Project 3: Contingency Management in Combination with MAT for Opioid Use Disorders

项目描述 由于阿片类药物使用障碍（OUD）导致的过量和死亡在非洲已达到流行病的比例， 在罗得岛州，迫切需要高效的OUD治疗。目前有5个FDA- 批准的药物配方，相对于安慰剂，已证明有效地帮助 患者可戒除阿片类药物。尽管如此，患者的阿片类药物戒断率是次优的：即使 当用最新的缓释制剂治疗时，只有约40%的患者保持禁欲 在治疗的前6个月内服用阿片类药物。应急管理（CM;即，动机性激励 实现预定义的治疗目标）是唯一的行为干预，以改善患者 当与FDA批准的药物治疗结合时，戒除阿片类药物。不幸的是，非常 由于组织和提供者层面的障碍，很少有OUD治疗中心提供CM。在 对有效治疗OUD的迫切需求的回应，以及确定最佳策略的需要， 为了在现实环境中实施循证创新，我们提出了一项3型混合试验，重点是 实施循证CM方案作为OUD治疗中阿片类药物治疗的辅助治疗 中心.更具体地说，我们建议在12个地点进行一项为期5年的随机分组试验， 罗得岛州，以测试两个全面实施条件的有效性。控制 条件是由SAMHSA资助的成瘾网络使用的最先进的员工培训策略 技术转让中心（ATTC），教学研讨会+绩效反馈+员工辅导）。的 实验条件是ATTC策略与外部领导教练（ELC;即，领导 培训侧重于可持续性规划），我们在下文中将其称为ATTC + ELC。ATTC + ELC 项目负责人先前的试点工作评估了ATTC实施战略， 在这个为期五年的项目中，罗得岛的12个阿片类药物治疗中心将被随机分配到其中一个 两种实施条件（ATTC与ATTC + ELC）。在每个参与的OUD治疗中心，数据将 从两名CM工作人员（n=24）、两名组织领导（n=24）和32名最近 住院患者（n=384）。目标1将通过实验比较两种实现条件， 两个实施结果（即，CM暴露、CM能力、CM可持续性）和患者结局 (i.e.,阿片类药物戒断日，阿片类药物相关问题）。目标2将测试执行环境， 执行准备程度作为执行条件与执行 关键研究成果。这两个目标的实现将满足以下方面的关键公共卫生需求： 需要提高OUD治疗的有效性，以及（B）需要提高关于 如何在实践环境中最好地实施循证创新。

Project Description With overdoses and deaths due to opioid use disorders (OUDs) having reached epidemic proportions in the state of Rhode Island, there is a critical 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 from opioids during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is the only behavioral intervention shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, very few OUD treatment centers provide CM due to a myriad of organization- and provider-level barriers. In response to the urgent need for effective OUD treatments, as well as the need to identify the best strategies to implement evidence-based innovations within real-world settings, we propose a type 3 hybrid trial focused on implementing an evidence-based CM protocol as an adjunct to opioid pharmacotherapy within OUD treatment centers. More specifically, we propose to conduct a 5-year cluster randomized trial with 12 sites across the state of Rhode Island to test the effectiveness of two comprehensive implementation conditions. The control condition is the state-of-the-art 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 paired with external leadership coaching (ELC; i.e., leadership coaching focused on sustainment planning), which we refer to hereafter as ATTC + ELC. The ATTC + ELC condition was informed by the Project Lead’s prior pilot work evaluating the ATTC implementation strategy. Over the five-year project, 12 opioid treatment centers across Rhode Island will be randomized to one of the two implementation conditions (ATTC vs. ATTC + ELC). At each participating OUD treatment center, data will be collected at multiple intervals from two CM staff (n=24), two organizational leaders (n=24), and 32 recently admitted patients (n=384). Aim 1 will experimentally compare the two implementation conditions in terms of both implementation outcomes (i.e., CM Exposure, CM Competence, CM Sustainability) and patient outcomes (i.e., Opioid Days of Abstinence, Opioid-Related Problems). Aim 2 will test implementation climate and implementation readiness as putative mediators of the relationship between implementation condition and the key study outcomes. Achievement of these two aims will address critical public health needs regarding (a) the need to improve OUD treatment effectiveness, and (b) the need to improve generalizable knowledge regarding how best to implement evidence-based innovations within practice settings.