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Clinical Trials/NCT04621292
NCT04621292CompletedNot Applicable

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.

Centre Hospitalier Annecy Genevois1 site in 1 country141 target enrollmentStarted: August 17, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
141
Locations
1
Primary Endpoint
Overall diagnostic performance of the two scales comparing the AUC

Study Overview

Brief 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.

Detailed 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%).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
75 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Sensitivity and specificity of the two scales(Up to emergency admission)
  • Number and proportion of complex elderly patients(Up to emergency admission)
  • Patient characteristics description(Up to emergency admission)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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