Implementing contingency management in opioid treatment centers across New England: A hybrid type 3 trial

项目说明 年，阿片类药物使用障碍(ODS)导致的过量和死亡已被宣布为公共卫生紧急情况 美国，揭示了对高效OUD治疗的迫切需求。目前有五个 FDA批准的药物配方，相对于安慰剂，已证明在帮助 患者获得阿片类药物的戒断。尽管如此，患者的阿片类药物戒断率并不理想：甚至 当使用最新的缓释制剂治疗时，只有大约40%的患者保持禁欲 在治疗的前6个月。应急管理(CM；即激励激励 实现预先定义的治疗目标)是仅有的可改善患者的行为干预措施之一 与FDA批准的药物治疗相结合时，戒除阿片类药物。然而，不幸的是， 乌德治疗中心对CM的摄取率仍然很低。为了应对以证据为基础的迫切需要 我们提出了一项大规模的3型杂交试验，比较了两种全面的 促进将中药作为药物治疗的辅助手段在大学中心内实施的策略。该控件 条件是SAMHSA资助的成瘾技术转移网络使用的工作人员培训战略 中心(ATTC；即教学研讨会+绩效反馈+员工培训)。实验条件 ATTC战略是否通过外部领导培训(ELC；即专注于以下方面的领导培训 维持规划)和绩效工资(P4P；即实现预定目标的货币奖金 实施目标)，以下我们将其称为E-ATTC。E-ATTC的要素由我们的 团队之前由美国国立卫生研究院资助的工作，评估组织级别的实施战略。使用集群 随机设计，新英格兰的30个OUD治疗中心将随机分为两个 五年项目的实施条件(ATTC与E-ATTC)。在每个OUD治疗中心，数据将 以多个间隔从两名CM工作人员(n=60)、两名组织领导人(n=60)和25名新员工那里收集 住院患者750例。此外，每个中心(n=750)将随机选择25个患者图表用于 审查以检查维持情况。数据收集将使用严格的、可复制的程序，包括电子 医疗记录审查，对状况视而不见的工作人员对录音的评级，经过充分验证的措施，以及 禁欲的生物验证。这项研究的具体目的是通过实验比较 实施结果(主要目标)和患者结果(次要目标)的两个条件。一个 探索性目标是测试两个组织级别的变量(即实施环境、领导力 参与)部分调节了实施条件和关键研究结果之间的关系。 研究目标的实现将通过以下方式解决关键的公共卫生需求：(A)告知如何以证据为基础 在乌德治疗中心实施实践，(B)改善乌德患者的预后 药物疗法，以及(C)增进关于执行战略为什么和如何奏效的知识。

Project Description Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in OUD treatment centers remains low. In response to the urgent need for evidence-based behavioral OUD treatments, we propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within OUD centers. The control condition is the staff training strategy used by the SAMHSA-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (ELC; i.e., leadership coaching focused on sustainment planning) and pay-for-performance (P4P; i.e., monetary bonuses for achieving pre-defined implementation goals), which we refer to hereafter as E-ATTC. Elements of E-ATTC were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. Using a cluster randomized design, 30 OUD treatment centers across New England will be randomized to one of the two implementation conditions (ATTC vs. E-ATTC) over the 5 year project. At each OUD treatment center, data will be collected at multiple intervals from two CM staff (n=60), two organizational leaders (n=60), and 25 newly admitted patients (n=750). Additionally, 25 patient charts per center (n=750) will be randomly selected for review to examine sustainment. Data collection will use rigorous, replicable procedures including electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes. Achievement of the Study Aims will address critical public health needs by (a) informing how evidence-based practice is implemented in OUD treatment centers, (b) improving the outcomes of OUD patients on pharmacotherapy, and (c) advancing knowledge about why and how implementation strategies work.