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

Boston Medical Center (BMC)

Status: Enrolling

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

Treatments: Other: Unrelated videos; Other: RETAIN

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06489535

H-44905

K23DA054363 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

RETAIN intervention

Experimental group

Description:

Participants randomized to the RETAIN intervention will receive Motivational Interviewing targeted to their clinical concerns and personalized support tailored to each participants' specific needs determined by their answers to intake questions.

Treatment:

Other: RETAIN

Control

Active Comparator group

Description:

Control arm participants will be offered different videos or podcast episodes that are unrelated to the study topics of infections, substance use, overdose, and medication management.

Treatment:

Other: Unrelated videos