feasibility, acceptability and cost of video directly observed … · 2017. 12. 25. ·...
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Feasibility, Acceptability and Cost of Video Directly Observed Therapy in Maryland
Samuel Holzman, MD
Johns Hopkins University School of Medicine Baltimore, Maryland
April 21, 2017
Disclosures
Financial Disclosures: None Funding: National Institutes of Health Small Business Innovation Research Grant Note: emocha Mobile Health Inc. is a privately owned and operated company
New guidelines prioritize daily therapy
DOT remains the preferred standard
Key principles: “To be consistent with principles of patient-centered care, decisions regarding use of DOT must be made in concert with the patient”
“Implementation of DOT may not be readily feasible when resources are limited”
The “least restrictive public health interventions that are effective are used to achieve adherence”
“DOT has expanded to other modalities such as web-based video and mobile phones which have been well received by both patients and health dept staff”
DOT Benefits DOT Challenges
+ High cost
+ Time intensive
+ Logistical limitations (patient travel +work obligations, holidays, etc.)
+ Increased patient support
+ Early identification of poor clinical response + Early detection of side effects
miDOT
miDOT
miDOT
Data Management & Security
Maryland Geography
<3.7/100,000
>3.7 /100,000
No reported cases
Funding: Design:
NIH Small Business and Innovation Research Grant (SBIR)
Pragmatic, prospective implementation study
Timeline: July 2016 - ongoing
Inclusion Criteria: Adult TB patients in Baltimore City, Montgomery Country and Anne Arundel County
Enrollment at the discretion of non-conflicted TB clinician/staff NO exclusion based on resistance pattern (ex. MDR), past adherence or English proficiency
Mixed Methods: Quantitative analysis
Feasibility
Outcome
Adherence +
Observed fraction
Metric
Study Design
Qualitative analysis
Pre/post surveys and interview (Patients + Staff)
Acceptability Cost analysis
“Ingredients” based approach with time-
motions studies
Cost
miDOT interven2on (n=20) Age, yr (median, IQR) 32 (22-‐48) Female, n (%) 12 (60) Origin, n (%) United States Foreign-‐born Unknown
2 (10) 16 (80) 2 (10)
Time in US, yr (median, IQR) 11 (4-‐19) Known TB contact, n (%) 0 (0) History of incarcera2on, n (%) 0 (0) Comorbidi2es, n (%) HIV infected Hypertension Diabetes History of malignancy
0 (0) 1 (6) 1 (6) 0 (0)
Tuberculosis type, n (%) Pulmonary Smear posi2ve Smear nega2ve Exclusively extrapulmonary Latent
7 (35.0) 2 (10.0) 8 (40.0) 3 (15.0)
Baseline Characteristics
Variable In-‐person DOT
miDOT Pvalue
Adherence, median (IQR) 92 (88-‐100)
92 (83-‐99)
0.41
DOT as % of observable doses, median (IQR) Observed fracHon
65
(62-‐71)
73
(63-‐92)
0.11
Self administration: Dose NOT taken under observation.
Feasibility
0
20
40
60
80
100
Pre-miDOT Post-miDOT
Perc
ent (
%)
Video DOT is effective
Disagree Agree
*
*
0
20
40
60
80
100
Pre-miDOT Post-miDOT
Perc
ent (
%)
Video DOT improves treatment adherence
(vs self-administration)
Disagree Agree
Staff opinions on impact of video DOT
Surveys collected on a 5-point Likert scale, dichotomized for analysis Analysis by McNemars test for paired proportions
Acceptability
Qualitative themes arising from pre/post interviews
“…sometimes they meet me … at work … I’m afraid ill be seen.”
patient privacy Patient
“… the fact that someone in a county car [is] not coming up to their house or their job in the community, [video DOT] definitely increases privacy for patients.”
“It was as least invasive possible, I'd say. That was probably the best part [of miDOT].”
miDOT improves patient privacy
Patient
Provider
“I'm about to start a [school] … [and] the schedule doesn't really match … I won't be able to do the class, and I need class more than I need this.”
In-person DOT is limited by logistical constraints
Patient
Acceptability Theme
DOT strategy Equipment Consumables Labor Total Incremental
In-person DOT (range)
$1751 ($69-$562)
$522 ($17-$141)
$1,8383 ($521-$6,169)
$2,065 ($608-$6,872)
Reference
miDOT (range)
$464 ($2-$136)
$4685 ($0-$1,200)
$131 ($37-$578)
$645 ($39-$1,914)
-$1,420
‘Ingredients’ approach: multiply quantity of consumables/labor utilized by unit costs Time motion studies at each site, and obtained local costing information from clinics/clinic managers Divide costs by category:
Labor Consumables (e.g. supplies) Equipment (e.g. vehicles, computers, etc)
‘Sensitivity analysis’ to examine different methods of implementation and different program structures
Costs
✶ Patients on miDOT maintained a high (and comparable) level of adherence.
✶ “Observed fraction” was increased on miDOT, though trend was not statistically significant.
✶ Both patients and staff felt miDOT was less burdensome and more private than in-person DOT ✶ Concern among some DOT workers that video DOT would replace them
✶ Cost estimates varied significantly
✶ Only at extreme estimates was miDOT more expensive, more miDOT lead to cost savings.
Conclusions and Considerations
Feasibility Acceptability Costs
✶ Patients were not randomized to miDOT, study participants represents a select subsample of TB clinic population
Patients selected for miDOT tended to be those unable to effectively participate in in-person DOT (conflict with work, school, travel, etc). May have lead to MORE CONSERVATIVE estimates. ✶ Pilot study with small sample size Will need larger follow-up study to improve generalizability
Implementation Considerations ✶ Video DOT may free-up time to intensify in-person care to those in need of such services
There will be ongoing need for in-person DOT. Patient-centered care is about building treatment around individual patient needs. Some will favor social support > flexibility.
✶ Opens the possibility for 7x per week DOT. Now shift towards daily therapy. Improvements in care may be seen with DOT extended to 7 days per week
Limitations
Special thanks to the DOT workers and nurse case managers at the following health departments: • Baltimore City Health Department • Montgomery County Health
Department • Ann Arundel Country Health
Department
emocha Mobile Health, Inc. • Katrina Rios, BA • Sebastian Seiguer, JD, MBA
Johns Hopkins • Maunank Shah, MD, PhD • Avi Zenilman
Acknowledgements