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

N/AActive Not RecruitingNCT05688423

Columbia University480 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Interventions

SIRI TeamBEHAVIORAL

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 UsualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

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

Time frame: 4 months post-randomization

Secondary Outcomes

Initiation of treatment before hospital discharge

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

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

Receipt of post-discharge treatment

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

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.

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

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

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

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

Post-discharge hospital visits

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

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

Substance use severity

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

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.

Alcohol use severity

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

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.

All-cause mortality

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

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