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: 10400426
• 负责人: Sara J. Becker
• 金额: $ 1.02万
• 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 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400426
• 关键词: Abstinence; Achievement; Address; Adoption; Behavior Therapy; Behavioral; Biological; Climate; Clinical Research; Clinical Trials Data Monitoring Committees; Collection; Combined Modality Therapy; Competence; Computerized Medical Record; Coupled; Data; Data Analyses; Data Collection; Educational workshop; Effectiveness; Elements; Epidemic; Evaluation; Evidence based practice; Exposure to; FDA approved; Feedback; Formulation; Funding; Goals; Hybrids; Incentives; Institutional Review Boards; Knowledge; Leadership; Learning; Letters; Manuscripts; Measurement; Measures; Mediating; Medicine; Mentors; Mentorship; 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; Preparation; Principal Investigator; Procedures; Psychological reinforcement; Public Health; Quality of Care; Randomized; Research; Research Personnel; Rewards; Schools; 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; Writing; addiction; blind; community setting; contingency management; design; effectiveness testing; evidence base; experimental study; follow-up; implementation barriers; implementation efforts; implementation outcomes; implementation strategy; improved; improved outcome; innovation; novel strategies; opioid overdose; opioid use disorder; overdose death; pilot trial; posters; 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 阿片类药物使用障碍（OUD）导致的过量和死亡已被宣布为公共卫生紧急事件， 美国，揭示了对高效OUD治疗的迫切需求。目前有五 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。应急管理（CM;即，激励措施 实现预定义的治疗目标）是唯一的行为干预措施之一，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。然而，不幸的是， OUD治疗中心的CM吸收率仍然很低。为了满足循证医学的迫切需要， 行为OUD治疗，我们提出了一个大规模的3型杂交试验比较两个全面的 战略，以促进CM的实施作为辅助药物治疗在OUD中心。控制 条件是由SAMHSA资助的成瘾技术转让网络使用的员工培训策略 中心（ATTC;即，教学研讨会+绩效反馈+员工辅导）。实验条件 是ATTC战略通过外部领导力培训（ELC;即，领导力培训侧重于 维持规划）和按业绩计薪（P4P;即，实现预定义的货币奖金 我们称之为E-ATTC。E-ATTC的要素是由我们的 团队先前NIH资助的工作，评估组织层面的实施策略。使用群集 随机设计，新英格兰的30个OUD治疗中心将随机分配至两个治疗中心之一 5年项目的实施条件（ATTC与E-ATTC）。在每个OUD治疗中心，数据将 从两名CM工作人员（n=60），两名组织领导人（n=60）和25名新的 住院患者（n=750）。此外，将随机选择每个中心的25份患者图表（n=750）， 审查以检查维持能力。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，由不了解病情的工作人员对录音进行评级，有效的措施，以及 禁欲的生物学验证本研究的具体目的是通过实验比较 关于实施结果（主要目标）和患者结果（次要目标）的两个条件。一个 探索性目的是测试两个组织级变量（即，执行环境、领导能力 参与度）部分中介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以下方式解决关键的公共卫生需求：（a）告知如何基于证据 实践在OUD治疗中心实施，（B）改善OUD患者的预后， 药物治疗，以及（c）增进关于实施战略为何以及如何发挥作用的知识。