Clinical trial NCT06489535: Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN)
Official title: Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Bloodstream Infection
Osteomyelitis
Endocarditis
Septic Arthritis
Epidural Abscess
Keywords: Recovery Management Checkups (RMC)
Serious injection related infections (SIRI)
Medications for OUD (MOUD)
Re-hospitalizations
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization process will involve assigning participants to either the intervention or control group The Randomization ratio will be 2:1 to intervention and will be done after enrollment by a research assistant through an automated Redcap feature.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of days on medications for opioid disorder (MOUD)
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Participant recruitment rates
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Feasibility of the RETAIN Intervention based on completion of study visits
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Acceptability of the RETAIN Intervention
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Secondary outcomes:
measure: Number of days of antibiotic completion
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Number of days of Opioid use
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Number of Hospitalizations
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Number of uncleaned injections
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: Number of unmonitored opioid use
timeFrame: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
measure: MOUD stigma
timeFrame: Baseline while hospitalized, and 6 month after discharge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Simeon Kimmel, MD
role: PRINCIPAL_INVESTIGATOR
References: