Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-03 @ 6:03 PM
Study NCT ID:
NCT02949635
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes After Hospitalization in Acute Geriatric Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3532}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death after discharge', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Number of death after discharge', 'timeFrame': '12 months'}, {'measure': 'Number of rehospitalization after discharge', 'timeFrame': 'at 3 and 12 months'}, {'measure': 'Number of institutionalization (NH admissions)', 'timeFrame': 'at 12 months'}, {'measure': 'Number of nosocomial infectious diseases during the index hospitalization', 'timeFrame': '60 days'}, {'measure': 'Duration of clostridium difficile infection', 'timeFrame': '60 days'}, {'measure': 'Length of stay of the index hospitalization', 'timeFrame': '60 days', 'description': 'The exact duration for this outcome will correspond to the duration of the index hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aged', 'Patient readmission', 'Geriatric Assessment', 'Mortality'], 'conditions': ['Geriatric Disorder']}, 'referencesModule': {'references': [{'pmid': '40211151', 'type': 'DERIVED', 'citation': "Prod'homme C, Deschasse G, Visade F, Hennion C, Charpentier A, Gaxatte C, Bloch F, Delecluse C, Puisieux F, Beuscart JB. Palliative use of midazolam in acute geriatric units: a multicenter ambispective study. BMC Geriatr. 2025 Apr 10;25(1):241. doi: 10.1186/s12877-025-05860-6."}, {'pmid': '35609637', 'type': 'DERIVED', 'citation': "Deschasse G, Charpentier A, Prod'homme C, Genin M, Delecluse C, Gaxatte C, Gerard C, Bukor Z, Devulder P, Couvreur LA, Bloch F, Puisieux F, Visade F, Beuscart JB. Transition to Comfort Care Only and End-of-Life Trajectories in an Acute Geriatric Unit: A Secondary Analysis of the DAMAGE Cohort. J Am Med Dir Assoc. 2022 Sep;23(9):1492-1498. doi: 10.1016/j.jamda.2022.04.016. Epub 2022 May 21."}, {'pmid': '34375411', 'type': 'DERIVED', 'citation': 'Deschasse G, Bloch F, Drumez E, Charpentier A, Visade F, Delecluse C, Loggia G, Lescure P, Attier-Zmudka J, Bloch J, Gaxatte C, Van Den Berghe W, Puisieux F, Beuscart JB. Development of a Predictive Score for Mortality at 3 and 12 Months After Discharge From an Acute Geriatric Unit as a Trigger for Advanced Care Planning. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1665-1672. doi: 10.1093/gerona/glab217.'}]}, 'descriptionModule': {'briefSummary': 'Three events can be considered of major importance for patients after a hospitalization in an AGU: death, hospital readmission, and institutionalization. Current published data do not allow the clinician to simultaneously estimate the risk of hospital readmission, institutionalization and death of an older patient according to his/her characteristics and various complications that occurred during the hospitalization. However, clinicians often need to estimate these risks at hospital discharge to adapt their therapeutic choices, their proposals post-hospital care, and provide reliable and fair information to the patient and his relatives.\n\nEstimating simultaneously the hazard for each of these three events can be complex. Indeed, a death event hinder the observation of re-hospitalization or institutionalization if death occurs before these events. The death should be considered a competing risk in these analyzes. Hospital readmission may modify the risk of death or institutionalization and should be considered as an intermediate factor for these event. This complexity cannot be accounted with classical statistical models, like logistic regression models.\n\nThe purpose of this study is to use more appropriate statistical models (multi-state models) to better estimate simultaneously the risks of hospital readmission, institutionalization, and death of a patient given after hospitalization in AGU, and to show that accuracy of these estimations can be improved by taking into account complications that occurred during the stay in AGU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive incident patients aged 75 years and older hospitalized in an acute geriatric unit will be eligible and included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 75 years and over\n* Hospitalized in Acute Geriatric Unit\n* Covered by a health insurance\n\nExclusion Criteria:\n\n* Refusal to participate to the study, as expressed by the patient or his/her next of kin'}, 'identificationModule': {'nctId': 'NCT02949635', 'acronym': 'DAMAGE', 'briefTitle': 'Patient Outcomes After Hospitalization in Acute Geriatric Unit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Risks of Death, Hospital Readmission, and Institutionalization After Hospitalization in Acute Geriatric Unit', 'orgStudyIdInfo': {'id': '2014_23'}, 'secondaryIdInfos': [{'id': '2014-A01670-47', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}, {'id': 'API 13-19-002', 'type': 'OTHER', 'domain': 'PHRC number, DGOS'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Beauvais', 'country': 'France', 'facility': 'CH Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Cardiologique, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lomme', 'country': 'France', 'facility': 'GHICL, Saint Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Saint-Quentin', 'country': 'France', 'facility': 'CH Saint Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}], 'overallOfficials': [{'name': 'Jean-Baptiste Beuscart, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}