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: 