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

NCT05688423 | Active Not Recruiting DMC

• 2 other identifiers: 20221134UG1DA013720
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Injection Site Infection; Substance Use Disorders

Keywords

substance use disorders; severe injection-related infections; randomized controlled trial; hospital-based care; harm reduction

Outcome Measures

Primary Outcomes (1)

• Mortality and Hospital Readmissions

  Binary: A participant is alive with no hospital readmission 4 months post-randomization vs. a participant has died or been readmitted to the hospital within 4 months post-randomization

  4 months post-randomization

Secondary Outcomes (9)

• Initiation of treatment before hospital discharge

  Course of hospital visit (expected to be within 1 month of randomization)

• Receipt of post-discharge treatment

  This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.

• Completion of planned antibiotic course for the index infection

  Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time

• Patient-directed discharge from index hospitalization

  Course of hospital visit (expected to be within 1 month of randomization)

• Post-discharge hospital visits

  This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.

Study Arms (2)

SIRI Team

EXPERIMENTAL

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.

Behavioral: SIRI Team

Treatment as Usual

ACTIVE COMPARATOR

Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.

Behavioral: Treatment as Usual

Interventions

SIRI Team BEHAVIORAL

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

SIRI Team

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be admitted to a participating hospital at the time of randomization
• Be 18 years of age or older
• Currently be experiencing a severe injection-related infection/SIRI or suspected SIRI
• Have an indication of injecting drugs in the prior year
• Provide informed consent
• Ability to communicate in English
• Provide sufficient locator information
• Sign a HIPAA form and/or EHR release to facilitate record abstraction
• Report being willing to return for follow-up visits

You may not qualify if:

• have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
• (or their legal guardian/representative) are unable or unwilling to give written informed consent
• are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
• are terminated via site principal investigator decision with agreement from one of the study lead investigators.

Sponsors & Collaborators

• Columbia University: lead
• University of Miami: collaborator
• Emory University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Miami - Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33601, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Lisa R Metsch, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• David P Serota, MD, MSc

  University of Miami

  PRINCIPAL INVESTIGATOR

• Daniel J Feaster, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Carlos del Rio, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Columbia University School of General Studies, Professor in Department of Sociomedical Sciences

Model Details: The study will recruit patients at bedside in the hospital setting at approximately six hospitals and randomly assign approximately 480 inpatients in 1:1 ratio to the SIRI Team vs. TAU. Randomization will be stratified by 1) hospital site, 2) primary drug (opioid versus non-opioid), and 3) admission to intensive care unit (ICU) as part of the index hospitalization (ICU versus non-ICU) as a proxy for severity of infection.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: January 18, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 18 months
• Access Criteria: Information will be de-identified.

Locations

US (6)