Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT03786250
Status:
UNKNOWN
Last Update Posted:
2018-12-26
First Post:
2018-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment in an Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with delirium', 'timeFrame': 'From date of admission until discharge, assessed up to 30 days'}], 'secondaryOutcomes': [{'measure': 'Number of patients with pain correctly treated', 'timeFrame': 'From date of admission until discharge, assessed up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency department', 'Older', 'Frailty'], 'conditions': ['Emergencies', 'Aging', 'Geriatric Assessment', 'Patient Discharge']}, 'descriptionModule': {'briefSummary': 'Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.\n\nObjective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017', 'detailedDescription': 'Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.\n\nObjective\n\n1. Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED).\n2. Analyze the impact on patient flows following the implementation of a Comprehensive Geriatric Assessment in the Emergency Department (ED).\n\nMethods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years).\n\nFirst period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the emergency medical teams. It basically consists of care adapted to the special needs of geriatric patients, with systematic screening of delirium, delirium prevention, early treatment, pain management with scales adapted to chronicity, conciliation of medication to discharge from the emergency department, among others A comparison will be made of health outcomes and patient flows in ED: direct discharge, admission to emergency observation unit, admission to short stay unit, transfer to intermediate hospital, admission, admission to critical care area, death, time spent in the Emergency Department (ED) and in intermediate hospital, mortality during admission at one and six months, re-entry or reconsultation in the Emergency Department at 30 days and six months will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '115 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients older than 65 years, attended in ED during the study periode.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients older than 65 years attended in the ED\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03786250', 'acronym': 'CGA_ED', 'briefTitle': 'Comprehensive Geriatric Assessment in an Emergency Department', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Comprehensive Geriatric Assessment in Emergency Department. Impact on Health and Patient Flows', 'orgStudyIdInfo': {'id': 'IIBSP-AGI-2017-14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Geriatric Assessment', 'type': 'PROCEDURE', 'otherNames': ['CGA'], 'description': 'Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mireia Puig, PhD', 'role': 'CONTACT', 'email': 'mpuigc@santpau.cat', 'phone': '+34616335291'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació Mutuam Conviure', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}