Center for Alcohol and Addiction Studies, Brown University School of Public Health, Box G-S121-5, Providence, RI, 02912, USA.
Addictions, Drug, & Alcohol Institute, University of Washington, 1107 NE 45th Street, Suite 120, Seattle, WA, 98105, USA.
Addict Sci Clin Pract. 2021 Oct 12;16(1):61. doi: 10.1186/s13722-021-00268-0.
Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).
A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).
There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.
This clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.
在美国，阿片类药物相关的过量和危害已被宣布为公共卫生紧急事件，这凸显了急需实施基于证据的治疗方法。当与阿片类药物使用障碍的药物联合使用时，应急管理（CM）是最有效的行为干预措施之一，但在阿片类药物治疗计划中的实施却非常有限。项目 MIMIC（最大限度地提高动机激励在诊所中的实施）由国家药物滥用研究所资助，旨在确定有效的策略，帮助阿片类药物治疗计划改善 CM 的实施，作为药物治疗的辅助手段。具体目标将测试两种不同策略对实施结果（主要目标）和患者结果（次要目标）的影响，以及测试实施效果的假设中介因素（探索性目标）。
采用 3 队列、集群随机、3 型混合设计，以阿片类药物治疗计划为随机单位。30 个计划随机分为两种条件之一。对照组是成瘾技术转让中心（ATTC）网络实施策略，包括三种核心方法：教学培训、绩效反馈和持续咨询。实验组是增强型 ATTC 策略，具有相同的核心 ATTC 要素加上两个额外的基于理论的要素。两个额外的要素是按绩效付费，旨在提高实施人员的外在动机，以及实施和维持促进，旨在针对员工的内在动机。将使用一种新颖的 CM 跟踪器工具收集数据，以记录 CM 会议的交付情况、会议录音、提供者调查和患者调查。实施结果包括 CM 暴露（每个患者接受的 CM 次数）、CM 技能（CM 保真度评级）和 CM 维持（在取消支持后接受 CM 的患者数量）。患者结果包括自我报告的阿片类药物戒断和阿片类药物相关问题（均在基线后 3 个月和 6 个月进行评估）。
迫切需要改善 CM 的实施，作为阿片类药物使用障碍药物治疗的辅助手段。与混合 3 型设计一致，项目 MIMIC 通过比较这两种多方面策略对实施和患者结果的影响，以及通过检查这些策略的影响可以在多大程度上通过假设的中介因素来解释，来推进实施科学。
这项临床试验已在 clinicaltrials.gov 注册（NCT03931174）。2019 年 4 月 30 日注册。https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.
