Scaling NavSTAR patient navigation across a health system

Implementing a Patient Navigation Intervention Across a Health System to Improve Outcomes for Patients With Opioid Use Disorder

This project will test whether NavSTAR, a hospital-to-community patient navigation program, helps adults with moderate-to-severe opioid use disorder start and stay in opioid agonist treatment after discharge.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 720 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Friends Research Institute, Inc. (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07262190 on ClinicalTrials.gov

What this trial studies

This type II hybrid implementation-effectiveness project will pilot and then test NavSTAR, a patient navigation program that helps hospitalized adults with opioid use disorder connect to opioid agonist treatment (OAT) and community supports after discharge. The team will first pilot NavSTAR with 32 patients across four Philadelphia hospitals and then enroll about 720 patients to test an Implementation Facilitation strategy for scaling across a health system. Primary outcomes include OAT initiation and hospital readmissions, along with reach, sustainability, and implementation process measures. The effort builds on a prior single-site randomized trial and engages hospital, community, and patient partners to address barriers to broad delivery.

Who should consider this trial

Good fit: Adults (18+) hospitalized in Philadelphia who meet DSM-5 criteria for moderate-to-severe opioid use disorder and can consent in English, and who are not already in recent OUD treatment, pregnant, being discharged to long-term inpatient care, or hospitalized for a suicide attempt.

Not a fit: People already enrolled in OUD treatment within 30 days, residents outside the City of Philadelphia, pregnant people, or those being discharged to long-term inpatient care or hospitalized for a suicide attempt are not eligible and therefore would not receive benefit from participation.

Why it matters

Potential benefit: If successful, NavSTAR could help more hospitalized patients with opioid use disorder start OAT, reduce rehospitalizations, and expand navigation services across health systems.

How similar studies have performed: A prior single-site randomized trial of NavSTAR with 400 participants increased OAT entry, reduced readmissions, and was highly cost-effective, so this study focuses on scaling those findings across multiple hospitals.

Eligibility criteria

Inclusion Criteria:

1. age 18 or older;
2. current DSM-5 criteria for moderate to severe OUD;
3. willing and able to provide informed consent in English.

Exclusion Criteria:

1. enrollment in OUD treatment 30-days prior to hospitalization;
2. residency outside the City of Philadelphia;
3. pregnancy;
4. planned discharge to a long-term inpatient care facility (e.g., hospice);
5. hospitalization for a suicide attempt.

Where this trial is running

Philadelphia, Pennsylvania

• Jefferson Health — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Karen Alexander, PhD

Conditions Opioid Use Disorder; patient navigation