- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949635
Patient Outcomes After Hospitalization in Acute Geriatric Unit (DAMAGE)
Risks of Death, Hospital Readmission, and Institutionalization After Hospitalization in Acute Geriatric Unit
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.
Estimating 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.
The 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Amiens, France
- CHU d'Amiens
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Beauvais, France
- CH Beauvais
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Caen, France
- CHU Caen
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Lille, France
- Hôpital Cardiologique, CHRU
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Lomme, France
- GHICL, Saint Philibert
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Saint quentin, France
- CH Saint Quentin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 75 years and over
- Hospitalized in Acute Geriatric Unit
- Covered by a health insurance
Exclusion Criteria:
- Refusal to participate to the study, as expressed by the patient or his/her next of kin
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of death after discharge
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of death after discharge
Time Frame: 12 months
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12 months
|
|
Number of rehospitalization after discharge
Time Frame: at 3 and 12 months
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at 3 and 12 months
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Number of institutionalization (NH admissions)
Time Frame: at 12 months
|
at 12 months
|
|
Number of nosocomial infectious diseases during the index hospitalization
Time Frame: 60 days
|
60 days
|
|
Duration of clostridium difficile infection
Time Frame: 60 days
|
60 days
|
|
Length of stay of the index hospitalization
Time Frame: 60 days
|
The exact duration for this outcome will correspond to the duration of the index hospitalization
|
60 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean-Baptiste Beuscart, MD, PhD, University Hospital, Lille
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014_23
- 2014-A01670-47 (Other Identifier: ID-RCB number, ANSM)
- API 13-19-002 (Other Identifier: PHRC number, DGOS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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