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

November 9, 2020 updated by: Centre Hospitalier Annecy Genevois

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

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Metz-Tessy, France, 74374
        • Centre Hospitalier Annecy Genevois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will focus on patients aged 75 and over who consult the Emergency Department of the Annecy Geneva Hospital.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bahman MOHEB KHOSRAVI, CH Annecy Genevois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 17, 2020

Primary Completion (ACTUAL)

October 16, 2020

Study Completion (ACTUAL)

October 16, 2020

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (ACTUAL)

November 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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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