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: 10665470
• 负责人: Sara J. Becker
• 金额: $ 72.23万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10665470
• 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 evaluation; 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 阿片类药物使用障碍 (OUD) 导致的过量用药和死亡已被宣布为突发公共卫生事件 美国，揭示了对高效 OUD 治疗的迫切需求。目前有五个 FDA 批准的药物配方，相对于安慰剂，已证明可有效帮助 患者戒除阿片类药物。尽管如此，患者的阿片类药物戒断率并不理想：甚至 当使用最新的缓释制剂治疗时，只有约 40% 的患者能够保持戒断 在治疗的前 6 个月内。应急管理（CM；即激励措施） 实现预先定义的治疗目标）是唯一被证明可以改善患者症状的行为干预措施之一 与 FDA 批准的药物治疗相结合时戒除阿片类药物。然而不幸的是， OUD 治疗中心对 CM 的吸收率仍然很低。为了满足基于证据的迫切需要 行为 OUD 治疗，我们提出了一项大规模 3 型混合试验，比较两种综合治疗 促进 CM 作为 OUD 中心内药物治疗的辅助手段实施的策略。控制 条件是 SAMHSA 资助的成瘾技术转让网络所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 是通过外部领导力辅导（ELC；即专注于领导力辅导）增强的 ATTC 策略 维持计划）和按绩效付费（P4P；即为实现预先设定的目标而提供的奖金） 实施目标），我们以下简称为 E-ATTC。 E-ATTC 的要素由我们告知 团队之前由 NIH 资助的评估组织级实施策略的工作。使用集群 随机设计，新英格兰地区的 30 个 OUD 治疗中心将被随机分配到两个治疗中心之一 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 员工 (n=60)、两名组织领导者 (n=60) 和 25 名新员工处多次收集 入院患者 (n=750)。此外，每个中心将随机选择 25 个患者图表 (n=750) 审查以检查维持情况。数据收集将使用严格的、可复制的程序，包括电子程序 医疗记录审查、工作人员对情况不知情的录音评级、经过充分验证的措施，以及 禁欲的生物学验证。该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 探索性目标是测试两个组织层面的变量（即实施氛围、领导力）是否 参与）部分中介了实施条件与关键研究成果之间的关系。 研究目标的实现将通过以下方式满足关键的公共卫生需求：(a) 告知如何基于证据 在 OUD 治疗中心实施这种做法，(b) 改善 OUD 患者的治疗结果 药物治疗，以及 (c) 增进关于实施策略为何以及如何发挥作用的知识。

项目成果

Sustainment of Contingency Management within Opioid Treatment Programs: COVID-Related Barriers and Innovative Workflow Adaptations.

阿片类药物治疗计划中应急管理的维持：与新冠病毒相关的障碍和创新工作流程调整。

• DOI: 10.1016/j.dadr.2021.100003
• 发表时间: 2021
• 期刊: Drug and alcohol dependence reports
• 作者: Becker,SaraJ;Bowen,CaitlynA;Reed,EllainaN;Lang,Sharon;Correia,Nicholas;Yermash,Julia;Yap,KimberlyR;Rash,CarlaJ;Garner,BryanR
• 通讯作者: Garner,BryanR

Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial.

• DOI: 10.1186/s13722-023-00409-7
• 发表时间: 2023-09-13
• 期刊: ADDICTION SCIENCE & CLINICAL PRACTICE
• 影响因子: 3.7
• 作者: Janssen, Tim;Garner, Bryan R.;Yermash, Julia;Yap, Kimberly R.;Becker, Sara J.
• 通讯作者: Becker, Sara J.

Virtual Training Is More Cost-Effective Than In-Person Training for Preparing Staff to Implement Contingency Management.

在培训员工实施应急管理方面，虚拟培训比面对面培训更具成本效益。

• DOI: 10.1007/s41347-022-00283-1
• 发表时间: 2022-10-12
• 期刊: Journal of technology in behavioral science

Is necessity also the mother of implementation? COVID-19 and the implementation of evidence-based treatments for opioid use disorders.

• DOI: 10.1016/j.jsat.2020.108210
• 发表时间: 2021-03
• 期刊: Journal of substance abuse treatment
• 影响因子: 3.9
• 作者: Becker SJ;Garner BR;Hartzler BJ
• 通讯作者: Hartzler BJ

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

• DOI: 10.1186/s13722-021-00268-0
• 发表时间: 2021-10-12
• 期刊: Addiction science & clinical practice
• 影响因子: 3.7
• 作者: Becker SJ;Murphy CM;Hartzler B;Rash CJ;Janssen T;Roosa M;Madden LM;Garner BR
• 通讯作者: Garner BR