- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877028
Frailty Screening in the Swedish Emergency Department Setting
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.
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Östergötland
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Linköping, Östergötland, Sweden, 58185
- University Hospital Linköping
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥65 years, able to answer any questions, alternatively have a proxy
Exclusion Criteria:
- Patients: <65 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality in 30 days
Time Frame: All cause mortality up to 90 days from index visit
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Investigate level of mortality in cohort at 30 days
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All cause mortality up to 90 days from index visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality in 7 and 90 days
Time Frame: All cause mortality up to 90 days from index visit
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Investigate level of mortality in cohort at 7 and 90 days
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All cause mortality up to 90 days from index visit
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Admission to hospital
Time Frame: Hospital admission on index visit, censored at 90 days
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Investigate level of all cause admissions in cohort
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Hospital admission on index visit, censored at 90 days
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ED length of stay
Time Frame: Length of stay at ED, censored at 4 days
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Investigate length of stay at ED
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Length of stay at ED, censored at 4 days
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Hospital length of stay
Time Frame: Hospital length of stay from index visit, censored at 90 days
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Investigate hospital length of stay
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Hospital length of stay from index visit, censored at 90 days
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Revisitis to the ED
Time Frame: Number of newly registered visits to the emergency department after index visit, censored at 90 days
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Number of newly registered visits to the emergency department after index visit
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Number of newly registered visits to the emergency department after index visit, censored at 90 days
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Fall prevalence after the index visit
Time Frame: Falls that resulted in further ED visits after index visit, censored in 90 days
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Falls that resulted in further ED visits
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Falls that resulted in further ED visits after index visit, censored in 90 days
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Alterations in medication during the visit (based on codes for Anatomical, Therapeutic, Chemical classification (ATC-code))
Time Frame: Alterations in medications from index visit and during the follow-up period, censored at 90 days
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Alterations in medication and during the follow-up period
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Alterations in medications from index visit and during the follow-up period, censored at 90 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-00875FSSED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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