Clinical trial NCT04877028: Frailty Screening in the Swedish Emergency Department Setting
Official title: Frailty Screening in the Swedish Emergency Department Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Frailty Syndrome
Emergency Department
Geriatric Assessment
CFS
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 1800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of all genders at the age of ≥65 years seeking medical care at the three ED instances in Region Östergötland.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Patients: \<65 years

Primary outcomes:
measure: Mortality in 30 days
timeFrame: All cause mortality up to 90 days from index visit
Secondary outcomes:
measure: Mortality in 7 and 90 days
timeFrame: All cause mortality up to 90 days from index visit
measure: Admission to hospital
timeFrame: Hospital admission on index visit, censored at 90 days
measure: ED length of stay
timeFrame: Length of stay at ED, censored at 4 days
measure: Hospital length of stay
timeFrame: Hospital length of stay from index visit, censored at 90 days
measure: Revisitis to the ED
timeFrame: Number of newly registered visits to the emergency department after index visit, censored at 90 days
measure: Fall prevalence after the index visit
timeFrame: Falls that resulted in further ED visits after index visit, censored in 90 days
measure: Alterations in medication during the visit (based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code))
timeFrame: Alterations in medications from index visit and during the follow-up period, censored at 90 days
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linköping
state: Östergötland
Study officials:
References:
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. doi: 10.1503/cmaj.050051.
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.
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.
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.
citation: 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.