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 与阿片类药物流行相交的19009年大流行导致护理交付的急剧转变 Oopioid使用障碍（OUD）。从历史上看，Metagadone已被作为直接观察的治疗（DOT） 阿片类药物治疗计划（OTP）。这种护理交付模式一直是由于 施加旅行伯恩（Burnen）以及对客户的工作和家庭责任的干扰。最大程度地减少感染力 风险，2020年3月16日，药物滥用和精神卫生服务管理局发行了毯子 OTP的例外，允许为所有“稳定”客户提供28天的带租用药物供应， 为“不太稳定”的客户提供的14天供应。这些变化为创新提供了机会 Metagadone护理交付模型，可以通过更少的面对面来允许更高的灵活性和以客户为中心 访问。然而，较少的点可能导致转移和药物毒性的风险增加。理想的模型 将优化灵活性和安全性。我们先前的一阶段研究证明了 创新的移动健康平台可提供异步，视频点，并筛选出症状 COVID-19用于用Meadadone治疗的患者。我们建议通过扩展来扩展我们的先前研究 通过混合类型2的大型多站点OTP组织的干预措施（视频点） 通过阶梯楔形群集随机试验设计的有效性实施研究，我们将在其中 我们的目标1：进行阶梯楔随机 试验以评估异步视频点对验证方法adone剂量的影响，增加 接受者和其他治疗结果。一个大型OTP组织中的三个诊所将是 随机分配给实施视频点的日历时间。将评估临床结果 通过电子健康记录（实施前后）和智能手机应用程序实用。 检查视频点的实现是否与（1）增加的主要结果有关 观察到的方法adone剂量的比例（远程或面对面）和（2）增加的剂量和（2） （3）次要的次要结果减少了OTP访问，（4）药物覆盖范围增加，（5） 增加了90天的治疗保留率。我们的目标2：进行形成性评估：a）了解障碍 并协助每个诊所实施视频点，b）了解有关和 视频点在主要利益相关者中的可接受性/可行性，c）开发最佳实践以支持最佳 视频点的可伸缩性。我们将对医疗提供者，计数，药房进行定性访谈 护士，临床领导者和客户了解（1）实施VDOT的障碍/促进者，（2） 改善视频点和未来实施的机会，以及（3）有关客户和 视频点有用的情况。这项研究的发现将为传播努力提供依据 并更广泛地为Metagadone实施视频点，以扩大访问并改善以患者为中心的护理 和有Oud的人的结果。