Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
- Conditions
- Serious Bacterial InfectionsOpioid Use Disorder
- Interventions
- Behavioral: Smart IOP InterventionBehavioral: Peer Recovery Coach
- Registration Number
- NCT05817825
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- English-speaking adults aged 18 and above
- Any DSM-5 substance use disorder
- Can identify at least 2 individuals who can act as points of contact following discharge from the hospital
- Psychotic disorder, active suicidality, or homicidally
- Condition likely to be terminal during the study period
- Unable to perform consent due to impaired mental status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group Smart IOP Intervention 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. Treatment Group Peer Recovery Coach 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.
- Primary Outcome Measures
Name Time Method 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. 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
Name Time Method Retention with MOUD treatment 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up 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.
Illicit opioid use 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up 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.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States