Trial Outcomes & Findings for Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder (NCT NCT04084392)

NCT ID: NCT04084392

Last Updated: 2024-07-10

Results Overview

Overall index hospital length of stay measured in days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 335 participants
• Primary outcome timeframe: approximately 3 to 42 days
• Results posted on: 2024-07-10

Participant Flow

Participant milestones

Measure	Usual Care Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Overall Study STARTED	168	167
Overall Study COMPLETED	168	167
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder

Baseline characteristics by cohort

Measure	Usual Care n=168 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=167 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.	Total n=335 Participants Total of all reporting groups
Age, Continuous	37.9 years n=93 Participants	38.7 years n=4 Participants	38 years n=27 Participants
Sex: Female, Male Female	69 Participants n=93 Participants	72 Participants n=4 Participants	141 Participants n=27 Participants
Sex: Female, Male Male	99 Participants n=93 Participants	95 Participants n=4 Participants	194 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	159 Participants n=93 Participants	161 Participants n=4 Participants	320 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	143 Participants n=93 Participants	144 Participants n=4 Participants	287 Participants n=27 Participants
Race/Ethnicity, Customized Race · Black or African American	20 Participants n=93 Participants	16 Participants n=4 Participants	36 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Race · Missing/Unknown	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	168 participants n=93 Participants	167 participants n=4 Participants	335 participants n=27 Participants

PRIMARY outcome

Timeframe: approximately 3 to 42 days

Overall index hospital length of stay measured in days

Outcome measures

Measure	Usual Care n=168 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=167 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Hospital Length of Stay	232.1 Hours Standard Deviation 267.4	215.0 Hours Standard Deviation 236.1

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Population: Data was missing for 24 participants.

Total costs, and costs for each admission and care resource used measured in dollars. This includes the cost of the index hospital admission along with any subsequent admissions during the 16-week follow up period.

Outcome measures

Measure	Usual Care n=151 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=160 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Combined Cost of Index Admission and Subsequent Admissions During the Study Period	1705.28 Dollars Interval 360.16 to 12146.33	9481.93 Dollars Interval 1478.28 to 29376.14

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Population: Data was not available for 247 participants (136 in usual care and 111 in bridge clinic).

Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider

Outcome measures

Measure	Usual Care n=32 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=56 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Number of Participants With Successful Care Linkage Linkage To Provider = Yes	19 Participants	45 Participants
Number of Participants With Successful Care Linkage Linkage To Provider = No	13 Participants	11 Participants

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Reported buprenorphine-naloxone (or naltrexone) prescriptions filled

Outcome measures

Measure	Usual Care n=31 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=46 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Number of MAT Prescriptions Filled by Participant	1 prescriptions filled Interval 0.0 to 6.0	10 prescriptions filled Interval 4.0 to 16.0

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Composite number of ED visits and readmissions

Outcome measures

Measure	Usual Care n=168 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=167 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Readmissions and Emergency Department (ED) Visits	0 events Interval 0.0 to 1.0	0 events Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Days alive out of the hospital and/or ED

Outcome measures

Measure	Usual Care n=168 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=167 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Hospital and ED Free Days	112 days Interval 111.0 to 112.0	112 days Interval 107.0 to 112.0

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Death in hospital or documented at 16-week follow up or in the medical record.

Outcome measures

Measure	Usual Care n=168 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=167 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Mortality	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Population: We were unable to assess the approximate number of times opioids were used based on the patient-reported answers provided. We were only able to determine if there was or was not recurrent opioid use.

The number of participants with recurrent opioid use.

Outcome measures

Measure	Usual Care n=32 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=56 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Recurrent Opioid Use	15 Participants	23 Participants

SECONDARY outcome

Timeframe: 16 weeks post-randomization

Any overdose self-reported at the 16-week follow up

Outcome measures

Measure	Usual Care n=32 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=54 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Overdose	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 16 weeks post-randomization

The Quality of Life - Schwartz Outcome Scale-10 (SOS10) survey has ten questions scored on a 0 (never) to 6 (all or nearly all of the time) scale that measures the broad domain of psychological well-being and quality of life. A total score is computed as the sum across the 10 questions. Therefore, the minimum total score is 0 (never) and the maximum score is 60 (all or nearly all of the time). Higher scores indicate greater well-being and psychological health. Therefore, higher scores are better.

Outcome measures

Measure	Usual Care n=32 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=54 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Quality of Life - Schwartz Outcome Scale-10 (SOS10).	41.5 score on a scale Interval 32.5 to 54.25	47 score on a scale Interval 26.0 to 53.75

SECONDARY outcome

Timeframe: 30 days

Population: Data was unavailable for 303 participants.

Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.

Outcome measures

Measure	Usual Care n=13 Participants Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment.	Bridge Clinic n=19 Participants Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. Bridge Clinic: Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
Opioid Use Within 30 Days No Use	2 Participants	2 Participants
Opioid Use Within 30 Days Single Use	4 Participants	0 Participants
Opioid Use Within 30 Days Multiple Use	7 Participants	17 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Bridge Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dave Marcovitz

Vanderbilt University Medical Center

Phone: 615-936-3555

Email: david.marcovitz@vumc.org

Results disclosure agreements

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