Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
Running, not enrolling · Not applicable
Conditions studied: Injection Site Infection, Substance Use Disorders
In brief
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.
Key facts
- Study ID
- NCT05688423
- Run by
- Columbia University
- People needed
- 480
- Starts
- 2024-01-05
- Expected to finish
- 2027-04-03
- Last updated by the study team
- 2025-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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…
- 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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of Miami - Jackson Memorial Hospital — Miami, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Utah Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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