NCT05688423

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study intervention ("SIRI Team") consists of a hospital-based multidisciplinary (ID/SUD consult) team that will provide intensive, integrated care for participants' ID and SUD both during the hospital stay and post-discharge for up to four months post-randomization. The SIRI Team will provide low barrier access to medications and harm reduction services for SUD; streamline ID/SUD treatment; provide longitudinal care with familiar providers; leverage different areas of expertise between physicians, advance practice providers, and patient navigators; and create patient-centered treatment plans, tailored to the individual, and informed by each patient's social circumstances, substance use, and personal goals/desires. The SIRI Team intervention will be grounded in a harm reduction approach. The intervention duration is approximately 4 months. Participants will complete follow-up visits at 4-, 8-, and 12-months post-randomization.

Conditions

• Injection Site Infection
• Substance Use Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-05
• Primary completion: 2027-04-03
• Completion: 2027-04-03
• First posted: 2023-01-18
• Last updated: 2025-10-21

Locations

6 sites across 1 country: United States