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

Columbia University

Status: Enrolling

Conditions: Substance Use Disorders; Injection Site Infection

Treatments: Behavioral: Treatment as Usual; Behavioral: SIRI Team

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05688423

UG1DA013720 (U.S. NIH Grant/Contract)

20221134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

SIRI Team

Experimental group

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.

Treatment:

Behavioral: SIRI Team

Treatment as Usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment as Usual