Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04084392
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2019-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.marcovitz@vumc.org', 'phone': '615-936-3555', 'title': 'Dr. Dave Marcovitz', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were tracked for each participant from study enrollment throughout the 16 week follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 0, 'seriousNumAtRisk': 168, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 0, 'seriousNumAtRisk': 167, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '232.1', 'spread': '267.4', 'groupId': 'OG000'}, {'value': '215.0', 'spread': '236.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately 3 to 42 days', 'description': 'Overall index hospital length of stay measured in days', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Combined Cost of Index Admission and Subsequent Admissions During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1705.28', 'groupId': 'OG000', 'lowerLimit': '360.16', 'upperLimit': '12146.33'}, {'value': '9481.93', 'groupId': 'OG001', 'lowerLimit': '1478.28', 'upperLimit': '29376.14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks post-randomization', 'description': '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.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was missing for 24 participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Successful Care Linkage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'title': 'Linkage To Provider = Yes', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Linkage To Provider = No', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks post-randomization', 'description': 'Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not available for 247 participants (136 in usual care and 111 in bridge clinic).'}, {'type': 'SECONDARY', 'title': 'Number of MAT Prescriptions Filled by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks post-randomization', 'description': 'Reported buprenorphine-naloxone (or naltrexone) prescriptions filled', 'unitOfMeasure': 'prescriptions filled', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Readmissions and Emergency Department (ED) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks post-randomization', 'description': 'Composite number of ED visits and readmissions', 'unitOfMeasure': 'events', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital and ED Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '112'}, {'value': '112', 'groupId': 'OG001', 'lowerLimit': '107', 'upperLimit': '112'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks post-randomization', 'description': 'Days alive out of the hospital and/or ED', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks post-randomization', 'description': 'Death in hospital or documented at 16-week follow up or in the medical record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks post-randomization', 'description': 'The number of participants with recurrent opioid use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Overdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks post-randomization', 'description': 'Any overdose self-reported at the 16-week follow up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Schwartz Outcome Scale-10 (SOS10).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '54.25'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '53.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '16 weeks post-randomization', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Use Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'OG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'classes': [{'categories': [{'title': 'No Use', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Single Use', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Multiple Use', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was unavailable for 303 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'FG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '335', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.\n\nUsual Care: Referral to an outpatient provider for addiction treatment.'}, {'id': 'BG001', 'title': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.\n\nBridge 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'groupId': 'BG000', 'lowerLimit': '31.8', 'upperLimit': '44.5'}, {'value': '38.7', 'groupId': 'BG001', 'lowerLimit': '32.1', 'upperLimit': '47.0'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '31.9', 'upperLimit': '45.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Missing/Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '335', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-07', 'size': 299509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-10T14:03', 'hasProtocol': True}, {'date': '2022-04-11', 'size': 205782, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-10T14:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 335}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2019-09-06', 'resultsFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2019-09-06', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-29', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': 'approximately 3 to 42 days', 'description': 'Overall index hospital length of stay measured in days'}], 'secondaryOutcomes': [{'measure': 'Combined Cost of Index Admission and Subsequent Admissions During the Study Period', 'timeFrame': '16 weeks post-randomization', 'description': '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.'}, {'measure': 'Number of Participants With Successful Care Linkage', 'timeFrame': '16 weeks post-randomization', 'description': 'Dichotomous self-reported outcome of linkage to a MAT provider as defined by attending at least one visit with a MAT provider'}, {'measure': 'Number of MAT Prescriptions Filled by Participant', 'timeFrame': '16 weeks post-randomization', 'description': 'Reported buprenorphine-naloxone (or naltrexone) prescriptions filled'}, {'measure': 'Readmissions and Emergency Department (ED) Visits', 'timeFrame': '16 weeks post-randomization', 'description': 'Composite number of ED visits and readmissions'}, {'measure': 'Hospital and ED Free Days', 'timeFrame': '16 weeks post-randomization', 'description': 'Days alive out of the hospital and/or ED'}, {'measure': 'Mortality', 'timeFrame': '16 weeks post-randomization', 'description': 'Death in hospital or documented at 16-week follow up or in the medical record.'}, {'measure': 'Recurrent Opioid Use', 'timeFrame': '16 weeks post-randomization', 'description': 'The number of participants with recurrent opioid use.'}, {'measure': 'Overdose', 'timeFrame': '16 weeks post-randomization', 'description': 'Any overdose self-reported at the 16-week follow up'}, {'measure': 'Quality of Life - Schwartz Outcome Scale-10 (SOS10).', 'timeFrame': '16 weeks post-randomization', 'description': '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.'}, {'measure': 'Opioid Use Within 30 Days', 'timeFrame': '30 days', 'description': 'Opioid use within 30 days as self-reported and assessed during the 16-week follow up phone call.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Opioid-use Disorder']}, 'referencesModule': {'references': [{'pmid': '38411964', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34717736', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients at VUH with active OUD being considered for MAT.\n* Patient accepting a transitional prescription for buprenorphine-naloxone or IM naltrexone whose outpatient plans are not fixed\n\nExclusion Criteria:\n\n* 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).\n* Patients previously randomized in this study.'}, 'identificationModule': {'nctId': 'NCT04084392', 'briefTitle': 'Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Evaluating the Impact of the Bridge Clinic in Patients With Opioid Use Disorder', 'orgStudyIdInfo': {'id': '191269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants randomized to this arm will receive care as usual.', 'interventionNames': ['Other: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bridge Clinic', 'description': 'Participants randomized to this arm will be referred to the Bridge Clinic to facilitate identification and referral to an outpatient provider for addiction treatment.', 'interventionNames': ['Other: Bridge Clinic']}], 'interventions': [{'name': 'Bridge Clinic', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Bridge Clinic']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Referral to an outpatient provider for addiction treatment.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'David Marcovitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported will be made available (including data dictionaries) after deidentification.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry, MD', 'investigatorFullName': 'David Marcovitz', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}