champ-path study updates -- nov. 2013

CHAMP-Path StudyUpdates

November 2013

CHAMP-Path Study Flowchart (Last Update: 28 Nov 2013)

Assessed for Eligibility (n=405)

Excluded (n=195) Not meeting inclusion criteria (n=129) Refused to participate (n=44) Other reasons (n=22)

Randomized (n=210)

Allocated to Pathway Care (n=100) Received Pathway Care (n=95) Did not receive Pathway Care (n=5)

Misclassification (n=5)

Allocated to Usual Care (n=110) Received Usual Care (n=100) Did not receive Usual Care (n=10)

Misclassification (n=10)

Lost to Follow-up (n=19) Misdiagnosis (n=9) Transferred to CCU/ICU (n=5) Re-enrollment (n=4) Enrolled & discharged same day (n=1)

Discontinued Pathway Care (n=4) Patient died (n=2) Discharged against medical advice (n=2)

Lost to Follow-up (n=21) Misdiagnosis (n=8) Transferred to CCU/ICU (n=6) Transferred to other specialty (n=1) Re-enrollment (n=6)

Discontinued Usual Care (n=4) Patient died (n=1) Discharged against medical advice (n=3)

Analyzed (n= ) Excluded from analysis (n= )

Analyzed (n= ) Excluded from analysis (n= )

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Missed (n=146)

CHAMP-Path Study

STATUS RECRUITING

Thank You for Your Support!

Total Enrolled Target Sample Size

210 504

THE CHAMP-PATH STUDY

Enrollment Status

PATHWAY ENROLLED TARGET

SAMPLE SIZE

Community Acquired Pneumonia 53 166

Heart Failure 49 90

Acute Kidney Injury 35 30

Asthma 29 90

DVT/PE 41 128

CHAMP-Path Study

Presentation Abstracts

KAIMRC 4th Annual Scientific Forum12-13 November 2013, Riyadh

Updates on CHAMP-Path: Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes through

Pathways: Pragmatic RCTs

Abstract Presentation #1

4th Annual Scientific Forum

“Research Day”

Abstract’s title Updates on CHAMP-Path : Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes through Pathways : Pragmatic RCTs

Names of authors Ismail S, Alaifan T,AlWithenani R, Ahmed A, Hafez J, Rashwan A, Matar E, Byelveld F, Carolus V, Scudder B, Yusuf O, Khalil M, Abdrabuh L, Abbas S, Karsou S, Zahrani Z,Gasim A, Elder K, Buhairi A, Baseer M,Thomson J, AlMadani D, Siddiqui M, Qureshi M,Melody O, Sawadi A, Shahrani K, AlHamdan H, and Quadri K.H.M

Department Collaborative health care professionals Presenting Author Dr. Sherine Ismail Title of the Presenting Author

Clinical Pharmacist ,Pharm.D , BCPS, Teaching Assistant, Principles and Practice of Clinical Research 2013, Harvard Medical School.

Contact information of Presenting author

Email: [email protected] Phone: Ext: Pager:

02624000 22863 or 22861 1732

Mobile no: 0548967266 Abstract: - Grant-Recipient of: King Abdullah International

Medical Research Center (RC10/134 J); CHAMP-Path ClinicalTrials.gov: NCT01561885

Should not exceed 300 words

Introduction: Patient Centeredness refers to healthcare that establishes partnership among healthcare practitioners, patients, and their families. Previous studies have shown that mixed methodologies (quantitative and qualitative) lead to better assessment of patient centeredness. No previous studies have been reported in Saudi Arabia employing a similar methodology to measure patient-centered care. The aim of this study was to explore the experience and satisfaction of patients admitted to medical wards within NGHA-WR. Methods: In June and July 2013, thirty-five internal medicine patients, discharged after 3 or more days were eligible to participate after verbal consent. Trained unit assistants interviewed patients using the modified, validated CHAMP-Path questionnaire [Cronbach's Alpha = 0.91], containing 47 items addressing patient satisfaction about services such as nutrition, health education, physician, nursing and pharmaceutical care. Two focus group discussions (FGD) were conducted on 7 additional patients. Data was analyzed with descriptive statistics using SPSS. Results: Nearly all patients were satisfied with both physician and nursing care. About half (45.7%) were not informed about the expected length of stay. Less than half (15, 42.0%) and 20(57.2%) were not satisfied with the comfort of the hospital, and the quality of food, respectively. However 31(88.7%) were satisfied with the cleanliness of the ward. Medication reconciliation and discharge counseling were received by 22(62.9%), and 19 (54.3%), respectively. A total of 27(77.1%) received nutritional counseling, 13(37.1%) health education, and 10(28.6%) were referred to social services. Fifty-seven percent reported moderate to complete pain relief. FGD reports revealed that male patients had a positive experience with nurses, while females did not. Unsuitable food timings and long waiting periods at emergency were also reported. Discussion: Despite several positives we believe the challenges identified in our study are a valid and reliable representation of patients’ values and preferences, offering opportunities for further improvement in quality of care.

Updates on CHAMP-Path : Collaborative Health Care Professionals Approach in Monitoring of Patient Centered Outcomes through Pathways : Pragmatic RCTs

Introduction: A Clinical pathway is an evidence-based integrated plan of care within a pre-defined time frame by multidisciplinary health care professionals. Usual care is the current practice within the Department of Medicine. There is a paucity of data and conflicting evidence about the utility of clinical pathways in actual practice. CHAMP-Path trials are designed to determine if collaborative, clinical pathway care (PC) versus usual care (UC) in a Joint Commission International (JCI) accredited facility will decrease the length of stay (LOS) across multiple medical diagnoses over 2 years. These 5 medical diagnoses are: Acute kidney Injury (AKI), Venous Thromboembolism (VTE), Asthma, Heart failure (HF) , and Community Acquired Pneumonia (CAP). We aim to report an update on the ongoing trials.

Grant-Recipient of: King Abdullah International Medical Research Center (RC10/134 J); CHAMP-Path ClinicalTrials.gov; number, NCT01561885.)

Methodology :CHAMP-Path studies are pragmatic, parallel, single blinded , randomized controlled trials. A Collaborative health care professionals of various departments ( Physicians, Pharmaceutical care, Nursing, Quality improvement, Dietitians, social works and patient educators ) designed evidence based clinical pathways. A pilot study was conducted from March 2012 to October 2012 and the study is currently on going. Practicing physicians in clinical teaching unit in general internal medicine wards were randomized to usual care (UC) or pathway care (PC) with only the PC arm having access to the clinical pathways.Patient randomization was computer-generated through permuted blocks at 1:1 ratio with unequal size blocks (4 and 6 ). Allocation concealment was done using opaque sealed envelopes distributed through emergency pharmacy. Eligibility criteria was age ≥ 14 yrs, hemodynamic stability, and pathway-specific inclusion and exclusion criteria. Residents were responsible for screening and enrolling patient after obtaining an informed consent. Patients are blinded to the allocated arm.The intervention is clinical pathways integrated into Computerized Prescriber Order Entry (CPOE) preset orders compared to usual care. The primary outcome is the reduction in LOS by two days. The secondary outcomes are patient centered outcomes assessed through patient satisfaction questionnaire , determinants of LOS, and 30 day re-admission.

Statistical analysis :The primary outcome will be reported as mean LOS � SD , 95% CI, p-value . Unpaired two-tailed student T-test will be used to test for significance among UC and PC. Chi-square test will be used to assess 30 days readmission rates and Regression analysis for determinants of LOS. Descriptive statistics for patient centered outcomes. (The SPSS statistical software will be used for data analysis).A sample size of 504 patients was calculated for all medical diagnoses (AKI: 30, VTE: 128, Asthma: 90, heart failure: 90, CAP: 166) to provide an 80% power with a level of significance of 5% and accounting for 10%-20% attrition rate.

Results : Trial Profile CHAMP-Path clinical trials

To date, 186 patients have been enrolled from March 2012 till September 2013 (almost 1/3 of the estimated sample size). AKI is almost achieving target sample as (29/30 ) patients enrolled while Asthma (26/90) , VTE (36/128) , CAP (46/ 166) and HF (46/90).

Ismail S, Alaifan T, AlWithenani R, Ahmed A, Hafez J, Rashwan A, Matar E, Byelveld F, Carolus V, Scudder B, Yusuf O, Khalil M, Abdrabuh L, Abbas S, Karsou S, Zahrani Z, Gasim A, Elder K, Buhairi A, Baseer M, Thomson J, AlMadani D, Siddiqui M, Qureshi M, Melody O, AlSawadi A , Shahrani K, ALHamdan H and Quadri K.H.M

Department : Collaborative Health Care Professionals and Department of Medicine (NGHA-Jeddah)

Discussion: CHAMP-Path pragmatic RCTs are recruiting patients at present, however many challenges of real life setting affect the enrollment rate . Misdiagnosis occurs frequently in CAP pathway .The challenges of rotating residents in medicine services, requires continuous education and organization for computerized pathway care access among teams. On the other hand, CHAMP-Path RCTs represent the effectiveness of clinical pathways in real life settings. In addition, the various clinical pathways initiated in this a JCI accredited facility, provide opportunities for addressing patient centeredness and improving the flow of patients in the medical wards, through the reduction of LOS.Conclusion : We propose that CHAMP-Path Pragmatic RCTs are pioneering studies in attempting to demonstrate whether integrated, patient-centered clinical pathways are truly effective in real life settings and in improving patient -important clinical outcomes. It is anticipated that 2 more years would be required to complete these trials.

Assessed for eligibility (363 patients)

Randomized (186 patients)

Pathway Care (91 patients)• (87) Patients received PC• (4) Patients did not receive PC (Misclassification)

Usual Care (95 patients)• (85) Patients received UC• (10) Patients did not receive UC (Misclassification)

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(18) patients Lost follow up : (Reasons) (8) Misdiagnosis (5)Transferred to CCU/ICU(4) Re-Enrollment (1) Enrolled & discharged same day(4) Discontinued intervention : (Reasons) (2 ) Died (2) Discharged against medical advice

Excluded (177) (113) Not meeting Inclusion Criteria(42) Refused to participate (22) Other reasons

(20 ) patients Lost follow up : (Reasons)(8) Misdiagnosis(6) Transferred to CCU/ICU(6) Re-Enrollment

(4 ) Discontinued intervention: (Reasons ) (3) Discharged against medical advice(1) Patient Died

ITT Analysis (n) = Not yet ITT Analysis (n) = Not yet

Measuring patient centeredness using the CHAMP-Path validated questionnaire & focus group

discussions: A pilot study



“Research Day” Abstract’s title Measuring patient centeredness using the CHAMP-Path

validated questionnaire & focus group discussions: A pilot study

Names of authors Jane Thomson, Doha AlMadani, Oyindamola Yusuf, Maryam Khalil, Muhammad Siddiqui, Bonnie Scudder, Arlene Rashwan, Eman Matar, Majed Farahat, Mohammad Alghamdi, Suzan Kashaan, Wafaa Bataweel, Sherine Ismail, Jani Hafez, Zeyad Zahrani, and Quadri KHM

Department Nursing (Medicine & Surgery), NGHA-WR and Champ-Path collaborators Presenting Author Ms. Jane Thomson Title of the Presenting Author Director Clinical Nursing: Medicine & Surgery, NGHA-WR



(02) 624-0000 24840 4840

Mobile no: Abstract: - Grant-Recipient of King Abdullah International Medical Research

Center (RC10/134 J); Registered on ClinicalTrials.gov (NCT01561885).


Introduction: Patient Centeredness refers to healthcare that establishes partnership among healthcare practitioners, patients, and their families. Previous studies have shown that mixed methodologies (quantitative and qualitative) lead to better assessment of patient centeredness. No previous studies have been reported in Saudi Arabia employing a similar methodology to measure patient-centered care. The aim of this study was to explore the experience and satisfaction of patients admitted to medical wards within NGHA-WR.

Methods:In June and July 2013, thirty-five internal medicine patients, discharged after 3 or more days were eligible to participate after verbal consent. Trained unit assistants interviewed patients using the modified, validated CHAMP-Path questionnaire [Cronbach's Alpha = 0.91], containing 47 items addressing patient satisfaction about services such as nutrition, health education, physician, nursing and pharmaceutical care. Two focus group discussions (FGD) were conducted on 7 additional patients. Data was analyzed with descriptive statistics using SPSS.

Results:Nearly all patients were satisfied with both physician and nursing care. About half (45.7%) were not informed about the expected length of stay. Less than half (15, 42.0%) and 20(57.2%) were not satisfied with the comfort of the hospital, and the quality of food, respectively. However 31(88.7%) were satisfied with the cleanliness of the ward. Medication reconciliation and discharge counseling were received by 22(62.9%), and 19 (54.3%), respectively. A total of 27(77.1%) received nutritional counseling, 13(37.1%) health education, and 10(28.6%) were referred to social services. Fifty-seven percent reported moderate to complete pain relief. FGD reports revealed that male patients had a positive experience with nurses, while females did not. Unsuitable food timings and long waiting periods at emergency were also reported.

Discussion: Despite several positives we believe the challenges identified in our study are a valid and reliable representation of patients’ values and preferences, offering opportunities for further improvement in quality of care.

Name: Jane Thomson, Doha AlMadani, Oyindamola Yusuf, Maryam Khalil, Muhammad Siddiqui, Bonnie Scudder, Arlene Rashwan,Eman Matar, Francis Byleveld, Virginia Carolus, Majed Farahat, Mohammad Alghamdi, Suzan Kashaan, Wafaa Bataweel, Sherine Ismail,Jani Hafez, Zeyad Zahrani, and Quadri KHM

Department: Nursing (Medicine & Surgery) with Collaborative Healthcare Professionals, NGHA-WR

INTRODUCTIONPatient Centeredness refers to healthcare that establishes apartnership among healthcare practitioners, patients, andtheir families. There is a worldwide drive to understand thebest way to measure people’s expectations and satisfactionwith healthcare. Previous studies have shown that mixedmethodologies (quantitative and qualitative) lead to betterassessment of patient centeredness.The aim of this study is to measure, understand, and act onthe experience of patients and their families admitted tomedical wards within NGHA-WR.

METHODOLOGYIn June and July 2013, thirty-five internal medicine patients,discharged after three or more days, were eligible toparticipate. Trained ward unit assistants interviewed patientsusing the modified, validated CHAMP-Path patient satisfactionquestionnaire [Cronbach's Alpha = 0.91], a 47-item instrumentwith a five-point scale used to rate satisfaction with the qualityof services provided by six departments (Physician, Nursing,Pharmacy, Nutrition, Health Education, and Social Services).Data was analyzed with descriptive statistics using SPSS.

Two focus group discussions (FGD) were conducted from eachgender. One group of four male patients and another group ofthree female patients.

RESULTS

The tables below show the highest and lowest rated items for the CHAMP-Path patient satisfaction questionnaire, as well as the services not received by the majority of respondents.

DISCUSSIONThis pilot study showed that the responses received from the patientsatisfaction questionnaire were reflective of the themes derived from the focusgroup discussions (FGD). Thus, both the quantitative and qualitative resultswere complementary to each other. However, the FGD probed deeper into thethoughts, feelings, and experience of the patients. The FGD was a newlyintroduced methodology, which our patient population received favorably.The results highlight perceived gaps within the healthcare services provided,such as health education and social services.Recommendations from this pilot may include setting up a task force toimprove Food, Fluid and Nutritional Care for patients; and to improve overallinter-disciplinary teamwork.In conclusion, this pilot study demonstrated the feasibility of this mixedmethodology for measuring patient centeredness, thus we intend to moveforward to conduct the study on a larger scale.

Images

“I know I had allergies to this medicine….nobody listened.”

“I was in ER for more than 10 hours……waiting on a chair. I’d

rather go to a bad hospital than to go through this ER.”

“I was supposed to be discharged in the morning.

But I left in the night…..I don’t know why.”

“They forgot to bring me food, I was given no tea or

milk with breakfast, food was cold, I would like a food

menu”

“What I need most is more mercy, more kindness and more humanity

from all staff”

“Different doctor, Different diagnosis, Different

treatment plan…. who to talk to?”

Measuring Patient Centeredness Using the CHAMP-Path Validated Questionnaire& Focus Group Discussions: A Pilot Study

HIG

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“I’m worried about giving the right care to my uncle after discharge…

I only received training once.”

“I feel this hospital has a sense of commitment.”

A pragmatic RCT comparing pathway-based versus usual care in Acute Kidney Injury (AKI) –

CHAMP-Path Study



“Research Day” Abstract’s title A pragmatic RCT comparing pathway-based versus usual care in

Acute Kidney Injury (AKI) – CHAMP-Path Study Names of authors Quadri KHM, Sherine Ismail, Zuhair Abunijem, Abdullah AlMalki,

Mohammed Balla, Mohammed Qureshi, Rehan Qureshi, Jani Hafez, Maryam Khalil, Thamer Alaifan, Atta Rehman, Oyindamola Yusuf, Garry Mackenzie, Omar Taleb, Abdulhameed Gasim, Zeyad Zahrani, Sulaiman Karsou

Department Medicine Presenting Author Quadri KHM Title of the Presenting Author Chairman, Department of Medicine



(012) 624-0000 21665 2099

Mobile no: 0563228917 Abstract: - CHAMP-Path Study: Grant-Recipient of King Abdullah International

Medical Research Center (RC 10/ 134/ J); Registered on ClinicalTrials.gov (NCT01561885)


INTRODUCTION:The CHAMP-Path AKI Trial is a pragmatic, parallel, single-blind RCT. The utility of AKI clinical pathways in reducing length of stay (LOS) has not been reported. Therefore, we aim to study LOS in AKI comparing pathway versus usual care as a part of the CHAMP-Path Trials.

METHODS:Enrollment began in March 2012. Patients presenting to the emergency department, older than 14 years with a serum creatinine increase of greater than1.5 times baseline (RIFLE Criteria), with AKI as the admitting diagnosis with hemodynamic stability were eligible. Patients with CKD stages 4 or 5, transplants, obstructive uropathy, glomerulonephritis, interstitial nephritis, and pregnancy were excluded. After informed consent patients were randomized and blinded to receive either pathway or usual care.

The AKI pathway was developed by multidisciplinary health care professionals. Pathways were integrated into a computerized prescriber order entry system (CPOE). General medicine physicians were randomized to provide either usual or pathway care, with only the pathway arm having access to CPOE. Patients were randomized via computer-generated sequence with allocation concealment by opaque sealed envelopes, via emergency pharmacy.

Primary Outcome: a decrease in LOS by 2 days. Secondary outcomes: 30 day re-hospitalization rate, determinants of (LOS), and in-hospital mortality. A sample size of 30 patients was estimated based on a mean LOS of 5 ± 1.8 days, powered at 80% with an alpha of 5% and 20% attrition rate. Mean LOS ±SD, 95% CI, p-values using an intention-to-treat analysis will be reported. Regression analysis will be used to identify determinants of LOS.

RESULTS:To date, 27 of 81 patients screened were enrolled, with 12 allocated to pathway and 15 to usual care.

CONCLUSION:The trial is expected to complete shortly, providing our first insight on AKI pathway effectiveness in pragmatic settings. Our results are expected to influence future pathway utilization in NGHA.

Quadri KHM, Sherine Ismail, Zuhair Abunijem, Abdullah AlMalki, Mohammed Balla, Mohammed Qureshi,Rehan Qureshi, Jani Hafez, Maryam Khalil, Thamer Alaifan, Atta Rehman, Oyindamola Yusuf, Garry Mackenzie,Omar Taleb, Abdulhameed Gasim, Zeyad Zahrani, Sulaiman Karsou

Collaborative Healthcare Professionals with the Department of Medicine, King Abdulaziz Medical City, Jeddah

IntroductionThe CHAMP-Path AKI Trial is a pragmatic, parallel, single-blind RCT which began enrollment in March 2012. The utility of AKI clinical pathways in reducing length of stay has not been reported. Therefore, we aim to study the length of stay (LOS) in AKI, comparing pathway versus usual care as a part of the CHAMP-Path Trials (NCT 01561885, ClincialTrials.gov). This is a description of the trial’s methodology and current status.

MethodologyThe AKI pathway was developed by a team of multidisciplinary health care professionals. Pathways were integrated into a computerized prescriber order entry system (CPOE).

General medicine physicians were randomized to provide either usual or pathway care, with only the pathway arm having access to the Pathways CPOE.

Screening & Enrollment:AKI Eligibility Criteria for patients presenting to ER Written Informed Consent Randomization via a computer-generated sequence, allocation concealment, opaque sealed envelopes through ER Pharmacy. Patient Blinding

Mean LOS � SD, 95% CI, p-values using an intention-to-treat analysis will be reported. Regression analysis will be used to identify determinants of LOS.

ResultsTo date, 29 patients out of a target sample size of 30 patients have been enrolled, with 14 allocated to pathway and 15 to usual care.

DiscussionOur study represents one of the first attempts to report outcomes on Acute Kidney Injury and length of hospitalization, exclusive of ICU settings. To our knowledge, this is the first randomized pragmatic trial comparing AKI management in a pathway-guided format compared with Usual Care. A multi-factorial etiology frequently makes it challenging to isolate the diagnosis of AKI from other principal causes of hospitalization, accounting for the large number of patients failing to meet the inclusion criteria. We also excluded patients with chronic kidney disease stages 4 & 5, as well as renal allograft recipients. The trial is expected to complete shortly, providing our first insight on AKI pathway effectiveness in real-life settings. Our results are expected to influence future pathway utilization in NGHA.

A Pragmatic RCT Comparing Pathway-based versus Usual Care in Acute Kidney Injury (AKI) – CHAMP-Path Study

GIM Physicians & Enrolled Patients Randomization

Pathway Care (CTU2)

Usual Care (CTU1)

Primary Outcome Decrease in LOS by 2 daysSecondary Outcome 30-day readmission rate, determinants of LOS, and in-hospital mortality

Sample Size 30 patients. (Estimation based on mean LOS of 5 � 1.8 days, powered at 80% with an alpha of 5% and 20% attrition rate).

INCLUSION CRITERIA EXCLUSION CRITERIA

Age > 14 years old Pregnancy

Serum Creatinine > 50% baseline(RIFLE Criteria)

ICU patients

AKI is the principal diagnosis Stage 4/5 Chronic Kidney Disease

Hemodynamic stability Kidney allograft recipients

Obstructive Uropathy

Glomerulonephritis

Interstitial Nephritis


Overcoming the challenges of screening and recruitment in a resident-driven pragmatic randomized trial–

The CHAMP-Path experience


“Research Day” Abstract’s title Overcoming the challenges of screening and recruitment in a

resident-driven pragmatic randomized trial– The CHAMP-Path experience

Names of authors Maryam Khalil, Thamer AlAifan, Raad AlWithenani, Akram Ahmad, Reham Alharbi, Samah Nawawi, Reem Assebaiei, Osamah Hakami, Abdullah AlSaeidi, Hadeel AlQurashi, Salwa Aidarous, Melody Omana, Sherine Ismail, Oyindamola Yusuf, Jani Hafez, Zeyad Zahrani, Gasim Abdulhameed, Sulaiman Karsou, and Quadri KHM

Department Medicine Presenting Author Maryam Khalil Title of the Presenting Author Research Assistant, KAIMRC (CHAMP-Path Study)



(012) 624-0000 21298 2436

Mobile no: 0508886840 Abstract: - CHAMP-Path Study: Grant-Recipient of King Abdullah International

Medical Research Center (RC 10/ 134/ J); Registered on ClinicalTrials.gov (NCT01561885)


INTRODUCTION:Successful patient recruitment in a clinical trial depends on motivation and participation. Studies have reported that less than half of participating physicians screen patients, and that only 20% of eligible patients are recruited. Pragmatic trials are particularly challenging in this respect. We report our experience with patient recruitment and the strategies employed to improve resident participation in the CHAMP-Path Study, a pragmatic, parallel, single-blind RCT designed to evaluate the effectiveness of five clinical pathways in reducing length of stay (LOS).

METHODS:In order to motivate residents to screen and recruit patients, we used the following strategies: making daily reminder calls to residents on-duty in the ER during the night and day; awarding certificates of appreciation periodically to the most supportive residents in recognition; and visibly updating the patient enrollment counter promptly.

To address resident barriers in recruitment, we made the following efforts: revised the Arabic translation of the Informed Consent and made it more patient-friendly; conducted Informed Consent workshops; provided research books for capacity-building; designed a resident-friendly flowchart to clarify recruitment procedures; and sponsored the most supportive residents to attend research conferences.

After employing these strategies we compared screening and enrollment rates between the pilot phase and the main phase to date. Statistical analyses were performed using the chi-squared test for proportions.

RESULTS:Screening rate improved significantly from 58.6% in the pilot study to 79.5% in the main study (p<0.0001). In addition recruitment rate also improved significantly from 38.8% in the pilot study to 55.1% (p=0.009) in the main study.

CONCLUSION:By employing diverse strategies to motivate and empower participating residents, we have successfully improved our patient screening and recruitment rates. Based on the current enhanced recruitment rate, we expect to complete the CHAMP-Path trials within the next two years.

Maryam Khalil, Thamer AlAifan, Raad AlWithenani, Akram Ahmad, Reham AlHarbi, Samah Nawawi,Reem Assebaiei, Osamah Hakami, Abdullah AlSaiedi, Hadeel AlQurashi, Salwa Aidarous, Melody Omana,Sherine Ismail, Oyindamola Yusuf, Jani Hafez, Zeyad Zahrani, Gasim Abdulhameed, Sulaiman Karsou,and KHM Quadri

Collaborative Healthcare Professionals with the Department of Medicine, King Abdulaziz Medical City, Jeddah

INTRODUCTION

METHODOLOGY

RESULTSBoth the screening rate and recruitment rate improved significantly, with a p-value of < 0.0001 and 0.009 respectively.

DISCUSSION & CONCLUSIONParticipating residents can be motivated to screen and recruit patients when diverse strategies areused. To boost recruitment, we used a blend of motivation and support techniques. The remindercalls and appreciation certificates were an attempt to build personal contact between the residentsand research team. Studies have shown that having regular and personal contact with participatingphysicians is one of the effective strategies for influencing participation2. It has also been reportedthat participating physicians gain motivation through the motivation of the research group2. Thuswe conducted workshops and established a research library – not only to breakdown recruitmentbarriers – but to also cultivate an enthusiasm for clinical research. As a different approach to otherstudies, we sponsored top recruiting residents to attend clinical research conferences, providedInformed Consent workshops, and used an enrollment counter. With consistent effort, we hope towitness further improvement. Based on the current enhanced recruitment rate, we expect tocomplete the CHAMP-Path trials within the next two years.

Overcoming the Challenges of Screening and Recruitment in a Resident-Driven, Pragmatic, Randomized Trial – The CHAMP-Path Experience

CHAMP-Path Study: Grant-Recipient of King Abdullah International Medical Research Center (RC 10/134/J); Registered on ClinicalTrials.gov (NCT01561885)

Less than 50% of participating

physicians actually recruit patients, and often only 20% of

eligible patients are enrolled.1

Successful patient recruitment in a clinical trial depends on themotivation and support of participating physicians. Studies havereported that less than 50% of participating physicians recruit patients,and that only 20% of eligible patients are enrolled1. Pragmatic trials areparticularly challenging in this respect. We report our experience withpatient recruitment and the strategies employed to improve residentparticipation in the CHAMP-Path Study, a pragmatic, parallel, single-blind RCT designed to evaluate the effectiveness of five clinicalpathways in reducing length of stay (LOS).

To address recruitment barriers, we: Made the Informed Consent form (Arabic version)

more patient-friendly Conducted Informed Consent workshops; Established a Research Library for capacity-building; Designed a flowchart to clarify recruitment procedures.

To motivate residents to participate, we: Made daily reminder and follow-up calls to residents

on-call in the ER to minimize forgetfulness; Awarded certificates of appreciation periodically to

the most supportive residents; Visibly updated the patient enrollment counter; Sponsored the most supportive and top recruiting

residents to attend clinical research conferences.

Statistical analysis:Screening and enrollment rates were compared betweenthe pilot study and the main study. Chi-squared test forproportions was used for statistical analysis.

References:1de Wit NJ, Quartero AO, Zuithoff AP, Numans ME: Participation and successful patient recruitment in primary care. J Fam Pract 2001, 50:9762 Fransen G, van Marrewijk C, Mujakovic S,et al. Pragmatic trials in primary care: methodological challenges and solutions demonstrated by the DIAMOND study.BMC Med Res Methodol 2007;7(16).

Acknowledgments

Department of Medicine--Department of Nursing-Ward 16, Ward 17, ER, Wards 3/4/20--Department of Pharmacy--Department of Quality Management--Department of Health Promotions-- Department of Clinical Nutrition-- Unit Assistants – Ward 16, Ward 17, ER, Wards 3/4/20--CHAMP-Path Team-

champ-path study updates -- nov. 2013

Health & Medicine

analyzed n

excluded n

followup n

misclassification n

misdiagnosis n

ccuicu n

analysis n

missed n