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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2027-04-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Injection Site Infection Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will recruit patients at bedside in the hospital setting at approximately six hospitals and randomly assign approximately 480 inpatients in 1:1 ratio to the SIRI Team vs. TAU. Randomization will be stratified by 1) hospital site, 2) primary drug (opioid versus non-opioid), and 3) admission to intensive care unit (ICU) as part of the index hospitalization (ICU versus non-ICU) as a proxy for severity of infection.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SIRI Team

Intervention Type 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.

1. Medications for SUD as integral to management of infectious complications
2. Integration of ID and SUD care
3. Longitudinal care with familiar providers
4. Multidisciplinary care and care coordination
5. Tailored antibiotic options and care settings
6. Harm reduction

Treatment as Usual

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

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type 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.

Interventions

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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.

1. Medications for SUD as integral to management of infectious complications
2. Integration of ID and SUD care
3. Longitudinal care with familiar providers
4. Multidisciplinary care and care coordination
5. Tailored antibiotic options and care settings
6. Harm reduction

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No