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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA054363 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RETAIN intervention | Experimental | 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. |
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| Control | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RETAIN | Other | There are 6 different modules that a participant in the RETAIN intervention group can be placed in: "Reinforce Antibiotic Completion", "Linkage to Antibiotic Treatment/Alternate Plan", "Reinforce Recovery", "Linkage to MOUD/Alternate Plan", "Reinforce Treatment Attendance", and "Harm Reduction Support". Participants may be assigned to no more than three modules at a time until they finish their antibiotics. After the completion of antibiotics, participants may only be in two modules. Participants' intervention can range from 15 minutes- 60 minutes depending on what modules they are placed in and how much support they feel they need. Interventions will begin at the two-week follow up after a participant has been discharged from Boston Medical Center (BMC). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simeon Kimmel, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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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.
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| Unrelated videos | Other | These videos unrelated to the study topics will last approximately 30-45 minutes. Depending on the method of communication, participants will watch a video (in person) or listen to a podcast (remote) |
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| 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 |
| MOUD stigma | Partial adaptation of MMT-SMS stigma scale will be used to assess this outcome based on self-report | Baseline while hospitalized, and 6 month after discharge |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D018805 | Sepsis |
| D010019 | Osteomyelitis |
| D004696 | Endocarditis |
| D001170 | Arthritis, Infectious |
| D020802 | Epidural Abscess |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001850 | Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D020819 | Perimeningeal Infections |
| D002494 | Central Nervous System Infections |
| D000038 | Abscess |
| D013492 | Suppuration |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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