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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA042326-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention.
Patients with opioid use disorder (OUD) frequently utilize hospitals due to soft tissue infections and other conditions that require inpatient level of care. Prior studies have indicated that OUD patients are often amenable to initiating buprenorphine treatment and can be successfully linked to outpatient treatment. However, hospitalized OUD patients initiated on buprenorphine have much lower treatment retention rates at 6-months compared to OUD patients initiating treatment in the outpatient setting. As such, there is a great need to identify strategies to improve treatment retention in this patient population. There is a growing body of evidence for the benefits of recovery coaches, who provide peer-delivered support services in the community. Tracing their origin to mutual support groups to supplement traditional clinical services, recovery coaches are individuals with lived experience of recovery. Studies of recovery coaches have demonstrated greater treatment retention, reduced substance use, and reduced inpatient utilization. However, no prior studies have examined the impact of recovery coaches in improving medication-assisted treatment retention. As such, the aim of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or methadone compared to the control intervention. Patients who are successfully initiated on buprenorphine or methadone, and are willing to engage in treatment after discharge, will be eligible to enroll. Assessments will be conducted at baseline, 4 weeks, 12 weeks, and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support. |
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| Control | No Intervention | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recovery coach | Behavioral | The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | Primary outcome was retention in MOUD treatment at 6-months after discharge. If referred to programs affiliated with Brigham and Women's Hospital (BWH), the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment. | 24 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Readmissions | Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission. | 24 weeks after baseline |
| Days to Treatment Discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joji Suzuki, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29141667 | Background | Friedmann PD, Suzuki J. More beds are not the answer: transforming detoxification units into medication induction centers to address the opioid epidemic. Addict Sci Clin Pract. 2017 Nov 15;12(1):29. doi: 10.1186/s13722-017-0092-y. No abstract available. |
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Recruitment for the study was conducted between February 2019 and December 2021 at Brigham and Women's Hospital, an urban academic hospital in Boston, Massachusetts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Subjects randomized to the experimental arm will be assigned to a recovery coach. In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support. Recovery coach: The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion. |
| FG001 | Control | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants not analyzed were either workbook manual pilot subjects (n=2), investigator-terminated (n=1), or found to be ineligible after enrollment (n=1).
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support. Recovery coach: The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Retention | Primary outcome was retention in MOUD treatment at 6-months after discharge. If referred to programs affiliated with Brigham and Women's Hospital (BWH), the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment. | All enrolled participants were included in analyses, apart from the workbook manual pilot subjects (n=2), the investigator-terminated participant (n=1), and the participant found to be ineligible after enrollment (n=1). | Posted | Count of Participants | Participants | 24 weeks after baseline |
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6 months following each participant's initial hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support. Recovery coach: The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
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Pilot study with a small sample size. Because of the launch of a "bridge" clinic at the hospital briefly after trial initiation, participants in both treatment arms may have had access to peer support, potentially diluting the impact of the intervention. Self-report used to ascertain MOUD treatment retention when medical records were not available to be examined. Illicit opioid use after hospital discharge relied on self-report without any toxicologic confirmation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joji Suzuki, MD | Brigham and Women's Hospital | 617-732-5752 | Jsuzuki2@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2020 | Jan 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2021 | Jan 2, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Number of days until MOUD treatment discontinuation. If referred to programs affiliated with BWH, the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment.
| 24 weeks after baseline |
| Days to Hospital Readmission | Number of days until hospital readmission. Electronic health records were used to establish hospital readmission. | 24 weeks after baseline |
| Incarcerated; unable to participate |
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| Withdrawal by Subject |
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| Death |
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| Found to be ineligible after allocation |
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| Relocated out of area |
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| BG001 | Control | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education (highest level completed) | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Work | Count of Participants | Participants |
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| Psychiatric history | Count of Participants | Participants |
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| Substance use disorder history | Count of Participants | Participants |
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| Medication for opioid use disorder (MOUD) initiated during hospitalization | Count of Participants | Participants |
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| OG001 | Control | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. |
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| Secondary | Readmissions | Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission. | All enrolled participants were included in analyses, apart from the workbook manual pilot subjects (n=2), the investigator-terminated participant (n=1), and the participant found to be ineligible after enrollment (n=1). | Posted | Count of Participants | Participants | 24 weeks after baseline |
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|
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| Secondary | Days to Treatment Discontinuation | Number of days until MOUD treatment discontinuation. If referred to programs affiliated with BWH, the electronic health records were used to confirm treatment retention. Otherwise, retention was determined through self-report or confirmation with collateral contacts. If the electronic health record was not available for confirmation and the participant was lost to follow-up, the missing data was imputed as discontinuation of MOUD treatment. | Also excluded are the workbook manual pilot subjects (n=2), the investigator-terminated participant (n=1), and the participant found to be ineligible after enrollment (n=1). Only individuals who discontinued treatment during the study are included in this analysis. In the experimental group, 4 individuals did not discontinue treatment. In the control group, 5 individuals did not discontinue treatment. A total of 9 individuals are excluded, Of those analyzed: Experimental: 9; Control: 7 | Posted | Mean | Standard Deviation | Days | 24 weeks after baseline |
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| Secondary | Days to Hospital Readmission | Number of days until hospital readmission. Electronic health records were used to establish hospital readmission. | Excluded participants are workbook manual pilot subjects (n=2), the investigator-terminated participant (n=1), and the participant found to be ineligible after enrollment (n=1). Only individuals who had a hospital readmission are included in this analysis. In the experimental condition, 6 individuals did not have a readmission. In the control condition, 6 individuals did not have a readmission, leaving a total of 13 people to be analyzed (Experimental: 7; Control :6). | Posted | Median | Standard Deviation | Days | 24 weeks after baseline |
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| 0 |
| 13 |
| 6 |
| 13 |
| 0 |
| 13 |
| EG001 | Control | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. | 1 | 12 | 7 | 12 | 0 | 12 |
| Hospitalization - acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| Hospitalization - bacteremia | General disorders | Non-systematic Assessment |
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| Hospitalization - opioid overdose | Psychiatric disorders | Non-systematic Assessment |
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| Hospitalization - abdominal bleed | Vascular disorders | Non-systematic Assessment |
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| Hospitalization - infected total knee replacement | Infections and infestations | Non-systematic Assessment |
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| Hospitalization - surgical fixation status post osteoarthritis | Surgical and medical procedures | Non-systematic Assessment |
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| Hospitalization - cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hospitalization - splenic rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hospitalization - endocarditis | Infections and infestations | Non-systematic Assessment |
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| hospitalization - acute on chronic back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| hospitalization - abdominal pain | General disorders | Non-systematic Assessment |
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| hospitalization - spinal epidural abscess | Infections and infestations | Non-systematic Assessment |
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| hospitalization - substance-induced psychosis | Psychiatric disorders | Non-systematic Assessment |
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| hospitalization - suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| hospitalization - septic arthritis | Infections and infestations | Non-systematic Assessment |
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| hospitalization - acute on chronic congestive heart failure | Cardiac disorders | Non-systematic Assessment |
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