Improving the transition to outpatient opioid use disorder treatment through patient navigation plus remote mHealth adherence support for patients initiated on buprenorphine in the hospital - ABSTRACT Opioid use disorder (OUD) represents a major public health crisis in the US, with over 550,000 people dying from opioid-involved overdoses between 2014 and 2023. Hospitals are increasingly adding services to offer medications for opioid use disorder (MOUD) like buprenorphine, however, there are profound gaps with linkage to outpatient programs, with up to 50% of patients failing to continue MOUD after discharge. Interventions are urgently needed to support linkage to outpatient buprenorphine treatment after discharge. Through a prior NIDA R34, we developed and pilot tested the MHealth Incentivized Adherence Plus Patient Navigation intervention (aka, MIAPP intervention). The intervention includes financial incentives to increase medication adherence and linkage to outpatient MOUD services, and a patient navigator who offers support during the transition out of hospital, including care coordination, motivational interviewing and medication adherence coaching. These services are delivered through an mHealth platform that facilitates remote video-based monitoring of medication adherence, delivery of financial incentives, and video-, text-, and voice-based communications with the patient navigator. The intervention is guided by the Information-Motivation-Behavioral Skills (IMB) Model – a well validated model of medication adherence in the context of other chronic conditions (e.g., HIV). Our pilot randomized clinical trial demonstrated the intervention and randomized trial procedures were feasible and acceptable, thus we propose to conduct a fully-powered, Hybrid Type I Effectiveness- Implementation study using randomized controlled trial design that will (1) test the effectiveness of the MIAPP intervention for improving treatment linkage and medication adherence during a critical period of transition from inpatient- to outpatient-based OUD treatment, and (2) illuminate early implementation insights that will inform future efforts to integrate this mHealth-based + patient navigation approach in hospital settings. In Aim #1 we will conduct a randomized controlled trial (n=160) to test the hypothesis that MIAPP, relative to usual care, increases 30-day linkage to outpatient MOUD treatment (primary outcome), increases 30-day medication adherence and 90-day MOUD coverage (secondary outcomes), and reduces 180-day hospital readmissions and ED encounters (tertiary outcomes). In Aim #2 we will characterize barriers, facilitators, and adaptations to the MIAPP intervention that would facilitate its future implementation in hospital settings through short surveys and semi-structured interviews with patients, clinical staff/providers, and other key informants. Data collection will be grounded in the Consolidated Framework for Implementation Research (clinical staff/providers, key informants) and IMB model (patients) to identify key influences on experiences. If effective, this approach that combines patient navigation with mHealth could provide a transformative service model that helps reduce substantial gaps in MOUD initiation and retention for people initiated on buprenorphine in hospital settings.
