Frailty Screening in the Swedish Emergency Department Setting

June 22, 2022 updated by: Daniel Wilhelms, University Hospital, Linkoeping

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

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

Observational

Enrollment (Actual)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • University Hospital Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Patients: <65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Investigate level of mortality in cohort at 30 days
All cause mortality up to 90 days from index visit

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
Investigate level of mortality in cohort at 7 and 90 days
All cause mortality up to 90 days from index visit
Admission to hospital
Time Frame: Hospital admission on index visit, censored at 90 days
Investigate level of all cause admissions in cohort
Hospital admission on index visit, censored at 90 days
ED length of stay
Time Frame: Length of stay at ED, censored at 4 days
Investigate length of stay at ED
Length of stay at ED, censored at 4 days
Hospital length of stay
Time Frame: Hospital length of stay from index visit, censored at 90 days
Investigate hospital length of stay
Hospital length of stay from index visit, censored at 90 days
Revisitis to the ED
Time Frame: Number of newly registered visits to the emergency department after index visit, censored at 90 days
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
Fall prevalence after the index visit
Time Frame: Falls that resulted in further ED visits after index visit, censored in 90 days
Falls that resulted in further ED visits
Falls that resulted in further ED visits after index visit, censored in 90 days
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

November 14, 2021

Study Completion (Actual)

November 14, 2021

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-00875FSSED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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