CompletedNot Applicable

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

Spain141,929 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

65 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients over 65 years of age who attend the emergency department for any reason during the study period Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

UCI and or death

Timeframe: up to 72 hours

Trial details

NCT IDNCT07194122

SponsorHospital Galdakao-Usansolo

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Elderly (People Aged 65 or More) trials