Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-01 @ 3:27 PM
Study NCT ID:
NCT01769495
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2013-01-14', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medical Resource utilization', 'timeFrame': '30 days and 180 days'}], 'primaryOutcomes': [{'measure': 'Mortality and readmissions to emergency department', 'timeFrame': '30 and 180 days'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 and 180 days', 'description': 'Secondary outcome to measure all cause mortality for patients admitted to the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergency department, Geriatrics, mortality, readmission rates.', 'Patients 75 years of age and older.'], 'conditions': ['Emergencies']}, 'descriptionModule': {'briefSummary': "Our hypothesis is that a rapid follow up for elderly patients in a Geriatric Clinic discharged from the Emergency Department (ED) will have fewer unplanned return ED visits and fewer unplanned hospital admissions with no attendant increase in mortality.\n\nPatients 75 years of age and older will be randomized following discharge from the ED into two groups. The first will receive standard post ED care. The second will receive an appointment to our Geriatric Clinic within 2-3 days for stabilization, further treatment and contact with the patient's primary physician to communicate the course of the patient's illness and to schedule subsequent follow-up with the patients regular medical provider.\n\nThere will be two primary outcomes: The first will be a composite of morality and/or return to the ED at 30 days, and the secondary primary outcome will be mortality. Economic data regarding resource utilization by patients will also be analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients 75 years of age and older discharged from the ED\n\nExclusion Criteria:\n\n* Younger than 75.'}, 'identificationModule': {'nctId': 'NCT01769495', 'briefTitle': 'Can a Rapid 2 Day Followup After Discharge From the ED Reduce Readmissions and Death for Patients 75 Years and Older?', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Randomized Trial of the Effect of a Geriatrics Appointment Within 2-3 Days of Discharge From the Emergency Department(ED) in Reducing ED and Hospital Readmissions for Patients 75 Years of Age and Older.', 'orgStudyIdInfo': {'id': 'DE 6366-SP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard post ED care'}, {'type': 'EXPERIMENTAL', 'label': '2-3 day return appointment', 'description': 'Patients will receive further treatment in Geriatric Clinic 2-3 days post ED discharge.', 'interventionNames': ['Other: 2-3 day return appointment']}], 'interventions': [{'name': '2-3 day return appointment', 'type': 'OTHER', 'description': '2-3 appointment in geriatric clinic following ED discharge', 'armGroupLabels': ['2-3 day return appointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'John S Kizer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill, NC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Duke Endowment', 'class': 'OTHER'}, {'name': 'The William R. Kenan, Jr. Charitable Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}