Frailty Screening in the Swedish Emergency Department Setting

Frailty Clinical Trial

Official title:

Frailty Screening in the Swedish Emergency Department Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877028
• Other study ID #: 2021-00875FSSED
• Status: Completed
• Start date: May 17, 2021
• Est. completion date: November 14, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: November 14, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients: <65 years

Related Conditions & MeSH terms

• CFS
• Emergencies
• Emergency Department
• Frailty
• Frailty Syndrome
• Geriatric Assessment

Locations

Country	Name	City	State
Sweden	University Hospital Linköping	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in 30 days	Investigate level of mortality in cohort at 30 days	All cause mortality up to 90 days from index visit
Secondary	Mortality in 7 and 90 days	Investigate level of mortality in cohort at 7 and 90 days	All cause mortality up to 90 days from index visit
Secondary	Admission to hospital	Investigate level of all cause admissions in cohort	Hospital admission on index visit, censored at 90 days
Secondary	ED length of stay	Investigate length of stay at ED	Length of stay at ED, censored at 4 days
Secondary	Hospital length of stay	Investigate hospital length of stay	Hospital length of stay from index visit, censored at 90 days
Secondary	Revisitis to the ED	Number of newly registered visits to the emergency department after index visit	Number of newly registered visits to the emergency department after index visit, censored at 90 days
Secondary	Fall prevalence after the index visit	Falls that resulted in further ED visits	Falls that resulted in further ED visits after index visit, censored in 90 days
Secondary	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	Alterations in medications from index visit and during the follow-up period, censored at 90 days