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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05817825
Collaborator
(none)
20
1
16

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smart IOP Intervention
  • Behavioral: Peer Recovery Coach
N/A

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) an in-person peer recovery coach who will function as the "smart Sponsor" to 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 30 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) an in-person peer recovery coach who will function as the "smartSponsor" to provide support and accountability to the participant.The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) an in-person peer recovery coach who will function as the "smartSponsor" to provide support and accountability to the participant.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) an in-person peer recovery coach who will function as the "smart Sponsor" to provide support and accountability to the participant.

Behavioral: Smart IOP Intervention
Smart IOP is a remotely delivered IOP program in operation since 2016, allowing patients to complete addiction treatment entirely online. The program consists of 72 video modules across 8 different topics, with each video module consisting of approximately one hour of content. After each video module, participants are required to correctly answer questions about the content to proceed to the next module. 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 Smart Sponsor during individual sessions. Videos can be viewed at a time that is most convenient to the participants. Participants are required to schedule live sessions with a recovery coach to proceed with the program. Individual sessions ensure participants are completing the program, review answers to the questions, and provide opportunities for patients to ask questions.

Behavioral: Peer Recovery Coach
Peer recovery coach: The Smart IOP program requires that patients identify a "smartSponsor", typically a family member or a friend, who provide accountability and encourage program completion. Prior research has identified that peers play an important role in the hospital by helping to build trust. Involvement of peers is a key principle in trauma-informed approaches that help to establish safety and hope. For this study, a certified peer recovery coach will serve as the smartSponsor. Peer recovery coaches are individuals in sustained recovery (>5 years) and certified to be coaches. The recovery coach for this study will 1) introduce Smart IOP to the participant, 2) assist in setting up the user account and the device, 3) encourage completion of the program, and 4) meet weekly with the participant to review progress, answer questions about the videos, review answers to questions, and encourage continuation of treatment after discharge.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the intervention program [Immediately Post Intervention]

    We expect the results to demonstrate adequate feasibility, as defined by exceeding the threshold for adequate recruitment feasibility and good program acceptability. The proportion of participants meeting a priori benchmarks for recruitment feasibility and program acceptability will be calculated.

Secondary Outcome Measures

  1. Less illicit opioid use [30-Day Follow Up]

    We expect the participants to report less opioid use at the 30-day follow-up compared to the baseline. This will be measured using the Timeline follow back (TLFB).

  2. Retention with MOUD treatment [30-Day Follow Up]

    The proportion of participants engaged in MOUD treatment during the 30-day period before and after the hospitalization will be assessed by self-report.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joji Suzuki, MD, Director, Division of Addiction Psychiatry, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05817825
Other Study ID Numbers:
  • 2023P000709
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023