Trial Outcomes & Findings for Substance Use Treatment and Recovery Team (NCT NCT05086796)

NCT ID: NCT05086796

Last Updated: 2025-01-23

Results Overview

Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 325 participants
• Primary outcome timeframe: During the inpatient stay, an average of 7 days
• Results posted on: 2025-01-23

Participant Flow

Participant milestones

Measure	Substance Use Treatment and Recovery Team (START) The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care Usual care for people with opioid use disorder.
Overall Study STARTED	164	161
Overall Study COMPLETED	125	104
Overall Study NOT COMPLETED	39	57

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Substance Use Treatment and Recovery Team

Baseline characteristics by cohort

Measure	Substance Use Treatment and Recovery Team (START) n=164 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=161 Participants Usual care for people with opioid use disorder.	Total n=325 Participants Total of all reporting groups
Age, Continuous	41.5 years n=5 Participants	40 years n=7 Participants	41 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	48 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	113 Participants n=7 Participants	213 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	81 Participants n=5 Participants	75 Participants n=7 Participants	156 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants n=5 Participants	86 Participants n=7 Participants	169 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	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	59 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	65 Participants n=5 Participants	60 Participants n=7 Participants	125 Participants n=5 Participants
Region of Enrollment United States	164 participants n=5 Participants	161 participants n=7 Participants	325 participants n=5 Participants

PRIMARY outcome

Timeframe: During the inpatient stay, an average of 7 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms.

Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=164 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=161 Participants Usual care for people with opioid use disorder.
In-hospital Initiation of MOUD Therapy	94 Participants	43 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit.

Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=125 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=104 Participants Usual care for people with opioid use disorder.
Linkage to Follow-up OUD Care	90 Participants	50 Participants

SECONDARY outcome

Timeframe: During the inpatient stay, an average of 7 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms.

Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=164 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=161 Participants Usual care for people with opioid use disorder.
OUD-specific Discharge Plan	81 Participants	44 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit and responded to this question.

Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=124 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=104 Participants Usual care for people with opioid use disorder.
Any Post-discharge MOUD Utilization	65 Participants	32 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who had a follow-up visit and responded to this question.

Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary). Visit must be specifically related to opioid use and may include an emergency department visit.

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=122 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=104 Participants Usual care for people with opioid use disorder.
Post-discharge Outpatient Medical Care	42 Participants	19 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intention-to-treat: All participants who met eligibility criteria and were randomized to one of the two arms and who responded to the question.

Days of use in the past 30 days after hospital discharge - Adapted National Survey of Drug Use and Health (NSDUH) (Continuous). "Use-days" range from 0 to 120 days with up to 30 days of use reportable for each of four opioid categories: pain medications excluding fentanyl, fentanyl, heroin/opium alone, heroin/opium mixed with another drug

Outcome measures

Measure	Substance Use Treatment and Recovery Team (START) n=122 Participants The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=103 Participants Usual care for people with opioid use disorder.
Past 30-day Number of Days With Any Opioid Use	0.0 days Interval 0.0 to 10.0	0.0 days Interval 0.0 to 14.0

Adverse Events

Substance Use Treatment and Recovery Team (START)

Serious events: 4 serious events

Other events: 1 other events

Deaths: 3 deaths

Usual Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Substance Use Treatment and Recovery Team (START) n=164 participants at risk The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=161 participants at risk Usual care for people with opioid use disorder.
Infections and infestations Necrotizing oft-tissue infection (NSTI)	0.61% 1/164 • Number of events 1 • 90 days - from date of enrollment to end of follow-up period.	0.00% 0/161 • 90 days - from date of enrollment to end of follow-up period.
Investigations	1.2% 2/164 • Number of events 2 • 90 days - from date of enrollment to end of follow-up period.	1.2% 2/161 • Number of events 2 • 90 days - from date of enrollment to end of follow-up period.
Cardiac disorders Cardiac arrest	0.00% 0/164 • 90 days - from date of enrollment to end of follow-up period.	0.62% 1/161 • Number of events 1 • 90 days - from date of enrollment to end of follow-up period.
Psychiatric disorders Hospitalized	0.61% 1/164 • Number of events 1 • 90 days - from date of enrollment to end of follow-up period.	0.00% 0/161 • 90 days - from date of enrollment to end of follow-up period.

Other adverse events

Measure	Substance Use Treatment and Recovery Team (START) n=164 participants at risk The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Substance Use Treatment and Recovery Team (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 use disorder 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	Usual Care n=161 participants at risk Usual care for people with opioid use disorder.
Social circumstances Grievance	0.61% 1/164 • Number of events 1 • 90 days - from date of enrollment to end of follow-up period.	0.00% 0/161 • 90 days - from date of enrollment to end of follow-up period.

Additional Information

Itai Danovitch, MD

Cedars-Sinai Medical Center

Phone: 310-423-2600

Email: itai.danovitch@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place