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Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

Primary Purpose

Opioid Use Disorder, Serious Bacterial Infections

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart IOP Intervention
Peer Recovery Coach
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English-speaking adults aged 18 and above DSM-5 opioid use disorder, severe Hospitalized for serious injection-related infection requiring long-term intravenous antibiotic treatment. Can identify at least 2 individuals who can act as points of contact following discharge from the hospital Exclusion Criteria: Psychotic disorder, active suicidality, or homicidally Condition likely to be terminal during the study period Unable to perform consent due to impaired mental status

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach to provide support and accountability to the participant.

    Outcomes

    Primary Outcome Measures

    Feasibility of the intervention program
    We expect the results to demonstrate adequate feasibility, as defined by exceeding the threshold for adequate recruitment feasibility and good program acceptability. Adequate recruitment feasibility is defined as enrolling more than 70% of those eligible individuals. Excellent program acceptability is defined as >70% of the participants complete at least 70% of the Smart IOP intervention, and good program acceptability if >60% of participants did.

    Secondary Outcome Measures

    Illicit opioid use
    As an exploratory outcome, we will evaluate, using the Timeline follow back (TLFB), the proportion of days using illicit opioids during the follow-up period compared to baseline.
    Retention with MOUD treatment
    As an exploratory outcome, we will evaluate the proportion of participants who successfully engaged with addiction treatment following completion of the intervention compared to baseline.

    Full Information

    First Posted
    March 7, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Institute on Drug Abuse (NIDA), Mclean Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05817825
    Brief Title
    Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
    Official Title
    Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Institute on Drug Abuse (NIDA), Mclean Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.
    Detailed Description
    The aim is to conduct a single-arm pilot study of 20 participants who are hospitalized for serious injection-related infections to complete the newly tailored program. The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach who will provide support and accountability to the participant. The feasibility of the intervention will be established by evaluating recruitment and the acceptability of the program according to a priori benchmarks. The study team will assess the program's preliminary efficacy by evaluating OUD-related outcomes for up to 28 days after discharge from the hospital. The study will be conducted at Brigham and Women's Hospital (BWH), an urban, 793-bed academic medical center located in Boston, MA, and a major teaching hospital for Harvard Medical School.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder, Serious Bacterial Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The trial is an open-label, single-arm, pilot feasibility trial.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach to provide support and accountability to the participant.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Smart IOP Intervention
    Intervention Description
    Smart IOP is a remotely delivered IOP program in operation since 2016, allowing patients to complete addiction treatment entirely online. The original program, consisting of 72 video modules across 8 different topics, will be adapted and tailored to hospitalized patients with serious infections from injection drug use. Participants will watch video content asynchronously, and will be required to correctly answer knowledge questions to proceed to the next module. The whole treatment program will require approximately 4 weeks to complete. Participants are also asked to answer questions about how to apply the knowledge to their own personal circumstances. The answers to these are reviewed by the peer recovery coach during weekly encounters. Videos can be viewed at a time that is most convenient to the participants. T
    Intervention Type
    Behavioral
    Intervention Name(s)
    Peer Recovery Coach
    Intervention Description
    Peer recovery coach, an individual in sustained recovery (>5 years) and certified to be a coach, will meet weekly with the participant to review progress, answer questions about the videos, review answers to questions, and encourage continuation of treatment after discharge. These meetings will occur in-person or remotely.
    Primary Outcome Measure Information:
    Title
    Feasibility of the intervention program
    Description
    We expect the results to demonstrate adequate feasibility, as defined by exceeding the threshold for adequate recruitment feasibility and good program acceptability. Adequate recruitment feasibility is defined as enrolling more than 70% of those eligible individuals. Excellent program acceptability is defined as >70% of the participants complete at least 70% of the Smart IOP intervention, and good program acceptability if >60% of participants did.
    Time Frame
    Immediately Post Intervention
    Secondary Outcome Measure Information:
    Title
    Illicit opioid use
    Description
    As an exploratory outcome, we will evaluate, using the Timeline follow back (TLFB), the proportion of days using illicit opioids during the follow-up period compared to baseline.
    Time Frame
    7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
    Title
    Retention with MOUD treatment
    Description
    As an exploratory outcome, we will evaluate the proportion of participants who successfully engaged with addiction treatment following completion of the intervention compared to baseline.
    Time Frame
    7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: English-speaking adults aged 18 and above DSM-5 opioid use disorder, severe Hospitalized for serious injection-related infection requiring long-term intravenous antibiotic treatment. Can identify at least 2 individuals who can act as points of contact following discharge from the hospital Exclusion Criteria: Psychotic disorder, active suicidality, or homicidally Condition likely to be terminal during the study period Unable to perform consent due to impaired mental status
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joji Suzuki, MD
    Phone
    617-732-5752
    Email
    jsuzuki2@bwh.harvard.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

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