Opioid-use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRecovery 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English speaking, adults aged 18-75 * Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of opioid use disorder, severe, actively using illicit opioids until the time of hospitalization * Have a working telephone * Can identify at least 2 individuals who can act as points of contact following discharge from the hospital * Willing to engage in treatment (either a psychosocial treatment program AND/OR medication treatment with methadone or buprenorphine)
Exclusion criteria
* Liver function test \>3x upper normal limit * Pregnant * Psychotic disorder, active suicidality or homicidality * Condition likely to be terminal in 24 weeks such as cancer * Unable to perform consent due to mental status * Engaged in substance abuse treatment in the last month prior to admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Retention | 24 weeks after baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | 24 weeks after baseline | Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission. |
| Days to Treatment Discontinuation | 24 weeks after baseline | 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. |
| Days to Hospital Readmission | 24 weeks after baseline | Number of days until hospital readmission. Electronic health records were used to establish hospital readmission. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Found to be ineligible after allocation | 0 | 1 |
| Overall Study | Incarcerated; unable to participate | 2 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Participation terminated due to prolonged inpatient stay (never able to receive intervention). | 1 | 0 |
| Overall Study | Relocated out of area | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 25 Participants |
| Age, Continuous | 46.1 years STANDARD_DEVIATION 13.7 | 39.7 years STANDARD_DEVIATION 10.1 | 42.8 years STANDARD_DEVIATION 12.2 |
| Education (highest level completed) Primary school | 4 Participants | 2 Participants | 6 Participants |
| Education (highest level completed) Secondary school | 8 Participants | 11 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital status Divorced / single / widowed | 9 Participants | 9 Participants | 18 Participants |
| Marital status Married / living as a couple | 3 Participants | 4 Participants | 7 Participants |
| Medication for opioid use disorder (MOUD) initiated during hospitalization Buprenorphine | 5 Participants | 8 Participants | 13 Participants |
| Medication for opioid use disorder (MOUD) initiated during hospitalization Methadone | 7 Participants | 5 Participants | 12 Participants |
| Psychiatric history Anxiety disorder History of diagnosis | 5 Participants | 6 Participants | 11 Participants |
| Psychiatric history Anxiety disorder No history of diagnosis | 7 Participants | 7 Participants | 14 Participants |
| Psychiatric history Attention Deficit Hyperactivity Disorder (ADHD) History of diagnosis | 3 Participants | 4 Participants | 7 Participants |
| Psychiatric history Attention Deficit Hyperactivity Disorder (ADHD) No history of diagnosis | 9 Participants | 9 Participants | 18 Participants |
| Psychiatric history Bipolar disorder History of diagnosis | 3 Participants | 1 Participants | 4 Participants |
| Psychiatric history Bipolar disorder No history of diagnosis | 9 Participants | 12 Participants | 21 Participants |
| Psychiatric history Major Depressive Disorder (MDD) History of diagnosis | 7 Participants | 12 Participants | 19 Participants |
| Psychiatric history Major Depressive Disorder (MDD) No history of diagnosis | 5 Participants | 1 Participants | 6 Participants |
| Psychiatric history Post-traumatic stress disorder (PTSD) History of diagnosis | 5 Participants | 7 Participants | 12 Participants |
| Psychiatric history Post-traumatic stress disorder (PTSD) No history of diagnosis | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
| Substance use disorder history Alcohol use disorder History of diagnosis | 5 Participants | 7 Participants | 12 Participants |
| Substance use disorder history Alcohol use disorder No history of diagnosis | 7 Participants | 6 Participants | 13 Participants |
| Substance use disorder history Amphetamine use disorder History of diagnosis | 1 Participants | 5 Participants | 6 Participants |
| Substance use disorder history Amphetamine use disorder No history of diagnosis | 11 Participants | 8 Participants | 19 Participants |
| Substance use disorder history Cannabis use disorder History of diagnosis | 4 Participants | 4 Participants | 8 Participants |
| Substance use disorder history Cannabis use disorder No history of diagnosis | 8 Participants | 9 Participants | 17 Participants |
| Substance use disorder history Cocaine use disorder History of diagnosis | 8 Participants | 9 Participants | 17 Participants |
| Substance use disorder history Cocaine use disorder No history of diagnosis | 4 Participants | 4 Participants | 8 Participants |
| Substance use disorder history Opioid use disorder History of diagnosis | 12 Participants | 13 Participants | 25 Participants |
| Substance use disorder history Opioid use disorder No history of diagnosis | 0 Participants | 0 Participants | 0 Participants |
| Substance use disorder history Sedative/hypnotic use disorder History of diagnosis | 2 Participants | 4 Participants | 6 Participants |
| Substance use disorder history Sedative/hypnotic use disorder No history of diagnosis | 10 Participants | 9 Participants | 19 Participants |
| Substance use disorder history Tobacco use disorder History of diagnosis | 7 Participants | 12 Participants | 19 Participants |
| Substance use disorder history Tobacco use disorder No history of diagnosis | 5 Participants | 1 Participants | 6 Participants |
| Work Employed | 5 Participants | 4 Participants | 9 Participants |
| Work Unemployed | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 1 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 6 / 13 | 7 / 12 |
Outcome results
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.
Time frame: 24 weeks after baseline
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Treatment Retention | 5 Participants |
| Control | Treatment Retention | 5 Participants |
p-value: =0.87Chi-squared
Secondary
Days to Hospital Readmission
Number of days until hospital readmission. Electronic health records were used to establish hospital readmission.
Time frame: 24 weeks after baseline
Population: 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).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Experimental | Days to Hospital Readmission | 72.57 Days | Standard Deviation 43.14 |
| Control | Days to Hospital Readmission | 67.67 Days | Standard Deviation 54.46 |
p-value: =0.85Log Rank
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.
Time frame: 24 weeks after baseline
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Days to Treatment Discontinuation | 59.11 Days | Standard Deviation 64.25 |
| Control | Days to Treatment Discontinuation | 26.71 Days | Standard Deviation 30.91 |
p-value: =0.92Log Rank
Secondary
Readmissions
Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission.
Time frame: 24 weeks after baseline
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Readmissions | 6 Participants |
| Control | Readmissions | 5 Participants |
p-value: =0.82Chi-squared