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NCT Number: NCT04621292

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

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.

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Key information

Conditions

Geriatric

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74374, France

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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.

  3. Patient characteristics description

    Time frame: Up to emergency admission

    Description of patient characteristics

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Registry information

Official study 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.

Acronym: SOCOLOC

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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