Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-07 @ 12:38 PM
Study NCT ID:
NCT04193033
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Implementing FLOW
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Natalie.Hundt@va.gov', 'phone': '713-440-4450', 'title': 'Dr. Natalie Hundt', 'organization': 'Michael E DeBakey VAMC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Because this was a cluster randomized stepped wedge trial in which 9 sites were randomized to receive the intervention at different times, we have no comparison sites which never received the intervention and the overall sample size (n = 9) was small. Additionally, the 9 sites were all in one VA Veterans Integrated Service Network (VISN), under the same VISN leadership, so some informal spread of information about the intervention via informal networks may have occurred.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not monitored.', 'description': 'Adverse Events were not collected in this site-level randomized trial. This implementation project sought to influence provider behavior; patients were not directly enrolled.', 'eventGroups': [{'id': 'EG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '.82', 'groupId': 'OG000'}, {'value': '.77', 'spread': '.62', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '1.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Linear Growth Curve Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition', 'unitOfMeasure': 'Percent of mental health patients', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'PRIMARY', 'title': "Effectiveness of Intervention's Impact on Clinic Access", 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '148.7', 'spread': '98.69', 'groupId': 'OG000'}, {'value': '222.33', 'spread': '337.32', 'groupId': 'OG001'}, {'value': '354.2', 'spread': '242.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Appointments freed up by FLOW consistent discharges from mental health clinics, by site', 'unitOfMeasure': 'Appointment slots', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'PRIMARY', 'title': 'Adoption: Percent of Mental Health Providers Who Use FLOW Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.24', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '8.09', 'spread': '7.33', 'groupId': 'OG001'}, {'value': '8.47', 'spread': '4.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Percent of mental health providers who use the FLOW intervention for at least 3 patients, compared to the total number of mental health providers in the participating clinics', 'unitOfMeasure': 'Percent of providers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'PRIMARY', 'title': 'Implementation Fidelity to the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}, {'value': '100', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist', 'unitOfMeasure': 'Percent of FLOW components', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'SECONDARY', 'title': "Maintenance of Effectiveness of Intervention's Impact on Clinic Access", 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '171.73', 'spread': '50.67', 'groupId': 'OG000'}, {'value': '81.26', 'spread': '95.76', 'groupId': 'OG001'}, {'value': '147', 'spread': '140.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.49', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Linear Growth Curve Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Time was included as a fixed effect and both time and intercept were included as random effects.'}], 'paramType': 'MEAN', 'timeFrame': '12-18 months', 'description': "Encounter slots 'freed up' by FLOW discharges", 'unitOfMeasure': 'Appointment slots', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'SECONDARY', 'title': 'Maintenance of Implementation Fidelity to the Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}, {'value': '100', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-24 months', 'description': 'Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months', 'unitOfMeasure': 'Percent of FLOW components', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}, {'type': 'SECONDARY', 'title': 'Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}]}, {'units': 'Sites', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'OG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'OG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '2.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Paired t-test, alpha = .05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'from 12-24 months', 'description': 'Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition, during the maintenance period', 'unitOfMeasure': 'Percent of mental health patients', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sites', 'denomUnitsSelected': 'Sites', 'populationDescription': 'Data only collected at site level - not participant level'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLOW Intervention', 'description': 'Sequence 1: 12 months of FLOW implementation, then 12 months of maintenance.\n\nSites received the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process. Because this is a site-level trial, participants and providers were not directly enrolled in the trial.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'FG001', 'title': 'Waitlist Until Time 2', 'description': 'Sequence 2: 3 months of usual care, 12 months of FLOW implementation, then 9 months of maintenance'}, {'id': 'FG002', 'title': 'Waitlist Until Time 3', 'description': 'Sequence 3: 6 months of usual care, 12 months of FLOW implementation, then 6 months of maintenance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': 'NA'}, {'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG001', 'numUnits': '3', 'numSubjects': 'NA'}, {'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG002', 'numUnits': '3', 'numSubjects': 'NA'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG000', 'numUnits': '3', 'numSubjects': 'NA'}, {'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG001', 'numUnits': '3', 'numSubjects': 'NA'}, {'comment': 'Data only collected at site level - not participant level', 'groupId': 'FG002', 'numUnits': '3', 'numSubjects': 'NA'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': 'NA'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': 'NA'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': 'NA'}]}]}], 'typeUnitsAnalyzed': 'sites'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FLOW Intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.\n\nFLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.'}, {'id': 'BG001', 'title': 'Waitlist Until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'id': 'BG002', 'title': 'Waitlist Until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'Sites', 'populationDescription': 'Data only collected at site level, not participant level.'}], 'populationDescription': 'This data was not collected for site level assessments.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-15', 'size': 469715, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-15T17:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Because this is a stepped wedge design QI clinical trial, masking is not feasible.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomization will be at the site level. All 9 sites will receive the intervention, using a stepped wedge design. Sites will be randomly allocated to one of three cohorts, and all sites within a cohort will receive the intervention at the same time. Cohort start dates will be offset by three months to allow examination of time effects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2019-11-25', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-21', 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reach: Percent of Specialty Mental Health Patients Transitioned to Primary Care', 'timeFrame': 'Change from baseline to 12 months', 'description': 'Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition'}, {'measure': "Effectiveness of Intervention's Impact on Clinic Access", 'timeFrame': 'Change from baseline to 12 months', 'description': 'Appointments freed up by FLOW consistent discharges from mental health clinics, by site'}, {'measure': 'Adoption: Percent of Mental Health Providers Who Use FLOW Intervention', 'timeFrame': '12 months', 'description': 'Percent of mental health providers who use the FLOW intervention for at least 3 patients, compared to the total number of mental health providers in the participating clinics'}, {'measure': 'Implementation Fidelity to the Protocol', 'timeFrame': '12 months', 'description': 'Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist'}], 'secondaryOutcomes': [{'measure': "Maintenance of Effectiveness of Intervention's Impact on Clinic Access", 'timeFrame': '12-18 months', 'description': "Encounter slots 'freed up' by FLOW discharges"}, {'measure': 'Maintenance of Implementation Fidelity to the Protocol', 'timeFrame': '12-24 months', 'description': 'Percent of all FLOW components implemented as designed, based upon the items in the FLOW implementation checklist, from 12 to 24 months'}, {'measure': 'Maintenance of Reach: Percentage of Specialty Mental Health Patients Transitioned to Primary Care', 'timeFrame': 'from 12-24 months', 'description': 'Percent of mental health patients in each of the participating clinics who are transitioned to primary care through use of the FLOW intervention, based upon electronic medical record data documenting this transition, during the maintenance period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental health'], 'conditions': ['Mental Health']}, 'referencesModule': {'references': [{'pmid': '39172402', 'type': 'DERIVED', 'citation': 'Smith TL, Yusuf ZI, Kim B, Amspoker AB, Hundt NE. An external facilitation case study analysis of an implementation trial of FLOW: A program for improving the transition of patients with mental health disorders back to primary care. Psychol Serv. 2024 Aug 22. doi: 10.1037/ser0000898. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "Adequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.", 'detailedDescription': "Our study sites requested that we pause implementation due to clinical efforts and site disruption related to COVID-19. Date of study resumption is unclear.\n\nAdequate access to mental health is one of the most important problems facing the VA and VISN 19. Mental health patients who are stabilized and recovered should be transitioned back to primary care to increase availability in mental health for new patients, and to signal to recovered patients that they are successfully recovered. Because there are currently no methods to identify who is recovered or tools and processes to assist in transitions, few patients 'graduate' mental health. The FLOW program consists of an algorithm to identify patients who are potentially appropriate for transition, a user-friendly online report to communicate this information to providers, materials to explain this process to patients and providers, and an electronic medical record (EMR) note template to document the transition. The investigators are partnering with VISN 19 to evaluate this program using a stepped wedge design with 9 sites randomly allocated into 3 steps in the wedge. Sites will receive an evidence-based implementation facilitation approach. The investigators will evaluate the number of patients transitioned, success of those transitions, and patient and provider satisfaction.\n\nSpecific aims for this proposal are:\n\n1. To evaluate the impact of FLOW, using the evaluation framework RE-AIM, including:\n\n 1. Reach of the program: % of clinic patients transitioned to PC using FLOW\n 2. Effectiveness: successful transition to primary care and impact on clinic access for future patients\n 3. Adoption: percent of providers in the selected clinics transitioning patients to primary care\n 4. Implementation: use of all FLOW components\n 5. Maintenance: sustainment of FLOW after withdrawal of external facilitation\n2. To evaluate structural and process implementation factors, including organizational readiness to change, staffing levels, interservice agreements about care, leadership support, and internal facilitation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study uses site-level randomization\n* Sites must be VA sites with substantial numbers of mental health patients\n\n * VA medical centers or large or very large community based outpatient clinics\n\nExclusion Criteria:\n\n* Non-VA sites and CBOCs smaller than large'}, 'identificationModule': {'nctId': 'NCT04193033', 'acronym': 'FLOW', 'briefTitle': 'Evaluation of Implementing FLOW', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Evaluation of Implementing FLOW: Transitioning Stabilized Mental Health Patients to Management in Primary Care (PEC 19-302)', 'orgStudyIdInfo': {'id': 'PEX 19-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLOW intervention', 'description': 'Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.', 'interventionNames': ['Other: FLOW intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist until Time 2', 'description': 'Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2.'}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist until Time 3', 'description': 'Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3.'}], 'interventions': [{'name': 'FLOW intervention', 'type': 'OTHER', 'description': 'The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.', 'armGroupLabels': ['FLOW intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Natalie E Hundt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This QI project uses site-level randomization and a stepped wedge design. Individual participants are not recruited into the study and do not provide informed consent. The quality improvement intervention is rolled out across sites, and the primary outcomes include access to care, which data are freely available to all VA investigators via the VA administrative and clinical databases.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}