Examining injectable buprenorphine implementation strategies in low-threshold and primary care settings

摘要 在这个K23提案中，成瘾医学医生Andrea Jakubowski博士描述了一个为期4年的指导 研究项目和严格的职业发展计划，这将有助于建立她作为一个独立的 临床研究者使用实施科学（IS）来设计和研究干预措施，以改善 阿片类药物使用障碍（OUD）患者的健康状况。注射用丁丙诺啡（iBUPE）是一种安全、循证的 治疗OUD，提供持续4-6周的丁丙诺啡水平。iBUPE临床试验 表现出较高的治疗保留率，减少非法阿片类药物的使用，并改善生活质量， 有OUD的人iBUPE可能对有心理社会障碍的患者特别有用， 每日舌下丁丙诺啡，最常用的处方制剂。但是，iBUPE有限 在现实环境中的吸收，可能是由于卫生系统和患者层面的障碍。因此，在严格的 实施研究，在30个月的时间里，我们将使用完善的信息系统方法， 一个初级保健诊所和一个“低门槛”诊所（基于注射器服务方案）， 目标1：确定iBUPE实施前的决定因素并制定实施方案 目标2：试行、完善和评估iBUPE实施战略;目标3：检查 iBUPE实施后的护理差距。在目标1方面， 实施研究，我们将使用来自工作人员和OUD患者焦点小组的数据， iBUPE实施前决定因素。然后，我们将制定和选择实施战略， 解决这些决定因素。对于目标2，我们将使用快速周期测试来试验和改进实施 战略布局然后，我们将使用普罗克特框架来评估实施结果（可接受性， 采用，可行性和保真度）使用工作人员焦点小组和研究日志和电子健康数据 记录（EHR）。在目标3中，我们将使用EHR数据为iBUPE治疗建立“级联护理”， 从对iBUPE感兴趣开始到6个月时治疗保留结束，iBUPE输送存在差距。我们 将通过进行40-80项定性研究， 与接受iBUPE治疗后出现不同结局的患者进行访谈（拒绝iBUPE，感兴趣 但不启动、启动但在3个月时不保留在治疗中、启动并在6个月时保留）。 我们将使用这些数据来开发可推广的iBUPE实现手册，我们将在未来进行测试 在LT和PC诊所网络中扩展iBUPE实施的R 01研究。为了实现这些目标，博士。 Jakubowski将继续接受IS框架应用，IS研究定性方法的培训， 企业家参与的研究。这样做，她将实现成为一名独立临床医生的目标 使用IS设计和研究干预措施以改善OUD患者健康的研究者。

ABSTRACT In this K23 proposal, Dr. Andrea Jakubowski, an addiction medicine physician, describes a 4-year mentored research project and a rigorous career development plan that will help establish her as an independent clinician investigator who uses implementation science (IS) to design and study interventions to improve the health of people with opioid use disorder (OUD). Injectable buprenorphine (iBUPE) is a safe, evidence-based treatment for OUD that provides continuous levels of buprenorphine for 4-6 weeks. Clinical trials with iBUPE demonstrate high treatment retention, reductions in illicit opioid use, and improvements in quality of life for persons with OUD. iBUPE may be especially useful for patients with psychosocial barriers to self-administering daily sublingual buprenorphine, the most commonly prescribed formulation. However, there is limited iBUPE uptake in real-world settings, likely due to health systems and patient level barriers. Thus, in a rigorous implementation study, over a 30-month period, we will use well-established IS methods to implement iBUPE in one primary care clinic and one "low-threshold" clinic (based in a syringe services program) with the following aims: Aim 1: To identify iBUPE pre-implementation determinants and develop implementation strategies; Aim 2: To pilot, refine, and evaluate iBUPE implementation strategies; Aim 3: To examine gaps in care following iBUPE implementation. For Aim 1, guided by Consolidated Framework for Implementation Research, we will use data from focus groups with staff and persons with OUD to identify iBUPE pre-implementation determinants. We will then develop and select implementation strategies that address these determinants. For Aim 2, we will use rapid cycle testing to pilot and refine implementation strategies. We will then use the Proctor framework to evaluate implementation outcomes (acceptability, adoption, feasibility and fidelity) using staff focus groups and data from study logs and the electronic health record (EHR). In Aim 3, we will use EHR data to establish "cascades of care" for iBUPE treatment, identifying gaps in iBUPE delivery beginning with interest in iBUPE and ending with treatment retention at 6 months. We will examine patient-level barriers that contribute to gaps in the care cascade by conducting 40-80 qualitative interview with patients who are offered iBUPE then experience different outcomes (decline iBUPE, interested but do not initiate, initiate but are not retained in treatment at 3 months, initiate and are retained at 6 months). We will use these data to develop generalizable iBUPE implementation manuals that we will test in a future R01 study of scaling iBUPE implementation in a network of LT and PC clinics. To accomplish these aims, Dr. Jakubowski will pursue training in application of IS frameworks, qualitative methods for IS research, and stakeholder-engaged research. In doing so, she will achieve her goal of becoming an independent clinician investigator who uses IS to design and study interventions to improve the health of people with OUD.