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

项目摘要 我是一位发表得很好的早期医学社会学家，正在申请NIDA资助的种族公平远见奖 重点关注创新、混合方法社区的可行性、可接受性和初步效果- 针对患有阿片类药物使用障碍(OUD)的非西班牙裔黑人(NHB)个体进行干预。本研究 将应用我对社区需求的理解，并在可扩展的环境中测试一种新的干预， 利用我作为这一领域的领导者的角色，传播研究结果并改善全国范围内的治疗机会。 在NHB人群中，与阿片类药物相关的过量增加最快。2020年，在新冠肺炎大流行期间，NHB 服药过量死亡增加了45%，几乎是非西班牙裔白人(NHW)增加的两倍。不成比例的 过量用药的增加与治疗、获取和利用方面的种族不平等相对应。卓有成效的 丁丙诺啡的治疗集中在卫生工作者比例高、收入高、 和私人保险。与nhw合并OUD的患者相比，NHB患者合并OUD的可能性降低77% 去办公室就诊，其中包括丁丙诺啡处方，尽管ODS的发病率相似。这 结构问题是我提出的研究的基础。专注于开发和测试的研究 文化高效、以社区为基础、结构称职的OUD治疗，具有严格的 迫切需要进行执行情况评估，以干预阻碍我们解决以下问题的结构性障碍 在NHB患者寻求医疗保健的环境中运行。大量的联邦资金扩大了获得 在社区卫生中心(CHC)提供治疗服务，为服务不足的人群提供护理和 但获得医疗服务的障碍仍然存在于国家卫生机构。我建议为一项全面的临床试验做准备， 测试丁丙诺啡治疗干预方案(治疗阿片类药物使用的系统中的种族公平 针对针对NHB患者的OUD治疗的结构性障碍的是 在社区卫生保健中心的背景下是可行的。Restore借鉴了结构能力、同行导航和 为患者和提供者提供有文化基础的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将以南部为基地 加利福尼亚州--美国阿片类药物危机的震中。项目阶段，以前沿实施为指导 科学，包括1)对CHC的提供者和患者的障碍和促进者的定性调查 向患有OUD的NHB患者专门提供丁丙诺啡；2)恢复到 常规护理，使用第一阶段的初步结果；和3)试点阶梯楔形随机对照试验 测试恢复的可行性、可接受性和初步效果，以及协议、程序 以及在儿童健康中心接受培训。这项研究有可能提高4家诊所的有效治疗率，并提供 以证据为基础的干预措施将在多个州进行大规模测试。改善了当地的治疗方法， 旨在达到NHBs的药物，将极大地减少目前过量服药差距的增加。

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.