Trial Outcomes & Findings for Substance Use Treatment and Recovery Team (START) (NCT NCT04314648)
NCT ID: NCT04314648
Last Updated: 2023-04-20
Results Overview
Received medication for an OUD or AUD between admission and discharge (Binary)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
During the inpatient stay, an average of 7 days
Results posted on
2023-04-20
Participant Flow
Participant milestones
| Measure |
START
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
50
|
|
Overall Study
COMPLETED
|
38
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed is patients with an alcohol use disorder (minus one patient who did not respond to this question)
Baseline characteristics by cohort
| Measure |
START
n=38 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=50 Participants
Usual care for people with alcohol or opioid use disorder.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 12.9 • n=38 Participants
|
44.5 years
STANDARD_DEVIATION 13.2 • n=50 Participants
|
44.5 years
STANDARD_DEVIATION 13.0 • n=88 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=38 Participants
|
10 Participants
n=50 Participants
|
22 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=38 Participants
|
40 Participants
n=50 Participants
|
66 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=38 Participants
|
18 Participants
n=50 Participants
|
28 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=38 Participants
|
32 Participants
n=50 Participants
|
60 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=38 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=38 Participants
|
4 Participants
n=50 Participants
|
8 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=38 Participants
|
43 Participants
n=50 Participants
|
74 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=38 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
50 participants
n=50 Participants
|
88 participants
n=88 Participants
|
|
Heavy Drinking among Patients with Alcohol Use Disorder
|
26 Participants
n=31 Participants • Number analyzed is patients with an alcohol use disorder (minus one patient who did not respond to this question)
|
32 Participants
n=41 Participants • Number analyzed is patients with an alcohol use disorder (minus one patient who did not respond to this question)
|
58 Participants
n=72 Participants • Number analyzed is patients with an alcohol use disorder (minus one patient who did not respond to this question)
|
|
Any Days of Opioid Use among Patients with Opioid Use Disorder
|
9 Participants
n=13 Participants • Number analyzed is patients with opioid use disorder.
|
11 Participants
n=14 Participants • Number analyzed is patients with opioid use disorder.
|
20 Participants
n=27 Participants • Number analyzed is patients with opioid use disorder.
|
|
Days of Alcohol Use among Patients with Alcohol Use Disorder
|
18.39 Days of Use
STANDARD_DEVIATION 10.34 • n=31 Participants • Number analyzed is patients with an alcohol use disorder.
|
21.21 Days of Use
STANDARD_DEVIATION 10.65 • n=42 Participants • Number analyzed is patients with an alcohol use disorder.
|
20.01 Days of Use
STANDARD_DEVIATION 10.54 • n=73 Participants • Number analyzed is patients with an alcohol use disorder.
|
|
Number of Drinks per Day among those with Alcohol Use Disorder who Drank in the Past 30 Days
|
10.21 Drinks per Day
STANDARD_DEVIATION 7.33 • n=28 Participants • Number analyzed is patients with an alcohol use disorder
|
9.97 Drinks per Day
STANDARD_DEVIATION 7.70 • n=38 Participants • Number analyzed is patients with an alcohol use disorder
|
10.08 Drinks per Day
STANDARD_DEVIATION 7.49 • n=66 Participants • Number analyzed is patients with an alcohol use disorder
|
PRIMARY outcome
Timeframe: During the inpatient stay, an average of 7 daysPopulation: All study participants.
Received medication for an OUD or AUD between admission and discharge (Binary)
Outcome measures
| Measure |
START
n=38 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=50 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Number of Patients With In-hospital Initiation of Medication for OUD or AUD
|
22 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 30 days post-dischargePopulation: Study participants who received a 1-month follow-up interview.
Received at least one visit post-discharge for medication and/or psychosocial care for OUD or AUD (Binary)
Outcome measures
| Measure |
START
n=29 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=44 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Number of Patients With Linkage to Follow-up Care for OUD or AUD
|
24 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 30-days post-dischargePopulation: Study participants with an alcohol use disorder who received a 1-month follow-up interview.
For men, consuming an average of more than two drinks per day; for women, consuming an average of more than one drink per day during the reporting period of 30 days, extended from the NIAAA definition of this level of drinking over 14 days), among patients with alcohol use disorder at follow-up (National Institute on Alcohol Abuse and Alcoholism, 2022). Obtained by combining the separate survey questions of # of days drinking and # of drinks per day in past 30 days) (binary)
Outcome measures
| Measure |
START
n=24 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=36 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Number of Patients With Heavy Drinking in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 30 days post-dischargePopulation: Study participants with opioid use disorder who received a 1-month follow-up interview.
Any days using opioids at follow-up, based on NSDUH 30-day substance use questions (Center for Behavioral Health Statistics and Quality, 2018), (binary)
Outcome measures
| Measure |
START
n=11 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=12 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Number of Patients With Any Days of Opioid Use in Past 30-days at Follow-up Among Patients With Opioid Use Disorder
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 30-days post-dischargePopulation: Study participants with alcohol use disorder who received a 1-month follow-up interview.
Number of days of any alcohol use in the past 30 days at follow-up among patients with an alcohol use disorder
Outcome measures
| Measure |
START
n=24 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=37 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Average Number of Days of Alcohol Use in Past 30-Days at Follow-Up Among Patients With Alcohol Use Disorder
|
4.08 Days of use
Standard Deviation 7.57
|
6.24 Days of use
Standard Deviation 9.37
|
PRIMARY outcome
Timeframe: 30-days post-dischargePopulation: Study participants with alcohol use disorder who drank in the past 30 days and received a 1-month follow-up interview.
Number of drinks per day among those with alcohol use disorder who drank in the past 30 days at follow-up
Outcome measures
| Measure |
START
n=11 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=17 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Average Number of Drinks Per Day in Past 30-days at Follow-up Among Patients With Alcohol Use Disorder
|
9.82 Drinks per day
Standard Deviation 9.60
|
7.00 Drinks per day
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: 90 days post-dischargePopulation: All study participants.
Patient was readmitted to Cedars Sinai Medical Center (the same hospital) for any reason, up to 90-days after discharge
Outcome measures
| Measure |
START
n=38 Participants
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid and alcohol use disorders, and to increase linkage to aftercare.
The components of the START intervention are as follows:
1. Triage
2. Engage, Assess, and Plan
3. Treat
4. Communicate and Coordinate
5. Follow up
6. Monitor
Substance Use Treatment and Recovery Team (START): Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
|
Usual Care
n=50 Participants
Usual care for people with alcohol or opioid use disorder.
|
|---|---|---|
|
Number of Patients Readmitted to Cedars-Sinai Medical Center (CSMC) Within 90 Days After Discharge
|
7 Participants
|
8 Participants
|
Adverse Events
START
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place