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Behavioral Intervention

Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic (IC) for Opioid Use Disorder (CHOICE-STAR Trial)

N/A
Waitlist Available
Led By Elana Rosenthal, MD
Research Sponsored by Elana Rosenthal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age ≥ 18 years
2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after discharge for index hospitalization
Awards & highlights

Summary

This is a three-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of two interventions (1) Integrated infectious diseases and Medication for Opioid Use Disorder outpatient clinic (IC) and (2) NavSTAR Intervention (NS) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids.

Who is the study for?
This trial is for hospitalized patients with opioid use disorder who have infections due to drug use, such as abscesses. Participants must meet certain health criteria to join.
What is being tested?
The study compares two approaches: an outpatient clinic integrating infectious disease and opioid use disorder treatments (IC), and the NavSTAR Intervention (NS) against usual care in reducing infection-related readmissions.
What are the potential side effects?
Since specific side effects are not listed, they may vary based on the interventions used. Generally, these could include typical reactions to medications or clinical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after discharge for index hospitalization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after discharge for index hospitalization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Infection Rehospitalization
Secondary study objectives
Cost Effectiveness
Hospital services utilization
Index infection
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: NavSTAR-CHOICE (NS)Experimental Treatment1 Intervention
The NavSTAR (NS) arm will consist of targeted support delivered by a Patient Navigation team (see Navigation Dyad, below) to enhance participants' linkage with outpatient OUD treatment and recommended medical care for infections and other presenting illnesses. The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care (initial linkage and subsequent retention) during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care, inpatient readmission, and other adverse outcomes.
Group II: Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic (IC)Experimental Treatment1 Intervention
The Integrated ID/MOUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating OUD, resolving the sentinel infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and MOUD treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers. The dual goals of the IC intervention are to 1) to facilitate accessibility to ID and OUD care and 2) to ensure care coordination between outpatient ID and MOUD providers.
Group III: Treatment As UsualActive Control1 Intervention
Will receive treatment for infection and opioid use disorder per the usual care at each hospital

Find a Location

Who is running the clinical trial?

Elana RosenthalLead Sponsor
George Washington UniversityOTHER
250 Previous Clinical Trials
458,376 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,075 Previous Clinical Trials
1,320,868 Total Patients Enrolled
~405 spots leftby Apr 2028
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