Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial

促进临时美沙酮的实施以增加治疗机会：多地点实施试验

• 批准号: 9979810
• 负责人: ROBERT P SCHWARTZ
• 金额: $ 56.43万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979810
• 关键词: Academic Detailing; Address; Admission activity; Adoption; Adult; Alcohol abuse; Awareness; Baltimore; Clinic; Clinical; Clinical effectiveness; Collaborations; Counseling; Data; Data Collection; Drug abuse; Effectiveness; Evaluation; Evidence based practice; Evidence based program; Feedback; Funding; HIV Infections; Health Services Accessibility; Healthcare; Individual; Intervention; Interview; Lead; Leadership; Learning; Manuals; Measures; Mental Health; Methadone; Modeling; National Institute of Drug Abuse; Opioid; Outcome; Paper; Patients; Performance; Pharmacotherapy; Primary Health Care; Procedures; Public Health; Registries; Regulation; Reporting; Research; Research Design; Risk; Services; Site; Structure; Substance Abuse Treatment Centers; Supervision; Test Result; Training; Treatment Cost; United States Substance Abuse and Mental Health Services Administration; Urine; Waiting Lists; Work; authority; design; effective therapy; effectiveness implementation study; health care service organization; illicit opioid; implementation trial; innovation; interest; medication administration; methadone patient; methadone treatment; operation; opioid agonist therapy; opioid epidemic; opioid mortality; opioid treatment program; opioid use; opioid use disorder; outreach; overdose death; primary outcome; programs; randomized trial; recruit; scale up; substance abuse treatment; trial design; uptake

The US is facing an unprecedented opioid epidemic. Methadone treatment is effective in reducing illicit opioid use and overdose death, yet waiting lists for Opioid Treatment Programs (OTPs) persist in numerous states. Federal regulations since 1993 permit the provision of interim methadone (IM) treatment – consisting of supervised methadone administration without routine counseling – for up to 120 days for people on OTP waiting lists. IM is on federal Substance Abuse and Mental Health Services Administration’s National Registry of Evidence-based Programs and Practices. Two randomized trials, including one conducted by our team, have shown that IM treatment is more effective than waiting list in increasing OTP admission and reducing illicit opioid use. Our team led the successful implementation and evaluation of IM in six Baltimore OTPs for 1,000 patients over an 18-month period. The Center for Substance Abuse Treatment recently commissioned the PI to author a white paper on IM that found barriers to the implementation of IM include lack of awareness and misconceptions about IM among some State Opioid Treatment Authorities (SOTAs) who must recommend its approval and OTP Directors who must implement it. Despite the ongoing opioid epidemic, IM’s effectiveness, and the persistence of OTP waiting lists, IM has rarely been used outside of research. Research is needed to find an effective approach to spur IM’s implementation. This application proposes a Type 3 implementation effectiveness study using a stepped-wedge randomized trial design in the context of Proctor’s implementation model. This study will adapt, deploy, and assess the effectiveness of an Implementation Facilitation strategy to spur the use of IM treatment. In this strategy, the PI will serve as the external facilitator to work with the National Association of State Alcohol and Drug Abuse Directors to co-lead a learning collaborative for participating SOTAs and OTP leadership of nine participating OTPs with waiting lists. Local OTP champions will be recruited and the PI will provide academic detailing, IM procedures training, and performance feedback to OTP staff. The IM operations manual from the team’s previous work will be used to train OTP staff. The Implementation Facilitation intervention will occur in 9 OTPs, and will include data collection for an estimated 6,120 adults on OTP waiting lists and 1,710 IM treatment admissions. The primary implementation outcome (Accessibility to methadone treatment), as well as secondary implementation (Uptake, Efficiency, Fidelity, Sustainability, Feasibility, and Acceptability) and clinical effectiveness (urine opioid testing results) outcomes will be measured using a combination of de-identified OTP data and qualitative SOTA and OTP staff semi- structured interviews. The proposed study is highly significant because it could demonstrate an effective approach to spur the implementation of IM treatment to reduce OTP waiting lists. This study is innovative in applying Implementation Facilitation, an approach used in mental health and primary care, to spur a significant change in how OTPs address the gap between treatment demand and capacity.

美国正面临前所未有的阿片类药物流行病。美沙酮治疗可有效减少非法阿片类药物 但许多州仍然存在阿片类药物治疗计划 (OTP) 的等待名单。 自 1993 年以来的联邦法规允许提供临时美沙酮 (IM) 治疗 – 包括 在没有常规咨询的情况下监督美沙酮给药——对于接受 OTP 的人最多 120 天 等候名单。 IM 已列入联邦药物滥用和心理健康服务管理局的国家登记处 循证计划和实践。两项随机试验，其中一项是由我们团队进行的， 研究表明，IM 治疗在增加 OTP 入院率和减少非法行为方面比等待名单更有效 阿片类药物的使用。我们的团队领导在巴尔的摩的 6 个 OTP 中成功实施和评估了 1,000 名 IM 超过 18 个月的患者。药物滥用治疗中心最近委托 PI 作者撰写了一份关于 IM 的白皮书，发现实施 IM 的障碍包括缺乏意识和 一些州阿片类药物治疗机构 (SOTA) 对 IM 存在误解，他们必须推荐其 批准和必须执行的 OTP 董事。尽管阿片类药物流行，但 IM 的有效性， 由于 OTP 等待名单的持续存在，IM 很少在研究之外使用。需要研究 找到一种有效的方法来促进 IM 的实施。该应用提出了类型 3 的实现 在 Proctor 实施的背景下使用阶梯式楔形随机试验设计的有效性研究 模型。本研究将调整、部署和评估实施促进策略的有效性，以 刺激 IM 治疗的使用。在此战略中，PI 将作为外部推动者与 全国酒精和药物滥用主任协会将共同领导一个学习合作项目 九个参与 OTP（有等候名单）的参与 SOTA 和 OTP 领导层。本地 OTP 冠军 将被招募，PI 将提供学术详细信息、IM 程序培训和绩效反馈 给 OTP 工作人员。团队之前工作中的 IM 操作手册将用于培训 OTP 员工。这 实施促进干预将在 9 个 OTP 中进行，并将包括估计的数据收集 6,120 名成人在 OTP 等候名单上，1,710 名 IM 治疗入院。主要实施成果 （美沙酮治疗的可及性）以及二级实施（吸收、效率、保真度、 可持续性、可行性和可接受性）和临床有效性（尿液阿片类药物检测结果）结果 将结合使用去识别化的 OTP 数据和定性 SOTA 和 OTP 工作人员半 结构化面试。拟议的研究非常重要，因为它可以证明有效的 刺激 IM 治疗实施的方法，以减少 OTP 等待名单。这项研究的创新之处在于 应用实施促进（一种用于心理健康和初级保健的方法）来刺激显着的 改变 OTP 如何解决治疗需求和能力之间的差距。