Clinical trial NCT05688423: Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
Official title: Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Injection Site Infection
Substance Use Disorders
Keywords: substance use disorders
severe injection-related infections
randomized controlled trial
hospital-based care
harm reduction
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Emory University
name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2023-01-18
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality and Hospital Readmissions
timeFrame: 4 months post-randomization
Secondary outcomes:
measure: Initiation of treatment before hospital discharge
timeFrame: Course of hospital visit (expected to be within 1 month of randomization)
measure: Receipt of post-discharge treatment
timeFrame: 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.
measure: Completion of planned antibiotic course for the index infection
timeFrame: Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time
measure: Patient-directed discharge from index hospitalization
timeFrame: Course of hospital visit (expected to be within 1 month of randomization)
measure: Post-discharge hospital visits
timeFrame: 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.
measure: New or recurrent acute bacterial or fungal infection post-index hospitalization
timeFrame: 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.
measure: Substance use severity
timeFrame: 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.
measure: Alcohol use severity
timeFrame: 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.
measure: All-cause mortality
timeFrame: At each of the follow-up times (4, 8 and 12 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Miami
country: United States
facility: University of Miami - Jackson Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Columbia University
name: Lisa R Metsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: David P Serota, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Daniel J Feaster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carlos del Rio, MD
role: PRINCIPAL_INVESTIGATOR
References: