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ACTIVE NOT RECRUITING
NCT05688423
NA

Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-01-05

Completion Date

2027-04-03

Last Updated

2025-10-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

SIRI Team

Participants randomized to the intervention will receive integrated ID and SUD care (SIRI Team) both during the hospitalization and after hospital discharge for 4 months post-randomization. The intervention is based upon six general principles for treating PWID with infectious complications and is informed by harm reduction. 1. Medications for SUD as integral to management of infectious complications 2. Integration of ID and SUD care 3. Longitudinal care with familiar providers 4. Multidisciplinary care and care coordination 5. Tailored antibiotic options and care settings 6. Harm reduction

BEHAVIORAL

Treatment as Usual

Participants assigned to the TAU group will receive the standard treatment for their severe injection-related infection and substance use disorder at each hospital. While TAU may differ between sites, it is typically comprised of a patient being cared for primarily by a hospital medicine physician (hospitalist) with consultation by infectious diseases (ID) and either psychiatry or addiction medicine physician. If the ID or addiction teams believe post-hospitalization follow up is indicated, each service will follow local protocols for arranging post-discharge continuation of care.

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Miami - Jackson Memorial Hospital

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Utah Hospital

Salt Lake City, Utah, United States