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FrailtyNCT04877028

Frailty Screening in the Swedish Emergency Department Setting

An observational study of Frailty and Frailty Syndrome, run by University Hospital, Linkoeping at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective observational study will investigate the correlation of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department(ED), in hospital length of stay and revisits to the ED. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Frailty Syndrome, Emergency Department
How many people
1,800 participants
Where
1 siteSweden
Study dates
17 May 2021to 14 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Patients of all genders at the age of ≥65 years seeking medical care at the three ED instances in Region Östergötland.

Who may be able to join

  • ≥65 years, able to answer any questions, alternatively have a proxy

Who cannot join

  • Patients: <65 years

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • University Hospital Linköping

    Linköping, Östergötland County, 58185

Other trials in Sweden

About this study

This prospective observational study will investigate the correlation of frailty in relation to serious outcomes. Serious outcomes are defined as: mortality within 30 days, admission to hospital, length of stay in the Emergency Department(ED), in hospital length of stay and revisits to the ED.

The exposure, frailty, will be assessed according to Clinical Frailty Scale. ED patients >65 years of age in a Swedish regional health care system (Region Östergötland, Sweden) comprising three EDs in Linköping, Norrköping and Motala. The outcomes will be compared according to the degree of frailty and censored over 7, 30 and 90 days respectively.

Read the detailed description

Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality.

The clinical frailty scale (CFS) is a measure of frailty based on clinical judgement in a 9 level scale, categorized as "vulnerable" (1-4), "mildly frail" (5), moderatly frail (6) and severely and very severely frail (7-8).". A validation study of the CFS in community-dwelling older people showed that it performed better than measures of cognition, function or comorbidity in assessing risk for death. In a prospective observational study including consecutive ED patients aged 65 years or older The Hosmer-Lemeshow test indicated a good agreement between predicted probability and observed frequency of 30-day mortality and ICU admission.

The aim of this study will be to investigate if the fraily, assessed according to CFS, is associated with increased 30-day mortality. in a Swedish Emergency Care context. Secondary outcomes included 7-and 90-day mortality, ED length of stay, hospital admission, hospital length of stay, subsequent falls and medication changes. Additionally, we collect data on morbidity and comorbidities to assess the association with the level of frailty. Since this is a multicenter study, possible geographic differences will be studied as well. Based on the results of this study, possible interventions could be identified to improve the care of the frail geriatric patients presenting at the ED.

Medical subject headings
Frailty, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality in 30 days

    Investigate level of mortality in cohort at 30 days

    Measured: All cause mortality up to 90 days from index visit

Secondary outcomes (7)

  1. Mortality in 7 and 90 days

    Investigate level of mortality in cohort at 7 and 90 days

    Measured: All cause mortality up to 90 days from index visit

  2. Admission to hospital

    Investigate level of all cause admissions in cohort

    Measured: Hospital admission on index visit, censored at 90 days

  3. ED length of stay

    Investigate length of stay at ED

    Measured: Length of stay at ED, censored at 4 days

  4. Hospital length of stay

    Investigate hospital length of stay

    Measured: Hospital length of stay from index visit, censored at 90 days

  5. Revisitis to the ED

    Number of newly registered visits to the emergency department after index visit

    Measured: Number of newly registered visits to the emergency department after index visit, censored at 90 days

  6. Fall prevalence after the index visit

    Falls that resulted in further ED visits

    Measured: Falls that resulted in further ED visits after index visit, censored in 90 days

  7. Alterations in medication during the visit (based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code))

    Alterations in medication and during the follow-up period

    Measured: Alterations in medications from index visit and during the follow-up period, censored at 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start17 May 2021
  3. Primary completion14 Nov 2021
  4. Study completion14 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04877028
Sponsor's protocol ID
2021-00875FSSED
Status last verified
Jun 2022
First submitted
1 May 2021
Last updated
23 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PubMed 16129869

  • Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.

    PubMed 21093718

  • Rockwood K, Theou O. Using the Clinical Frailty Scale in Allocating Scarce Health Care Resources. Can Geriatr J. 2020 Sep 1;23(3):210-215. doi: 10.5770/cgj.23.463. eCollection 2020 Sep.

    PubMed 32904824

  • Wallis SJ, Wall J, Biram RW, Romero-Ortuno R. Association of the clinical frailty scale with hospital outcomes. QJM. 2015 Dec;108(12):943-9. doi: 10.1093/qjmed/hcv066. Epub 2015 Mar 15.

    PubMed 25778109

  • Kaeppeli T, Rueegg M, Dreher-Hummel T, Brabrand M, Kabell-Nissen S, Carpenter CR, Bingisser R, Nickel CH. Validation of the Clinical Frailty Scale for Prediction of Thirty-Day Mortality in the Emergency Department. Ann Emerg Med. 2020 Sep;76(3):291-300. doi: 10.1016/j.annemergmed.2020.03.028. Epub 2020 Apr 24.

    PubMed 32336486

  • Munir Ehrlington S, Horlin E, Toll John R, Wretborn J, Wilhelms D. Frailty is associated with 30-day mortality: a multicentre study of Swedish emergency departments. Emerg Med J. 2024 Aug 21;41(9):514-519. doi: 10.1136/emermed-2023-213444.

    PubMed 39053972

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Frailty Syndrome, run by University Hospital, Linkoeping at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality in 30 days (time frame: All cause mortality up to 90 days from index visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04877028, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.

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