NavSTAR Implementation Effectiveness Trial Across a Health System

ConditionOpioid Use Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorFriends Research Institute, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

age 18 or older;

current DSM-5 criteria for moderate to severe OUD;

willing and able to provide informed consent in English.

Disqualifiers

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);

Trial design

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

720 Participants

are divided into 2 treatment groups

Group A: Treatment as UsualNo intervention 0 interventions

Group B: NavSTARExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

3 months

Secondary outcomes

Feasibility: Demonstrated ability to enroll participants in the intervention

Feasibility will be measured based on the number of participants who received the intervention during the implementation period.

Time frame

From baseline until end of study, approximately 30 months

Inpatient readmissions (30 days)

Information on acute care hospital inpatient readmission within 30 days will be assessed using health records and self-report (in the event of inconsistency, objective data will dominate).

Time frame

30 days

Inpatient readmissions

Inpatient hospital readmissions (number of events) will be assessed using health record review and self-report (in the event of inconsistencies, objective data will dominate).

Time frame

through 3, 6, and 12 months

Emergency department visits

Emergency Department utilization (number of events) will be assessed via health record review and self-report (in the event of inconsistency, objective data will dominate).

Time frame

through 3, 6, and 12 months

Other outcomes

Rate of Patient-Directed Discharge

Patient-directed discharge from the index hospitalization (i.e., "against medical advice") will be determined by health record review.

Time frame

At discharge (assessed up to 12 months)

Mortality

Mortality will be tracked from participant monitoring and death records

Time frame

through 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Friends Research Institute, Inc.

Lead sponsor

Thomas Jefferson University

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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