Planning grant for a multi-site trial to examine the effectiveness of recovery community centers serving Black communities to support persons using medications for opioid use disorder

为多地点试验规划拨款，以检查为黑人社区服务的康复社区中心支持使用阿片类药物使用障碍药物的人的有效性

• 批准号: 10588672
• 负责人: Bettina B. Hoeppner
• 金额: $ 74.24万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2025-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10588672
• 关键词: Address; Black race; Buprenorphine; COVID-19 pandemic; Caring; Clinic; Clinical; Clinical Practice Guideline; Communities; Confidence Intervals; Consensus; Data; Dimensions; Effectiveness; Enrollment; Environment; FDA approved; Feedback; Funding; Gold; Grant; Growth; Guidelines; Happiness; Health Services Accessibility; Heart; Improve Access; Infrastructure; Interview; Investments; Logistics; Longitudinal Studies; Methadone; Modeling; Monoclonal Antibody R24; Naltrexone; National Institute of Drug Abuse; Nature; Outcome; Outcome Measure; Participant; Pathway interactions; Patient-Focused Outcomes; Patients; Perception; Persons; Pharmaceutical Preparations; Procedures; Randomized; Randomized Clinical Trials; Recovery; Research; Science; Services; Site; Surveys; Testing; Time; United States Dept. of Health and Human Services; Work; care systems; clinical care; community based participatory research; community center; design; follow up assessment; health disparity; improved; indexing; insight; lens; multi-site trial; opioid epidemic; opioid use disorder; peer; person centered; primary outcome; public health emergency; recruit; secondary outcome; standard care; success; treatment as usual; treatment duration; trial comparing

Project Summary To address the ongoing opioid epidemic, the U.S. Department of Health and Human Services (HHS) seeks to improve access to treatment and recovery services. Currently, the gold-standard treatment for opioid use disorder (OUD) is long-term treatment using FDA-approved medications (MOUDs). Early discontinuation of MOUD use represents a critical barrier to the effectiveness of MOUDs, as more than half of persons who start MOUD use discontinue it early. Approaches are needed that support persons initiating MOUD treatment to stay engaged in medication assisted recovery over the longer term. Recovery community centers (RCCs) are emerging as an important third component of recovery-oriented systems of care that, until recently, were comprised solely of professional treatment and mutual-help organizations. These centers provide a welcoming recovery-oriented environment for persons using MOUDs that provide a range of recovery-oriented, peer- delivered services over the long-term. Despite recent rapid large-scale investment in their growth, empirical data on the functioning and outcomes of RCCs are extremely limited. Critically needed is research that can speak to the effectiveness of RCCs. To address this need, and in line with RFA-DA-22-034's use of the R34 Planning Grant mechanism, we propose to conduct three preparatory studies that can inform the design and logistics of a planned subsequent rigorous R01-level trial. Our proposal builds on two key strengths: (1) our existing and growing NIDA-funded infrastructure to advance the science on RCCs (R24 DA051988; M-PIs: Hoeppner & Kelly), which allowed us to build relationships with RCCs nationwide and gain insight into consensus around appropriate outcome measures, and (2) the existing relationships of the RCCs participating in this project with MOUD-providing clinics near them. Because the COVID-19 pandemic is widening health disparity gaps, including widening disparities in OUD care, our focus is on RCCs serving Black communities. Using a community-based participatory research approach, our aims are to provide insight into key components of the planned subsequent rigorous R01-level trial using three distinct lines of inquiry. Aim 1 is to conduct a (small, multi-site) naturalistic longitudinal study of MOUD clinic patients to provide insight into the appropriateness of study procedures, and to receive feedback on randomization procedures. Aim 2 is to conduct a (small, multi-site) pilot randomized clinical trial (RCT) comparing two randomized groups of persons engaged in MOUD clinical care: those who receive linkage to their nearby RCC vs. those who do not. Aim 3 widens the lens beyond the RCCs participating in Aims 1 and 2. Directors and front desk staff of MOUD- providing clinics near RCCs serving Black communities will be surveyed and interviewed to identify barriers to incorporating a potential RCC linkage into MOUD clinics' standard clinical care models. Together, these three studies will guide the design of a large-scale subsequent R01 level RCT.

项目摘要 为了解决持续的阿片类药物流行病，美国卫生与公众服务部（HHS）寻求 改善获得治疗和康复服务的机会。目前，阿片类药物使用的黄金标准治疗 疾病（OUD）是使用FDA批准的药物（MOUD）的长期治疗。提前停用 MOUD的使用是MOUD有效性的一个关键障碍，因为超过一半的人开始使用MOUD， MOUD使用尽早停止。需要采取方法，支持开始MOUD治疗的人， 长期从事药物辅助康复。康复社区中心（RCCs） 作为康复护理系统的第三个重要组成部分，直到最近， 完全由专业治疗和互助组织组成。这些中心提供了一个欢迎 为使用MOUD的人员提供一个面向恢复的环境， 长期提供服务。尽管最近对它们的增长进行了快速的大规模投资， 关于驻地协调员的运作和成果的数据极为有限。迫切需要的是研究， 这是关于RCCs的有效性。为了满足这一需求，并根据RFA-DA-22-034对R34的使用 规划补助金机制，我们建议进行三项预备研究，为设计和 计划的后续严格R 01水平试验的后勤工作。我们的建议建立在两个主要优势之上：（1）我们的 现有的和不断增长的NIDA资助的基础设施，以促进RCC的科学（R24 DA 051988; M-PI： Hoeppner & Kelly），这使我们能够与全国的RCCs建立关系，并深入了解 围绕适当的结果测量达成共识，以及（2）参与的RCCs的现有关系 在这个项目中，MOUD提供的诊所就在他们附近。因为COVID-19大流行正在扩大健康 差距，包括在OUD护理的差距扩大，我们的重点是在RCCs服务黑人社区。 使用以社区为基础的参与式研究方法，我们的目标是提供洞察关键 计划随后进行的严格的R 01级试验的组成部分，使用三个不同的调查路线。目标1是 对MOUD诊所患者进行（小型，多地点）自然主义纵向研究，以深入了解 研究程序的适当性，并接收关于随机化程序的反馈。目标二是 进行一项（小型、多中心）先导性随机临床试验（RCT），比较两组随机人群 从事MOUD临床护理：那些谁收到链接到他们附近的RCC与那些谁没有。目标3 扩大了透镜的范围，使之超出参与目标1和2的区域合作中心。MOUD的主管和前台工作人员- 将对在为黑人社区服务的RCC附近提供诊所进行调查和访谈，以确定 将潜在的RCC链接纳入MOUD诊所的标准临床护理模式。在一起，这三个 研究将指导后续大规模R 01水平RCT的设计。