Trial Outcomes & Findings for Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients. (NCT NCT03212794)
NCT ID: NCT03212794
Last Updated: 2023-12-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
24 weeks after baseline
Results posted on
2023-12-26
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Participation terminated due to prolonged inpatient stay (never able to receive intervention).
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Incarcerated; unable to participate
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Found to be ineligible after allocation
|
0
|
1
|
|
Overall Study
Relocated out of area
|
2
|
0
|
Baseline Characteristics
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
Baseline characteristics by cohort
| Measure |
Experimental
n=13 Participants
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.
|
Control
n=12 Participants
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education (highest level completed)
Primary school
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education (highest level completed)
Secondary school
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
Divorced / single / widowed
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital status
Married / living as a couple
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Work
Employed
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Work
Unemployed
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Psychiatric history
Major Depressive Disorder (MDD) · History of diagnosis
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Psychiatric history
Major Depressive Disorder (MDD) · No history of diagnosis
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Psychiatric history
Bipolar disorder · History of diagnosis
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Psychiatric history
Bipolar disorder · No history of diagnosis
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Psychiatric history
Attention Deficit Hyperactivity Disorder (ADHD) · History of diagnosis
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Psychiatric history
Attention Deficit Hyperactivity Disorder (ADHD) · No history of diagnosis
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Psychiatric history
Anxiety disorder · History of diagnosis
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Psychiatric history
Anxiety disorder · No history of diagnosis
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Psychiatric history
Post-traumatic stress disorder (PTSD) · History of diagnosis
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Psychiatric history
Post-traumatic stress disorder (PTSD) · No history of diagnosis
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Substance use disorder history
Opioid use disorder · History of diagnosis
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Substance use disorder history
Opioid use disorder · No history of diagnosis
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Substance use disorder history
Tobacco use disorder · History of diagnosis
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Substance use disorder history
Tobacco use disorder · No history of diagnosis
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Substance use disorder history
Cocaine use disorder · History of diagnosis
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Substance use disorder history
Cocaine use disorder · No history of diagnosis
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Substance use disorder history
Amphetamine use disorder · History of diagnosis
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Substance use disorder history
Amphetamine use disorder · No history of diagnosis
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Substance use disorder history
Cannabis use disorder · History of diagnosis
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Substance use disorder history
Cannabis use disorder · No history of diagnosis
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Substance use disorder history
Alcohol use disorder · History of diagnosis
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Substance use disorder history
Alcohol use disorder · No history of diagnosis
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Substance use disorder history
Sedative/hypnotic use disorder · History of diagnosis
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Substance use disorder history
Sedative/hypnotic use disorder · No history of diagnosis
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Medication for opioid use disorder (MOUD) initiated during hospitalization
Buprenorphine
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Medication for opioid use disorder (MOUD) initiated during hospitalization
Methadone
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after baselinePopulation: 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).
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.
Outcome measures
| Measure |
Experimental
n=13 Participants
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.
|
Control
n=12 Participants
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
|---|---|---|
|
Treatment Retention
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after baselinePopulation: 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).
Percentage of participants experiencing hospital readmission at 6 months. The electronic health records were used to establish hospital readmission.
Outcome measures
| Measure |
Experimental
n=13 Participants
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.
|
Control
n=12 Participants
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
|---|---|---|
|
Readmissions
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after baselinePopulation: 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
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.
Outcome measures
| Measure |
Experimental
n=9 Participants
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.
|
Control
n=7 Participants
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
|---|---|---|
|
Days to Treatment Discontinuation
|
59.11 Days
Standard Deviation 64.25
|
26.71 Days
Standard Deviation 30.91
|
SECONDARY outcome
Timeframe: 24 weeks after baselinePopulation: 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).
Number of days until hospital readmission. Electronic health records were used to establish hospital readmission.
Outcome measures
| Measure |
Experimental
n=7 Participants
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.
|
Control
n=6 Participants
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
|---|---|---|
|
Days to Hospital Readmission
|
72.57 Days
Standard Deviation 43.14
|
67.67 Days
Standard Deviation 54.46
|
Adverse Events
Experimental
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental
n=13 participants at risk
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.
|
Control
n=12 participants at risk
Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Renal and urinary disorders
Hospitalization - acute kidney injury
|
7.7%
1/13 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
General disorders
Hospitalization - bacteremia
|
7.7%
1/13 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Psychiatric disorders
Hospitalization - opioid overdose
|
7.7%
1/13 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
0.00%
0/12 • 6 months following each participant's initial hospital discharge
|
|
Vascular disorders
Hospitalization - abdominal bleed
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Infections and infestations
Hospitalization - infected total knee replacement
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
|
Surgical and medical procedures
Hospitalization - surgical fixation status post osteoarthritis
|
7.7%
1/13 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
0.00%
0/12 • 6 months following each participant's initial hospital discharge
|
|
Skin and subcutaneous tissue disorders
Hospitalization - cellulitis
|
15.4%
2/13 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
16.7%
2/12 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
|
Injury, poisoning and procedural complications
Hospitalization - splenic rupture
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Infections and infestations
Hospitalization - endocarditis
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
|
Musculoskeletal and connective tissue disorders
hospitalization - acute on chronic back pain
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
General disorders
hospitalization - abdominal pain
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Infections and infestations
hospitalization - spinal epidural abscess
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 2 • 6 months following each participant's initial hospital discharge
|
|
Psychiatric disorders
hospitalization - substance-induced psychosis
|
7.7%
1/13 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
0.00%
0/12 • 6 months following each participant's initial hospital discharge
|
|
Psychiatric disorders
hospitalization - suicidal ideation
|
7.7%
1/13 • Number of events 3 • 6 months following each participant's initial hospital discharge
|
0.00%
0/12 • 6 months following each participant's initial hospital discharge
|
|
Infections and infestations
hospitalization - septic arthritis
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
|
Cardiac disorders
hospitalization - acute on chronic congestive heart failure
|
0.00%
0/13 • 6 months following each participant's initial hospital discharge
|
8.3%
1/12 • Number of events 1 • 6 months following each participant's initial hospital discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place