Patient-controlled analgesia for acute pain among hospitalized people with opioid use disorder: A hybrid effectiveness-implementation study - Dr. Michele Buonora proposes a five-year mentored research and career development plan that will establish her as an independent clinician investigator using implementation science to develop, test, and disseminate interventions to improve outcomes for people with opioid use disorder (POUD) and pain. Among hospitalized POUD, experiencing poorly controlled acute pain leads to poor health outcomes including self-directed discharge and poor retention in treatment for OUD. However, acute pain is challenging to treat in hospitalized POUD. Full agonist opioids (FAO) are a mainstay of hospital-based acute pain treatment, however standard dosing strategies are often insufficient in POUD due to opioid tolerance, opioid-induced hyperalgesia, and/or receptor-blocking effects of medications for OUD. Patient-controlled analgesia (PCA) is a safe and effective method for administering high doses of FAO and is widely used to treat severe acute pain in hospitalized patients without OUD, but data in POUD are lacking. Thus, the PI proposes a hybrid type 1 effectiveness-implementation study, in which she will partner with a Community Leadership Board to examine the safety, effectiveness, and implementation of PCA for acute pain in hospitalized POUD. The aims are: 1) To examine safety of PCA for acute pain in hospitalized POUD; 2) To examine effectiveness of PCA for acute pain in hospitalized POUD; and 3) To examine implementation of PCA and factors influencing PCA implementation in hospitalized POUD. We will conduct a pilot trial at two large teaching hospitals in NYC, with one hospital randomized to a PCA-facilitation intervention, and the second as a control. For Aims 1 and 2, we will examine the safety (in-hospital opioid overdose, sedation and falls) and effectiveness (pain intensity, patient satisfaction and self-direct discharge) of PCA by comparing outcomes between hospitalized POUD treated with PCA at the intervention hospital and those receiving treatment as usual at the control hospital, in the 6 months following implementation of the PCA-facilitation intervention. In Aim 3, we will identify the determinants of PCA implementation (adoption, acceptability, and feasibility) at the patient-, clinician-, and system-level. We will also identify barriers and facilitators to PCA implementation using semi-structured interviews in 20 hospitalized POUD, 10 inner setting stakeholders (hospital-based clinicians and leaders), and 10 outer setting stakeholders (family and/or caretakers). To accomplish these aims, Dr. Buonora will pursue training in: 1) design and conduct of clinical trials; 2) application of Implementation Science frameworks in research, 3) community-engaged research, and 4) underlying mechanisms of acute pain. In doing so, she will advance her goal of becoming an independent clinician investigator who develops and tests interventions to improve outcomes for people with OUD (POUD) and pain.
