- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621292
Prospective Study Assessing Two Scales for Identification of Complex Elderly Patients in the Emergency Department (SOCOLOC)
Prospective Comparative Study of the SoCoLoc vs ISAR Scales for the Identification of Complex Elderly Patients in the Emergency Department of the Annecy Genevois Hospital.
With the help of medical progress, life expectancy has increased in our country, resulting in an increase in the number of elderly people and especially so-called complex patients. These complex elderly patients present with a combination of poly pathology, locomotor disorders and loss of autonomy, which leads to increased risks of hospitalization, re-hospitalization or difficulty in remaining at home. These risks could be reduced by early adapted care specific to this type of patient. To do this, it is necessary to identify these complex elderly patients as early as possible in their care pathway.
Screening complex elderly patients in the emergency department would require trained and educated staff, or the use of a simple, rapid and reliable diagnostic scale. The purpose of this study is to compare two scales for the screening of complex elderly patients, whose use is adapted to the Hospital Emergency Department environment.
This study assess the diagnostic performance of the ISAR and SoCoLoc scales for complex elderly patients.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Metz-Tessy, France, 74374
- Centre Hospitalier Annecy Genevois
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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:
- Patients over 75 years of age
- Patient presenting to the "Emergency Department" of the Annecy Genevois hospital, whatever the reason for consultation, from Monday to Friday between 8:00 a.m. and 8:00 p.m.
- Patient informed of the study and not opposed to participation
Exclusion Criteria:
- Patients under guardianship or curatorship
- Patients under the safeguard of justice
- Patient presenting for a life-threatening emergency
- Patient unable to answer the questions on the scales
- Patient does not speak French
- Patients who have already been included in the study: any patient already included in the study and making another trip to the emergency department cannot be included a second time.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall diagnostic performance of the two scales comparing the AUC
Time Frame: Up to emergency admission
|
The overall diagnostic performance of each scale will be measured using the area under the ROC curve (sensitivity vs. 1-specificity). The performance of the two scales will be measured and compared using a parametric or non-parametric Z-test for matched data according to the number of events observed, i.e. the number of "complex" patients. A ROC curve will be performed in order to determine the best positivity threshold of each scale. Patients will be classified as "complex" or "non-complex" by the blind adjudication committee of the results of the two scales. |
Up to emergency admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of the two scales
Time Frame: Up to emergency admission
|
Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of SoCoLoc and ISAR
|
Up to emergency admission
|
Number and proportion of complex elderly patients
Time Frame: Up to emergency admission
|
Number and proportion of complex elderly patients, as well as its 95% confidence interval, evaluated according to the definition accepted by the adjudication committee.
|
Up to emergency admission
|
Patient characteristics description
Time Frame: Up to emergency admission
|
Description of patient characteristics
|
Up to emergency admission
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bahman MOHEB KHOSRAVI, CH Annecy Genevois
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-05
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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