SBIR-STTR Award

Methadone remains a cornerstone of treatment for opioid use disorders (OUD). Daily or frequent supervised treatment with visual confirmation of ingestion (directly-observed therapy or “DOT”), is the standard of care for methadone treatment in federally licensed opioid treatment programs (OTPs) in the United States. DOT ensures adherence and mitigates the risk of medication poisonings and diversion; however, these same policies present major challenges to infection control. The COVID-19 pandemic has spurred initiatives to increase the number of non-observed take-home doses. Remote systems for monitoring DOT of methadone and screening of patients for COVID-19 are desperately needed by OTPs: the emocha mobile health provides a solution. Specific Aim #1 is to evaluate the acceptability, feasibility, and outcomes of an innovative mHealth platform to deliver asynchronous video-based DOT services plus COVID-19 symptom screening via smartphone for patients receiving methadone at an opioid treatment program that was implemented rapidly in response to COVID-19. In order to provide remote supervision and recovery support for patients with extended take-home doses due to the COVID-19 pandemic, Evergreen Treatment Services (ETS) rapidly implemented emocha’s video DOT pilot program for patients on methadone for OUD on April 16, 2020 and enrolled 38 patients within 2 weeks. We will conduct a retrospective, observational study of patients who utilized the video-DOT/symptom screening app during this pilot. Specific Aim #2 is to evaluate usability and user experiences of the innovative mHealth platform to deliver asynchronous video-based DOT services plus COVID-19 symptom screening via smartphone for patients receiving methadone at an opioid treatment program that was rapidly implemented in response to COVID-19. A usability study will be conducted with subsets of “high-use”, “medium-use” and “low-use” patients who participated in the pilot and the five counselors who offered the app and used the app’s web-based clinician-facing portal. The researchers will conduct usability testing sessions to objectively measure the duration of time and number of errors associated with completing video-DOT tasks and will obtain subjective ratings of the difficulty and helpfulness of video-DOT tasks and features. This Phase I research will well-position the team to submit a grant for Phase II in order to measure efficacy and further develop the model for business sustainability, which will allow for rapid translation to other OTPs.

Public Health Relevance Statement:
PROJECT NARRATIVE In early 2020, the opioid epidemic in the United States collided with the global COVID-19 pandemic. COVID-19 poses a particularly grave risk to persons with opioid use disorder (OUD) who are treated with methadone in opioid treatment programs where the standard of care is directly-observed therapy (DOT). The overarching goal of the propose research is to assess the feasibility, safety and acceptability of an innovative mobile health platform to provide asynchronous, video DOT and to screen for symptoms of COVID-19 for patients treated for OUD with methadone.

Project Terms:
active method; Adherence; Algorithms; American; arm; base; Buprenorphine; Businesses; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Chronic Obstructive Airway Disease; Clinic; Clinical; clinical center; comorbidity; COVID-19; COVID-19 pandemic; Diabetes Mellitus; Directly Observed Therapy; Dose; Enrollment; Ensure; experience; Face; Future; Goals; Grant; health care service utilization; Hepatitis C; high risk; HIV; Home environment; Hypertension; Incentives; Individual; Infection Control; Ingestion; innovation; insight; Interruption; Intervention; Measures; Medical; medication compliance; Medication Management; Methadone; methadone treatment; mHealth; Modeling; Monitor; Muscle Cramp; Observational Study; Online Systems; opioid epidemic; opioid treatment program; opioid use disorder; Outcome; pandemic disease; patient screening; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Phase; Policies; Positioning Attribute; prevent; Professional counselor; Professional Organizations; programs; Recovery; Reporting; Research; Research Personnel; response; Risk; Risk-Benefit Assessment; rural area; Safety; Scheme; screening; Services; Social Distance; social vulnerability; standard of care; Supervision; support tools; Symptoms; System; Technology; Testing; Time; tool; Toxic effect; Translations; treatment comparison; Treatment Efficacy; Treatment outcome; treatment services; Tuberculosis; United States; United States Substance Abuse and Mental Health Services Administration; usability; Visual; web app

The COVID-19 pandemic intersecting with the opioid epidemic led to dramatic shifts in the delivery of care foropioid use disorders (OUD). Historically, methadone has been provided as directly-observed therapy (DOT) atopioid treatment programs (OTPs). This model of care delivery has been a barrier to accessing care due toimposed travel burden and disruption to work and family responsibilities for clients. To minimize infectiousrisks, on March 16, 2020 the Substance Abuse and Mental Health Services Administration issued a blanketexception to OTPs allowing for 28 day supplies of take-home medications for all "stable" clients, and up to14-day supplies for clients who are "less stable". These changes created an opportunity to innovatemethadone care delivery models to allow more flexibility and client-centeredness by requiring fewer in-personvisits. Yet, less frequent DOT could lead to increased risk for diversion and medication toxicity. An ideal modelwould optimize both flexibility and safety. Our prior Phase I research demonstrated the feasibility of aninnovative mobile health platform to provide asynchronous, video DOT and to screen for symptoms ofCOVID-19 for patients treated for OUD with methadone. We propose to extend our prior research by scalingthe intervention (video-DOT) across a large, multisite OTP organization via a Hybrid Type 2Effectiveness-Implementation study with stepped wedge cluster randomized trial design in which we willsimultaneously test implementation and clinical outcomes. Our Aim 1: Conduct a stepped wedge randomizedtrial to evaluate the impact of asynchronous video-DOT on verification of methadone dosing, increasedtake-homes, and other treatment outcomes. Three clinics within a single, large OTP organization will berandomly assigned to calendar time for implementation of video-DOT. Clinical outcomes will be assessedpragmatically via electronic health records (pre- and post-implementation) and via the smartphone applicationto examine if implementation of video-DOT is associated with primary outcomes of (1) increases in theproportion of methadone doses that are observed (remote or in-person) and (2) increased take-homes, andsecondary outcomes of (3) reduced in-person OTP visits, (4) increased medication coverage, and (5)increased 90-day treatment retention. Our Aim 2: Conduct a formative evaluation to: a) understand barriersand facilitators to implementation of video-DOT at each clinic, b) understand perspectives on andacceptability/feasibility of video-DOT among key stakeholders, and c) develop best practices to support optimalscalability of video-DOT. We will conduct qualitative interviews with medical providers, counselors, dispensarynurses, clinical leaders, and clients to understand (1) barriers/facilitators to implementing VDOT, (2)opportunities to improve video-DOT and future implementations, and (3) perspectives regarding clients andcircumstances for which video-DOT is useful. The findings of this research will inform efforts to disseminateand implement video-DOT for methadone more broadly to expand access and improve patient-centered careand outcomes for persons with OUD.

Public Health Relevance Statement:
PROJECT NARRATIVE Methadone is an effective treatment for opioid use disorder (OUD) yet historically the care delivery model requires directly-observed therapy (DOT) at opioid treatment programs which is a barrier to clients. The pandemic initially exacerbated those challenges but ultimately led to the revision of regulations, paving the way for more flexible models of care. Our prior Phase I research demonstrated the feasibility, safety, and acceptability of an innovative mobile health platform to provide asynchronous, video DOT and to screen for symptoms of COVID-19 for patients treated for OUD with methadone; this proposal aims to test the implementation of video direct observe therapy (video-DOT) for methadone across a large, multisite OTP organization via a Hybrid Type 2 Effectiveness Implementation study with stepped wedge cluster randomized trial design.

Project Terms: