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

Primary Purpose

Injection Site Infection, Substance Use Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SIRI Team
Treatment as Usual
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injection Site Infection focused on measuring substance use disorders, severe injection-related infections, randomized controlled trial, hospital-based care, harm reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Have an indication of injecting drugs in the prior year Provide informed consent Ability to communicate in English or Spanish 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SIRI Team

    Treatment as Usual

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Initiation of treatment before hospital discharge
    Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage
    Receipt of post-discharge treatment
    Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage
    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
    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
    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
    Alcohol use severity
    Continuous: Assessed via Alcohol Use Disorders Identification Test (AUDIT) scale; Range of scores [0 - 40], higher scores indicate worse outcome
    All-cause mortality
    Binary: Mortality from all causes at any of the follow-up timepoints vs. alive at all timepoints

    Full Information

    First Posted
    November 21, 2022
    Last Updated
    January 17, 2023
    Sponsor
    Columbia University
    Collaborators
    University of Miami, Emory University, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05688423
    Brief Title
    Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
    Acronym
    CTN0121
    Official Title
    Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2025 (Anticipated)
    Study Completion Date
    September 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University
    Collaborators
    University of Miami, Emory University, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injection Site Infection, Substance Use Disorders
    Keywords
    substance use disorders, severe injection-related infections, randomized controlled trial, hospital-based care, harm reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SIRI Team
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SIRI Team
    Intervention Description
    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. Medications for SUD as integral to management of infectious complications Integration of ID and SUD care Longitudinal care with familiar providers Multidisciplinary care and care coordination Tailored antibiotic options and care settings Harm reduction
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as Usual
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mortality and Hospital Readmissions
    Description
    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 Outcome Measure Information:
    Title
    Initiation of treatment before hospital discharge
    Description
    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)
    Title
    Receipt of post-discharge treatment
    Description
    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.
    Title
    Completion of planned antibiotic course for the index infection
    Description
    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
    Title
    Patient-directed discharge from index hospitalization
    Description
    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)
    Title
    Post-discharge hospital visits
    Description
    Count: # of post-discharge hospital visits using repeated measures across all 3 follow-up visits
    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.
    Title
    New or recurrent acute bacterial or fungal infection post-index hospitalization
    Description
    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
    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.
    Title
    Substance use severity
    Description
    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.
    Title
    Alcohol use severity
    Description
    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.
    Title
    All-cause mortality
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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 Have an indication of injecting drugs in the prior year Provide informed consent Ability to communicate in English or Spanish 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lauren K Gooden, PhD, MPH
    Phone
    7867039819
    Email
    lkg2129@columbia.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Terri Liguori, M.Ed., Ed.S.
    Email
    tl2547@columbia.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lisa R Metsch, PhD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David P Serota, MD, MSc
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Daniel J Feaster, PhD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carlos del Rio, MD
    Organizational Affiliation
    Emory University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
    IPD Sharing Time Frame
    Within 18 months
    IPD Sharing Access Criteria
    Information will be de-identified.
    IPD Sharing URL
    https://datashare.nida.nih.gov/

    Learn more about this trial

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