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

在新英格兰各地的阿片类药物治疗中心实施应急管理：一项混合 3 型试验

• 批准号: 10215461
• 负责人: Sara J. Becker
• 金额: $ 69.28万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10215461
• 关键词: Abstinence; Achievement; Address; Adoption; Behavior Therapy; Behavioral; Biological; Climate; Cluster randomized trial; Combined Modality Therapy; Competence; Computerized Medical Record; Coupled; Data; Data Collection; Educational workshop; Effectiveness; Elements; Epidemic; Evidence based practice; Experimental Designs; FDA approved; Feedback; Formulation; Funding; Goals; Hybrids; Incentives; Knowledge; Leadership; Learning; Letters; Measurement; Measures; Mediating; Methods; Modeling; Motivation; National Institute of Drug Abuse; New England; Opioid; Outcome; Outcome Study; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Performance; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Pilot Projects; Placebos; Procedures; Psychological reinforcement; Public Health; Quality of Care; Randomized; Research; Rewards; Sampling; Site; Technology Transfer; Testing; Time; Training; United States; United States National Institutes of Health; United States Substance Abuse and Mental Health Services Administration; Urine; Work; addiction; base; blind; community setting; contingency management; design; effectiveness testing; evidence base; experimental study; follow-up; implementation barriers; implementation efforts; implementation measures; implementation outcomes; implementation strategy; improved; improved outcome; innovation; novel; novel strategies; opioid overdose; opioid use disorder; overdose death; pilot trial; practice setting; public health emergency; public health relevance; response; treatment center; trial comparing; uptake

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.

项目描述 因阿片类药物使用障碍而导致的过量服用和死亡（OUD）已被宣布为公共卫生紧急情况 美国，迫切需要对高效的Oud治疗。目前有五个 FDA批准的药物配方，相对于安慰剂，它们在帮助方面表现出了有效性 患者对阿片类药物的禁欲。尽管如此，患者的阿片类药物的禁欲率是次优的： 当用最新的扩展释放配方治疗时，只有约40％的患者保持禁欲 在治疗的前六个月中。应急管理（cm;即，激励的激励措施 实现预定义的治疗目标）是显示改善患者的唯一行为干预措施之一 与FDA批准的药物疗法结合使用阿片类药物的禁欲。但是不幸的是， OUD治疗中心中CM的吸收仍然很低。响应迫切需要基于证据的 行为OUD处理，我们提出了一项大规模3型混合试验，比较了两个综合 促进CM实施的策略，作为OUD中心内药物疗法的辅助手段。控件 条件是SAMHSA资助的成瘾技术转移网络使用的员工培训策略 中心（attc;即教学研讨会 +绩效反馈 +员工教练）。实验条件 是由外部领导教练增强的ATTC策略（ELC；即领导教练专注于 维持计划）和绩效付费（P4P；即实现预定的货币奖金 实施目标），我们将其称为E-ATTC。 E-ATTC的元素已由我们的信息告知 团队先前由NIH资助的工作评估组织级实施策略。使用集群 随机设计，新英格兰的30个OUD治疗中心将被随机分为两个 在5年项目中实施条件（ATTC与E-ATTC）。在每个OUD治疗中心，数据将 可以从两名CM员工（n = 60），两个组织领导者（n = 60）和25个新的25个新员工中收集多个间隔 录取的患者（n = 750）。此外，将随机选择每个中心25个患者图表（n = 750） 审查以检查维持。数据收集将使用严格，可复制的程序，包括电子 医疗记录审查，工作人员对状况视而不见的录音的评级，验证良好的措施和 禁欲的生物验证。该研究的具体目的是实验比较 实施结果的两个条件（主要目的）和患者结果（次要目的）。一个 探索性目的是测试两个组织级变量（即实施环境，领导 参与）部分介导了实施条件与关键研究结果之间的关系。 研究目标的实现将通过（a）告知循证基于证据的公共卫生需求 练习是在OUD治疗中心实施的，（b）改善OUD患者的结果 药物疗法，以及（c）促进有关实施策略的工作和方式的知识。