NavSTAR Implementation Effectiveness Trial Across a Health System

NCT ID: NCT07262190

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2029-08-01

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.

Detailed Description

Opioid agonist treatment (OAT) is protective against overdose, yet less than 20% of people with opioid use disorder (OUD) engage in such treatment. Hospital utilization is high among people with OUD and can be a 'reachable moment' to initiate OAT. However, most hospitals lack the capacity to follow up with patients after discharge. Patient navigation (PN) interventions following hospital discharge can help patients engage in OAT and navigate complex systems of care. However, challenges persist in implementing PN interventions on a wide scale, as they require coordination across organizations, data sharing, dedicated personnel, and resources. To bring these interventions to scale, strategies are needed to determine feasibility, reach, and sustainability. Testing innovative implementation strategies for PN interventions has the potential for significant impact, as it will demonstrate implementation success of an intervention that can address the opioid epidemic in real-world settings and close the research-to-practice translation gap. The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services to Avoid Rehospitalization (NavSTAR). The research team showed in a single-site randomized trial with 400 participants that NavSTAR significantly improved OAT entry, reduced readmissions, and was highly cost-effective compared to treatment as usual. The present study will test an Implementation Facilitation (IF) strategy to provide training, resources, and performance feedback to implement NavSTAR in five hospitals in Philadelphia. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in improving outcomes for patients with OUD. During the R33 phase, a type II hybrid-implementation-effectiveness trial of NavSTAR will be conducted with 720 participants using a randomized stepped-wedge design.

The proposed study is a type II hybrid implementation-effectiveness trial of Navigation Services to Avoid Rehospitalization (NavSTAR). The present study will test an Implementation Facilitation (IF) strategy following Proctor's conceptual model of implementation, using an external facilitator and internal local clinical champions to provide training, resources and performance feedback to implement NavSTAR in five hospitals. It is hypothesized that engaging stakeholders in an IF strategy will yield an implementation process that is feasible, acceptable, and effective in expanding engagement in OAT post-discharge. This type II hybrid implementation-effectiveness randomized stepped-wedge trial (N=720) will examine NavSTAR's sustained use in a hospital system to improve outcomes for patients with OUD.

R33 Specific Aims:

• Aim 1: Determine the successful implementation of NavSTAR in terms of a) feasibility, b) reach, and c) sustainability using the newly developed hospital system protocol.
• Aim 2: Determine the effectiveness of NavSTAR to a) improve OAT initiation in the three months post-discharge, b) decrease hospital utilization (inpatient readmissions and emergency department visits), c) reduce overdoses (fatal and non-fatal), and d) improve other patient outcomes (e.g., quality of life, substance use).

The proposed study has high public health significance because it will develop and test an implementation strategy for an intervention (NavSTAR) to improve OAT engagement and outcomes for patients with OUD. The study will yield novel data on how best to implement NavSTAR across a health system operating in an epicenter of the OUD crisis. Study findings will help to develop a path to scale-up this important intervention to address the opioid epidemic.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

NavSTAR (Philly adaptation)

Intervention Type: 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

Interventions

NavSTAR (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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jefferson Health

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen Alexander, PhD

Role: CONTACT

kalexander@friendsresearch.org

2673983560

Jan Gryczynski, PhD

Role: CONTACT

jgryczynski@friendsresearch.org

443-676-4219

Facility Contacts

Karen Alexander, PhD

Role: primary

kalexander@friendsresearch.org

267-398-3560

References

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.

Reference Type: BACKGROUND

PMID: 33819055 (View on PubMed)

Other Identifiers

R33DA059033

Identifier Type: NIH

Identifier Source: secondary_id

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R33DA059033

Identifier Type: NIH

Identifier Source: org_study_id

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