NavSTAR Implementation Effectiveness Trial Across a Health System

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Friends Research Institute, Inc.
Study ID
NCT07262190
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NavSTAR (Philly adaptation) — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Sep 2025
Primary completion
Jan 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
720 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Treatment as Usual
    Treatment as usual consists of standard management by the medical or surgical team during inpatient admission, and usual care from the addiction consult service, if applicable, which provides social work consults, withdrawal symptom management, and initiation of naltrexone, buprenorphine, or methadone. All standard hospital services will be available to participants.
  • Experimental: NavSTAR
    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

Primary Outcome Measure

Rate of Opioid Agonist Treatment initiation [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jefferson HealthPhiladelphiaPennsylvania19107
Karen Alexander, PhD
[email protected]
267-398-3560

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By research site
Jefferson Health· Philadelphia, PA

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