.
142 Transition Team (intervention)
143 The transition team group participants received in-home education to start injectable therapy by 144 the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided with 145 an appropriate glucometer in addition to education regarding medication, storage, injection 146 technique, sharps disposal, NDSS registration, an education package in the relevant language, and 147 CDE contact details.
148 Further contact with participants was based on CDE evaluation of the participant’s capacity to 149 self-manage injectable therapy. Once the CDE ascertained that participants were able to self-150 manage without further intervention, the endocrinologist was notified. Participants were then 151 linked with community CDE services, if necessary, for ongoing monitoring of self-management.
152 Follow-up with the same endocrinologist was provided within four weeks, and at 16 weeks post-153 randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist liaised with 154 the participant’s GP regarding changes to management and plans for ongoing follow-up after the 155 16-week visit.
156 Data collection
157 Baseline demographic, medication and medical data were collected and participants completed 158 the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at enrolment. Whether 159 the patient was from a culturally and linguistically diverse (CALD) background was recorded. 160 Follow-up data were collected at 16 weeks post-randomization, including rates of hospital 161 readmissions and emergency presentations, length of hospital stay (LOS), glycaemic control as 162 measured by HbA1c and treatment satisfaction using the DTSQ change version (DTSQc). Initial 163 attempts to collect DTSQc questionnaires in the standard care group was by reply-paid mail, 164 however after a limited response rate using this method, patients were contacted by phone. 165 Study participation ceased at the 16-week endocrinology appointment, and final data collection 166 occurred. Further follow-up for ongoing diabetes management was arranged at conclusion of the 167 study.
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168
169 Ethics
170 Ethics approval was obtained from the hospital human ethics committee and the community 171 healthcare provider ethics committee. Each participant provided written informed consent.
172
173 Outcomes
174 The primary outcome measured was feasibility (proportion of participants in the transition team 175 group completing the intervention as per protocol). Secondary outcomes were safety, as defined 176 by hospital readmission and emergency department presentations within 16 weeks post-177 randomization, and patient satisfaction with care (measured by DTSQ). Exploratory outcomes 178 were change in HbA1c and length of hospital stay (days).
179
180 Sample size determination
181 Due to the pilot nature of the study, the sample size estimation was based on precision arguments: 182 assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of participants 183 randomized into transition team group would be able to complete the intervention as per 184 protocol), the sample of 55 participants randomized to the transition team group provides the 185 precision (desired half-width of the 95% confidence interval) of 0.08.
186 The same number of participants was to be randomized to the standard care group, thus ensuring 187 80% power to detect potential medium-to-large effects of transition team intervention compared 188 to the standard care (Cohen’s d=0.55) assuming the settings of alpha=0.05. Thus, the total sample 189 size for this study was proposed as 110 participants.
190
191 Statistical methods
192 The demographic and clinical characteristics of participants were summarized as medians 193 (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical 194 variables.
195 The feasibility of the intervention was estimated as a proportion of participants in the transition 196 team group completing the intervention as per protocol with corresponding 95% confidence 197 interval (95% CI).
198 The difference in safety profiles (diabetes related hospital presentation or admission) between two 199 groups was investigated using Fisher's exact test.
200 DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 201 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 202 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the auxillary 203 variables demonstrating significant association with the DTSQ data being missing, into the 204 median regression model.
205 Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 206 rank-sum test.
207 Statistical analysis was performed using STATA software (StataCorp, College Station, TX, 208 USA).
209 All statistical tests were two sided and were performed at a significance level of α = 0.05.
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210 Statistical analysis was performed on both intention to treat and per protocol bases. Per protocol 211 analysis was deemed necessary to account for the patients who were initially assigned to 212 transition team but withdrew prior to intervention; in this situation they received standard care.
213 Patient and public involvement
214 Patients must be actively involved in changes to diabetes management, and require education 215 regarding therapy changes and administration of injectable medications. Effective education of 216 patients can be difficult in the hospital setting, particularly in the setting of concurrent acute 217 illness. It is subject to a number of limitations including acute illness, pain and a sense of being 218 overwhelmed in hospital. These clinical observations contributed to the formulation of our 219 research questions, however there was no direct patient involvment in this.
220 Patients were not involved in the original study design, and involvement of patients in 221 recruitment was impractical as patients were hospitalised at the time of recruitment. A qualitative 222 analysis of a subgroup of patients’ experiences and their perceptions of the intervention was 223 performed, and this will be reported separately.
224 Following publication of our findings, the paper outlining study results will be sent to the study 225 participants.
226
227
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229 Results
230 One hundred and five participants were randomised to transition team or standard care. Following 231 initial drop outs, 103 participants received the intervention or standard care (Figure 1). 55 232 participants randomised to the transition team and 48 participants randomised to receive standard 233 care were included in the per protocol analysis (figure 1). Participants randomised to the 234 transition team withdrew for a variety of reasons such as decisions to change treatment, change of 235 discharge destination, and changes to clinical status. Of these, five participants withdrew 236 following the home visit by the CDE but prior to completing the endocrinologist component of 237 the intervention. For the purposes of the per protocol analysis, these participants crossed over to 238 the standard care group.
239 One participant in the transition team group was unable to be followed up as they were being 240 actively palliated for terminal malignancy, and one died before completion of the trial, for reasons 241 unrelated to diabetes. One participant withdrew from the standard care group and one died before 242 final data analysis in this group.
243 Baseline characteristics of participants are outlined in Table 1. No differences between groups at 244 baseline were identified.
245
246 Feasibility
247 Forty seven out of 55 participants in the transition team group completed the study as per protocol 248 (85%, 95%CI: 73%, 94%).
249 Safety
250 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 251 care) and one for inability to cope with insulin management at home due to change in social 252 circumstances (transition team). Neither participant was admitted.
253 Patient satisfaction
254 A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc 255 transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) Wilcoxon-256 Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline DTSQs value, 257 the transition team median DTSQc value was 4 points higher than the standard care median 258 (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 (16.7% missing) of 259 the standard care patients and 36 (34.5% missing) of the transition team patients, thus the 260 “missingness” of the data was not likely to be random. On the sensitivity analysis adjusted for the 261 variables significantly associated with the missing DTSQc data at 16 weeks, the results remained 262 qualitatively similar.
263 HbA1c
264 No statistically significant difference in change in HbA1c (standard care median HbA1c -1.5% 265 (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -0.2%), p = 266 0.83) was observed, Figure 3, Table 2. An equal number of patients (8) in each group did not 267 have an HbA1c measurement at 16 weeks.
268 Length of Stay
269 There was a trend towards a reduced length of stay in the transition team group when analysed on 270 a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team median 6 (IQR 271 3.0-12.0), p=0.06), Figure 4, Table 3.
272
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273
274
275 Discussion
276
277 Key findings
278 The most important finding in this trial was that a transition team to initiate injectable diabetes 279 therapies following discharge is a feasible model of care. These data suggest that a transition 280 team is safe and acceptable with a trend towards reduced length of hospital stay. Moreover, 281 patients randomized to the transition team group had greater treatment satisfaction as 282 demonstrated by a greater difference in DTSQc score.
283
284
285 Relationship with previous studies
286287 The results pertaining to the quality of this intervention are supported by results from other 288 studies examining home-based care in diabetes. The quality markers of this intervention include 289 feasibility and objective measures of medical indices, including readmission and emergency 290 presentation rates, change in HbA1c from baseline and length of stay, and patient-reported 291 outcomes. 292293 We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when 294 analysed on a per protocol basis. Future studies with greater numbers may demonstrate 295 statistically significant reductions in length of hospital stay.296
297 We demonstrated significant improvements in treatment satisfaction in the transition team group. 298 The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical trials and 299 validated in several languages. The status version (DTSQs) evaluates baseline satisfaction with 300 diabetes treatment and the change version (DTSQc) evaluates the impact of an intervention on 301 satisfaction with treatment (14, 15, 16). Interpretability of this parameter is limited by missing 302 data, and there is potential for bias due to some data being obtained over the phone by a research 303 assistant, rather than in person. 304305 Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 306 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical difference 307 detected between the reduction in HbA1c in the transition team and the standard care group. 308309 Other quality outcomes assessed included emergency department presentations and hospital 310 readmissions. There were no significant differences in our study. This suggests that patient safety 311 is unlikely to be compromised by delivery of home-based education. However, given the limited 312 literature in this field, further studies with greater numbers would be necessary to validate these 313 findings.
314
315 Study implications
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316 Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to improve 317 outcomes over the course of disease. Escalating rates of diabetes necessitates the development of 318 feasible alternative models of care, with the potential to improve clinical outcomes and health 319 care costs. This study has investigated one such option, and has demonstrated feasibility, 320 improved treatment satisfaction, and a trend to reduced length of stay, with no safety concerns 321 detected.
322
323
324
325 Conclusion
326 The results of this novel pilot study suggest that use of a transition team provides a feasible 327 alternative model of care for patients with type 2 diabetes requiring initiation of injectable 328 therapies. More research is necessary to validate these findings in larger populations, and to 329 ascertain whether it may lead to reduced length of stay and healthcare costs.
330
331 Funding
332 The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who 333 funded this project. A/Prof Ekinci was supported by Australian National Health and Medical 334 Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship, Royal 335 Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop Medical 336 Research Foundation research grant.
337
338 Acknowledgements
339 The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned by 340 Prof Clare Bradley) and sourced from HPR Ltd.341 The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes 342 education for the intervention group.
343
344 Competing Interests statement
345 We have read and understood BMJ policy on declaration of interests and declare that we have no 346 competing interests.
347
348
349 Authors Statement
350 F Pyrlis - involved in development of trial, clinical management of participants, performed final 351 write up
352 R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
353 S Arthur - logistics of trial (research assistant), data collection and statistical analysis
354 B Zhai - logistics of trial (research assistant), final data collection and statistical analysis
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355 S Baqar - recruitment of participants and management of logistics of trial (research assistant), 356 data collection and analysis
357 L Churilov - statistical analysis
358 J Zajac - supervisory/ advisory role
359 E Ekinci - development of protocol, supervisory and advisory role during trial, assisted with 360 statistical analysis and final write up
361
362 Data Statement: Dataset is restricted but can be provided upon reasonable request
363
364 Figure Legend
365 Figure 1 – Recruitment and participation flowchart
366 Figure 2 – Change in treatment satisfaction (DTSQ)
367 Figure 3 – a) Change in HbA1c (%) intention to treat analysis b) Change in HbA1c (%) per 368 protocol analysis
369 Figure 4 – a) Length of hospital stay (days) by intention to treat analysis b) Length of hospital 370 stay (days) by per protocol analysis
371 Table 1 - Comparison of baseline clinical and biochemical characteristics between in the control 372 and transition team groups by initial randomization/ intention to treat
373 Table 2 - Results by intention to treat analysis. Differences in hospital readmission rates, change 374 in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
375 Table 3 - Results by per Protocol analysis. Differences in hospital readmission rates, change in 376 HbA1c, length of hospital stay, & treatment satisfaction according to management received.377
378
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379 References380 1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010. 381 http://www.aihw.gov.au/diabetes-indicators/deaths)382 2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes prevalence 383 for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103:137-149384 3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children and 385 young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. No. 386 CVD 53; Diabetes Series No 21,) 387 http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359388 4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient 389 HbA1c testing: a prospective observational study. BMJ open diabetes research & care. 390 2015;3(1):e000113391 5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for coronary 392 artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9393 6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and new 394 hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3395 7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of diabetes 396 self-management education in the hospital setting. Primary Care Diabetes. 397 2014;8(3):187-94.
398 8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al. Strategies 399 for Improving Participation in Diabetes Education. A Qualitative Study. PLoS One. 400 2014; 9(4)
401 9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult inpatients 402 with diabetes. October 2015 403 10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of 404 inpatient diabetes management, education, and improved discharge transition on 405 glycemic control 12 months after discharge. Diabetes Research and Clinical Practice. 406 2012;98:249-56
407 11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of diabetes 408 self-management education in the hospital setting. Primary Care Diabetes. 409 2014;8(3):187-94.
410 12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an 411 educational health strategy for self-care in diabetes. Visita domiciliária: estratégia 412 educativa em saúde para o autocuidado em diabetes. 2014;27(1):23
413 13. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-414 digital-version2.pdf
415 14. Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction 416 developed from the responses of people with tablet-treated diabetes. Diabetic Medicine. 417 1990; 7:445-451.
418 15. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing 419 quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
420 16. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change version 421 for use alongside status version provides appropriate solution where ceiling effects occur. 422 Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J, Valentine J and Witthaus
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423 E (2007) The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) 424 evaluated in insulin glargine trials shows greater responsiveness to improvements than 425 the original DTSQ. Health and Quality of Life Outcomes. 1999; 5 (5) 57426427428429
430
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Table 1 Comparison of baseline clinical and biochemical characteristics between in the control and transition team groups by initial randomization/ intention to treat.
Characteristic Control group (n=48)
Transitions group (n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (33.3%) 22 (40%)
Median type 2 diabetes (SD) 7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and Fisher Exact tests used for binary variables
Table 2. Results by intention to treat analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Control group (n=48) Transitions group (n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -0.2%)
0.83
Length of stay (days) (median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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For peer review onlyTable 3. Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group (n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days) (median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
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Figure 1: Recruitment and participation flowchart
Inpatients commencing injectable diabetes therapies
Intention to treat analysis Analysed (n=55)
6 patients did not have follow-up HbA1c 19 patients did not complete DTSQc
Transition team care (n=55) • Received allocated intervention (n=47) • Did not receive allocated intervention (n= 8)
6 patients did not have follow-up HbA1c 8 patients did not complete DTSQc
Standard care (n= 50) • Received allocated care (n=48) • Withdrew prior to baseline data collection due
to changes in care during hospitalisation, so could not be included in analysis (n=2)
Intention to treat analysis Analysed (n=48)
Randomised (n=105)
Per protocol analysis Analysed (n=47)
Per protocol analysis Analysed (n=56)
Participants who did not receive transition team intervention (n= 8)
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Figure 2: Change in treatment satisfaction (DTSQ)
401x555mm (96 x 96 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
725x555mm (96 x 96 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis
794x555mm (96 x 96 DPI)
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CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial*
Section/TopicItem No Checklist item
Reported on page No
Title and abstract1a Identification as a pilot or feasibility randomised trial in the title 11b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see
CONSORT abstract extension for pilot trials)2,3
Introduction2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot
trial4Background and
objectives2b Specific objectives or research questions for pilot trial 3, 4
Methods3a Description of pilot trial design (such as parallel, factorial) including allocation ratio 4Trial design3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 54a Eligibility criteria for participants 4Participants4b Settings and locations where the data were collected 44c How participants were identified and consented 4
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
5
6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed
6Outcomes
6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a7a Rationale for numbers in the pilot trial 6Sample size7b When applicable, explanation of any interim analyses and stopping guidelines n/a
Randomisation:8a Method used to generate the random allocation sequence 5Sequence
generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5Allocationconcealmentmechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
5
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 5
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interventions11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
assessing outcomes) and hown/aBlinding
11b If relevant, description of the similarity of interventions 5Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 6
Results13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly
assigned, received intended treatment, and were assessed for each objective8Participant flow (a
diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 8
14a Dates defining the periods of recruitment and follow-up 4Recruitment14b Why the pilot trial ended or was stopped 4
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 14Numbers analysed 16 For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers
should be by randomised group8
Outcomes and estimation
17 For each objective, results including expressions of uncertainty (such as 95% confidence interval) for anyestimates. If relevant, these results should be by randomised group
8
Ancillary analyses 18 Results of any other analyses performed that could be used to inform the future definitive trial 8Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) n/a
19a If relevant, other important unintended consequences n/a
DiscussionLimitations 20 Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility 2, 9Generalisability 21 Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies 9Interpretation 22 Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and
considering other relevant evidence9
22a Implications for progression from pilot to future definitive trial, including any proposed amendments n/a
Other informationRegistration 23 Registration number for pilot trial and name of trial registry 1Protocol 24 Where the pilot trial protocol can be accessed, if available n/aFunding 25 Sources of funding and other support (such as supply of drugs), role of funders 10
26 Ethical approval or approval by research review committee, confirmed with reference number 1
Citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355.
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*We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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For peer review onlyFeasibility of using a transition diabetes team to commence injectable therapies post discharge from a tertiary hospital
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583.R2
Article Type: Original research
Date Submitted by the Author: 20-Dec-2018
Complete List of Authors: Pyrlis, Felicity; Austin Health, EndocrinologyOgrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research InstituteArthur, Sonja; University of Melbourne, MedicineZhai, Cathy; University of Melbourne, MedicineChurilov, Leonid; University of Melbourne, MedicineBaqar, Sara; Austin Health, EndocrinologyZajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne, MedicineEkinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
<b>Primary Subject Heading</b>: Diabetes and endocrinology
Secondary Subject Heading: Patient-centred medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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1 Feasibility of using a transition diabetes team to commence injectable therapies post 2 discharge from a tertiary hospital
3
4 Pyrlis, F1, Ogrin, R2,3, Arthur, S³, Zhai, C3, Churilov, L³, Baqar, S1, Zajac, J D1,3, Ekinci, E. I. 5 1,3
6 1 Endocrinology Department, Austin Health, Heidelberg, Australia
7 2 Royal District Nursing Service, Melbourne, Australia
8 3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
9
10 Corresponding Author: 11 Dr Felicity Pyrlis12 Endocrinology Department, Austin Health13 300 Waterdale Road, Heidelberg, VIC 308114 Australia 15 Email: [email protected]
16
17 Word count: 2468
18 Keywords: diabetes, inpatient, insulin, injectable, discharge
19 Ethical Approval: HREC Austin Health, Victoria, Australia (LNR_13_Austin_179)
2021
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22 Article Summary:
2324 This study aimed to investigate if the use of a transition team was feasible for patients 25 with diabetes being discharged from hospital on injectable diabetes therapies.26 This pilot, randomised controlled trial was conducted between 2014 and 2016 27 conjointly by a tertiary referral hospital and a community healthcare provider.28 Hospital inpatients (n=105) on new injectable diabetes therapies were randomised to 29 transition team (receiving in-home diabetes education 24-48 hours post-discharge, 30 with endocrinologist review 2-4 weeks and 16 weeks post-discharge) or standard 31 care.32 The primary outcome was feasibility, defined by percentage of patients successfully 33 receiving the intervention.34 This study demonstrated that the use of a novel transition diabetes team is a feasible 35 alternative model of care.
36
37 Strengths and limitations of the study:
38 A strength of this study was the successful collaboration of two large organisations providing 39 support for the transition of care from hospital to home.
40 We acknowledge the limitations of the study.
41 Eight patients in each group did not have follow-up HbA1c measurements, despite active 42 encouragement.
43 The follow-up diabetes treatment satisfaction questionnaire change version (DTSQc) was 44 completed by 40 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the 45 transition team patients,and the number of missing DTSQc questionnaires may have limited 46 interpretability of DTSQc results. .
47 Withdrawal of participants from the transition team in hospital prior to the intervention may 48 reflect reluctance in hospitalized patients to accept health providers entering their home, 49 which may be a limitation of this model.
50
51
52
53
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55 Abstract
56 Objectives: This study aimed to investigate if the use of a transition team was feasible for 57 patients with diabetes being discharged from hospital on injectable diabetes therapies.
58
59 Design, Setting, Participants: This pilot, randomised controlled trial was conducted between 60 2014 and 2016 conjointly by a tertiary referral hospital and a community healthcare provider. 61 Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 1:1 to 62 transition team or standard care. The transition team received in-home diabetes education 24-63 48 hours post-discharge, with endocrinologist review 2-4 weeks and 16 weeks post-discharge.
64
65 Main outcome measures: The primary outcome was feasibility, defined by percentage of 66 patients successfully receiving the intervention. Secondary outcomes included safety, defined 67 by hospital readmission and emergency department presentations within 16 weeks post-68 randomization, and treatment satisfaction, measured using Diabetes Treatment Satisfaction 69 Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS), and change in 70 Haemoglobin A1c (HbA1c) throughout the study.71
72 Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in 73 safety between groups was detected. No difference in change in HbA1c between groups was 74 detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team 75 median HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a trend towards reduced 76 length of stay in the transition team group (per protocol, standard care median LOS 8 (IQR 77 5.5-12); transition team median LOS 6 (IQR3-12), p=0.06). There was a significant 78 improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 79 8.5, 16); transition team DTSQc median 15 (IQR 10, 17.5), p=0.047), although 80 interpretability is limited by missing data.
81 Conclusion: This study demonstrated that the use of a novel transition diabetes team is a 82 feasible alternative model of care.
83
84
85
86
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87 Introduction
88 Despite stability in diabetes-related mortality (1), global prevalence of diabetes is rising (2). 89 Consequently, health care costs related to diabetes continue to increase over time (3).
90 It has been demonstrated that 34% of hospital inpatients aged over 54 admitted to a tertiary 91 hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 92 2 diabetes have longer hospital length of stay and higher mortality rates compared to those 93 without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemic 94 control at the time of hospital admission, often result in the need for intensification with 95 injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an 96 opportunity to identify those with poor glycaemic control and optimise diabetes management 97 (8). However, commencement of injectable therapies can be difficult in the context of 98 concurrent acute illness.
99 Guidelines recommend that patients are required to demonstrate self-management with 100 injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling 101 patients to effectively self-manage, and assists in optimising glycaemic control post-discharge 102 (10). However, diabetes education in the hospital setting is subject to a number of limitations 103 including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes 104 education may prove more effective based on understanding a patient’s life context and 105 allowing adaptation of self-management routines such as timing of injection, sharps disposal 106 and medication storage to suit the patient’s home environment (12).
107 This pilot study developed and evaluated the use of a transition team comprising in-home 108 diabetes education by a credentialed diabetes educator (CDE), and early post-discharge 109 assessment by an endocrinologist. We hypothesized that the proposed intervention would be 110 feasible and would not negatively affect patient satisfaction when compared to standard care.
111
112
113 Methods
114 Design
115 This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in 116 metropolitan Melbourne and a community-based healthcare provider. Study participants were 117 recruited during inpatient admissions between March 2014 and November 2015 and follow-118 up continued until March 2016. The trial was stopped after funding was exhausted and 119 sufficient participants were recruited.
120 Participants
121 Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, 122 were screened for the study, and randomised to receive the intervention or standard care after 123 providing informed consent. Participant inclusion criteria were the ability to provide 124 informed consent, the presence of type 2 diabetes, age > 18 years, requirement to commence 125 or change injectable therapies therefore requiring a CDE to provide education prior to 126 discharge, medically stable and awaiting diabetes education, reside within a 30-minute travel 127 radius of the hospital, ability to attend hospital for outpatient follow-up and stable glycaemia 128 defined as blood glucose levels between 5-15 mmol/L in the 24 hours prior to randomisation. 129 Patients were excluded if they did not fulfil inclusion criteria130
131 Randomisation
132 Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 133 investigator without patient contact. Group allocations were concealed by writing allocations
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134 on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant 135 given their allocation by a research assistant after informed consent was obtained. Due to the 136 difference in treatment protocols, the study was open label to the participants and 137 investigators.
138 Intervention
139 Standard Care
140 Participants randomised to standard care were educated by hospital credentialed diabetes 141 educators (CDEs) prior to discharge. Diabetes education regarding injectable therapies in our 142 institution complies with guidelines of the Australian Diabetes Educators Association (13). 143 This comprised education regarding injectable therapy, storage, injection technique, and 144 sharps disposal, and provision of additional resources when required. Additional resources 145 included National Diabetes Services Scheme (NDSS) registration, supply of glucometer if 146 required, written patient information regarding diabetes, and outpatient follow-up. The NDSS 147 is a scheme administered by the Australian federal government which provides access for 148 people living with diabetes to education and equipment in order to enhance their ability to 149 effectively self-manage their diabetes. Participants were discharged when medically 150 appropriate and the inpatient team were satisfied that the participant could safely administer 151 the injectable therapy. Prior to discharge, appropriate follow-up was organised. General 152 Practitioners (GPs) were notified that participants had commenced or changed treatment.
153 Transition Team (intervention)
154 The transition team group participants received in-home education to start injectable therapy 155 by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided 156 with an appropriate glucometer in addition to education regarding medication, storage, 157 injection technique, sharps disposal, NDSS registration, an education package in the relevant 158 language, and CDE contact details.
159 Further contact with participants was based on CDE evaluation of the participant’s capacity to 160 self-manage injectable therapy. Once the CDE ascertained that participants were able to self-161 manage without further intervention, the endocrinologist was notified. Participants were then 162 linked with community CDE services, if necessary, for ongoing monitoring of self-163 management.
164 Follow-up with the same endocrinologist was provided within four weeks, and at 16 weeks 165 post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist 166 liaised with the participant’s GP regarding changes to management and plans for ongoing 167 follow-up after the 16-week visit.
168 Data collection
169 Baseline demographic, medication and medical data were collected and participants 170 completed the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at 171 enrolment. Whether the patient was from a culturally and linguistically diverse (CALD) 172 background was recorded. Follow-up data were collected at 16 weeks post-randomization, 173 including rates of hospital readmissions and emergency presentations, length of hospital stay 174 (LOS), glycaemic control as measured by HbA1c and treatment satisfaction using the DTSQ 175 change version (DTSQc). Initial attempts to collect DTSQc questionnaires in the standard 176 care group was by reply-paid mail, however after a limited response rate using this method, 177 patients were contacted by phone. Study participation ceased at the 16-week endocrinology 178 appointment, and final data collection occurred. Further follow-up for ongoing diabetes 179 management was arranged at conclusion of the study.
180
181 Ethics
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182 Ethics approval was obtained from the hospital human ethics committee and the community 183 healthcare provider ethics committee. Each participant provided written informed consent.
184
185 Outcomes
186 The primary outcome measured was feasibility (proportion of participants in the transition 187 team group completing the intervention as per protocol). Secondary outcomes were safety, as 188 defined by hospital readmission and emergency department presentations within 16 weeks 189 post-randomization, and patient satisfaction with care (measured by DTSQ). Exploratory 190 outcomes were change in HbA1c and length of hospital stay (days).
191
192 Sample size determination
193 Due to the pilot nature of the study, the sample size estimation was based on precision 194 arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of 195 participants randomized into transition team group would be able to complete the intervention 196 as per protocol), the sample of 55 participants randomized to the transition team group 197 provides the precision (desired half-width of the 95% confidence interval) of 0.08.
198 The same number of participants was to be randomized to the standard care group, thus 199 ensuring 80% power to detect potential medium-to-large effects of transition team 200 intervention compared to the standard care (Cohen’s d=0.55) assuming the settings of 201 alpha=0.05. Thus, the total sample size for this study was proposed as 110 participants.
202
203 Statistical methods
204 The demographic and clinical characteristics of participants were summarized as medians 205 (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical 206 variables.
207 The feasibility of the intervention was estimated as a proportion of participants in the 208 transition team group completing the intervention as per protocol with corresponding 95% 209 confidence interval (95% CI).
210 The difference in safety profiles (diabetes related hospital presentation or admission) between 211 two groups was investigated using Fisher's exact test.
212 DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 213 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 214 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the 215 auxillary variables demonstrating significant association with the DTSQ data being missing, 216 into the median regression model.
217 Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 218 rank-sum test.
219 Statistical analysis was performed using STATA software (StataCorp, College Station, TX, 220 USA).
221 All statistical tests were two sided and were performed at a significance level of α = 0.05.
222 Statistical analysis was performed on both intention to treat and per protocol bases. Per 223 protocol analysis was deemed necessary to account for the patients who were initially 224 assigned to transition team but withdrew prior to intervention; in this situation they received 225 standard care.
226 Patient and public involvement
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227 Patients must be actively involved in changes to diabetes management, and require education 228 regarding therapy changes and administration of injectable medications. Effective education 229 of patients can be difficult in the hospital setting, particularly in the setting of concurrent 230 acute illness. It is subject to a number of limitations including acute illness, pain and a sense 231 of being overwhelmed in hospital. These clinical observations contributed to the formulation 232 of our research questions, however there was no direct patient involvment in this.
233 Patients were not involved in the original study design, and involvement of patients in 234 recruitment was impractical as patients were hospitalised at the time of recruitment. A 235 qualitative analysis of a subgroup of patients’ experiences and their perceptions of the 236 intervention was performed, and this will be reported separately.
237 Following publication of our findings, the paper outlining study results will be sent to the 238 study participants.
239
240
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242 Results
243 One hundred and five participants were randomised to transition team or standard care. 244 Following initial drop outs, 103 participants received the intervention or standard care (Figure 245 1). 55 participants randomised to the transition team and 48 participants randomised to 246 receive standard care were included in the per protocol analysis (figure 1). Participants 247 randomised to the transition team withdrew for a variety of reasons such as decisions to 248 change treatment, change of discharge destination, and changes to clinical status. Of these, 249 five participants withdrew following the home visit by the CDE but prior to completing the 250 endocrinologist component of the intervention. For the purposes of the per protocol 251 analysis, these participants crossed over to the standard care group.
252 One participant in the transition team group was unable to be followed up as they were being 253 actively palliated for terminal malignancy, and one died before completion of the trial, for 254 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 255 died before final data analysis in this group.
256 Baseline characteristics of participants are outlined in Table 1. No differences between groups 257 at baseline were identified.
258
259 Feasibility
260 Forty seven out of 55 participants in the transition team group completed the study as per 261 protocol (85%, 95%CI: 73%, 94%).
262 Safety
263 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 264 care) and one for inability to cope with insulin management at home due to change in social 265 circumstances (transition team). Neither participant was admitted.
266 Patient satisfaction
267 A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc 268 transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) 269 Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline 270 DTSQs value, the transition team median DTSQc value was 4 points higher than the standard 271 care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 272 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team 273 patients, thus the “missingness” of the data was not likely to be random. On the sensitivity 274 analysis adjusted for the variables significantly associated with the missing DTSQc data at 16 275 weeks, the results remained qualitatively similar.
276 HbA1c
277 No statistically significant difference in change in HbA1c (standard care median HbA1c -278 1.5% (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -279 0.2%), p = 0.83) was observed, Figure 3, Table 2. An equal number of patients (8) in each 280 group did not have an HbA1c measurement at 16 weeks.
281 Length of Stay
282 There was a trend towards a reduced length of stay in the transition team group when 283 analysed on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team 284 median 6 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3.
285
286
287
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288 Discussion
289
290 Key findings
291 The most important finding in this trial was that a transition team to initiate injectable 292 diabetes therapies following discharge is a feasible model of care. These data suggest that a 293 transition team is safe and acceptable with a trend towards reduced length of hospital stay. 294 Moreover, patients randomized to the transition team group had greater treatment satisfaction 295 as demonstrated by a greater difference in DTSQc score.
296
297
298 Relationship with previous studies
299300 The results pertaining to the quality of this intervention are supported by results from other 301 studies examining home-based care in diabetes. The quality markers of this intervention 302 include feasibility and objective measures of medical indices, including readmission and 303 emergency presentation rates, change in HbA1c from baseline and length of stay, and patient-304 reported outcomes. 305306 We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when 307 analysed on a per protocol basis. Future studies with greater numbers may demonstrate 308 statistically significant reductions in length of hospital stay.309
310 We demonstrated significant improvements in treatment satisfaction in the transition team 311 group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical 312 trials and validated in several languages. The status version (DTSQs) evaluates baseline 313 satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of 314 an intervention on satisfaction with treatment (14, 15, 16). Interpretability of this parameter is 315 limited by missing data, and there is potential for bias due to some data being obtained over 316 the phone by a research assistant, rather than in person. 317318 Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 319 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 320 difference detected between the reduction in HbA1c in the transition team and the standard 321 care group. 322323 Other quality outcomes assessed included emergency department presentations and hospital 324 readmissions. There were no significant differences in our study. This suggests that patient 325 safety is unlikely to be compromised by delivery of home-based education. However, given 326 the limited literature in this field, further studies with greater numbers would be necessary to 327 validate these findings.
328
329 Study implications
330 Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to 331 improve outcomes over the course of disease. Escalating rates of diabetes necessitates the 332 development of feasible alternative models of care, with the potential to improve clinical 333 outcomes and health care costs. This study has investigated one such option, and has
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334 demonstrated feasibility, improved treatment satisfaction, and a trend to reduced length of 335 stay, with no safety concerns detected.
336
337
338
339 Conclusion
340 The results of this novel pilot study suggest that use of a transition team provides a feasible 341 alternative model of care for patients with type 2 diabetes requiring initiation of injectable 342 therapies. More research is necessary to validate these findings in larger populations, and to 343 ascertain whether it may lead to reduced length of stay and healthcare costs.
344
345 Funding
346 The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who 347 funded this project. A/Prof Ekinci was supported by Australian National Health and Medical 348 Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship, 349 Royal Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop 350 Medical Research Foundation research grant.
351
352 Acknowledgements
353 The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned 354 by Prof Clare Bradley) and sourced from HPR Ltd.355 The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes 356 education for the intervention group.
357
358 Competing Interests statement
359 We have read and understood BMJ policy on declaration of interests and declare that we have 360 no competing interests.
361
362
363 Authors Statement
364 F Pyrlis - involved in development of trial, clinical management of participants, performed 365 final write up
366 R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
367 S Arthur - logistics of trial (research assistant), data collection and statistical analysis
368 B Zhai - logistics of trial (research assistant), final data collection and statistical analysis
369 S Baqar - recruitment of participants and management of logistics of trial (research assistant), 370 data collection and analysis
371 L Churilov - statistical analysis
372 J Zajac - supervisory/ advisory role
373 E Ekinci - development of protocol, supervisory and advisory role during trial, assisted with 374 statistical analysis and final write up
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375
376 Data Statement: Dataset is restricted but can be provided upon reasonable request
377
378 Figure Legend
379 Figure 1 – Recruitment and participation flowchart
380 Figure 2 – Change in treatment satisfaction (DTSQ)
381 Figure 3 – a) Change in HbA1c (%) intention to treat analysis b) Change in HbA1c (%) per 382 protocol analysis
383 Figure 4 – a) Length of hospital stay (days) by intention to treat analysis b) Length of hospital 384 stay (days) by per protocol analysis
385 Table 1 - Comparison of baseline clinical and biochemical characteristics between in the 386 control and transition team groups by initial randomization/ intention to treat
387 Table 2 - Results by intention to treat analysis. Differences in hospital readmission rates, 388 change in HbA1c, length of hospital stay, & treatment satisfaction according to original 389 randomization.
390 Table 3 - Results by per Protocol analysis. Differences in hospital readmission rates, change 391 in HbA1c, length of hospital stay, & treatment satisfaction according to management 392 received.393
394
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395 References396 1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010. 397 http://www.aihw.gov.au/diabetes-indicators/deaths)398 2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes 399 prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 400 103:137-149401 3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children 402 and young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. 403 No. CVD 53; Diabetes Series No 21,) 404 http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359405 4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient 406 HbA1c testing: a prospective observational study. BMJ open diabetes research & 407 care. 2015;3(1):e000113408 5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for 409 coronary artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9410 6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and 411 new hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3412 7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 413 diabetes self-management education in the hospital setting. Primary Care Diabetes. 414 2014;8(3):187-94.
415 8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al. 416 Strategies for Improving Participation in Diabetes Education. A Qualitative Study. 417 PLoS One. 2014; 9(4)
418 9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult 419 inpatients with diabetes. October 2015 420 10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of 421 inpatient diabetes management, education, and improved discharge transition on 422 glycemic control 12 months after discharge. Diabetes Research and Clinical Practice. 423 2012;98:249-56
424 11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of diabetes 425 self-management education in the hospital setting. Primary Care Diabetes. 426 2014;8(3):187-94.
427 12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an 428 educational health strategy for self-care in diabetes. Visita domiciliária: estratégia 429 educativa em saúde para o autocuidado em diabetes. 2014;27(1):23
430 13. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-431 digital-version2.pdf
432 14. Bradley C, Lewis KS. Measures of psychological well-being and treatment 433 satisfaction developed from the responses of people with tablet-treated diabetes. 434 Diabetic Medicine. 1990; 7:445-451.
435 15. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing 436 quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
437 16. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change 438 version for use alongside status version provides appropriate solution where ceiling 439 effects occur. Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J, 440 Valentine J and Witthaus E (2007) The Diabetes Treatment Satisfaction 441 Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows
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442 greater responsiveness to improvements than the original DTSQ. Health and Quality 443 of Life Outcomes. 1999; 5 (5) 57444445446447
448
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Table 1 Comparison of baseline clinical and biochemical characteristics between in the control and transition team groups by initial randomization/ intention to treat.
Characteristic Standard care (n=48)
Transitions group (n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (33.3%) 22 (40%)
Median duration type 2 diabetes (SD)
7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and Fisher Exact tests used for binary variables
Table 2. Results by intention to treat analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Standard care (n=48) Transitions group (n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -0.2%)
0.83
Length of stay (days) (median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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Table 3. Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group (n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days) (median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
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Figure 1: Recruitment and participation flowchart
Inpatients commencing injectable diabetes therapies
Intention to treat analysis Analysed (n=55)
6 patients did not have follow-up HbA1c 19 patients did not complete DTSQc
Transition team care (n=55) • Received allocated intervention (n=47) • Did not receive allocated intervention (n= 8)
6 patients did not have follow-up HbA1c 8 patients did not complete DTSQc
Standard care (n= 50) • Received allocated care (n=48) • Withdrew prior to baseline data collection due
to changes in care during hospitalisation, so could not be included in analysis (n=2)
Intention to treat analysis Analysed (n=48)
Randomised (n=105)
Per protocol analysis Analysed (n=47)
Per protocol analysis Analysed (n=56)
Participants who did not receive transition team intervention (n= 8)
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Figure 2: Change in treatment satisfaction (DTSQ)
114x180mm (150 x 150 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
292x227mm (150 x 150 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis.
233x185mm (150 x 150 DPI)
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CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial*
Section/TopicItem No Checklist item
Reported on page No
Title and abstract1a Identification as a pilot or feasibility randomised trial in the title 11b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see
CONSORT abstract extension for pilot trials)2,3
Introduction2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot
trial4Background and
objectives2b Specific objectives or research questions for pilot trial 3, 4
Methods3a Description of pilot trial design (such as parallel, factorial) including allocation ratio 4Trial design3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 54a Eligibility criteria for participants 4Participants4b Settings and locations where the data were collected 44c How participants were identified and consented 4
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
5
6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed
6Outcomes
6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a7a Rationale for numbers in the pilot trial 6Sample size7b When applicable, explanation of any interim analyses and stopping guidelines n/a
Randomisation:8a Method used to generate the random allocation sequence 5Sequence
generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5Allocationconcealmentmechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
5
Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to 5
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interventions11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
assessing outcomes) and hown/aBlinding
11b If relevant, description of the similarity of interventions 5Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 6
Results13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly
assigned, received intended treatment, and were assessed for each objective8Participant flow (a
diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 8
14a Dates defining the periods of recruitment and follow-up 4Recruitment14b Why the pilot trial ended or was stopped 4
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 14Numbers analysed 16 For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers
should be by randomised group8
Outcomes and estimation
17 For each objective, results including expressions of uncertainty (such as 95% confidence interval) for anyestimates. If relevant, these results should be by randomised group
8
Ancillary analyses 18 Results of any other analyses performed that could be used to inform the future definitive trial 8Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) n/a
19a If relevant, other important unintended consequences n/a
DiscussionLimitations 20 Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility 2, 9Generalisability 21 Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies 9Interpretation 22 Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and
considering other relevant evidence9
22a Implications for progression from pilot to future definitive trial, including any proposed amendments n/a
Other informationRegistration 23 Registration number for pilot trial and name of trial registry 1Protocol 24 Where the pilot trial protocol can be accessed, if available n/aFunding 25 Sources of funding and other support (such as supply of drugs), role of funders 10
26 Ethical approval or approval by research review committee, confirmed with reference number 1
Citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355.
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*We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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For peer review onlyFeasibility of using a transition diabetes team to commence injectable therapies post discharge from a tertiary hospital:
a pilot, randomised controlled trial
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583.R3
Article Type: Original research
Date Submitted by the Author: 18-Mar-2019
Complete List of Authors: Pyrlis, Felicity; Austin Health, EndocrinologyOgrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research InstituteArthur, Sonja; University of Melbourne, MedicineZhai, Cathy; University of Melbourne, MedicineChurilov, Leonid; University of Melbourne, MedicineBaqar, Sara; Austin Health, EndocrinologyZajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne, MedicineEkinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
<b>Primary Subject Heading</b>: Diabetes and endocrinology
Secondary Subject Heading: Patient-centred medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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1 Feasibility of using a transition diabetes team to commence injectable therapies post 2 discharge from a tertiary hospital: a pilot, randomised controlled trial
3
4 Pyrlis, F1, Ogrin, R2,3, Arthur, S³, Zhai, C3, Churilov, L³, Baqar, S1, Zajac, J D1,3, Ekinci, E. I. 5 1,3
6 1 Endocrinology Department, Austin Health, Heidelberg, Australia
7 2 Royal District Nursing Service, Melbourne, Australia
8 3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
9
10 Corresponding Author: 11 Dr Felicity Pyrlis12 Endocrinology Department, Austin Health13 300 Waterdale Road, Heidelberg, VIC 308114 Australia 15 Email: [email protected]
16
17 Word count: 2456
18 Keywords: diabetes, inpatient, insulin, injectable, discharge
19 Ethical Approval: HREC Austin Health, Victoria, Australia (LNR_13_Austin_179)
2021
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22 Article Summary:
2324 This study aimed to investigate if the use of a transition team was feasible for patients 25 with diabetes being discharged from hospital on injectable diabetes therapies.26 This pilot, randomised controlled trial was conducted between 2014 and 2016 27 conjointly by a tertiary referral hospital and a community healthcare provider.28 Hospital inpatients (n=105) on new injectable diabetes therapies were randomised to 29 transition team (receiving in-home diabetes education 24-48 hours post-discharge, 30 with endocrinologist review 2-4 weeks and 16 weeks post-discharge) or standard 31 care.32 The primary outcome was feasibility, defined by percentage of patients successfully 33 receiving the intervention.34 This study demonstrated that the use of a novel transition diabetes team is a feasible 35 alternative model of care.
36
37
38
39
40
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42 Abstract
43 Objectives: This study aimed to investigate if the use of a transition team was feasible for 44 patients with diabetes being discharged from hospital on injectable diabetes therapies.
45
46 Design: Pilot, randomised controlled trial.
47
48 Setting: The trial was conducted between 2014 and 2016 conjointly by a tertiary referral 49 hospital and a community healthcare provider.
50
51 Participants: Hospital inpatients (n=105) on new injectable diabetes therapies were 52 randomised 1:1 to transition team or standard care. The transition team received in-home 53 diabetes education 24-48 hours post-discharge, with endocrinologist review 2-4 weeks and 16 54 weeks post-discharge.
55
56 Main outcome measures: The primary outcome was feasibility, defined by percentage of 57 patients successfully receiving the intervention. Secondary outcomes included safety, defined 58 by hospital readmission and emergency department presentations within 16 weeks post-59 randomization, and treatment satisfaction, measured using Diabetes Treatment Satisfaction 60 Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS), and change in 61 Haemoglobin A1c (HbA1c) throughout the study.62
63 Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in 64 safety between groups was detected. No difference in change in HbA1c between groups was 65 detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team 66 median HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a trend towards reduced 67 length of stay in the transition team group (per protocol, standard care median LOS 8 (IQR 68 5.5-12); transition team median LOS 6 (IQR3-12), p=0.06). There was a significant 69 improvement in patient satisfaction in the transition team (standard care median 10.5 (IQR 70 8.5, 16); transition team DTSQc median 15 (IQR 10, 17.5), p=0.047), although 71 interpretability is limited by missing data.
72 Conclusion: This study demonstrated that the use of a novel transition diabetes team is a 73 feasible alternative model of care.
74
75
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76 Strengths and limitations of the study:
77 A strength of this study was the successful collaboration of two large organisations providing 78 support for the transition of care from hospital to home. The feasibility of delivering this 79 patient-centred alternative model of care was established.
80 Withdrawal of participants from the transition team in hospital prior to the intervention may 81 reflect reluctance in patients recovering from acute illness to return to hospital or accept 82 health providers entering their home.
83 Eight patients in each group did not have follow-up HbA1c measurements, and the follow-up 84 diabetes treatment satisfaction questionnaire change version (DTSQc) was not completed by 85 16.7% of the standard care patients and 34.5% of the transition team patients. Missing data 86 may have limited interpretability of results.
87 Overall, this novel intervention was found to be feasible and acceptable to people living with 88 diabetes.
89
90
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91 Introduction
92 Despite stability in diabetes-related mortality (1), global prevalence of diabetes is rising (2). 93 Consequently, health care costs related to diabetes continue to increase over time (3).
94 It has been demonstrated that 34% of hospital inpatients aged over 54 admitted to a tertiary 95 hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 96 2 diabetes have longer hospital length of stay and higher mortality rates compared to those 97 without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemia 98 management at the time of hospital admission, often result in the need for intensification with 99 injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an
100 opportunity to identify those with poor glycaemic control and optimise diabetes management 101 (8). However, commencement of injectable therapies can be difficult in the context of 102 concurrent acute illness.
103 Guidelines recommend that patients are required to demonstrate self-management with 104 injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling 105 patients to effectively self-manage, and assists in optimising glycaemic control post-discharge 106 (10). However, diabetes education in the hospital setting is subject to a number of limitations 107 including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes 108 education may prove more effective based on understanding a patient’s life context and 109 allowing adaptation of self-management routines such as timing of injection, sharps disposal 110 and medication storage to suit the patient’s home environment (12).
111 This pilot study developed and evaluated the use of a transition team comprising in-home 112 diabetes education by a credentialed diabetes educator (CDE), and early post-discharge 113 assessment by an endocrinologist. We hypothesized that the proposed intervention would be 114 feasible and would not negatively affect patient satisfaction when compared to standard care.
115
116
117 Methods
118 Design
119 This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in 120 metropolitan Melbourne and a community-based healthcare provider. Study participants were 121 recruited during inpatient admissions between March 2014 and November 2015 and follow-122 up continued until March 2016. The trial was stopped after funding was exhausted and 123 sufficient participants were recruited.
124 Participants
125 Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, 126 were screened for the study, and randomised to receive the intervention or standard care after 127 providing informed consent. Participant inclusion criteria were the ability to provide 128 informed consent, the presence of type 2 diabetes, age > 18 years, requirement to commence 129 or change injectable therapies therefore requiring a CDE to provide education prior to 130 discharge, medically stable and awaiting diabetes education, reside within a 30-minute travel 131 radius of the hospital, ability to attend hospital for outpatient follow-up and stable glycaemia 132 defined as blood glucose levels between 5-15 mmol/L in the 24 hours prior to randomisation. 133 Patients were excluded if they did not fulfil inclusion criteria.134
135 Randomisation
136 Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 137 investigator without patient contact. Group allocations were concealed by writing allocations
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138 on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant 139 given their allocation by a research assistant after informed consent was obtained. Due to the 140 difference in treatment protocols, the study was open label to the participants and 141 investigators.
142 Intervention
143 Standard Care
144 Participants randomised to standard care were educated by hospital credentialed diabetes 145 educators (CDEs) prior to discharge. Diabetes education regarding injectable therapies in our 146 institution complies with guidelines of the Australian Diabetes Educators Association (13). 147 This comprised education regarding the injectable therapy and its storage, and sharps 148 disposal. Additional resources were provided when required. Additional resources included 149 National Diabetes Services Scheme (NDSS) registration, supply of glucometer if required, 150 written patient information regarding diabetes, and outpatient follow-up. The NDSS is a 151 scheme administered by the Australian federal government which provides access for people 152 living with diabetes to education and equipment in order to enhance their ability to effectively 153 self-manage their diabetes. Participants were discharged when medically appropriate and the 154 inpatient team was satisfied that the participant could safely administer the injectable therapy. 155 Prior to discharge, appropriate follow-up was organised. General Practitioners (GPs) were 156 notified that participants had commenced or changed treatment.
157 Transition Team (intervention)
158 The transition team group participants received in-home education to start injectable therapy 159 by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided 160 with an appropriate glucometer in addition to education regarding medication, storage, 161 injection technique, sharps disposal, NDSS registration, an education package in the relevant 162 language, and CDE contact details.
163 Further contact with participants was based on CDE evaluation of the participant’s capacity to 164 self-manage injectable therapy. Once the CDE ascertained that participants were able to self-165 manage without further intervention, the endocrinologist was notified. Participants were then 166 linked with community CDE services, if necessary, for ongoing monitoring of self-167 management.
168 Follow-up with the same endocrinologist was provided within four weeks, and at 16 weeks 169 post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist 170 liaised with the participant’s GP regarding changes to management and plans for ongoing 171 follow-up after the 16-week visit.
172 Data collection
173 Baseline demographic, medication and medical data were collected and participants 174 completed the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at 175 enrolment. Whether the patient was from a culturally and linguistically diverse (CALD) 176 background was recorded. Follow-up data were collected at 16 weeks post-randomization, 177 including rates of hospital readmissions and emergency presentations, length of hospital stay 178 (LOS), glycaemic control as measured by HbA1c and treatment satisfaction using the DTSQ 179 change version (DTSQc). Initial attempts to collect DTSQc questionnaires in the standard 180 care group was by reply-paid mail, however after a limited response rate using this method, 181 patients were contacted by phone. Study participation ceased at the 16-week endocrinology 182 appointment, and final data collection occurred. Further follow-up for ongoing diabetes 183 management was arranged at conclusion of the study.
184
185 Ethics
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186 Ethics approval was obtained from Austin Health human research ethics committee (reference 187 LNR/13/Austin 179) and the community healthcare provider ethics committee. Each 188 participant provided written informed consent.
189
190 Outcomes
191 The primary outcome measured was feasibility (proportion of participants in the transition 192 team group completing the intervention as per protocol). Secondary outcomes were safety, as 193 defined by hospital readmission and emergency department presentations within 16 weeks 194 post-randomization, and patient satisfaction with care (measured by DTSQ). Exploratory 195 outcomes were change in HbA1c and length of hospital stay (days).
196
197 Sample size determination
198 Due to the pilot nature of the study, the sample size estimation was based on precision 199 arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of 200 participants randomized into transition team group would be able to complete the intervention 201 as per protocol) (14), the sample of 55 participants randomized to the transition team group 202 provides the precision (desired half-width of the 95% confidence interval) of 0.08.
203 The same number of participants was to be randomized to the standard care group, thus 204 ensuring 80% power to detect potential medium-to-large effects of transition team 205 intervention compared to the standard care (Cohen’s d=0.55) assuming the settings of 206 alpha=0.05. Thus, the total sample size for this study was proposed as 110 participants.
207
208 Statistical methods
209 The demographic and clinical characteristics of participants were summarized as medians 210 (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical 211 variables.
212 The feasibility of the intervention was estimated as a proportion of participants in the 213 transition team group completing the intervention as per protocol with corresponding 95% 214 confidence interval (95% CI).
215 The difference in safety profiles (diabetes related hospital presentation or admission) between 216 two groups was investigated using Fisher's exact test.
217 DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 218 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 219 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the 220 auxillary variables demonstrating significant association with the DTSQ data being missing, 221 into the median regression model.
222 Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 223 rank-sum test.
224 Statistical analysis was performed using STATA software (StataCorp, College Station, TX, 225 USA).
226 All statistical tests were two sided and were performed at a significance level of α = 0.05.
227 Statistical analysis was performed on both intention to treat and per protocol bases. Per 228 protocol analysis was deemed necessary to account for the patients who were initially 229 assigned to transition team but withdrew prior to intervention; in this situation they received 230 standard care.
231 Patient and public involvement
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232 Patients must be actively involved in changes to diabetes management, and require education 233 regarding therapy changes and administration of injectable medications. Effective education 234 of patients can be difficult in the hospital setting, particularly in the setting of concurrent 235 acute illness. It is subject to a number of limitations including acute illness, pain and a sense 236 of being overwhelmed in hospital. These clinical observations contributed to the formulation 237 of our research questions, however there was no direct patient involvement in this.
238 Patients were not involved in the original study design, and involvement of patients in 239 recruitment was impractical as patients were hospitalised at the time of recruitment. A 240 qualitative analysis of a subgroup of patients’ experiences and their perceptions of the 241 intervention was performed, and this will be reported separately.
242
243
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245 Results
246 One hundred and five participants were randomised to transition team or standard care. 247 Following initial drop outs, 103 participants received the intervention or standard care (Figure 248 1). 55 participants randomised to the transition team and 48 participants randomised to 249 receive standard care were included in the per protocol analysis (figure 1). Participants 250 randomised to the transition team withdrew for a variety of reasons such as decisions to 251 change treatment, change of discharge destination, and changes to clinical status. Of these, 252 five participants withdrew following the home visit by the CDE but prior to completing the 253 endocrinologist component of the intervention. For the purposes of the per protocol 254 analysis, these participants crossed over to the standard care group.
255 One participant in the transition team group was unable to be followed up as they were being 256 actively palliated for terminal malignancy, and one died before completion of the trial, for 257 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 258 died before final data analysis in this group.
259 Baseline characteristics of participants are outlined in Table 1. No differences between groups 260 at baseline were identified.
261
262 Feasibility
263 Forty seven out of 55 participants in the transition team group completed the study as per 264 protocol (85%, 95%CI: 73%, 94%).
265 Safety
266 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 267 care) and one for inability to cope with insulin management at home due to change in social 268 circumstances (transition team). Neither participant was admitted.
269 Patient satisfaction
270 A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc 271 transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) 272 Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline 273 DTSQs value, the transition team median DTSQc value was 4 points higher than the standard 274 care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 275 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team 276 patients, thus the “missingness” of the data was not likely to be random. On the sensitivity 277 analysis adjusted for the variables significantly associated with the missing DTSQc data at 16 278 weeks, the results remained qualitatively similar.
279 HbA1c
280 No statistically significant difference in change in HbA1c (standard care median HbA1c -281 1.5% (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -282 0.2%), p = 0.83) was observed, Figure 3, Table 2. An equal number of patients (8) in each 283 group did not have an HbA1c measurement at 16 weeks.
284 Length of Stay
285 There was a trend towards a reduced length of stay in the transition team group when 286 analysed on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team 287 median 6 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3.
288
289
290
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291 Discussion
292
293 Key findings
294 The most important finding in this trial was that a transition team to initiate injectable 295 diabetes therapies following discharge is a feasible model of care. These data suggest that a 296 transition team is safe and acceptable with a trend towards reduced length of hospital stay. 297 Moreover, patients randomized to the transition team group had greater treatment satisfaction 298 as demonstrated by a greater difference in DTSQc score.
299
300
301 Relationship with previous studies
302303 The results pertaining to the quality of this intervention are supported by results from other 304 studies examining home-based care in diabetes. The quality markers of this intervention 305 include feasibility and objective measures of medical indices, including readmission and 306 emergency presentation rates, change in HbA1c from baseline and length of stay, and patient-307 reported outcomes. 308309 We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when 310 analysed on a per protocol basis. Future studies with greater numbers may demonstrate 311 statistically significant reductions in length of hospital stay.312
313 We demonstrated significant improvements in treatment satisfaction in the transition team 314 group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical 315 trials and validated in several languages. The status version (DTSQs) evaluates baseline 316 satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of 317 an intervention on satisfaction with treatment (15, 16, 17). Interpretability of this parameter is 318 limited by missing data, and there is potential for bias due to some data being obtained over 319 the phone by a research assistant, rather than in person. 320321 Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 322 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 323 difference detected between the reduction in HbA1c in the transition team and the standard 324 care group. 325326 Other quality outcomes assessed included emergency department presentations and hospital 327 readmissions. There were no significant differences in our study. This suggests that patient 328 safety is unlikely to be compromised by delivery of home-based education. However, given 329 the limited literature in this field, further studies with greater numbers would be necessary to 330 validate these findings.
331
332 Study implications
333 Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to 334 improve outcomes over the course of disease. Escalating rates of diabetes necessitates the 335 development of feasible alternative models of care, with the potential to improve clinical 336 outcomes and health care costs. This study has investigated one such option, and has
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337 demonstrated feasibility, improved treatment satisfaction, and a trend to reduced length of 338 stay, with no safety concerns detected.
339
340
341
342 Conclusion
343 The results of this novel pilot study suggest that use of a transition team provides a feasible 344 alternative model of care for patients with type 2 diabetes requiring initiation of injectable 345 therapies. More research is necessary to validate these findings in larger populations, and to 346 ascertain whether it may lead to reduced length of stay and healthcare costs.
347
348 Funding
349 The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who 350 funded this project. A/Prof Ekinci was supported by Australian National Health and Medical 351 Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship, 352 Royal Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop 353 Medical Research Foundation research grant.
354
355 Acknowledgements
356 The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned 357 by Prof Clare Bradley) and sourced from HPR Ltd.358 The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes 359 education for the intervention group.
360
361 Competing Interests statement
362 We have read and understood BMJ policy on declaration of interests and declare that we have 363 no competing interests.
364
365
366 Authors Statement
367 F Pyrlis - involved in development of trial, clinical management of participants, performed 368 final write up
369 R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
370 S Arthur - logistics of trial (research assistant), data collection and statistical analysis
371 B Zhai - logistics of trial (research assistant), final data collection and statistical analysis
372 S Baqar - recruitment of participants and management of logistics of trial (research assistant), 373 data collection and analysis
374 L Churilov - statistical analysis
375 J Zajac - supervisory/ advisory role
376 E Ekinci - development of protocol, supervisory and advisory role during trial, assisted with 377 statistical analysis and final write up
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378
379 Data Statement: Deindentified patient data is available upon reasonable request from the 380 corresponding author within 3 months up to 6 months following publication.
381
382 Figure Legend
383 Figure 1 – Recruitment and participation flowchart
384 Figure 2 – Change in treatment satisfaction (DTSQ)
385 Figure 3 – a) Change in HbA1c (%) intention to treat analysis b) Change in HbA1c (%) per 386 protocol analysis
387 Figure 4 – a) Length of hospital stay (days) by intention to treat analysis b) Length of hospital 388 stay (days) by per protocol analysis
389 Table 1 - Comparison of baseline clinical and biochemical characteristics between in the 390 control and transition team groups by initial randomization/ intention to treat
391 Table 2 - Results by intention to treat analysis. Differences in hospital readmission rates, 392 change in HbA1c, length of hospital stay, & treatment satisfaction according to original 393 randomization.
394 Table 3 - Results by per Protocol analysis. Differences in hospital readmission rates, change 395 in HbA1c, length of hospital stay, & treatment satisfaction according to management 396 received.397
398
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399 References400 1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010. 401 http://www.aihw.gov.au/diabetes-indicators/deaths)402 2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes 403 prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 404 103:137-149405 3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children 406 and young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. 407 No. CVD 53; Diabetes Series No 21,) 408 http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359409 4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient 410 HbA1c testing: a prospective observational study. BMJ open diabetes research & 411 care. 2015;3(1):e000113412 5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for 413 coronary artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9414 6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and 415 new hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3416 7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 417 diabetes self-management education in the hospital setting. Primary Care Diabetes. 418 2014;8(3):187-94.
419 8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al. 420 Strategies for Improving Participation in Diabetes Education. A Qualitative Study. 421 PLoS One. 2014; 9(4)
422 9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult 423 inpatients with diabetes. October 2015 424 10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact 425 of inpatient diabetes management, education, and improved discharge transition on 426 glycemic control 12 months after discharge. Diabetes Research and Clinical Practice. 427 2012;98:249-56
428 11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 429 diabetes self-management education in the hospital setting. Primary Care Diabetes. 430 2014;8(3):187-94.
431 12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an 432 educational health strategy for self-care in diabetes. Visita domiciliária: estratégia 433 educativa em saúde para o autocuidado em diabetes. Acta Paulista de Enfermagem. 434 2014;27(1):23
435 13. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-436 digital-version2.pdf
437 14. Perez A, Reales P, Barahona MJ, Romero MG, Minambres I. Efficacy and feasibility 438 of basal-bolus insulin regimens and a discharge strategy in hospitalized patients with 439 type 2 diabetes – the HO.SMIDIA study. International Journal of Clinical Practice. 440 2014; 68, 10, 1264-71.
441 15. Bradley C, Lewis KS. Measures of psychological well-being and treatment 442 satisfaction developed from the responses of people with tablet-treated diabetes. 443 Diabetic Medicine. 1990; 7:445-451.
444 16. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing 445 quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
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446 17. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change 447 version for use alongside status version provides appropriate solution where ceiling 448 effects occur. Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J, 449 Valentine J and Witthaus E (2007) The Diabetes Treatment Satisfaction 450 Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows 451 greater responsiveness to improvements than the original DTSQ. Health and Quality 452 of Life Outcomes. 1999; 5 (5) 57453454455456
457
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Table 1 Comparison of baseline clinical and biochemical characteristics between in the control and transition team groups by initial randomization/ intention to treat.
Characteristic Standard care (n=48)
Transitions group (n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (33.3%) 22 (40%)
Median duration type 2 diabetes (SD)
7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and Fisher Exact tests used for binary variables
Table 2. Results by intention to treat analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Standard care (n=48) Transitions group (n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -0.2%)
0.83
Length of stay (days) (median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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Table 3. Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group (n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days) (median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
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Figure 1: Recruitment and participation flowchart
Inpatients commencing injectable diabetes therapies
Intention to treat analysis Analysed (n=55)
6 patients did not have follow-up HbA1c 19 patients did not complete DTSQc
Transition team care (n=55) • Received allocated intervention (n=47) • Did not receive allocated intervention (n= 8)
6 patients did not have follow-up HbA1c 8 patients did not complete DTSQc
Standard care (n= 50) • Received allocated care (n=48) • Withdrew prior to baseline data collection due
to changes in care during hospitalisation, so could not be included in analysis (n=2)
Intention to treat analysis Analysed (n=48)
Randomised (n=105)
Per protocol analysis Analysed (n=47)
Per protocol analysis Analysed (n=56)
Participants who did not receive transition team intervention (n= 8)
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Figure 2: Change in treatment satisfaction (DTSQ)
114x180mm (150 x 150 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
292x227mm (150 x 150 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis.
233x185mm (150 x 150 DPI)
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CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial*
Section/TopicItem No Checklist item
Reported on page No
Title and abstract1a Identification as a pilot or feasibility randomised trial in the title 11b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see
CONSORT abstract extension for pilot trials)3
Introduction2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot
trial5Background and
objectives2b Specific objectives or research questions for pilot trial 5
Methods3a Description of pilot trial design (such as parallel, factorial) including allocation ratio 5, 6Trial design3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 64a Eligibility criteria for participants 5Participants4b Settings and locations where the data were collected 54c How participants were identified and consented 5, 6
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
6
6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed
6Outcomes
6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a7a Rationale for numbers in the pilot trial 7Sample size7b When applicable, explanation of any interim analyses and stopping guidelines n/a
Randomisation:8a Method used to generate the random allocation sequence 5, 6Sequence
generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5, 6Allocationconcealmentmechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
5, 6
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Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
5, 6
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
n/aBlinding
11b If relevant, description of the similarity of interventions 6Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 7
Results13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly
assigned, received intended treatment, and were assessed for each objective9Participant flow (a
diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 9
14a Dates defining the periods of recruitment and follow-up 5Recruitment14b Why the pilot trial ended or was stopped 5
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 15Numbers analysed 16 For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers
should be by randomised group9
Outcomes and estimation
17 For each objective, results including expressions of uncertainty (such as 95% confidence interval) for anyestimates. If relevant, these results should be by randomised group
9
Ancillary analyses 18 Results of any other analyses performed that could be used to inform the future definitive trial 9Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) n/a
19a If relevant, other important unintended consequences n/a
DiscussionLimitations 20 Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility 4, 10Generalisability 21 Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies 10Interpretation 22 Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and
considering other relevant evidence10
22a Implications for progression from pilot to future definitive trial, including any proposed amendments n/a
Other informationRegistration 23 Registration number for pilot trial and name of trial registry 1, 7Protocol 24 Where the pilot trial protocol can be accessed, if available n/aFunding 25 Sources of funding and other support (such as supply of drugs), role of funders 11
26 Ethical approval or approval by research review committee, confirmed with reference number 1, 7
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Citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355.*We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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For peer review onlyFeasibility of using a transition diabetes team to commence injectable therapies post discharge from a tertiary hospital:
a pilot, randomised controlled trial
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583.R4
Article Type: Original research
Date Submitted by the Author: 11-May-2019
Complete List of Authors: Pyrlis, Felicity; Austin Health, EndocrinologyOgrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research InstituteArthur, Sonja; University of Melbourne, MedicineZhai, Cathy; University of Melbourne, MedicineChurilov, Leonid; University of Melbourne, MedicineBaqar, Sara; Austin Health, EndocrinologyZajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne, MedicineEkinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
<b>Primary Subject Heading</b>: Diabetes and endocrinology
Secondary Subject Heading: Patient-centred medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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1 Feasibility of using a transition diabetes team to commence injectable therapies post discharge 2 from a tertiary hospital: a pilot, randomised controlled trial
3
4 Pyrlis, F1, Ogrin, R2,3, Arthur, S³, Zhai, C3, Churilov, L³, Baqar, S1, Zajac, J D1,3, Ekinci, E. I. 1,3
5 1 Endocrinology Department, Austin Health, Heidelberg, Australia
6 2 Royal District Nursing Service, Melbourne, Australia
7 3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
8
9 Corresponding Author: 10 Dr Felicity Pyrlis11 Endocrinology Department, Austin Health12 300 Waterdale Road, Heidelberg, VIC 308113 Australia 14 Email: [email protected]
15
16 Word count: 2481
17 Keywords: diabetes, inpatient, insulin, injectable, discharge
18 Ethical Approval: HREC Austin Health, Victoria, Australia (LNR_13_Austin_179)
1920
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21 Abstract
22 Objectives: This study aimed to investigate if the use of a transition team was feasible for 23 patients with diabetes being discharged from hospital on injectable diabetes therapies.
24
25 Design: Pilot, randomised controlled trial.
26
27 Setting: The trial was conducted between 2014 and 2016 conjointly by a tertiary referral 28 hospital and a community healthcare provider.
29
30 Participants: Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 31 1:1 to transition team or standard care. The transition team received in-home diabetes education 32 24-48 hours post-discharge, with endocrinologist review 2-4 weeks and 16 weeks post-33 discharge.
34
35 Main outcome measures: The primary outcome was feasibility, defined by percentage of 36 patients successfully receiving the intervention. Secondary outcomes included safety, defined 37 by hospital readmission and emergency department presentations within 16 weeks post-38 randomization, and treatment satisfaction, measured using Diabetes Treatment Satisfaction 39 Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS), and change in 40 Haemoglobin A1c (HbA1c) throughout the study.41
42 Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in 43 safety between groups was detected. No difference in change in HbA1c between groups was 44 detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team 45 median HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a trend towards reduced 46 length of stay in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5-47 12); transition team median LOS 6 (IQR3-12), p=0.06). There was a significant improvement 48 in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5, 16); transition 49 team DTSQc median 15 (IQR 10, 17.5), p=0.047), although interpretability is limited by 50 missing data.
51 Conclusion: This study demonstrated that the use of a novel transition diabetes team is a 52 feasible alternative model of care.
53
54
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55 Strengths and limitations of the study:
56 A strength of this study was the successful collaboration of two large organisations providing 57 support for the transition of care from hospital to home.
58 Withdrawal of participants from the transition team in hospital prior to the intervention may 59 reflect reluctance in patients recovering from acute illness to return to hospital or accept health 60 providers entering their home.
61 Missing data may have limited interpretability of results.
62 Overall, this novel, patient-centred intervention was found to be feasible and acceptable to 63 people living with diabetes.
64
65
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66 Introduction
67 Despite stability in diabetes-related mortality (1), global prevalence of diabetes is rising (2). 68 Consequently, health care costs related to diabetes continue to increase over time (3).
69 It has been demonstrated that 34% of hospital inpatients aged over 54 admitted to a tertiary 70 hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 71 2 diabetes have longer hospital length of stay and higher mortality rates compared to those 72 without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemia 73 management at the time of hospital admission, often result in the need for intensification with 74 injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an 75 opportunity to identify those with poor glycaemic control and optimise diabetes management 76 (8). However, commencement of injectable therapies can be difficult in the context of 77 concurrent acute illness.
78 Guidelines recommend that patients are required to demonstrate self-management with 79 injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling 80 patients to effectively self-manage, and assists in optimising glycaemic control post-discharge 81 (10). However, diabetes education in the hospital setting is subject to a number of limitations 82 including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes 83 education may prove more effective based on understanding a patient’s life context and 84 allowing adaptation of self-management routines such as timing of injection, sharps disposal 85 and medication storage to suit the patient’s home environment (12).
86 This pilot study developed and evaluated the use of a transition team comprising in-home 87 diabetes education by a credentialed diabetes educator (CDE), and early post-discharge 88 assessment by an endocrinologist. We hypothesized that the proposed intervention would be 89 feasible and would not negatively affect patient satisfaction when compared to standard care.
90
91
92 Methods
93 Design
94 This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in 95 metropolitan Melbourne, Australia, and a community-based healthcare provider. Study 96 participants were recruited during inpatient admissions between March 2014 and November 97 2015 and follow-up continued until March 2016. The trial was stopped after funding was 98 exhausted and sufficient participants were recruited.
99 Participants
100 Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, 101 were screened for the study, and randomised to receive the intervention or standard care after 102 providing informed consent. Baseline characteristics of the participants are outlined in table 1. 103 Funding of participants’ healthcare is through the Australian government’s universal health 104 insurance system, Medicare.
105 Participant inclusion criteria were the ability to provide informed consent, the presence of type 106 2 diabetes, age > 18 years, requirement to commence or change injectable therapies therefore 107 requiring a CDE to provide education prior to discharge, medically stable and awaiting diabetes 108 education, reside within a 30-minute travel radius of the hospital, ability to attend hospital for 109 outpatient follow-up and stable glycaemia defined as blood glucose levels between 5-15 110 mmol/L in the 24 hours prior to randomisation. Patients were excluded if they did not fulfil 111 inclusion criteria.112
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113 Randomisation
114 Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 115 investigator without patient contact. Group allocations were concealed by writing allocations 116 on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant given 117 their allocation by a research assistant after informed consent was obtained. Due to the 118 difference in treatment protocols, the study was open label to the participants and investigators.
119 Intervention
120 Standard Care
121 Participants randomised to standard care were educated by hospital credentialed diabetes 122 educators (CDEs) prior to discharge. Diabetes education regarding injectable therapies in our 123 institution complies with guidelines of the Australian Diabetes Educators Association (13). 124 This comprised education regarding the injectable therapy and its storage, and sharps disposal. 125 Additional resources were provided when required. Additional resources included National 126 Diabetes Services Scheme (NDSS) registration, supply of glucometer if required, written 127 patient information regarding diabetes, and outpatient follow-up. The NDSS is a scheme 128 administered by the Australian federal government which provides access for people living 129 with diabetes to education and equipment in order to enhance their ability to effectively self-130 manage their diabetes. Participants were discharged when medically appropriate and the 131 inpatient team was satisfied that the participant could safely administer the injectable therapy. 132 Prior to discharge, appropriate follow-up was organised. General Practitioners (GPs) were 133 notified that participants had commenced or changed treatment.
134 Transition Team (intervention)
135 The transition team group participants received in-home education to start injectable therapy 136 by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided 137 with an appropriate glucometer in addition to education regarding medication, storage, injection 138 technique, sharps disposal, NDSS registration, an education package in the relevant language, 139 and CDE contact details.
140 Further contact with participants was based on CDE evaluation of the participant’s capacity to 141 self-manage injectable therapy. Once the CDE ascertained that participants were able to self-142 manage without further intervention, the endocrinologist was notified. Participants were then 143 linked with community CDE services, if necessary, for ongoing monitoring of self-144 management.
145 Follow-up with the same endocrinologist was provided within four weeks, and at 16 weeks 146 post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist 147 liaised with the participant’s GP regarding changes to management and plans for ongoing 148 follow-up after the 16-week visit.
149 Data collection
150 Baseline demographic, medication and medical data were collected and participants completed 151 the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at enrolment. 152 Whether the patient was from a culturally and linguistically diverse (CALD) background was 153 recorded. Follow-up data were collected at 16 weeks post-randomization, including rates of 154 hospital readmissions and emergency presentations, length of hospital stay (LOS), glycaemic 155 control as measured by HbA1c and treatment satisfaction using the DTSQ change version 156 (DTSQc). Initial attempts to collect DTSQc questionnaires in the standard care group was by 157 reply-paid mail, however after a limited response rate using this method, patients were 158 contacted by phone. Study participation ceased at the 16-week endocrinology appointment, 159 and final data collection occurred. Further follow-up for ongoing diabetes management was 160 arranged at conclusion of the study.
161
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162 Ethics
163 Ethics approval was obtained from Austin Health human research ethics committee (reference 164 LNR/13/Austin 179) and the community healthcare provider ethics committee. Each participant 165 provided written informed consent.
166
167 Outcomes
168 The primary outcome measured was feasibility (proportion of participants in the transition team 169 group completing the intervention as per protocol). Secondary outcomes were safety, as defined 170 by hospital readmission and emergency department presentations within 16 weeks post-171 randomization, and patient satisfaction with care (measured by DTSQ). Exploratory outcomes 172 were change in HbA1c and length of hospital stay (days).
173
174 Sample size determination
175 Due to the pilot nature of the study, the sample size estimation was based on precision 176 arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of 177 participants randomized into transition team group would be able to complete the intervention 178 as per protocol) (14), the sample of 55 participants randomized to the transition team group 179 provides the precision (desired half-width of the 95% confidence interval) of 0.08.
180 The same number of participants was to be randomized to the standard care group, thus ensuring 181 80% power to detect potential medium-to-large effects of transition team intervention 182 compared to the standard care (Cohen’s d=0.55) assuming the settings of alpha=0.05. Thus, the 183 total sample size for this study was proposed as 110 participants.
184
185 Statistical methods
186 The demographic and clinical characteristics of participants were summarized as medians 187 (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical 188 variables.
189 The feasibility of the intervention was estimated as a proportion of participants in the transition 190 team group completing the intervention as per protocol with corresponding 95% confidence 191 interval (95% CI).
192 The difference in safety profiles (diabetes related hospital presentation or admission) between 193 two groups was investigated using Fisher's exact test.
194 DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 195 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 196 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the 197 auxillary variables demonstrating significant association with the DTSQ data being missing, 198 into the median regression model.
199 Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 200 rank-sum test.
201 Statistical analysis was performed using STATA software (StataCorp, College Station, TX, 202 USA).
203 All statistical tests were two sided and were performed at a significance level of α = 0.05.
204 Statistical analysis was performed on both intention to treat and per protocol bases. Per protocol 205 analysis was deemed necessary to account for the patients who were initially assigned to 206 transition team but withdrew prior to intervention; in this situation they received standard care.
207 Patient and public involvement
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208 Patients must be actively involved in changes to diabetes management, and require education 209 regarding therapy changes and administration of injectable medications. Effective education 210 of patients can be difficult in the hospital setting, particularly in the setting of concurrent acute 211 illness. It is subject to a number of limitations including acute illness, pain and a sense of being 212 overwhelmed in hospital. These clinical observations contributed to the formulation of our 213 research questions, however there was no direct patient involvement in this.
214 Patients were not involved in the original study design, and involvement of patients in 215 recruitment was impractical as patients were hospitalised at the time of recruitment. A 216 qualitative analysis of a subgroup of patients’ experiences and their perceptions of the 217 intervention was performed, and this will be reported separately.
218
219
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221 Results
222 One hundred and five participants were randomised to transition team or standard care. 223 Following initial drop outs, 103 participants received the intervention or standard care (Figure 224 1). 55 participants randomised to the transition team and 48 participants randomised to receive 225 standard care were included in the per protocol analysis (figure 1). Participants randomised to 226 the transition team withdrew for a variety of reasons such as decisions to change treatment, 227 change of discharge destination, and changes to clinical status. Of these, five participants 228 withdrew following the home visit by the CDE but prior to completing the endocrinologist 229 component of the intervention. For the purposes of the per protocol analysis, these participants 230 crossed over to the standard care group.
231 One participant in the transition team group was unable to be followed up as they were being 232 actively palliated for terminal malignancy, and one died before completion of the trial, for 233 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 234 died before final data analysis in this group.
235 Baseline characteristics of participants are outlined in Table 1. No differences between groups 236 at baseline were identified.
237
238 Feasibility
239 Forty seven out of 55 participants in the transition team group completed the study as per 240 protocol (85%, 95%CI: 73%, 94%).
241 Safety
242 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 243 care) and one for inability to cope with insulin management at home due to change in social 244 circumstances (transition team). Neither participant was admitted.
245 Patient satisfaction
246 A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc 247 transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) 248 Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline 249 DTSQs value, the transition team median DTSQc value was 4 points higher than the standard 250 care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 251 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team 252 patients, thus the “missingness” of the data was not likely to be random. On the sensitivity 253 analysis adjusted for the variables significantly associated with the missing DTSQc data at 16 254 weeks, the results remained qualitatively similar.
255 HbA1c
256 No statistically significant difference in change in HbA1c (standard care median HbA1c -1.5% 257 (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -0.2%), p 258 = 0.83) was observed, Figure 3, Table 2. An equal number of patients (8) in each group did not 259 have an HbA1c measurement at 16 weeks.
260 Length of Stay
261 There was a trend towards a reduced length of stay in the transition team group when analysed 262 on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team median 6 263 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3.
264
265
266
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267 Discussion
268
269 Key findings
270 The most important finding in this trial was that a transition team to initiate injectable diabetes 271 therapies following discharge is a feasible model of care. These data suggest that a transition 272 team is safe and acceptable with a trend towards reduced length of hospital stay. Moreover, 273 patients randomized to the transition team group had greater treatment satisfaction as 274 demonstrated by a greater difference in DTSQc score.
275
276
277 Relationship with previous studies
278279 The results pertaining to the quality of this intervention are supported by results from other 280 studies examining home-based care in diabetes. The quality markers of this intervention include 281 feasibility and objective measures of medical indices, including readmission and emergency 282 presentation rates, change in HbA1c from baseline and length of stay, and patient-reported 283 outcomes. 284285 We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when 286 analysed on a per protocol basis. Future studies with greater numbers may demonstrate 287 statistically significant reductions in length of hospital stay.288
289 We demonstrated significant improvements in treatment satisfaction in the transition team 290 group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical 291 trials and validated in several languages. The status version (DTSQs) evaluates baseline 292 satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of 293 an intervention on satisfaction with treatment (15, 16, 17). Interpretability of this parameter is 294 limited by missing data, and there is potential for bias due to some data being obtained over the 295 phone by a research assistant, rather than in person. 296297 Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 298 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 299 difference detected between the reduction in HbA1c in the transition team and the standard care 300 group. 301302 Other quality outcomes assessed included emergency department presentations and hospital 303 readmissions. There were no significant differences in our study. This suggests that patient 304 safety is unlikely to be compromised by delivery of home-based education. However, given 305 the limited literature in this field, further studies with greater numbers would be necessary to 306 validate these findings.
307
308 Study implications
309 Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to improve 310 outcomes over the course of disease. Escalating rates of diabetes necessitates the development 311 of feasible alternative models of care, with the potential to improve clinical outcomes and health 312 care costs. This study has investigated one such option, and has demonstrated feasibility,
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313 improved treatment satisfaction, and a trend to reduced length of stay, with no safety concerns 314 detected.
315
316
317
318 Conclusion
319 The results of this novel pilot study suggest that use of a transition team provides a feasible 320 alternative model of care for patients with type 2 diabetes requiring initiation of injectable 321 therapies. More research is necessary to validate these findings in larger populations, and to 322 ascertain whether it may lead to reduced length of stay and healthcare costs.
323
324 Funding
325 The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who 326 funded this project. A/Prof Ekinci was supported by Australian National Health and Medical 327 Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship, Royal 328 Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop Medical 329 Research Foundation research grant.
330
331 Acknowledgements
332 The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned 333 by Prof Clare Bradley) and sourced from HPR Ltd.334 The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes 335 education for the intervention group.
336
337 Competing Interests statement
338 We have read and understood BMJ policy on declaration of interests and declare that we have 339 no competing interests.
340
341
342 Authors Statement
343 F Pyrlis - involved in development of trial, clinical management of participants, performed final 344 write up
345 R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
346 S Arthur - logistics of trial (research assistant), data collection and statistical analysis
347 C Zhai - logistics of trial (research assistant), final data collection and statistical analysis
348 S Baqar - recruitment of participants and management of logistics of trial (research assistant), 349 data collection and analysis
350 L Churilov - statistical analysis
351 J Zajac - supervisory/ advisory role
352 E Ekinci - development of protocol, supervisory and advisory role during trial, assisted with 353 statistical analysis and final write up
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354
355 Data Statement: Deindentified patient data is available upon reasonable request from the 356 corresponding author within 3 months up to 6 months following publication.
357
358 Figure Legend
359 Figure 1 – Recruitment and participation flowchart
360 Figure 2 – Change in treatment satisfaction (DTSQ)
361 Figure 3 – a) Change in HbA1c (%) intention to treat analysis b) Change in HbA1c (%) per 362 protocol analysis
363 Figure 4 – a) Length of hospital stay (days) by intention to treat analysis b) Length of hospital 364 stay (days) by per protocol analysis
365 Table 1 - Comparison of baseline clinical and biochemical characteristics between in the control 366 and transition team groups by initial randomization/ intention to treat
367 Table 2 - Results by intention to treat analysis. Differences in hospital readmission rates, 368 change in HbA1c, length of hospital stay, & treatment satisfaction according to original 369 randomization.
370 Table 3 - Results by per Protocol analysis. Differences in hospital readmission rates, change in 371 HbA1c, length of hospital stay, & treatment satisfaction according to management received.372
373
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374 References375 1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010. 376 http://www.aihw.gov.au/diabetes-indicators/deaths)377 2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes prevalence 378 for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103:137-149379 3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children and 380 young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. No. 381 CVD 53; Diabetes Series No 21,) 382 http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359383 4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient 384 HbA1c testing: a prospective observational study. BMJ open diabetes research & care. 385 2015;3(1):e000113386 5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for 387 coronary artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9388 6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and new 389 hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3390 7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 391 diabetes self-management education in the hospital setting. Primary Care Diabetes. 392 2014;8(3):187-94.
393 8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al. Strategies 394 for Improving Participation in Diabetes Education. A Qualitative Study. PLoS One. 395 2014; 9(4)
396 9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult 397 inpatients with diabetes. October 2015 398 10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of 399 inpatient diabetes management, education, and improved discharge transition on 400 glycemic control 12 months after discharge. Diabetes Research and Clinical Practice. 401 2012;98:249-56
402 11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 403 diabetes self-management education in the hospital setting. Primary Care Diabetes. 404 2014;8(3):187-94.
405 12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an 406 educational health strategy for self-care in diabetes. Visita domiciliária: estratégia 407 educativa em saúde para o autocuidado em diabetes. Acta Paulista de Enfermagem. 408 2014;27(1):23
409 13. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-410 digital-version2.pdf
411 14. Perez A, Reales P, Barahona MJ, Romero MG, Minambres I. Efficacy and feasibility 412 of basal-bolus insulin regimens and a discharge strategy in hospitalized patients with 413 type 2 diabetes – the HO.SMIDIA study. International Journal of Clinical Practice. 414 2014; 68, 10, 1264-71.
415 15. Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction 416 developed from the responses of people with tablet-treated diabetes. Diabetic 417 Medicine. 1990; 7:445-451.
418 16. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing 419 quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
420 17. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change 421 version for use alongside status version provides appropriate solution where ceiling
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422 effects occur. Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J, Valentine 423 J and Witthaus E (2007) The Diabetes Treatment Satisfaction Questionnaire change 424 version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to 425 improvements than the original DTSQ. Health and Quality of Life Outcomes. 1999; 5 426 (5) 57427428429430
431
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Table 1 Comparison of baseline clinical and biochemical characteristics between in the control and transition team groups by initial randomization/ intention to treat.
Characteristic Standard care (n=48)
Transitions group (n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (33.3%) 22 (40%)
Median duration type 2 diabetes (SD)
7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and Fisher Exact tests used for binary variables
Table 2. Results by intention to treat analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Standard care (n=48) Transitions group (n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -0.2%) 0.83
Length of stay (days) (median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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Table 3. Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group (n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days) (median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
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Figure 1: Recruitment and participation flowchart
Inpatients commencing injectable diabetes therapies
Intention to treat analysis Analysed (n=55)
6 patients did not have follow-up HbA1c 19 patients did not complete DTSQc
Transition team care (n=55) • Received allocated intervention (n=47) • Did not receive allocated intervention (n= 8)
6 patients did not have follow-up HbA1c 8 patients did not complete DTSQc
Standard care (n= 50) • Received allocated care (n=48) • Withdrew prior to baseline data collection due
to changes in care during hospitalisation, so could not be included in analysis (n=2)
Intention to treat analysis Analysed (n=48)
Randomised (n=105)
Per protocol analysis Analysed (n=47)
Per protocol analysis Analysed (n=56)
Participants who did not receive transition team intervention (n= 8)
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Figure 2: Change in treatment satisfaction (DTSQ)
114x180mm (150 x 150 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
292x227mm (150 x 150 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis.
233x185mm (150 x 150 DPI)
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CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial*
Section/TopicItem No Checklist item
Reported on page No
Title and abstract1a Identification as a pilot or feasibility randomised trial in the title 11b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see
CONSORT abstract extension for pilot trials)3
Introduction2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot
trial5Background and
objectives2b Specific objectives or research questions for pilot trial 5
Methods3a Description of pilot trial design (such as parallel, factorial) including allocation ratio 5, 6Trial design3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 64a Eligibility criteria for participants 5Participants4b Settings and locations where the data were collected 54c How participants were identified and consented 5, 6
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
6
6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed
6Outcomes
6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a7a Rationale for numbers in the pilot trial 7Sample size7b When applicable, explanation of any interim analyses and stopping guidelines n/a
Randomisation:8a Method used to generate the random allocation sequence 5, 6Sequence
generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5, 6Allocationconcealmentmechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
5, 6
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Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
5, 6
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
n/aBlinding
11b If relevant, description of the similarity of interventions 6Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 7
Results13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly
assigned, received intended treatment, and were assessed for each objective9Participant flow (a
diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 9
14a Dates defining the periods of recruitment and follow-up 5Recruitment14b Why the pilot trial ended or was stopped 5
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 15Numbers analysed 16 For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers
should be by randomised group9
Outcomes and estimation
17 For each objective, results including expressions of uncertainty (such as 95% confidence interval) for anyestimates. If relevant, these results should be by randomised group
9
Ancillary analyses 18 Results of any other analyses performed that could be used to inform the future definitive trial 9Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) n/a
19a If relevant, other important unintended consequences n/a
DiscussionLimitations 20 Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility 4, 10Generalisability 21 Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies 10Interpretation 22 Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and
considering other relevant evidence10
22a Implications for progression from pilot to future definitive trial, including any proposed amendments n/a
Other informationRegistration 23 Registration number for pilot trial and name of trial registry 1, 7Protocol 24 Where the pilot trial protocol can be accessed, if available n/aFunding 25 Sources of funding and other support (such as supply of drugs), role of funders 11
26 Ethical approval or approval by research review committee, confirmed with reference number 1, 7
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Citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355.*We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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For peer review onlyFeasibility of using a transition diabetes team to commence injectable therapies post discharge from a tertiary hospital:
a pilot, randomised controlled trial
Journal: BMJ Open
Manuscript ID bmjopen-2018-023583.R5
Article Type: Research
Date Submitted by the Author: 05-Aug-2019
Complete List of Authors: Pyrlis, Felicity; Austin Health, EndocrinologyOgrin, Rajna; University of Melbourne, Medicine; Bolton Clarke Research InstituteArthur, Sonja; University of Melbourne, MedicineZhai, Cathy; University of Melbourne, MedicineChurilov, Leonid; University of Melbourne, MedicineBaqar, Sara; Austin Health, EndocrinologyZajac, Jeffrey; Austin Health, Endocrinology; University of Melbourne, MedicineEkinci , Elif ; Austin Health, Endocrinology; University of Melbourne, Medicine
<b>Primary Subject Heading</b>: Diabetes and endocrinology
Secondary Subject Heading: Patient-centred medicine
Keywords: diabetes, insulin, inpatient, injectable, discharge
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1 Feasibility of using a transition diabetes team to commence injectable therapies post discharge 2 from a tertiary hospital: a pilot, randomised controlled trial
3
4 Pyrlis, F1, Ogrin, R2,3, Arthur, S³, Zhai, C3, Churilov, L³, Baqar, S1, Zajac, J D1,3, Ekinci, E. I. 1,3
5 1 Endocrinology Department, Austin Health, Heidelberg, Australia
6 2 Royal District Nursing Service, Melbourne, Australia
7 3Department of Medicine Austin Health, University of Melbourne, Melbourne, Australia
8
9 Corresponding Author: 10 Dr Felicity Pyrlis11 Endocrinology Department, Austin Health12 300 Waterdale Road, Heidelberg, VIC 308113 Australia 14 Email: [email protected]
15
16 Word count: 2542
17 Keywords: diabetes, inpatient, insulin, injectable, discharge
18 Ethical Approval: HREC Austin Health, Victoria, Australia (LNR_13_Austin_179)
1920
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21 Abstract
22 Objectives: This study aimed to investigate if the use of a transition team was feasible for 23 patients with diabetes being discharged from hospital on injectable diabetes therapies.
24
25 Design: Pilot, randomised controlled trial.
26
27 Setting: The trial was conducted between 2014 and 2016 conjointly by a tertiary referral 28 hospital and a community healthcare provider.
29
30 Participants: Hospital inpatients (n=105) on new injectable diabetes therapies were randomised 31 1:1 to transition team or standard care. The transition team received in-home diabetes education 32 24-48 hours post-discharge, with endocrinologist review 2-4 weeks and 16 weeks post-33 discharge.
34
35 Main outcome measures: The primary outcome was feasibility, defined by percentage of 36 patients successfully receiving the intervention. Secondary outcomes included safety, defined 37 by hospital readmission and emergency department presentations within 16 weeks post-38 randomization, and treatment satisfaction, measured using Diabetes Treatment Satisfaction 39 Questionnaire (DTSQ). Exploratory outcomes included length of stay (LOS), and change in 40 Haemoglobin A1c (HbA1c) throughout the study.41
42 Results: The intervention was deemed feasible (85%; (95% CI: 73%, 94%)). No difference in 43 safety between groups was detected. No difference in change in HbA1c between groups was 44 detected (standard care median HbA1c -1.5% (IQR-3.7% to -0.2%) versus transition team 45 median HbA1c -1.9% (IQR -3.8% to -0.2%), p = 0.83). There was a trend towards reduced 46 length of stay in the transition team group (per protocol, standard care median LOS 8 (IQR 5.5-47 12); transition team median LOS 6 (IQR3-12), p=0.06). There was a significant improvement 48 in patient satisfaction in the transition team (standard care median 10.5 (IQR 8.5, 16); transition 49 team DTSQc median 15 (IQR 10, 17.5), p=0.047), although interpretability is limited by 50 missing data.
51 Conclusion: This study demonstrated that the use of a novel transition diabetes team is a 52 feasible alternative model of care.
53
54
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55 Strengths and limitations of the study:
56 A strength of this study was the successful collaboration of two large organisations providing 57 support for the transition of care from hospital to home.
58 Withdrawal of participants from the transition team in hospital prior to the intervention may 59 reflect reluctance in patients recovering from acute illness to return to hospital or accept health 60 providers entering their home.
61 Missing data may have limited interpretability of results.
62 Overall, this novel, patient-centred intervention was found to be feasible and acceptable to 63 people living with diabetes.
64
65
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66 Introduction
67 Despite stability in diabetes-related mortality (1), global prevalence of diabetes is rising (2). 68 Consequently, health care costs related to diabetes continue to increase over time (3).
69 It has been demonstrated that 34% of hospital inpatients aged over 54 admitted to a tertiary 70 hospital have diabetes mellitus (4). Many studies have demonstrated that inpatients with type 71 2 diabetes have longer hospital length of stay and higher mortality rates compared to those 72 without (5, 6). Factors such as stress hyperglycaemia, medications, and inadequate glycaemia 73 management at the time of hospital admission, often result in the need for intensification with 74 injectable diabetes therapies (7). Furthermore, the hospitalisation period provides an 75 opportunity to identify those with poor glycaemic control and optimise diabetes management 76 (8). However, commencement of injectable therapies can be difficult in the context of 77 concurrent acute illness.
78 Guidelines recommend that patients are required to demonstrate self-management with 79 injectable therapies prior to hospital discharge (9). Diabetes education is crucial in enabling 80 patients to effectively self-manage, and assists in optimising glycaemic control post-discharge 81 (10). However, diabetes education in the hospital setting is subject to a number of limitations 82 including acute illness, pain and a sense of being overwhelmed (11). Home-based diabetes 83 education may prove more effective based on understanding a patient’s life context and 84 allowing adaptation of self-management routines such as timing of injection, sharps disposal 85 and medication storage to suit the patient’s home environment (12).
86
87 Prior to assessing the effectiveness in a full scale Phase III randomised trial, the feasibility and 88 safety of such an intervention needs to be evaluated (13). This can be accomplished by 89 conducting a pilot, feasibility study that would assess both feasibility and safety of the 90 intervention in question, the recruitment potential, and would increase clinical experience with 91 the study intervention (13).
92
93 This pilot study therefore developed and evaluated the use of a transition team comprising in-94 home diabetes education by a credentialed diabetes educator (CDE), and early post-discharge 95 assessment by an endocrinologist. We hypothesized that the proposed intervention would be 96 feasible and would not negatively affect patient satisfaction when compared to standard care.
97
98
99 Methods
100 Design
101 This pilot, randomised controlled trial was conducted conjointly by a tertiary hospital in 102 metropolitan Melbourne, Australia, and a community-based healthcare provider. Study 103 participants were recruited during inpatient admissions between March 2014 and November 104 2015 and follow-up continued until March 2016. The trial was stopped after funding was 105 exhausted and sufficient participants were recruited.
106 Participants
107 Hospital inpatients with type 2 diabetes, commencing or altering injectable diabetes therapies, 108 were screened for the study, and randomised to receive the intervention or standard care after 109 providing informed consent. Baseline characteristics of the participants are outlined in table 1. 110 Funding of participants’ healthcare is through the Australian government’s universal health 111 insurance system, Medicare.
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112 Participant inclusion criteria were the ability to provide informed consent, the presence of type 113 2 diabetes, age > 18 years, requirement to commence or change injectable therapies therefore 114 requiring a CDE to provide education prior to discharge, medically stable and awaiting diabetes 115 education, reside within a 30-minute travel radius of the hospital, ability to attend hospital for 116 outpatient follow-up and stable glycaemia defined as blood glucose levels between 5-15 117 mmol/L in the 24 hours prior to randomisation. Patients were excluded if they did not fulfil 118 inclusion criteria.119
120 Randomisation
121 Participants were randomised in a 1:1 ratio using permuted block randomisation, by an 122 investigator without patient contact. Group allocations were concealed by writing allocations 123 on a card, and placing in sealed, unlabelled envelopes, with each consecutive participant given 124 their allocation by a research assistant after informed consent was obtained. Due to the 125 difference in treatment protocols, the study was open label to the participants and investigators.
126 Intervention
127 Standard Care
128 Participants randomised to standard care were educated by hospital credentialed diabetes 129 educators (CDEs) prior to discharge. Diabetes education regarding injectable therapies in our 130 institution complies with guidelines of the Australian Diabetes Educators Association (14). 131 This comprised education regarding the injectable therapy and its storage, and sharps disposal. 132 Additional resources were provided when required. Additional resources included National 133 Diabetes Services Scheme (NDSS) registration, supply of glucometer if required, written 134 patient information regarding diabetes, and outpatient follow-up. The NDSS is a scheme 135 administered by the Australian federal government which provides access for people living 136 with diabetes to education and equipment in order to enhance their ability to effectively self-137 manage their diabetes. Participants were discharged when medically appropriate and the 138 inpatient team was satisfied that the participant could safely administer the injectable therapy. 139 Prior to discharge, appropriate follow-up was organised. General Practitioners (GPs) were 140 notified that participants had commenced or changed treatment.
141 Transition Team (intervention)
142 The transition team group participants received in-home education to start injectable therapy 143 by the CDE within 24-48 hours of discharge. At the initial visit, the participant was provided 144 with an appropriate glucometer in addition to education regarding medication, storage, injection 145 technique, sharps disposal, NDSS registration, an education package in the relevant language, 146 and CDE contact details.
147 Further contact with participants was based on CDE evaluation of the participant’s capacity to 148 self-manage injectable therapy. Once the CDE ascertained that participants were able to self-149 manage without further intervention, the endocrinologist was notified. Participants were then 150 linked with community CDE services, if necessary, for ongoing monitoring of self-151 management.
152 Follow-up with the same endocrinologist was provided within four weeks, and at 16 weeks 153 post-randomization. HbA1c was assessed at baseline and 16 weeks. The endocrinologist 154 liaised with the participant’s GP regarding changes to management and plans for ongoing 155 follow-up after the 16-week visit.
156 Data collection
157 Baseline demographic, medication and medical data were collected and participants completed 158 the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at enrolment. 159 Whether the patient was from a culturally and linguistically diverse (CALD) background was 160 recorded. Follow-up data were collected at 16 weeks post-randomization, including rates of
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161 hospital readmissions and emergency presentations, length of hospital stay (LOS), glycaemic 162 control as measured by HbA1c and treatment satisfaction using the DTSQ change version 163 (DTSQc). Initial attempts to collect DTSQc questionnaires in the standard care group was by 164 reply-paid mail, however after a limited response rate using this method, patients were 165 contacted by phone. Study participation ceased at the 16-week endocrinology appointment, 166 and final data collection occurred. Further follow-up for ongoing diabetes management was 167 arranged at conclusion of the study.
168
169 Ethics
170 Ethics approval was obtained from Austin Health human research ethics committee (reference 171 LNR/13/Austin 179) and the community healthcare provider ethics committee. Each participant 172 provided written informed consent.
173
174 Outcomes
175 The primary outcome measured was feasibility (proportion of participants in the transition team 176 group completing the intervention as per protocol). Secondary outcomes were safety, as defined 177 by hospital readmission and emergency department presentations within 16 weeks post-178 randomization, and patient satisfaction with care (measured by DTSQ). Exploratory outcomes 179 were change in HbA1c and length of hospital stay (days).
180
181 Sample size determination
182 Due to the pilot nature of the study, the sample size estimation was based on precision 183 arguments: assuming the feasibility of transition team intervention being 0.9 (i.e. that 90% of 184 participants randomized into transition team group would be able to complete the intervention 185 as per protocol) (15), the sample of 55 participants randomized to the transition team group 186 provides the precision (desired half-width of the 95% confidence interval) of 0.08.
187 The same number of participants was to be randomized to the standard care group, thus ensuring 188 80% power to detect potential medium-to-large effects of transition team intervention 189 compared to the standard care (Cohen’s d=0.55) assuming the settings of alpha=0.05. Thus, the 190 total sample size for this study was proposed as 110 participants.
191
192 Statistical methods
193 The demographic and clinical characteristics of participants were summarized as medians 194 (interquartile ranges, IQRs) for continuous variables and counts (proportions) for categorical 195 variables.
196 The feasibility of the intervention was estimated as a proportion of participants in the transition 197 team group completing the intervention as per protocol with corresponding 95% confidence 198 interval (95% CI).
199 The difference in safety profiles (diabetes related hospital presentation or admission) between 200 two groups was investigated using Fisher's exact test.
201 DTSQ outcomes were analyzed using Wilcoxon-Mann-Whitney test and a median regression 202 model with the DTSQ score at 16 weeks post-randomization as an output and treatment group 203 and baseline DTSQ score as inputs. Sensitivity analysis was conducted by including the 204 auxillary variables demonstrating significant association with the DTSQ data being missing, 205 into the median regression model.
206 Differences in change in HbA1c and LOS between groups were investigated using Wilcoxon 207 rank-sum test.
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208 Statistical analysis was performed using STATA software (StataCorp, College Station, TX, 209 USA).
210 All statistical tests were two sided and were performed at a significance level of α = 0.05.
211 Statistical analysis was performed on both intention to treat and per protocol bases. Per protocol 212 analysis was deemed necessary to account for the patients who were initially assigned to 213 transition team but withdrew prior to intervention; in this situation they received standard care.
214 Patient and public involvement
215 Patients must be actively involved in changes to diabetes management, and require education 216 regarding therapy changes and administration of injectable medications. Effective education 217 of patients can be difficult in the hospital setting, particularly in the setting of concurrent acute 218 illness. It is subject to a number of limitations including acute illness, pain and a sense of being 219 overwhelmed in hospital. These clinical observations contributed to the formulation of our 220 research questions, however there was no direct patient involvement in this.
221 Patients were not involved in the original study design, and involvement of patients in 222 recruitment was impractical as patients were hospitalised at the time of recruitment. A 223 qualitative analysis of a subgroup of patients’ experiences and their perceptions of the 224 intervention was performed, and this will be reported separately.
225
226
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228 Results
229 One hundred and five participants were randomised to transition team or standard care. 230 Following initial drop outs, 103 participants received the intervention or standard care (Figure 231 1). 55 participants randomised to the transition team and 48 participants randomised to receive 232 standard care were included in the per protocol analysis (figure 1). Participants randomised to 233 the transition team withdrew for a variety of reasons such as decisions to change treatment, 234 change of discharge destination, and changes to clinical status. Of these, five participants 235 withdrew following the home visit by the CDE but prior to completing the endocrinologist 236 component of the intervention. For the purposes of the per protocol analysis, these participants 237 crossed over to the standard care group.
238 One participant in the transition team group was unable to be followed up as they were being 239 actively palliated for terminal malignancy, and one died before completion of the trial, for 240 reasons unrelated to diabetes. One participant withdrew from the standard care group and one 241 died before final data analysis in this group.
242 Baseline characteristics of participants are outlined in Table 1. No differences between groups 243 at baseline were identified.
244
245 Feasibility
246 Forty seven out of 55 participants in the transition team group completed the study as per 247 protocol (85%, 95%CI: 73%, 94%).
248 Safety
249 There was one hospital presentation in each group (Table 2), one for hypoglycaemia (standard 250 care) and one for inability to cope with insulin management at home due to change in social 251 circumstances (transition team). Neither participant was admitted.
252 Patient satisfaction
253 A significant improvement in satisfaction with diabetes treatment was demonstrated (DTSQc 254 transition team median 15 (IQR 10.0, 17.5), standard care median 10.5 (IQR 8.5,16.0) 255 Wilcoxon-Mann-Whitney, p=0.047), Figure 2, Table 2. On analysis adjusted for the baseline 256 DTSQs value, the transition team median DTSQc value was 4 points higher than the standard 257 care median (95%CI: 0.25, 7.75; p=0.037). The follow-up DTSQc was completed by 40 258 (16.7% missing) of the standard care patients and 36 (34.5% missing) of the transition team 259 patients, thus the “missingness” of the data was not likely to be random. On the sensitivity 260 analysis adjusted for the variables significantly associated with the missing DTSQc data at 16 261 weeks, the results remained qualitatively similar.
262 HbA1c
263 No statistically significant difference in change in HbA1c (standard care median HbA1c -1.5% 264 (IQR-3.7%, -0.2%) versus transition team group median HbA1c -1.9% (IQR -3.8%, -0.2%), p 265 = 0.83) was observed, Figure 3, Table 2. An equal number of patients (8) in each group did not 266 have an HbA1c measurement at 16 weeks.
267 Length of Stay
268 There was a trend towards a reduced length of stay in the transition team group when analysed 269 on a per protocol basis (standard care median LOS 8 (IQR 5.5-12.0), transition team median 6 270 (IQR 3.0-12.0), p=0.06), Figure 4, Table 3.
271
272
273
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274 Discussion
275
276 Key findings
277 The most important finding in this trial was that a transition team to initiate injectable diabetes 278 therapies following discharge is a feasible model of care. These data suggest that a transition 279 team is safe and acceptable with a trend towards reduced length of hospital stay. Moreover, 280 patients randomized to the transition team group had greater treatment satisfaction as 281 demonstrated by a greater difference in DTSQc score.
282
283
284 Relationship with previous studies
285286 The results pertaining to the quality of this intervention are supported by results from other 287 studies examining home-based care in diabetes. The quality markers of this intervention include 288 feasibility and objective measures of medical indices, including readmission and emergency 289 presentation rates, change in HbA1c from baseline and length of stay, and patient-reported 290 outcomes. 291292 We demonstrated a trend towards (p=0.06) reduced length of stay in the transition team when 293 analysed on a per protocol basis. Future studies with greater numbers may demonstrate 294 statistically significant reductions in length of hospital stay.295
296 We demonstrated significant improvements in treatment satisfaction in the transition team 297 group. The diabetes treatment satisfaction questionnaire (DTSQ) is widely used in clinical 298 trials and validated in several languages. The status version (DTSQs) evaluates baseline 299 satisfaction with diabetes treatment and the change version (DTSQc) evaluates the impact of 300 an intervention on satisfaction with treatment (16, 17, 18). Interpretability of this parameter is 301 limited by missing data, and there is potential for bias due to some data being obtained over the 302 phone by a research assistant, rather than in person. 303304 Analysis of HbA1c at baseline and at 16 weeks revealed a significant treatment effect with 305 HbA1c reduction approaching 2% in both groups. Importantly, there was no statistical 306 difference detected between the reduction in HbA1c in the transition team and the standard care 307 group. 308309 Other quality outcomes assessed included emergency department presentations and hospital 310 readmissions. There were no significant differences in our study. This suggests that patient 311 safety is unlikely to be compromised by delivery of home-based education. However, given 312 the limited literature in this field, further studies with greater numbers would be necessary to 313 validate these findings.
314
315 Study implications
316 Hospitalisation in patients with type 2 diabetes provides an opportunity to intervene to improve 317 outcomes over the course of disease. Escalating rates of diabetes necessitates the development 318 of feasible alternative models of care, with the potential to improve clinical outcomes and health 319 care costs. This study has investigated one such option, and has demonstrated feasibility,
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320 improved treatment satisfaction, and a trend to reduced length of stay, with no safety concerns 321 detected.
322
323
324
325 Conclusion
326 The results of this novel pilot study suggest that use of a transition team provides a feasible 327 alternative model of care for patients with type 2 diabetes requiring initiation of injectable 328 therapies. More research is necessary to validate these findings in larger populations, and to 329 ascertain whether it may lead to reduced length of stay and healthcare costs.
330
331 Funding
332 The Lord Mayor’s Charitable Foundation and the Estate of the Late Glen W A Griffiths who 333 funded this project. A/Prof Ekinci was supported by Australian National Health and Medical 334 Research Council (NHMRC) Early Career Fellowship, Viertel Clinical Investigatorship, Royal 335 Australasian College of Physicians (RACP) Fellowship and Sir Edward Weary Dunlop Medical 336 Research Foundation research grant.
337
338 Acknowledgements
339 The Diabetes Treatment Satisfaction Questionnaire (DTSQ) used in this publication is owned 340 by Prof Clare Bradley) and sourced from HPR Ltd.341 The team gratefully acknowledges Mr Paul Steel, CDE, for providing the in-home diabetes 342 education for the intervention group.
343
344 Competing Interests statement
345 We have read and understood BMJ policy on declaration of interests and declare that we have 346 no competing interests.
347
348
349 Authors Statement
350 F Pyrlis - involved in development of trial, clinical management of participants, performed final 351 write up
352 R Ogrin - involved in development of protocol, supervision of trial, reviewed final write up
353 S Arthur - logistics of trial (research assistant), data collection and statistical analysis
354 C Zhai - logistics of trial (research assistant), final data collection and statistical analysis
355 S Baqar - recruitment of participants and management of logistics of trial (research assistant), 356 data collection and analysis
357 L Churilov - statistical analysis
358 J Zajac - supervisory/ advisory role
359 E Ekinci - development of protocol, supervisory and advisory role during trial, assisted with 360 statistical analysis and final write up
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361
362 Data Statement: Deindentified patient data is available upon reasonable request from the 363 corresponding author within 3 months up to 6 months following publication.
364
365 Figure Legend
366 Figure 1 – Recruitment and participation flowchart
367 Figure 2 – Change in treatment satisfaction (DTSQ)
368 Figure 3 – a) Change in HbA1c (%) intention to treat analysis b) Change in HbA1c (%) per 369 protocol analysis
370 Figure 4 – a) Length of hospital stay (days) by intention to treat analysis b) Length of hospital 371 stay (days) by per protocol analysis
372 Table 1 - Comparison of baseline clinical and biochemical characteristics between in the control 373 and transition team groups by initial randomization/ intention to treat
374 Table 2 - Results by intention to treat analysis. Differences in hospital readmission rates, 375 change in HbA1c, length of hospital stay, & treatment satisfaction according to original 376 randomization.
377 Table 3 - Results by per Protocol analysis. Differences in hospital readmission rates, change in 378 HbA1c, length of hospital stay, & treatment satisfaction according to management received.379
380
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381 References382 1. Australian Institute of Health and welfare. Diabetes deaths. Canberra: AIHW. 2010. 383 http://www.aihw.gov.au/diabetes-indicators/deaths)384 2. Guariguata L, Whiting DR, Hambleton I et al. Global estimates of diabetes prevalence 385 for 2013 and projections for 2035. Diabetes Res Clin Pract 2014; 103:137-149386 3. Australian Institute of Health and welfare. Type 2 Diabetes in Australia’s children and 387 young people:a working paper. Canberra: AIHW. 2014. Canberra: (AIHW Cat. No. 388 CVD 53; Diabetes Series No 21,) 389 http://www.aihw.gov.au/WorkArea.DowloadAsset.aspx?id=50129546359390 4. Nanayakkara N, Nguyen H, Churilov L, Kong A, Pang N, Hart GK, et al. Inpatient 391 HbA1c testing: a prospective observational study. BMJ open diabetes research & care. 392 2015;3(1):e000113393 5. Medhi, Marshall, Burke; HbA1c predicts length of stay in patients admitted for 394 coronary artery bypass surgery. Heart Dis 2001 Mar-Apr; 3(2):77-9395 6. Baker, S et al. Outcomes for general medical inpatients with diabetes mellitus and new 396 hyperglycaemia, MJA 2008 Mar 17; 188(6): 340-3397 7. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 398 diabetes self-management education in the hospital setting. Primary Care Diabetes. 399 2014;8(3):187-94.
400 8. Schafer I, Pawels M, Kuver C, Pohontsch NJ, Scherer M, Bussche Hv et al. Strategies 401 for Improving Participation in Diabetes Education. A Qualitative Study. PLoS One. 402 2014; 9(4)
403 9. Joint British Diabetes Societies for Inpatient Care. Discharge planning for adult 404 inpatients with diabetes. October 2015 405 10. Wexler DJ, Beauharnais CC, Regan S, Nathan DM, Cagliero E, Larkin ME. Impact of 406 inpatient diabetes management, education, and improved discharge transition on 407 glycemic control 12 months after discharge. Diabetes Research and Clinical Practice. 408 2012;98:249-56
409 11. Korytkowski MT, Koerbel GL, Kotagal L, Donihi A, DiNardo MM. Pilot trial of 410 diabetes self-management education in the hospital setting. Primary Care Diabetes. 411 2014;8(3):187-94.
412 12. de Carvalho Torres H, dos Santos LM, de Souza Cordeiro PMC. Home visit: an 413 educational health strategy for self-care in diabetes. Visita domiciliária: estratégia 414 educativa em saúde para o autocuidado em diabetes. Acta Paulista de Enfermagem. 415 2014;27(1):23
416 13. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, 417 Giangregorio L, Goldsmith C. A tutorial on pilot studies: the what, why and how. BMC 418 Medical Research Methodology. 2010; 10(1).
419 14. https://www.adea.com.au/wp-content/uploads/2015/11/Injection-Technique-Final-420 digital-version2.pdf
421 15. Perez A, Reales P, Barahona MJ, Romero MG, Minambres I. Efficacy and feasibility 422 of basal-bolus insulin regimens and a discharge strategy in hospitalized patients with 423 type 2 diabetes – the HO.SMIDIA study. International Journal of Clinical Practice. 424 2014; 68, 10, 1264-71.
425 16. Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction 426 developed from the responses of people with tablet-treated diabetes. Diabetic 427 Medicine. 1990; 7:445-451.
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428 17. Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing 429 quality of life. Diabetes Metabolism Research and Reviews. 2002; 18: S64-S69
430 18. Bradley C. The Diabetes Treatment Satisfaction Questionnaire (DTSQ): change 431 version for use alongside status version provides appropriate solution where ceiling 432 effects occur. Diabetes Care 22, 3,530-2. Bradley C, Plowright R, Stewart J, Valentine 433 J and Witthaus E (2007) The Diabetes Treatment Satisfaction Questionnaire change 434 version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to 435 improvements than the original DTSQ. Health and Quality of Life Outcomes. 1999; 5 436 (5) 57437438439440
441
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Table 1 Comparison of baseline clinical and biochemical characteristics between in the control and transition team groups by initial randomization/ intention to treat.
Characteristic Standard care (n=48)
Transitions group (n=55)
Mean age (SD) 59.4 (10.92) 62.96 (16.31)
Number Male (%) 32(66.7%) 38 (69.1%)
Number CALD* (%) 16 (33.3%) 22 (40%)
Median duration type 2 diabetes (SD)
7.48 (7.78) 10.18 (9.77)
Mean HbA1c baseline (%, SD)
mmol/mol (mmol/mol, SD)
9.81% (2.64)
83.7 (5.36)
10.06% (2.23)
86.4 (0.87)
*CALD = culturally and linguistically diverse
# two-sample Wilcoxon rank-sum (Mann-Whitney) test used for continuous variables, and Fisher Exact tests used for binary variables
Table 2. Results by intention to treat analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to original randomization.
Standard care (n=48) Transitions group (n=55)
P-value
Readmission (count (%)) 1/48 (2%) 1/55 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5,16) 15 (10,17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7, -0.2%) -1.9% (-3.8, -0.2%) 0.83
Length of stay (days) (median, IQR)
8 (5.5,11.5) 7 (3,12) 0.26
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Table 3. Results by per Protocol analysis. Differences in hospital readmission rates, change in HbA1c, length of hospital stay, & treatment satisfaction according to management received.
Control group (n=56) Transitions group (n=47)
P-value
Readmission (count (%)) 1/56 (2%) 1/47 (2%) >0.99
DTSQc (median, IQR) 10.5 (8.5, 16) 15 (10, 17.5) 0.047
Change HbA1c (median, IQR)
-1.5% (-3.7%, -0.2%) -1.85% (-4, -0.2%) 0.85
Length of stay (days) (median, IQR)
8 (5.5, 12) 6 (3, 12) 0.06
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Figure 1: Recruitment and participation flowchart
Inpatients commencing injectable diabetes therapies
Intention to treat analysis Analysed (n=55)
6 patients did not have follow-up HbA1c 19 patients did not complete DTSQc
Transition team care (n=55) • Received allocated intervention (n=47) • Did not receive allocated intervention (n= 8)
6 patients did not have follow-up HbA1c 8 patients did not complete DTSQc
Standard care (n= 50) • Received allocated care (n=48) • Withdrew prior to baseline data collection due
to changes in care during hospitalisation, so could not be included in analysis (n=2)
Intention to treat analysis Analysed (n=48)
Randomised (n=105)
Per protocol analysis Analysed (n=47)
Per protocol analysis Analysed (n=56)
Participants who did not receive transition team intervention (n= 8)
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Figure 2: Change in treatment satisfaction (DTSQ)
114x180mm (150 x 150 DPI)
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Figure 3: A. Change in HbA1c (%) intention to treat analysis and B. Change in HbA1c (%) per protocol analysis
292x227mm (150 x 150 DPI)
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Figure 4: A. Length of hospital stay (days) by intention to treat analysis and B. Length of hospital stay (days) per protocol analysis.
233x185mm (150 x 150 DPI)
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CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial*
Section/TopicItem No Checklist item
Reported on page No
Title and abstract1a Identification as a pilot or feasibility randomised trial in the title 11b Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see
CONSORT abstract extension for pilot trials)3
Introduction2a Scientific background and explanation of rationale for future definitive trial, and reasons for randomised pilot
trial5Background and
objectives2b Specific objectives or research questions for pilot trial 5
Methods3a Description of pilot trial design (such as parallel, factorial) including allocation ratio 5, 6Trial design3b Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons 64a Eligibility criteria for participants 5Participants4b Settings and locations where the data were collected 54c How participants were identified and consented 5, 6
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
6
6a Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed
6Outcomes
6b Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons n/a6c If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial n/a7a Rationale for numbers in the pilot trial 7Sample size7b When applicable, explanation of any interim analyses and stopping guidelines n/a
Randomisation:8a Method used to generate the random allocation sequence 5, 6Sequence
generation 8b Type of randomisation(s); details of any restriction (such as blocking and block size) 5, 6Allocationconcealmentmechanism
9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
5, 6
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Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
5, 6
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
n/aBlinding
11b If relevant, description of the similarity of interventions 6Statistical methods 12 Methods used to address each pilot trial objective whether qualitative or quantitative 7
Results13a For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly
assigned, received intended treatment, and were assessed for each objective9Participant flow (a
diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons 9
14a Dates defining the periods of recruitment and follow-up 5Recruitment14b Why the pilot trial ended or was stopped 5
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 15Numbers analysed 16 For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers
should be by randomised group9
Outcomes and estimation
17 For each objective, results including expressions of uncertainty (such as 95% confidence interval) for anyestimates. If relevant, these results should be by randomised group
9
Ancillary analyses 18 Results of any other analyses performed that could be used to inform the future definitive trial 9Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) n/a
19a If relevant, other important unintended consequences n/a
DiscussionLimitations 20 Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility 4, 10Generalisability 21 Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies 10Interpretation 22 Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and
considering other relevant evidence10
22a Implications for progression from pilot to future definitive trial, including any proposed amendments n/a
Other informationRegistration 23 Registration number for pilot trial and name of trial registry 1, 7Protocol 24 Where the pilot trial protocol can be accessed, if available n/aFunding 25 Sources of funding and other support (such as supply of drugs), role of funders 11
26 Ethical approval or approval by research review committee, confirmed with reference number 1, 7
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Citation: Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355.*We strongly recommend reading this statement in conjunction with the CONSORT 2010, extension to randomised pilot and feasibility trials, Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.
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