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

美国正面临前所未有的阿片类药物流行。美沙酮治疗可有效减少非法阿片类药物 使用和过量死亡，但阿片类药物治疗计划（OTP）的等待名单在许多州仍然存在。 自1993年以来，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OTP患者长达120天 等候名单IM是联邦药物滥用和精神卫生服务管理局的国家登记处 循证方案和实践。两项随机试验，包括我们团队进行的一项， 研究表明，IM治疗在增加OTP入院率和减少非法 阿片类药物使用我们的团队在6个巴尔的摩OTP中成功实施和评估了IM， 患者在18个月内。药物滥用治疗中心最近委托PI 我写了一份关于IM的白色文件，发现IM实施的障碍包括缺乏意识， 一些国家阿片类药物治疗机构（SOTA）对IM的误解，他们必须建议 批准和OTP董事谁必须执行它。尽管持续的阿片类药物流行病，IM的有效性， 以及OTP等待列表的持久性，IM很少在研究之外使用。的研究需要 找到一种有效的方法来推动IM的实施。本申请提出了类型3实现 在普罗克特实施的背景下，使用阶梯楔形随机试验设计的有效性研究 模型这项研究将调整、部署和评估执行便利化战略的有效性， 刺激IM治疗的使用。在这一战略中，PI将作为外部促进者， 国家酒精和药物滥用主任全国协会共同领导一个学习合作， 参与的特别行动任务区和检察官办公室领导9个参与的检察官办公室，有等待名单。地方检察官办公室的拥护者 将被招募，PI将提供学术细节，IM程序培训和绩效反馈 检察官办公室工作人员。该小组以前工作中的信息管理业务手册将用于培训检察官办公室工作人员。的 将在9个示范点开展促进执行工作的干预活动，并将包括收集数据， 6，120名成人在OTP等候名单上，1，710名IM治疗入院。主要执行成果 （获得美沙酮治疗），以及二级实施（吸收，效率，忠诚， 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 将使用去除身份的检察官办公室数据和定性的特别任务授权和检察官办公室工作人员半 结构化面试这项研究非常重要，因为它可以证明一种有效的 方法，以刺激实施IM治疗，以减少OTP等待名单。本研究具有创新性， 应用实施促进，一种用于精神卫生和初级保健的方法， OTP如何解决治疗需求和能力之间的差距的变化。

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.