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NCT Number: NCT05688423

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Injection Site Infection Behavior Chemically-Induced Disorders Harm Reduction Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  • 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

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.

Primary outcomes

  1. Mortality and Hospital Readmissions

    Time frame: 4 months post-randomization

    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

Secondary outcomes

  1. Initiation of treatment before hospital discharge

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

    Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage

  2. Receipt of post-discharge treatment

    Time frame: 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.

    Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage

  3. Completion of planned antibiotic course for the index infection

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

    Binary: If patient completed planned antibiotic course for the index infection vs. if they did not complete antibiotic course

  4. Patient-directed discharge from index hospitalization

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

    Binary: Patient discharges themselves from the hospital prior to the attending physician's orders to discharge vs. does not discharge themselves

  5. Post-discharge hospital visits

    Time frame: 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.

    Count: # of post-discharge hospital visits using repeated measures across all 3 follow-up visits

  6. New or recurrent acute bacterial or fungal infection post-index hospitalization

    Time frame: 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.

    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

  7. Substance use severity

    Time frame: 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.

    Continuous: Assessed via Drug Abuse Screening Test (DAST-10) scale; Range of scores [0 - 10], higher scores indicate worse outcome

  8. Alcohol use severity

    Time frame: 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.

    Continuous: Assessed via Alcohol Use Disorders Identification Test (AUDIT) scale; Range of scores [0 - 40], higher scores indicate worse outcome

  9. All-cause mortality

    Time frame: At each of the follow-up times (4, 8 and 12 months)

    Binary: Mortality from all causes at any of the follow-up timepoints vs. alive at all timepoints

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Acronym: CTN0121

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2023
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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