Opioid Use, Opioid-use Disorder
Conditions
Brief summary
This study aims to determine whether referral to the Bridge Clinic reduces overall index hospital length of stay when compared to direct referral to a long-term outpatient addiction provider for patients with active opioid use disorder (OUD) being considered for medications-for-addiction treatment (MAT).
Interventions
OTHERBridge 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.
OTHERUsual Care
Referral to an outpatient provider for addiction treatment.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Programmatic evaluation - eligible participants will be individually randomized to either direct referral to a long-term outpatient addiction provider or referral to the Bridge Clinic while long-term outpatient addiction provider is located/identified.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatients at VUH with active OUD being considered for MAT. * Patient accepting a transitional prescription for buprenorphine-naloxone or IM naltrexone whose outpatient plans are not fixed
Exclusion criteria
* Deemed ineligible for referral to outpatient Bridge Clinic by the Addiction Consult Team (examples include but are not limited to patients with severe, active co-occurring psychiatric disorders requiring a higher level of psychiatric care or patients for whom methadone maintenance is deemed the best choice of MAT). * Patients previously randomized in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | approximately 3 to 42 days | Overall index hospital length of stay measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Care Linkage | 16 weeks post-randomization | Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider |
| Number of MAT Prescriptions Filled by Participant | 16 weeks post-randomization | Reported buprenorphine-naloxone (or naltrexone) prescriptions filled |
| Readmissions and Emergency Department (ED) Visits | 16 weeks post-randomization | Composite number of ED visits and readmissions |
| Hospital and ED Free Days | 16 weeks post-randomization | Days alive out of the hospital and/or ED |
| Combined Cost of Index Admission and Subsequent Admissions During the Study Period | 16 weeks post-randomization | 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. |
| Recurrent Opioid Use | 16 weeks post-randomization | The number of participants with recurrent opioid use. |
| Overdose | 16 weeks post-randomization | Any overdose self-reported at the 16-week follow up |
| Quality of Life - Schwartz Outcome Scale-10 (SOS10). | 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. |
| Opioid Use Within 30 Days | 30 days | Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call. |
| Mortality | 16 weeks post-randomization | Death in hospital or documented at 16-week follow up or in the medical record. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants randomized to this arm will receive care as usual.
Usual Care: Referral to an outpatient provider for addiction treatment. | 168 |
| 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. | 167 |
| Total | 335 |
Baseline characteristics
| Characteristic | Usual Care | Bridge Clinic | Total |
|---|---|---|---|
| Age, Continuous | 37.9 years | 38.7 years | 38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 161 Participants | 320 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 20 Participants | 16 Participants | 36 Participants |
| Race/Ethnicity, Customized Race Missing/Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Race White | 143 Participants | 144 Participants | 287 Participants |
| Region of Enrollment United States | 168 participants | 167 participants | 335 participants |
| Sex: Female, Male Female | 69 Participants | 72 Participants | 141 Participants |
| Sex: Female, Male Male | 99 Participants | 95 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 168 | 2 / 167 |
| other Total, other adverse events | 0 / 168 | 0 / 167 |
| serious Total, serious adverse events | 0 / 168 | 0 / 167 |
Outcome results
Primary
Hospital Length of Stay
Overall index hospital length of stay measured in days
Time frame: approximately 3 to 42 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Hospital Length of Stay | 232.1 Hours | Standard Deviation 267.4 |
| Bridge Clinic | Hospital Length of Stay | 215.0 Hours | Standard Deviation 236.1 |
Secondary
Combined Cost of Index Admission and Subsequent Admissions During the Study Period
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.
Time frame: 16 weeks post-randomization
Population: Data was missing for 24 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Combined Cost of Index Admission and Subsequent Admissions During the Study Period | 1705.28 Dollars |
| Bridge Clinic | Combined Cost of Index Admission and Subsequent Admissions During the Study Period | 9481.93 Dollars |
Secondary
Hospital and ED Free Days
Days alive out of the hospital and/or ED
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Hospital and ED Free Days | 112 days |
| Bridge Clinic | Hospital and ED Free Days | 112 days |
Secondary
Mortality
Death in hospital or documented at 16-week follow up or in the medical record.
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Mortality | 4 Participants |
| Bridge Clinic | Mortality | 2 Participants |
Secondary
Number of MAT Prescriptions Filled by Participant
Reported buprenorphine-naloxone (or naltrexone) prescriptions filled
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Number of MAT Prescriptions Filled by Participant | 1 prescriptions filled |
| Bridge Clinic | Number of MAT Prescriptions Filled by Participant | 10 prescriptions filled |
Secondary
Number of Participants With Successful Care Linkage
Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider
Time frame: 16 weeks post-randomization
Population: Data was not available for 247 participants (136 in usual care and 111 in bridge clinic).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Successful Care Linkage | Linkage To Provider = Yes | 19 Participants |
| Usual Care | Number of Participants With Successful Care Linkage | Linkage To Provider = No | 13 Participants |
| Bridge Clinic | Number of Participants With Successful Care Linkage | Linkage To Provider = Yes | 45 Participants |
| Bridge Clinic | Number of Participants With Successful Care Linkage | Linkage To Provider = No | 11 Participants |
Secondary
Opioid Use Within 30 Days
Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.
Time frame: 30 days
Population: Data was unavailable for 303 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Opioid Use Within 30 Days | No Use | 2 Participants |
| Usual Care | Opioid Use Within 30 Days | Single Use | 4 Participants |
| Usual Care | Opioid Use Within 30 Days | Multiple Use | 7 Participants |
| Bridge Clinic | Opioid Use Within 30 Days | No Use | 2 Participants |
| Bridge Clinic | Opioid Use Within 30 Days | Single Use | 0 Participants |
| Bridge Clinic | Opioid Use Within 30 Days | Multiple Use | 17 Participants |
Secondary
Overdose
Any overdose self-reported at the 16-week follow up
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Overdose | 4 Participants |
| Bridge Clinic | Overdose | 1 Participants |
Secondary
Quality of Life - Schwartz Outcome Scale-10 (SOS10).
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.
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Quality of Life - Schwartz Outcome Scale-10 (SOS10). | 41.5 score on a scale |
| Bridge Clinic | Quality of Life - Schwartz Outcome Scale-10 (SOS10). | 47 score on a scale |
Secondary
Readmissions and Emergency Department (ED) Visits
Composite number of ED visits and readmissions
Time frame: 16 weeks post-randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Readmissions and Emergency Department (ED) Visits | 0 events |
| Bridge Clinic | Readmissions and Emergency Department (ED) Visits | 0 events |
Secondary
Recurrent Opioid Use
The number of participants with recurrent opioid use.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Recurrent Opioid Use | 15 Participants |
| Bridge Clinic | Recurrent Opioid Use | 23 Participants |