Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Bloodstream Infection; Osteomyelitis; Endocarditis; Septic Arthritis; Epidural Abscess

• Registration Number: NCT06489535
• Lead Sponsor: Boston Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-03
• Study First Posted: 2024-07-08
• Study Start: 2025-01-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Between 18 and 65 years of age
• Able to provide Informed Consent
• Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended

Exclusion Criteria

• Not able to give informed consent
• Cognitive ability (defined through Research Assistant (RA) determination)
• Inability to complete assessments in English or Spanish (defined through RA determination).
• Exclusion for any reason under PI discretion
• Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
• In police custody or expecting incarceration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant recruitment rates	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.
Feasibility of the RETAIN Intervention based on completion of study visits	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	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.
Acceptability of the RETAIN Intervention	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	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.
Number of days on medications for opioid disorder (MOUD)	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.

Secondary Outcome Measures

Name	Time	Method
Number of uncleaned injections	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	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.
MOUD stigma	Baseline while hospitalized, and 6 month after discharge	Partial adaptation of MMT-SMS stigma scale will be used to assess this outcome based on self-report
Number of days of antibiotic completion	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	Self-report yes or no.
Number of days of Opioid use	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	The TLFB method will be used to assess this outcome based on self-report.
Number of Hospitalizations	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	The TLFB method will be used to assess this outcome based on self-report.
Number of unmonitored opioid use	Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge	Self Report based on Opioid use

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States