Prospective Study Assessing Two Scales for Identification of Complex Elderly Patients in the Emergency Department

Geriatric Clinical Trial

— SOCOLOC  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621292
• Other study ID #: 20-05
• Status: Completed
• Start date: August 17, 2020
• Est. completion date: October 16, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The assumption of the study is that at least one of these two scales (ISAR or SoCoLoc) is adapted to the constraints of hospital emergencies and that it presents good performances for the screening of elderly patients in complex medico-social situations (sensitivity ≥ 90% and specificity ≥ 50%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Geriatric

Locations

Country	Name	City	State
France	Centre Hospitalier Annecy Genevois	Metz-Tessy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall diagnostic performance of the two scales comparing the AUC	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	Sensitivity and specificity of the two scales	Sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio and negative likelihood ratio of SoCoLoc and ISAR	Up to emergency admission
Secondary	Number and proportion of complex elderly patients	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
Secondary	Patient characteristics description	Description of patient characteristics	Up to emergency admission