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.

项目概要 为了解决持续存在的阿片类药物流行问题，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，阿片类药物使用的金标准治疗 疾病 (OUD) 是使用 FDA 批准的药物 (MOUD) 进行的长期治疗。提前终止 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使用请尽早停止。需要采取一些方法来支持开始 MOUD 治疗的人 长期坚持药物辅助康复。康复社区中心 (RCC) 是 正在成为以康复为导向的护理系统的重要第三个组成部分，直到最近， 仅由专业治疗和互助组织组成。这些中心提供热情的服务 为使用 MOUD 的人员提供以恢复为导向的环境，提供一系列以恢复为导向的、同伴 长期提供服务。尽管最近对其增长进行了大规模的快速投资，但实证 关于农村信用社的运作和成果的数据极其有限。迫切需要的是能够 谈论农村信用社的有效性。为了满足这一需求，并符合 RFA-DA-22-034 对 R34 的使用 规划拨款机制，我们建议进行三项准备性研究，为设计和 计划的后续严格 R01 级试验的后勤。我们的建议建立在两个关键优势之上：（1）我们的 NIDA 资助的现有和不断增长的基础设施，以推进 RCC 科学发展（R24 DA051988；M-PI： Hoeppner & Kelly），这使我们能够与全国范围内的 RCC 建立关系并深入了解 就适当的结果措施达成共识，以及 (2) 参与的农村信用社的现有关系 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范围 差距，包括 OUD 护理方面不断扩大的差距，我们的重点是为黑人社区提供服务的 RCC。 使用基于社区的参与式研究方法，我们的目标是深入了解关键问题 计划的后续严格 R01 级试验的组成部分使用三个不同的调查线。目标 1 是 对 MOUD 诊所患者进行（小型、多地点）自然纵向研究，以深入了解 研究程序的适当性，并接收有关随机化程序的反馈。目标 2 是 进行一项（小型、多中心）试点随机临床试验 (RCT)，比较两组随机分组的人 从事 MOUD 临床护理：那些与附近的 RCC 连接的人与那些没有连接的人。目标 3 扩大了参与目标 1 和 2 的农村信用社的范围。MOUD 的主任和前台工作人员- 将对为黑人社区提供服务的 RCC 附近提供的诊所进行调查和访谈，以找出为黑人社区提供服务的障碍 将潜在的 RCC 联系纳入 MOUD 诊所的标准临床护理模式。这三个人在一起 研究将指导后续大规模R01级RCT的设计。