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

Substance Use Disorders Clinical Trial

— CTN0121  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688423
• Other study ID #: 20221134
• Secondary ID: UG1DA013720
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Lauren K Gooden, PhD, MPH
• Phone: 7867039819
• Email: lkg2129[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Injection Site Infection
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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
• 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

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Miami - Jackson Memorial Hospital	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Tampa General Hospital	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Emory University, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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.
Secondary	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
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)