Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-30 @ 4:48 AM
Study NCT ID:
NCT05166603
Status:
TERMINATED
Last Update Posted:
2024-01-22
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Expanding Access to Comprehensive Geriatrics Care Via Telehealth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dawn.bravata2@va.gov', 'phone': '3179882676', 'title': 'Dawn M. Bravata, MD', 'organization': 'US Department of Veterans Affairs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90-days', 'description': 'All unexpected, serious adverse events will be recorded', 'eventGroups': [{'id': 'EG000', 'title': 'TeleGRACE', 'description': 'Patients receive a virtual home visit and care from the GRACE team\n\nTeleGRACE: Patients receive a virtual home visit and care from the GRACE team', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients receive usual care', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '90-day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TeleGRACE', 'description': 'Patients receive a virtual home visit and care from the GRACE team\n\nTeleGRACE: Patients receive a virtual home visit and care from the GRACE team'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients receive usual care'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90-days from discharge from the index hospitalization', 'description': 'The primary outcome is 90-day all-cause mortality measured from the date of discharge from the index hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TeleGRACE', 'description': 'Patients receive a virtual home visit and care from the GRACE team\n\nTeleGRACE: Patients receive a virtual home visit and care from the GRACE team'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients receive usual care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TeleGRACE', 'description': 'Patients receive a virtual home visit and care from the GRACE team\n\nTeleGRACE: Patients receive a virtual home visit and care from the GRACE team'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients receive usual care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77.7', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '77.0', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '77.4', 'spread': '5.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-15', 'size': 339556, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-24T15:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'whyStopped': 'Inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2021-12-08', 'resultsFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-24', 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day All-cause Mortality', 'timeFrame': '90-days from discharge from the index hospitalization', 'description': 'The primary outcome is 90-day all-cause mortality measured from the date of discharge from the index hospitalization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['comprehensive geriatrics assessment', 'telehealth', 'home visit'], 'conditions': ['Geriatric Syndrome']}, 'descriptionModule': {'briefSummary': 'The overall objective of the TeleGRACE project is to improve the care and outcomes of older Veterans with a recent inpatient stay by expanding access to the evidence-based GRACE program, by evaluating a telehealth implementation.', 'detailedDescription': 'The TeleGRACE evaluation will focus on three primary aims and a secondary aim:\n\nPrimary Aim 1: To examine the effectiveness of the TeleGRACE program, the investigators designed a randomized controlled implementation trial (RCT) powered for the primary outcome of 90-day all-cause mortality. The investigators will also examine its effectiveness for the secondary outcomes including 90-day readmissions, 1-year ED utilization (VA and non-VA), 1-year all-cause readmissions, 1-year mortality, as well as patient, caregiver, and staff satisfaction. The investigators hypothesize that patients who receive TeleGRACE will have lower 90-day mortality than patients in usual care.\n\nPrimary Aim 2: to examine the implementation of the TeleGRACE program. The implementation strategy is reflecting \\& evaluating. Implementation outcomes are based on the REAIM framework and include reach, efficacy (Aim 1), and implementation (total number of Veterans served, fidelity).\n\nPrimary Aim 3: to conduct a business-case analysis (BCA). The business case analysis will calculate the net financial savings or loss for TeleGRACE as the difference in the overall intervention costs and savings due to downstream benefits for patients receiving TeleGRACE versus usual care controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans discharged from the Indianapolis VA medical center (VAMC) for an medical/surgical diagnosis (excludes substance use disorder-related admissions; excludes planned admissions) within the prior week\n* Age 70 years\n* Not enrolled in home-based primary care (HBPC)\n* Not enrolled in hospice\n* Not in dialysis\n* Primary care visit within VA in the prior 2 years\n* Not residing in nursing home, skilled nursing facility, or CLC.\n* Living \\>20 miles but \\<60 miles from the Indianapolis VAMC facility\n* CAN score 95th percentile for mortality or missing CAN score\n* Discharged from the hospital alive\n\nExclusion Criteria:\n\n* Patients who have been randomized to the control arm after their index hospitalization who become readmitted to the hospital may not be re-randomized.\n* By definition, GRACE patients are not eligible for TeleGRACE due to the drive distance \\>20 miles from the Indianapolis VAMC\n* Enrolled in home-based primary care (HBPC)\n* Enrolled in hospice\n* Dialysis (hemodialysis or peritoneal dialysis)\n* Residing in nursing home, skilled nursing facility, or CLC.\n* Living \\<20 miles or 60 miles from the Indianapolis VAMC facility'}, 'identificationModule': {'nctId': 'NCT05166603', 'acronym': 'TeleGRACE', 'briefTitle': 'Expanding Access to Comprehensive Geriatrics Care Via Telehealth', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Expanding Access to Comprehensive Geriatrics Care Via Telehealth (QUE 20-010)', 'orgStudyIdInfo': {'id': 'QUX 21-007'}, 'secondaryIdInfos': [{'id': 'QUE HX0003205-01', 'type': 'OTHER_GRANT', 'domain': 'VA HSRD QUERI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TeleGRACE', 'description': 'Patients receive a virtual home visit and care from the GRACE team', 'interventionNames': ['Other: TeleGRACE']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients receive usual care'}], 'interventions': [{'name': 'TeleGRACE', 'type': 'OTHER', 'description': 'Patients receive a virtual home visit and care from the GRACE team', 'armGroupLabels': ['TeleGRACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202-2884', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard L. Roudebush VA Medical Center, Indianapolis, IN', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Dawn M. Bravata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Richard L. Roudebush VA Medical Center, Indianapolis, IN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}