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.

项目摘要 2019冠状病毒病大流行与阿片类药物流行交织在一起，导致为儿童提供的护理发生了巨大变化。 阿片类药物使用障碍（OUD）。从历史上看，美沙酮一直作为直接观察治疗（DOT）提供， 阿片类药物治疗计划（OTP）。这种护理提供模式一直是获得护理的障碍， 给客户造成了旅行负担和工作及家庭责任中断。为了尽量减少传染性 2020年3月16日，物质滥用和精神卫生服务管理局发布了一项一揽子计划， 一次性用药例外，允许所有“稳定”客户28天的带回家的药物供应， 14-为“不太稳定”的客户提供日常用品。这些变化创造了创新的机会 美沙酮护理服务模式，以减少面对面的需求，从而提高灵活性和以客户为中心 探访然而，不太频繁的DOT可能会导致转移和药物毒性的风险增加。理想模型 将优化灵活性和安全性。我们之前的第一阶段研究证明了 创新的移动的健康平台，提供异步、视频DOT，并筛选 COVID-19用于接受美沙酮治疗的OUD患者。我们建议通过缩放扩展我们先前的研究 通过混合类型2在大型多站点OTP组织中进行干预（视频DOT） 连续性-采用阶梯式楔形分组随机试验设计的实施研究，我们将 同时测试实施和临床结果。我们的目标1：进行阶梯式楔形随机化 试验，以评估影响异步视频DOT验证美沙酮剂量，增加 以及其他治疗结果。一个大型OTP组织内的三个诊所将 随机分配到日历时间的视频DOT的实施。将评估临床结局 通过电子健康记录（实施前和实施后）和通过智能手机应用程序 检查视频DOT的实施是否与以下主要结果相关：（1）增加 观察到的美沙酮剂量比例（远程或亲自）和（2）增加的带回家，以及 次要结局为（3）减少OTP亲自访视，（4）增加药物覆盖率，和（5） 增加90天治疗保留。我们的目标2：进行形成性评估，以：a）了解障碍 和促进者在每个诊所实施视频DOT，B）了解 c）制定最佳做法，支持最佳的 视频DOT的可扩展性。我们将对医疗服务提供者、咨询师、药房进行定性访谈， 护士、临床负责人和客户了解（1）实施VDOT的障碍/促进因素，（2） 改进视频DOT和未来实施的机会，以及（3）关于客户和 在这种情况下，视频DOT是有用的。这项研究的结果将有助于传播 并更广泛地实施美沙酮的视频DOT，以扩大获得和改善以患者为中心的护理 和结果。