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

美国正面临一场史无前例的阿片类药物流行。美沙酮治疗在减少非法阿片类药物方面有效 使用和过量死亡，然而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--服用口服避孕药的患者最长可持续120天 等待名单。IM是关于联邦药物滥用和精神卫生服务管理局的国家登记的 以证据为基础的项目和实践。两项随机试验，其中一项由我们团队进行， 已经表明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。我们的团队在巴尔的摩的6个OTP中成功实施和评估了1,000个IM 患者超过18个月的时间。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 一些国家阿片类药物治疗当局(SOTAS)对IM的误解，他们必须推荐其 必须执行的审批和OTP主管。尽管阿片类药物仍在流行，但IM的有效性， 以及OTP等待名单的持久性，IM很少在研究之外使用。需要研究来 找到一种有效的方法来推动IM的实施。此应用程序提出了类型3实现 采用阶梯式楔形随机试验设计在普罗科特方案实施中的有效性研究 模特。这项研究将调整、部署和评估实施促进战略的有效性，以 刺激IM治疗的使用。在这一战略中，PI将充当外部推动者，与 全国州酒精和药物滥用主管协会共同领导一个学习合作项目 9个有等待名单的参与OTP的参与SOTA和OTP领导。本地OTP冠军 将被招聘，PI将提供学术细节、IM程序培训和绩效反馈 致OTP工作人员。团队以前工作中的IM操作手册将用于培训OTP工作人员。这个 实施促进干预将在9个OTP中进行，并将包括为估计的 6120名成年人在OTP等待名单上，1710名IM治疗入院。主要执行成果 (美沙酮治疗的可及性)，以及二次实施(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(尿阿片类药物测试结果)结果 将结合未识别的OTP数据和定性的SOTA和OTP工作人员半 结构化面谈。这项拟议的研究具有重要意义，因为它可以证明 刺激IM治疗的实施方法，以减少OTP等待名单。这项研究在以下方面具有创新性 应用实施促进，这是一种用于心理健康和初级保健的方法，以刺激显著的 改变OTP解决治疗需求和能力之间的差距的方式。

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.