Pilot Testing of the emPath Platform to Improve Medication for Opioid Use Disorder (MOUD) Linkage and Retention Among Adults With Opioid Use Disorder in Durham, North Carolina
Pilot Testing of the emPath Intervention to Improve MOUD Linkage and Retention in Durham, NC
Study Overview
Status
Intervention / Treatment
Detailed Description
This emPath pilot program will test the V1.0 app's core features (field-first app registration with access via personal device or a tablet stationed at community outreach sites, a secure telemedicine video visit portal designed for drop-in visits during outreach sessions, a secure in-app patient-provider messaging feature) combined with outreach staff facilitation at Project MAPS Durham mobile and fixed-site outreach sessions, to complete these aims:
Aim 1: Pilot the emPath prototype platform to initiate and maintain participants receiving community-based outreach services on all-virtual delivery of medications for opioid-use disorder (MOUD) using a low barrier care strategy.
Investigators will enroll up to 50 people with opioid use disorder for participation in the pilot program using a pilot feasibility-implementation trial. The primary feasibility outcome of interest is retention in care, defined by at least one virtual visit conducted before and after the expected 6-month time-point from enrollment.
Aim 2: Elucidate implementation determinants for the emPath pilot program. Study investigators will perform semi-structured qualitative interviews with up to 20 people who use drugs (PWUD) participants and 10 outreach staff participants to evaluate program implementation, as guided by Forney's conceptual framework for care access (PWUD) and the Consolidated Framework for Implementation Research (staff).
Researchers will use descriptive statistics to describe the baseline characteristics of the sample, including sociodemographics and substance use patterns (e.g., R). Retention defined as telemedicine visit attendance at baseline and before and after the 3 and/or 6-month follow-up time-point (whichever later timepoint is available based on when the participant was recruited) will be summarized with descriptive statistics following analysis of abstracted app paradata and electronic medical record data. As an exploratory question, there will be comparison of retention-in-care and secondary outcomes (e.g., participants who reported personal smartphone ownership at baseline vs not), as well as several baseline demographics (e.g., active injection drug use, housing status, criminal legal involvement in last year). Survey measures for implementation evaluation will be analyzed using descriptive statistics.
Side effects of buprenorphine/naloxone (Suboxone®) are rare and include headache, nausea, constipation, sweating, trouble sleeping, and numbness or pain in the mouth where a patient places the medication. More serious risks include breathing problems, especially if this medication is combined with alcohol, benzodiazepines (like Xanax or Valium), or other sedating drugs. Providers will regularly assess for these side effects during visits per standard of care. Participants will receive buprenorphine/naloxone medication (sublingual) at no added cost to themselves, in addition to related provider services during visits. Currently buprenorphine/naloxone (sublingual tablet formulation) is offered free of cost through a subsidy program for uninsured patients in Durham County, and also carries no associated co-pay for insured patients with Medicaid or Medicare (participants with other forms of insurance may be charged a co-pay). Long-acting injectable formulations will not be offered for this pilot study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacqueline Hodges, MD MPH
- Phone Number: 919 681 1309
- Email: jacqueline.hodges@duke.edu
Study Contact Backup
- Name: Amy Hobbie
- Email: amy.hobbie@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27703
- Recruiting
- Project MAPS (Mobile Addiction Treatment and Primary Care Services)
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Contact:
- Jacqueline Hodges, MD MPH
- Phone Number: 919 681 1309
- Email: jacqueline.hodges@duke.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Outreach program PWOUD (n=50):
- Age 18 or older
- Screen positive for moderate to high risk opioid use by WHO-ASSIST
- Not currently prescribed any form of MOUD
- Able to speak and understand English
- Able and willing to provide informed consent
Inclusion Criteria for Outreach Staff (n=10):
- Age 18 or older
- Employed by the preceding 1 month or longer at time of enrollment
- Able and willing to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: emPath Intervention
Participants receive access to the emPath telemedicine platform and virtual MOUD care.
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Community-partnered telemedicine platform providing registration, video visits, messaging, and low-barrier MOUD access.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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feasibility, as measured by retention in care
Time Frame: up to 6 month visit
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Retention in care is defined by at least one virtual visit conducted before and after the expected 3- or 6-month timepoint from enrollment, whichever later timepoint is available based on the participant's timing of enrollment during the study period.
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up to 6 month visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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acceptability
Time Frame: 3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete
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Surveys (intervention acceptability, appropriateness, fidelity) Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the acceptability of intervention measure (AIM).
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3-month follow-up assessment via the AIM survey, ≤ 5 minutes to complete 6-month follow-up assessment (if applicable) via the AIM survey, ≤ 5 minutes to complete
|
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appropriateness
Time Frame: 3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes
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Program participants and outreach staff will complete a 3 and 6-month follow-up assessment (if applicable) including additional validated survey tools for the implementation evaluation: the intervention appropriateness measure (IAM)
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3-month IAM assessment ≤ 5 minutes 6-month IAM assessment (if applicable) ≤ 5 minutes
|
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intervention fidelity
Time Frame: Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes
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To measure implementation protocol fidelity, staff will complete in a baseline survey and 6-month assessment several items related to their contributions to program activities, roles and responsibilities in relation to the implementation protocol.
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Baseline survey ≤ 5 minutes 6-month survey ≤ 5 minutes
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Intervention reach, as measured by weekly and monthly rates of participant platform feature engagement (dashboard, messaging, queue, video portal)
Time Frame: From enrollment through the end of the study period, up to 12 months
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From enrollment through the end of the study period, up to 12 months
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Intervention adoption, as measured by weekly and monthly rates of staff platform feature engagement (dashboard, messaging, queue, video portal)
Time Frame: From enrollment through the end of the study period, up to 12 months
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Program participants and outreach staff will provide informed consent upon enrollment for abstraction of back-end platform paradata to analyze frequency of platform log-ins, usage patterns (messaging feature, telemedicine portal) and content of messaging feature.
Participants will be counseled that no messaging content analyzed by the study team will be shared with others, including outreach staff, and will only be presented with pilot program findings for research purposes in aggregate form as counts by topic (e.g., medication management, eligibility navigation) or de-identified illustrative 'quotations.'
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From enrollment through the end of the study period, up to 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacqueline Hodges, MD MPH, Duke University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00120378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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