Video observed therapy to enhance flexibility and reduce in-person visits for patients treated with methadone in a multi-site opioid treatment program

视频观察治疗可增强灵活性并减少在多地点阿片类药物治疗计划中接受美沙酮治疗的患者的亲自就诊

• 批准号: 10760641
• 负责人: Kevin A Hallgren
• 金额: $ 65.45万
• 依托单位: EMOCHA MOBILE HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10760641
• 关键词: COVID-19 pandemic; COVID-19 patient; Calendar; Caring; Client; Clinic; Clinical; Cluster randomized trial; Data; Directly Observed Therapy; Dose; Electronic Health Record; Evaluation; Event; Family; Feedback; Funding; Graduation Rates; Guidelines; Health Services Accessibility; Home; Hybrids; Ingestion; Intervention; Interview; Medical; Methadone; Modeling; National Institute of Drug Abuse; Nurses; Observational Study; Outcome; Patient-Centered Care; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Professional counselor; Provider; Randomized; Regulation; Research; Risk; Safety; Sampling; Secure; Service delivery model; Services; Site; Symptoms; Testing; Thinking; Time; Toxic effect; Training; Travel; Treatment outcome; United States Substance Abuse and Mental Health Services Administration; Visit; Work; acceptability and feasibility; care delivery; catalyst; design; effective therapy; effectiveness/implementation study; flexibility; formative assessment; future implementation; handheld mobile device; implementation facilitators; improved; innovation; mHealth; methadone treatment; opioid epidemic; opioid treatment program; opioid use disorder; pandemic disease; pandemic potential; post implementation; primary outcome; randomized trial; secondary outcome; smartphone application; support tools; treatment adherence; treatment duration; trial design

PROJECT SUMMARY The COVID-19 pandemic intersecting with the opioid epidemic led to dramatic shifts in the delivery of care for opioid use disorders (OUD). Historically, methadone has been provided as directly-observed therapy (DOT) at opioid treatment programs (OTPs). This model of care delivery has been a barrier to accessing care due to imposed travel burden and disruption to work and family responsibilities for clients. To minimize infectious risks, on March 16, 2020 the Substance Abuse and Mental Health Services Administration issued a blanket exception to OTPs allowing for 28 day supplies of take-home medications for all “stable” clients, and up to 14-day supplies for clients who are “less stable”. These changes created an opportunity to innovate methadone care delivery models to allow more flexibility and client-centeredness by requiring fewer in-person visits. Yet, less frequent DOT could lead to increased risk for diversion and medication toxicity. An ideal model would optimize both flexibility and safety. Our prior Phase I research demonstrated the feasibility 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. We propose to extend our prior research by scaling the intervention (video-DOT) across a large, multisite OTP organization via a Hybrid Type 2 Effectiveness-Implementation study with stepped wedge cluster randomized trial design in which we will simultaneously test implementation and clinical outcomes. Our Aim 1: Conduct a stepped wedge randomized trial to evaluate the impact of asynchronous video-DOT on verification of methadone dosing, increased take-homes, and other treatment outcomes. Three clinics within a single, large OTP organization will be randomly assigned to calendar time for implementation of video-DOT. Clinical outcomes will be assessed pragmatically via electronic health records (pre- and post-implementation) and via the smartphone application to examine if implementation of video-DOT is associated with primary outcomes of (1) increases in the proportion of methadone doses that are observed (remote or in-person) and (2) increased take-homes, and secondary 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 barriers and facilitators to implementation of video-DOT at each clinic, b) understand perspectives on and acceptability/feasibility of video-DOT among key stakeholders, and c) develop best practices to support optimal scalability of video-DOT. We will conduct qualitative interviews with medical providers, counselors, dispensary nurses, 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 and circumstances for which video-DOT is useful. The findings of this research will inform efforts to disseminate and implement video-DOT for methadone more broadly to expand access and improve patient-centered care and outcomes for persons with OUD.

项目总结