Philly NavSTAR Implementation Trial

NCT06634277 | Completed DMC

• 1 other identifier: R61DA059033
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

Patient Navigation (PN) interventions following hospitalization can reduce the differences that certain groups have been trying to access opioid use disorder treatment. These differences, which affect racial minority groups the most, contribute to the opioid overdose epidemic. However, 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. Our 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, we will conduct a large trial with 720 patient participants to see if we can reach people who need the intervention, and create a sustainable plan to continue the intervention after the grant award period.

Conditions

Opioid Use Disorder

Keywords

patient navigation

Outcome Measures

Primary Outcomes (1)

• Opioid Agonist Treatment (OAT) initiation

  Post-discharge OAT initiation will be measured by self-report at follow-up, with verification through records where applicable (e.g., Community Behavioral Health system).

  3 months

Secondary Outcomes (10)

• Acceptability: Extent to which the intervention will be deemed acceptable by participants

  3 months

• Appropriateness: Extent to which the intervention will be deemed appropriate by participants

  3 months

• Changes in Psychological distress from baseline to 3 months

  Baseline to 3-month follow-up

• Opioid use (oral fluid)

  3 months

• Changes in Social Support from Baseline to Follow-up

  Baseline to 3 month follow-up

Study Arms (1)

NavSTAR

EXPERIMENTAL

NavSTAR is a Patient Navigation service model to reduce internal and external barriers to recommended service engagement. It includes motivational interventions in tandem with proactive barrier resolution, targeting areas of addiction, medical, self-care, and basic needs.

Behavioral: NavSTAR (Philly adaptation)

Interventions

NavSTAR (Philly adaptation) BEHAVIORAL

Patient Navigation

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 (2)

Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

Location

Friends Research Institute

Philadelphia, Pennsylvania, 19125, United States

Location

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

Study Officials

• Karen Alexander, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

• Jan Gryczynski, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single group pilot study with sequential implementation in 4 hospitals

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: October 9, 2024
• Study Start: August 9, 2024
• Primary Completion: July 26, 2025
• Study Completion: August 31, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)