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

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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.