- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475442
Prognostic Factors of Hospitalization for Patients Aged 75 and Over in Emergency Department in France - Monocentric Retrospective Cohort Study (PROFACTHOS)
Prognostic Factors of Hospitalization for Patients Aged 75 and Over in Emergency Department in France - Monocentric Retrospective Cohort Study - PROFACTHOS
A geriatric patient is defined as a patient aged 75 and over who meets certain medical or social vulnerability criteria and is characterised by coexisting physical and/or psychological dependence. The proportion of patients with a geriatric profile in the general population is growing. The average time spent in the emergency department by the elderly population is about 3 hours longer than for patients under 75 years old in France, which is associated with the risk of decompensation of chronic conditions, confusion, falls or agitation. An overnight stay in the emergency department for these patients increases the risk of mortality and the length of hospital stay.
Several prognostic scores for hospitalization have been studied in adult populations. The most widely used scores are the Sydney Triage to Admission Risk Tool (START), the Ambulatory (AMB) and the Glasgow Admission Prediction Score (GAPS). Studies have compared these three scores and demonstrated the greater robustness of GAPS. The CalcuLation of the Elderly Admission Risk in the Emergency Department (CLEARED) tool, developed for the elderly population, has lower performance than GAPS. A systematic review of the literature studied the power of GAPS for the geriatric population and highlighted the need for validation in the target population. No validated hospitalization prognostic score was found in France for this population. The research hypothesis is that GAPS would detect hight probability of admission at the time of triage for the patients aged 75 and over in emergency department in France. The primary objective of this monocentric study is to evaluate the prognostic performance of GAPS for the target population (on the group 1). The secondary objectives consist of developing and internally validating a new score (PROFACTHOS) (on the group 2), then performing a temporal validation of PROFACTHOS with comparison to the GAPS (on the group 1), and finally to determine the threshold for classifying patients with a high probability of hospitalization for the score with the strongest discriminatory performance among GAPS or PROFACTHOS.
Group 1: Patients aged 75 and over admitted to emergency department from 10/01/2024 to 09/30/2025.
Group 2 : Patients aged 75 and over admitted to emergency department from 10/01/2022 to 09/30/2023
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Manon BOILLET, Advanced Practice Nurse
- Phone Number: 45340 +33 05 49 44 44 44
- Email: manon.boillet@chu-poitiers.fr
Study Contact Backup
- Name: Christine SZCZUCZYNSKI, Advanced Practice Nurse
- Phone Number: 45734 +33 05 49 44 44
- Email: christine.szczuczynski@chu-poitiers.fr
Study Locations
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France
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Poitiers, France, France, 86021
- CHU Poitiers
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Contact:
- Manon BOILLET, Advanced Practice Nurse
- Phone Number: 45340 +33 05 49 44 44 44
- Email: manon.boillet@chu-poitiers.fr
-
Contact:
- Christine SZCZUCZYNSKI, Advanced Practice Nurse
- Phone Number: 45734 +33 05 49 44 44 44
- Email: christine.szczuczynski@chu-poitiers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult over or equal 75 years old
- Patient admitted to the emergency department between 10/01/2022 and 09/30/2023 for the second group, and between 10/01/2024 and 09/30/2025 for the first group
- Patient and/or family and/or trusteeship who doesn't refused to participate
Exclusion Criteria:
- Patient died before admitted to emergency department
- Patient already included in the study
- File created by mistake, identified by the mention "Erreur de dossier"
- Patient deprived of total or partial liberty by a judicial or administrative decision
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the prognostic performance of GAPS in a population of patients aged 75 and over admitted to emergency departments in France
Time Frame: 1 day
|
The performance of GAPS will be evaluated by measuring the area under the ROC (receiver operating characteristic) curve (AUC) with the population of group 1.
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1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To develop a prognostic hospitalization score (PROFACTHOS) based on data from the patient's initial clinical exam.
Time Frame: 1 day
|
The PROFACTHOS prognostic score will be developed to predict the following binary event: hospitalization of the patient at the end of treatment.
Potential predictive factors were established based on existing literature and by consulting a team of emergency physicians and geriatricians at Poitiers University Hospital.
The performance of the prognostic score will be evaluated using the AUC (area under the ROC curve) and the Brier score.
It will be carried out with the population of group 2.
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1 day
|
|
Temporal validation of the hospitalization prognostic score PROFACTHOS
Time Frame: 1 day
|
The PROFACTHOS hospitalization prognostic score will be temporally validated using data from a time period independent of that used for its construction, with patients from group 1.
The performance of the score will be measured by the area under the ROC (receiver operating characteristic) curve (AUC) and the Brier score.
|
1 day
|
|
To compare the performance of both scores GAPS and PROFACTHOS
Time Frame: 1 day
|
The prognostic performance of the GAPS and PROFACTHOS scores will be evaluated and compared by their AUC, with patients from group 1.
|
1 day
|
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To determine the threshold for classifying patients with a high probability of hospitalization for the score with the strongest discriminatory performance among GAPS or PROFACTHOS
Time Frame: 1 day
|
The threshold will be determined in order to obtain optimal positive and negative predictive values.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROFACTHOS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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