NavSTAR Implementation Effectiveness Trial Across a Health System

NCT07262190 | Recruiting DMC

• 1 other identifier: R33DA059033
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder

Keywords

patient navigation

Outcome Measures

Primary Outcomes (1)

• Rate of Opioid Agonist Treatment initiation

  Post-discharge rate of OAT initiation will be ascertained via health record review and self-report with verification through records where applicable (e.g., Community Behavioral Health system).

  3 months

Secondary Outcomes (10)

• Feasibility: Demonstrated ability to enroll participants in the intervention

  From baseline until end of study, approximately 30 months

• Inpatient readmissions (30 days)

  30 days

• Inpatient readmissions

  through 3, 6, and 12 months

• Emergency department visits

  through 3, 6, and 12 months

• Self-reported days of opioid use in the past 30 days

  Baseline to 3-, 6-, and 12-months

Other Outcomes (2)

• Rate of Patient-Directed Discharge

  At discharge (assessed up to 12 months)

• Mortality

  through 12 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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.

NavSTAR

EXPERIMENTAL

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

Behavioral: NavSTAR (Philly adaptation)

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

NavSTAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• Thomas Jefferson University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

• Gryczynski J, Nordeck CD, Welsh C, Mitchell SG, O'Grady KE, Schwartz RP. Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial. Ann Intern Med. 2021 Jul;174(7):899-909. doi: 10.7326/M20-5475. Epub 2021 Apr 6.

  PMID: 33819055 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Karen Alexander, PhD

CONTACT

2673983560; kalexander@friendsresearch.org

Jan Gryczynski, PhD

CONTACT

443-676-4219; jgryczynski@friendsresearch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A stepped wedge cluster randomized design will be used, in which all five sites begin in a control phase and are sequentially randomized to cross over to the intervention at staggered time points, permitting both within-site and between-site comparisons over time

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: December 3, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data and metadata will be deposited in a recognized repository such as the Inter-university Consortium for Political and Social Research (ICPSR) or another NIH-approved repository recommended by NINR. Once archived, datasets will be assigned persistent unique identifiers (such as DOIs) and indexed using repository tools and NIH-mandated descriptors to ensure they are findable and citable. De-identified data will be made available no later than the first publication of primary results or the end of the performance period, whichever comes first. Derived or summary datasets associated with publications will be shared with minimal delay. Shared data will remain available for at least five years following project completion, or longer if required by the repository or by NIH policy.
• Access Criteria: FRI is committed to facilitating access to study data for individual researchers or other stakeholders, upon reasonable request and execution of a data sharing and use agreement

Locations

US (1)