Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial.

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial.
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DOI:
10.1186/s13722-021-00268-0
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发表时间:
2021-10-12
影响因子:
3.7
通讯作者:
Garner BR
Garner BR
中科院分区:
医学2区
文献类型:
--
作者:
Becker SJ;Murphy CM;Hartzler B;Rash CJ;Janssen T;Roosa M;Madden LM;Garner BR

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在美国,与阿片类药物有关的过量和危害已被宣布为公共卫生紧急事件,这突出表明迫切需要实施循证治疗。应急管理(CM)是与阿片类药物使用障碍药物联合使用时最有效的行为干预措施之一,但其在阿片类药物治疗计划中的实施非常有限。项目MIMIC(最大限度地实施激励措施在诊所)是由国家药物滥用研究所资助,以确定有效的策略,帮助阿片类药物治疗计划改善CM的实施作为一种辅助药物。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,以及测试实施有效性的假定中介(探索性目标)。使用3队列、整群随机化、3型混合设计,阿片类药物治疗方案作为随机化单位。30个程序被随机分配到两个条件之一。控制条件是成瘾技术转移中心(ATTC)网络实施战略,其中包括三个核心方法:教学培训,绩效反馈和持续咨询。实验条件是增强的ATTC策略,具有相同的核心ATTC元素加上两个额外的理论驱动的元素。另外两个要素是按业绩计薪,其目的是增加执行工作人员的外在动机,以及促进执行和维持,其目标是工作人员的内在动机。将使用一种新型的CM Tracker工具收集数据,以记录CM会话交付、会话录音、提供者调查和患者调查。实施结果包括CM暴露(每位患者提供的CM会话数量)、CM技能(CM保真度评级)和CM维持(移除支持后接受CM的患者数量)。患者结局包括自我报告的阿片类戒断和阿片类相关问题(均在基线后3个月和6个月进行评估)。迫切需要改善CM作为阿片类药物使用障碍的辅助药物的实施。与其混合3型设计相一致,MIMIC项目通过比较这两种多方面策略对实施和患者结局的影响,以及通过检查这些策略的影响在多大程度上可以由假定的中介解释,来推进实施科学。试验注册:本临床试验已在clinicaltrials.gov注册(NCT 03931174)。2019年4月30日注册。https://clinicaltrials.gov/ct2/show/NCT03931174? term=project+mimic&draw=2&rank=1
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. Trial registration: 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
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发表时间: 1986-12-01
影响因子: 7.6
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期刊: Implementation science : IS
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发表时间: 2005-04-01
影响因子: 9.5
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发表时间: 2018-04-01
影响因子: 4.2
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