Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients (CTN0121)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use Disorders; Injection Site Infection
• Intervention / Treatment: Behavioral: SIRI Team; Behavioral: Treatment as Usual

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami - Jackson Memorial Hospital
    • Tampa, Florida, United States, 33601
      • Tampa General Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

All individuals meeting any of the exclusion criteria will be excluded from study participation. Specifically, individuals will be excluded from participation if they:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIRI Team; 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; 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.; Medications for SUD as integral to management of infectious complications; Integration of ID and SUD care; Longitudinal care with familiar providers; Multidisciplinary care and care coordination; Tailored antibiotic options and care settings; Harm reduction
Active Comparator: Treatment as Usual; Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of treatment before hospital discharge	Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage	Course of hospital visit (expected to be within 1 month of randomization)
Receipt of post-discharge treatment	Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage	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	Binary: If patient completed planned antibiotic course for the index infection vs. if they did not complete antibiotic course	Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time
Patient-directed discharge from index hospitalization	Binary: Patient discharges themselves from the hospital prior to the attending physician's orders to discharge vs. does not discharge themselves	Course of hospital visit (expected to be within 1 month of randomization)
Post-discharge hospital visits	Count: # of post-discharge hospital visits using repeated measures across all 3 follow-up 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.
New or recurrent acute bacterial or fungal infection post-index hospitalization	Binary: Participant has a recurrent or persistent acute bacterial or fungal infection during the period of assessment vs. does not have a recurrent or persistent acute bacterial or fungal infection	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.
Substance use severity	Continuous: Assessed via Drug Abuse Screening Test (DAST-10) scale; Range of scores [0 - 10], higher scores indicate worse outcome	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.
Alcohol use severity	Continuous: Assessed via Alcohol Use Disorders Identification Test (AUDIT) scale; Range of scores [0 - 40], higher scores indicate worse outcome	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.
All-cause mortality	Binary: Mortality from all causes at any of the follow-up timepoints vs. alive at all timepoints	At each of the follow-up times (4, 8 and 12 months)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Miami; Emory University; The Emmes Company, LLC
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): April 3, 2027

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; harm reduction; substance use disorders; severe injection-related infections; hospital-based care
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Substance-Related Disorders; Harm Reduction; Therapeutics
• Other Study ID Numbers: 20221134; UG1DA013720 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
• IPD Sharing Time Frame: Within 18 months
• IPD Sharing Access Criteria: Information will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No