Philly NavSTAR Implementation Trial

Opioid agonist treatment (OAT) is protective against overdose, yet less than 20% of people with opioid use disorder (OUD) engage in such treatment. Hospital utilization is high among people with OUD and can be a 'reachable moment' to initiate OAT. However, most hospitals lack the capacity to follow up with patients after discharge. Theory-based, empirically supported patient navigator (PN) interventions following hospital discharge reduce inequities in accessing community-based OAT by helping patients navigate complex systems of care. However, challenges persist in implementing PN interventions on a wide scale, as they require coordination across institutions, data sharing, dedicated personnel, and community resources. This is especially true in settings that reach diverse, resource-challenged communities. To bring these interventions to scale, strategies are needed to assess factors that influence PN implementation in hospitals to increase feasibility, reach, and sustainability. Testing innovative implementation strategies for PN interventions has the potential for significant impact, as it will demonstrate implementation success of an intervention that can address the opioid epidemic in real-world settings and close the research-to-practice translation gap. The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services To Avoid Rehospitalization (NavSTAR). Our research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly increased OAT entry, reduced readmissions, and was highly cost-effective compared to treatment as usual. The present study will test an Implementation Facilitation (IF) strategy following Proctor's conceptual model using an external facilitator and an internal local clinical champion to provide training, resources, and performance feedback to implement NavSTAR in four hospitals. We hypothesize that engaging stakeholders (including patients, clinicians, and community leaders) in an IF strategy will create and test an implementation process that is feasible, acceptable, and effective in expanding access to OAT post-discharge. The R61 phase will conduct process mapping to identify existing hospital workflow and then refine an IF strategy through sequential pilot trials at 4 hospital sites in preparation for the R33 phase. The team's NavSTAR operations manual will be adapted to the sites to train the existing staff. R61 milestones include the creation of an implementation toolkit and data-sharing agreements.

The developmental R61 phase will focus on needs assessment and identifying IF strategies for system-wide adoption of NavSTAR in preparation for the R33 trial phase. This will be accomplished through four inter-related processes: 1) Process mapping with the CAB and CAP, 2) Conducting qualitative interviews to gain diverse stakeholder input, 3) Modifying the IF strategy, and 4) Conducting four short-duration, iterative pilot testing cycles in four hospitals to examine the IF strategy for feasibility and acceptability. Pilot testing will occur with existing personnel (master's level social workers) utilizing the NavSTAR manual of operations. Interviews with current participants in the pilot testing, organizational stakeholders, navigators, and clinician champions will be conducted both before and after the pilot testing cycles.

Aim 1: Providers, staff, organizational leadership, and patients at the four hospitals will be asked to participate in the study (N=40) by completing interviews about current navigation/ discharge processes and optimal IF strategies.

Aim 2: Patients will be recruited across four hospitals (8 at each hospital) to conduct a pilot trial (N=32) of NavSTAR implementation. The CAB/CAP feedback, stakeholder interviews, and results of the pilot testing cycles will inform the final implementation toolkit used in the R33 phase.