- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03549585
End-of-Life Patient Identification Assistance in Acute GEriatric Medicine (ARPEGE)
End-of-Life Patient Identification Assistance in Acute GEriatric Medicine: Construction and Validation of a Prognostic Tool
The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015.
The 8 items of the CriSTAL tool will be collected prospectively in all patients hospitalized successively in the 2 post-emergency geriatric services (PUG) of the University Hospital of Toulouse, over a period of 9 months, by a dedicated clinical research associate. Patient survival will be assessed by obtaining the vital status of the cohort via CépiDC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As the population ages, the prevalence of chronic diseases increases. Let's take the example of cardiovascular, respiratory or neurological diseases, including Alzheimer's disease. These pathologies are at the origin of decompensations requiring sometimes multiple hospitalizations. It is clear that the goals of care (curative or palliative) are not always related to life expectancy. Decision making, especially in an acute context, is often tricky. The use of a tool with certain parameters of the patient could help to guide the reflection. The present study propose a tool proposed by an Australian team (CriSTAL), which lists items described in the literature as a risk factor for the death of elderly patients. This tool is currently being studied in several types of populations around the world (general population, cancer patients, hospitalized etc.).
This is a prospective study aimed at evaluating routine, single-center care, conducted at Toulouse University Hospital.
The successive inclusion of hospitalized patients in Post Emergencies Geriatric (PUG) unity will be carried out over a period of 9 months.
The primary outcome will be the vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31052
- University Hospital TOULOUSE
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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:
- Any geriatric patient hospitalized via emergencies at Post Emergencies Geriatric (PUG) unity
- Oral agreement of non-opposition to the use of the data relative to their hospitalization and relative to their evolution within 3 months following the hospitalization
Exclusion Criteria:
- Patient having expressed his opposition to the use of data related to his hospitalization
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The vital status (alive / deceased) at 3 months
Time Frame: 3 months
|
The vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.Survival will be collected in a data base.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 8 items of the CriSTAL tool
Time Frame: 3 months
|
Socio-demographic data of the geriatric patient in the emergencies
|
3 months
|
The 8 items of the CriSTAL tool
Time Frame: 3 months
|
The reason for admission of geriatric patients in the emergencies
|
3 months
|
The 8 items of the CriSTAL tool
Time Frame: 3 months
|
The variables potentially associated with the three-month death like Cognitive impairment
|
3 months
|
The 8 items of the CriSTAL tool
Time Frame: 3 months
|
The variables potentially associated with the three-month death : Hospitalization in intensive care during the last year
|
3 months
|
The 8 items of the CriSTAL tool
Time Frame: 3 months
|
ECG anomaly : ACFA, tachycardia, rhythm disorder> 5 per min, Q or ST segment abnormality
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fati Nourhashemi, MD, University Hospital, Toulouse
Publications and helpful links
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/15/7732
- 2016-A00116-45 (Other Identifier: ID-RCB)
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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