Racial Equity in Systems to Treat Opioid Use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial

治疗所有人阿片类药物使用障碍的系统中的种族平等（RESTORE）：一项试点随机对照试验

• 批准号: 10740668
• 负责人: Sabrina Lynn Smiley
• 金额: $ 105.35万
• 依托单位: SAN DIEGO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10740668
• 关键词: Address; Award; Black American; Black Populations; Black race; Buprenorphine; COVID-19 pandemic; California; Caring; Clinic; Clinical Trials; Communities; Competence; Disparity; Education; Evidence based intervention; Foundations; Funding; Health Services Accessibility; Healthcare; Income; Inequity; Insurance; Intervention; Investigation; Medical; Methods; National Institute of Drug Abuse; Neighborhood Health Center; Not Hispanic or Latino; Office Visits; Overdose; Patients; Phase; Prevalence; Privatization; Procedures; Protocols documentation; Provider; Publishing; Racial Equity; Randomized, Controlled Trials; Research; Role; System; Testing; Training; Underserved Population; Work; black patient; buprenorphine treatment; community engagement; design; effective therapy; feasibility testing; implementation evaluation; implementation science; improved; innovation; novel; opioid epidemic; opioid mortality; opioid overdose; opioid use disorder; overdose death; patient-level barriers; peer; provider-level barriers; racial disparity; routine care; sociologist; treatment services; underserved area

Project Summary I am a well-published, early stage medical sociologist applying for a NIDA-funded Racial Equity Visionary Award focused on the feasibility, acceptability, and preliminary efficacy of an innovative, mixed methods, community- engaged intervention targeting non-Hispanic Black (NHB) individuals with opioid use disorder (OUD). This study will apply my understanding of community needs and OUD, to test a novel intervention in a scalable setting, leveraging my role as a leader in this field to disseminate findings and improve treatment access nationwide. Opioid-related overdoses are increasing fastest in NHB individuals. In 2020, amid the COVID-19 pandemic, NHB overdose deaths increased by 45%, nearly double the increase in non-Hispanic Whites (NHW). Disproportionate increases in overdoses correspond to racial inequities in OUD treatment access and utilization. An effective treatment, buprenorphine, is concentrated among communities with high percentages of NHWs, higher income, and private insurance. Compared with NHW patients with OUD, NHB patients with OUD are 77% less likely to have an office visit that includes a buprenorphine prescription, despite similar prevalence of OUDs. This structural problem is at the foundation of my proposed research. Research focused on developing and testing culturally effective, community grounded, and structurally competent OUD treatments with rigorous implementation assessments is urgently needed to intervene on structural barriers to OUD treatment that operate in settings in which NHB individuals seek healthcare. Significant federal funding has expanded access to OUD treatment services in Community Health Centers (CHCs) that provide care to underserved populations and areas but barriers to accessing care remain in NHBs. I propose to prepare for a fully powered clinical trial by testing whether a buprenorphine treatment intervention protocol (Racial Equity in Systems to Treat Opioid Use Disorder for Everyone—RESTORE) that targets structural barriers to OUD treatment for NHB individuals is feasible in the context of CHCs. RESTORE draws upon concepts of structural competency, peer navigation, and culturally grounded OUD education for both patients and providers. Community engagement will be continuous, exemplified by the use of peer navigators to connect patients to care. RESTORE will be based in Southern California—an epicenter of the nation’s opioid crisis. Project Phases, guided by cutting edge implementation science, include 1) a qualitative investigation into provider and patient barriers to and facilitators of CHCs’ provision of buprenorphine specifically to NHB individuals with OUD; 2) the operationalization of RESTORE into routine care, using preliminary findings from Phase I; and 3) a pilot stepped-wedge randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of RESTORE, as well as the protocols, procedures and training in CHCs. This study has the potential to improve effective treatment rates in 4 clinics and provide an evidence-based intervention to be tested at scale across multiple states. Improvements in local treatments, designed to reach NHBs, will greatly reduce the current increase in overdose disparities.

项目摘要 我是一个出版良好，早期阶段的医学社会学家申请一个NIDA资助的种族平等有远见的奖 重点是可行性，可接受性，和初步疗效的创新，混合方法，社区- 参与干预针对非西班牙裔黑人（NHB）与阿片类药物使用障碍（OUD）的个人。本研究 将运用我对社区需求和OUD的理解，在可扩展的环境中测试一种新的干预措施， 利用我在这一领域的领导作用，在全国范围内传播研究结果并改善治疗。 阿片类药物相关的过量在NHB个体中增加最快。2020年，在新冠肺炎疫情的影响下， 过量死亡增加了45%，几乎是非西班牙裔白人（NHW）的两倍。不相称 过量用药的增加与OUD治疗获得和利用方面的种族不平等相对应。有效 治疗，丁丙诺啡，集中在社区与高比例的NHW，较高的收入， 私人保险。与患有OUD的NHW患者相比，患有OUD的NHB患者发生以下疾病的可能性低77%： 有一个办公室访问，其中包括丁丙诺啡处方，尽管类似的OUD患病率。这 结构问题是我提出研究的基础。研究侧重于开发和测试 文化上有效的，以社区为基础的，结构上有能力的OUD治疗， 迫切需要进行实施评估，以干预OUD治疗的结构性障碍， 在NHB个人寻求医疗保健的环境中运作。大量的联邦资金已经扩大了 社区卫生中心（CHC）的OUD治疗服务，为服务不足的人群提供护理， 但获得护理的障碍仍然存在于NHB中。我建议准备一个充分的临床试验， 测试丁丙诺啡治疗干预方案（阿片类药物使用治疗系统中的种族平等） 针对NHB个体OUD治疗的结构性障碍， 在CHC中可行。RESTORE借鉴了结构能力、同伴导航和 为患者和提供者提供基于文化的OUD教育。社区参与将是持续的， 例如，使用同行导航器将患者与护理联系起来。RESTORE将位于南部 加州-国家阿片类药物危机的中心。项目阶段，以尖端实施为指导 科学，包括1）定性调查提供者和患者的障碍和促进者的社区卫生中心， 专门向患有OUD的NHB个体提供丁丙诺啡; 2）RESTORE的操作化， 常规护理，使用I期研究的初步结果; 3）一项先导性逐步楔形随机对照试验 测试RESTORE的可行性、可接受性和初步有效性，以及方案、程序 在社区卫生服务中心进行培训。这项研究有可能提高4个诊所的有效治疗率， 这是一项基于证据的干预措施，将在多个州进行大规模测试。局部治疗的改进， 旨在接触NHB，将大大减少目前过量差异的增加。