Frailty Screening in the Swedish Emergency Department Setting

NCT ID: NCT04877028

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2021-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Frailty Syndrome Emergency Department Geriatric Assessment CFS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\- Patients: \<65 years
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Wilhelms

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Linköping

Linköping, Östergötland County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16129869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21093718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32904824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25778109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32336486 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39053972 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-00875FSSED

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.