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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants randomized to this arm will receive care as usual. |
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| Bridge Clinic | Active Comparator | Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge Clinic | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Overall index hospital length of stay measured in days | approximately 3 to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Marcovitz, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38411964 | Derived | Marcovitz D, Dear ML, Donald R, Edwards DA, Kast KA, Le TDV, Shah MV, Ferrell J, Gatto C, Hennessy C, Buie R, Rice TW, Sullivan W, White KD, Van Winkle G, Wolf R, Lindsell CJ; Vanderbilt Learning Healthcare System Platform Investigators. Effect of a Co-Located Bridging Recovery Initiative on Hospital Length of Stay Among Patients With Opioid Use Disorder: The BRIDGE Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2356430. doi: 10.1001/jamanetworkopen.2023.56430. | |
| 34717736 |
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Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.
The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | Overall index hospital length of stay measured in days | Posted | Mean | Standard Deviation | Hours | approximately 3 to 42 days |
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Adverse events were tracked for each participant from study enrollment throughout the 16 week follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants randomized to this arm will receive care as usual. Usual Care: Referral to an outpatient provider for addiction treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dave Marcovitz | Vanderbilt University Medical Center | 615-936-3555 | david.marcovitz@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2022 | Nov 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2022 | Nov 10, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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| Usual Care | Other | Referral to an outpatient provider for addiction treatment. |
|
| 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 |
| 16 weeks post-randomization |
| Number of MAT Prescriptions Filled by Participant | Reported buprenorphine-naloxone (or naltrexone) prescriptions filled | 16 weeks post-randomization |
| Readmissions and Emergency Department (ED) Visits | Composite number of ED visits and readmissions | 16 weeks post-randomization |
| Hospital and ED Free Days | Days alive out of the hospital and/or ED | 16 weeks post-randomization |
| Mortality | Death in hospital or documented at 16-week follow up or in the medical record. | 16 weeks post-randomization |
| Recurrent Opioid Use | The number of participants with recurrent opioid use. | 16 weeks post-randomization |
| Overdose | Any overdose self-reported at the 16-week follow up | 16 weeks post-randomization |
| 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. | 16 weeks post-randomization |
| Opioid Use Within 30 Days | Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call. | 30 days |
| Derived |
| Marcovitz DE, White KD, Sullivan W, Limper HM, Dear ML, Buie R, Edwards DA, Chastain C, Kast KA, Lindsell CJ; Vanderbilt Learning Health System Investigators. Bridging Recovery Initiative Despite Gaps in Entry (BRIDGE): study protocol for a randomized controlled trial of a bridge clinic compared with usual care for patients with opioid use disorder. Trials. 2021 Oct 30;22(1):757. doi: 10.1186/s13063-021-05698-4. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Data was missing for 24 participants. | Posted | Median | Inter-Quartile Range | Dollars | 16 weeks post-randomization |
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| 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 | Data was not available for 247 participants (136 in usual care and 111 in bridge clinic). | Posted | Count of Participants | Participants | 16 weeks post-randomization |
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| Secondary | Number of MAT Prescriptions Filled by Participant | Reported buprenorphine-naloxone (or naltrexone) prescriptions filled | Posted | Median | Inter-Quartile Range | prescriptions filled | 16 weeks post-randomization |
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| Secondary | Readmissions and Emergency Department (ED) Visits | Composite number of ED visits and readmissions | Posted | Median | Inter-Quartile Range | events | 16 weeks post-randomization |
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| Secondary | Hospital and ED Free Days | Days alive out of the hospital and/or ED | Posted | Median | Inter-Quartile Range | days | 16 weeks post-randomization |
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| Secondary | Mortality | Death in hospital or documented at 16-week follow up or in the medical record. | Posted | Count of Participants | Participants | 16 weeks post-randomization |
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| Secondary | Recurrent Opioid Use | The number of participants with recurrent opioid use. | 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. | Posted | Count of Participants | Participants | 16 weeks post-randomization |
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| Secondary | Overdose | Any overdose self-reported at the 16-week follow up | Posted | Count of Participants | Participants | 16 weeks post-randomization |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | 16 weeks post-randomization |
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| Secondary | Opioid Use Within 30 Days | Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call. | Data was unavailable for 303 participants. | Posted | Count of Participants | Participants | 30 days |
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| 4 |
| 168 |
| 0 |
| 168 |
| 0 |
| 168 |
| EG001 | 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. | 2 | 167 | 0 | 167 | 0 | 167 |
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| Multiple Use |
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