RecruitingNot ApplicableNCT07262190

NavSTAR Implementation Effectiveness Trial Across a Health System

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

Sponsor

Friends Research Institute, Inc.

Enrollment

720 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

Summary

Patient Navigation (PN) interventions following hospitalization can improve outcomes for people with opioid use disorder treatment. Delivering PN interventions on a wide scale requires many resources and coordination across institutions. This will use an evidence-based process to find solutions to these significant barriers by engaging community, hospital, and patient partners. This study is being conducted to learn more about how to implement NavSTAR, a patient navigation intervention for people with opioid use disorder, across a health system. The research team showed in a previous study with 400 participants that NavSTAR significantly increased entry into opioid use disorder treatment, reduced readmissions to the hospital, and was highly cost- effective compared to treatment as usual. This study will first pilot NavSTAR with 32 patient participants across 4 hospitals in the City of Philadelphia. Then, a large trial with 720 patient participants will be conducted to see if people who need the intervention are reached, and a sustainable plan will be created to continue the intervention after the grant award period.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria5

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

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Interventions

BEHAVIORALNavSTAR (Philly adaptation)

NavSTAR consists of TAU plus contact with a trained patient navigator who delivers the NavSTAR intervention, inclusive of theory-based motivational content, during and after discharge from the hospital. The patient navigator also has access to a small participant fund to assist with overcoming structural barriers to care (e.g., phone, obtaining IDs, a meal, a taxi ride etc.). Using the NavSTAR PN manual, the PN will address internal and external barriers to engagement in OAT through motivational intervention techniques and proactive case management and care coordination services. Contact with the PN begins at the bedside while the participant is admitted to the hospital and continues for 3 months after discharge