Poor Outcomes Among Patients Aged 65 and Older Presenting to the Emergency Department(EDEN-RICAPPS Study)

NCT07194122 | Completed

• 1 other identifier: HGaldakaoUsansolo
• Study Type: observational
• Target: 141,929
• Locations: 1 country
• Sites: 1

Brief Summary

Our objective is to create and validate predictive models of poor outcome in people over 65 years of age seen in emergency departments. To this end, models will be developed and validated internally, adapting the reference values of vital signs to this population segment and also taking into account their most frequent reasons for consultation. We will use the EDEN cohort of 18374 patients recruited in one week in 2019 in 40 Spanish hospitals. Subsequently, they will be externally validated in a cohort of 18000 patients prospectively recruited in 7 hospitals in 2024. In addition, the predictive capacity of the FIM frailty scale will be measured. lnformation will be collected from electronic medical records regarding socio-demographic data, functional status, reasons for consultation, clinical and ED history including comorbidities, previous and prescribed ED treatments and vital signs. The main dependent variable is poor outcome defined as ED exitus, admission to ICU/ICU or conventional admission, as well as mortality, revisits and readmissions 30 days after hospital discharge. Updated poor outcome models will be provided that can serve as a basis for creating triage models adapted to the over-65s in the future.

Conditions

Elderly (People Aged 65 or More); Vital Signs

Keywords

EDEN cohort; vital signs; elderly patients; cut-off points; adverse outcomes

Outcome Measures

Primary Outcomes (1)

• UCI and or death

  Intra-emergency room

  up to 72 hours

Secondary Outcomes (2)

• readmission or ICU admission or death

  up to one month after discharge

• UCI admission OR mortality

  in-hospital mortality or up to 7 days in discharged patients

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients over 65 years of age who attend the emergency department for any reason during the study period

You may qualify if:

• patients over 65 years of age who attend the emergency department for any reason during the study period

You may not qualify if:

• arrival at the emergency department in critical condition in pre-mortem situations,
• absence of a carer in situations of severe dependency
• presence of mental illness, and refusal to participate in the study.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital San Carlos, Madrid: collaborator

Study Sites (1)

Hospital Galdakao-Usansolo

Usansolo, Bizkaia, 48950, Spain

Location

Related Links

• Related Info

Study Officials

• Susana García Gutiérrez

  Osakidetza, Hospital Galdakao-Usansolo

  PRINCIPAL INVESTIGATOR

• Juan Gonzalez del Castillo, PhD

  Hospital San Carlos, Madrid

  STUDY DIRECTOR

• Oscar Miró, PhD

  Hospital Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 26, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: https://zenodo.org/records/15729462
• Access Criteria: https://zenodo.org/records/15729462

Locations

ES (1)