Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
NCT Number: NCT06489535
Acronym: RETAIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Bloodstream Infection|Osteomyelitis|Endocarditis|Septic Arthritis|Epidural Abscess
Interventions: OTHER: RETAIN|OTHER: Unrelated videos
Sponsor: Boston Medical Center
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Boston Medical Center, Boston, Massachusetts, 02118, United States

Summary:
This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.

Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.

The study objectives are to:

* Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
* Establish preliminary estimates of intervention efficacy.
* Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.

Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program

Primary Outcome Measures: Number of days on medications for opioid disorder (MOUD), The timeline follow back (TLFB) method will be used to assess this outcome based on self-report., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Participant recruitment rates, Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Feasibility of the RETAIN Intervention based on completion of study visits, The rates of completion of study visits will be calculated by dividing the number of completed study visits by the total number of study visits., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Acceptability of the RETAIN Intervention, Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean and higher scores are associated with better acceptability., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Secondary Outcome Measures: Number of days of antibiotic completion, Self-report yes or no., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Number of days of Opioid use, The TLFB method will be used to assess this outcome based on self-report., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Number of Hospitalizations, The TLFB method will be used to assess this outcome based on self-report., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Number of uncleaned injections, Self Report based on the The Bacterial Skin Index Risk Score (BIRSI) score, which includes questions about alcohol pad and sterile water use, handwashing, rotating injection sites, injecting subcutaneously or in the muscle ("skin/muscle popping"), and clean needle use, was used as a continuous score to measure risk of skin and soft tissue infections., Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge|Number of unmonitored opioid use, Self Report based on Opioid use, Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge