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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03549585
Other study ID # RC31/15/7732
Secondary ID 2016-A00116-45
Status Completed
Phase
First received
Last updated
Start date June 27, 2017
Est. completion date September 30, 2019

Study information

Verified date January 2022
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Criteria for Screening and Triaging to Appropriate aLternative care
CriSTAL Tool (Criteria for Screening and Treatment of Appropriate Long-Term Care) is a multidimensional geriatric tool that lists 18 elements of the literature, under construction and validation by an Australian retrospective study. This tool is a practical questionnaire and easy to use in current care, with items adapted to the geriatric dimension. The investigators chose to target hospitalized geriatric patients through emergencies.

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Steinmeyer Z, Piau A, Thomazeau J, Kai SHY, Nourhashemi F. Mortality in hospitalised older patients: the WHALES short-term predictive score. BMJ Support Palliat Care. 2021 Nov 25. pii: bmjspcare-2021-003258. doi: 10.1136/bmjspcare-2021-003258. [Epub ahead — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The vital status (alive / deceased) at 3 months The vital status (alive / deceased) at 3 months of hospitalization in acute geriatric medicine.Survival will be collected in a data base. 3 months
Secondary The 8 items of the CriSTAL tool Socio-demographic data of the geriatric patient in the emergencies 3 months
Secondary The 8 items of the CriSTAL tool The reason for admission of geriatric patients in the emergencies 3 months
Secondary The 8 items of the CriSTAL tool The variables potentially associated with the three-month death like Cognitive impairment 3 months
Secondary The 8 items of the CriSTAL tool The variables potentially associated with the three-month death : Hospitalization in intensive care during the last year 3 months
Secondary The 8 items of the CriSTAL tool ECG anomaly : ACFA, tachycardia, rhythm disorder> 5 per min, Q or ST segment abnormality 3 months
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