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FrailtyNCT04869878

Inter-rater Reliability of the Clinical Frailty Scale in a Swedish Emergency Department Setting

An observational study of Frailty, run by University Hospital, Linkoeping at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Frailty is a common clinical syndrome in older adults, which may be assessed through various assessment tools. One frequently used tool is the Clinical Frailty Scale (CFS) which potentially can be adopted for daily use in the Emergency Department and has been appraised for reliability to some extent, but have so far… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty
How many people
100 participants
Where
1 siteSweden
Study dates
3 May 2021to 31 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Health care professionals: Physicians, nurses and assistant nurses who are the responsible healthcare professionals for the enrolled patients Patients: Patients of all genders at the age of ≥65 years seeking medical care at the three ED instances in Region Östergötland.

Who may be able to join

  • Health-care professionals:
  • Working in the ED, as part of the emergency-care team that are responsible for a patient ≥65 years
  • Patients:
  • ≥65 years

Who cannot join

  • Health care professionals:
  • Unwilling to provide informed consent
  • Patients:
  • ≤65 years

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Akutmottagningen US Östergötland

    Linköping, Östergötland County, 58185

Other trials in Sweden

About this study

Frailty is a common clinical syndrome in older adults, which may be assessed through various assessment tools. One frequently used tool is the Clinical Frailty Scale (CFS) which potentially can be adopted for daily use in the Emergency Department and has been appraised for reliability to some extent, but have so far not been evaluated in the Swedish emergency care context.

The purpose of this study is to evaluate the inter-rater reliability of the Clinical Frailty Scale (CFS) in a clinical Swedish Emergency Department (ED) setting. Members of multidisciplinary emergency care teams will conduct the assessments individually.

Read the detailed description

The CFS is introduced and tested as part of a quality-improvement process regarding elderly people within the Emergency departments (EDs) of Region Östergötland (Östergötland County) in Sweden.

CFS is a 9-point scale developed within the Canadian Study of Health and Aging. It comprises of a pictograms and a clinical description to help assign scores ranging from very fit to terminally ill. CFS enables clinicians to rapidly stratify the degree of frailty in the elderly with the help of questions and clinical assessment. However, since the assessment is judgement based, it is important that the inter-rater reliability is satisfactory.

This study is part of a larger project where all eligible patients who visit the ED (24/7) for a period of four weeks will be enrolled and then subsequently assessed with CFS by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). For this study, each professional on the team will individually assess each patient. First, a clinical judgement is performed (frail/not frail) without any instrument, and then the patient is assessed by using the CFS. This will take place during work shifts when someone from the research team is present and can arrange the assessments, as well as ensure that they are conducted independently. These work shifts will be selected using the online application Research Randomizer, to randomly include all hours of the day as well as eligible health-care professionals.

The research-team member will collect the assigned CFS-scores and information on the age, gender, profession, position (emergency physician or intern/resident from other specialities) and the number of years in the profession of each assessor. Informed consent will be obtained from all health-care professionals who participate. No data that can identify any patient will be collected.

Sample size is determined to be 100 patients, which would be more than sufficient with a power of 90% and α 0,05.

Conditions
Frailty
Keywords
Inter-rater reliability, Clinical Frailty Scale, Frailty assessment, Frailty, Observer variation, Emergency service
Medical subject headings
Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of inter-rater reliability regarding frailty as assessed by CFS

    Inter-rater reliability of the CFS, expressed as Intraclass Correlation Coefficient

    Measured: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED

Secondary outcomes (2)

  1. Level of correlation between degree of frailty (CFS 1-9) and degree of inter-rater reliability

    Investigates whether inter-rater reliability, expressed as Intraclass Correlation Coefficient, varies between scale scores in CFS. Described descriptively.

    Measured: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED

  2. Agreement between CFS and clinical judgement (frail/not frail)

    Investigates the agreement between a clinical judgement (with no frailty tool) regarding the patient being frail or not, compared to frailty according to the CFS (cut-off 5). Expressed as a percentage.

    Measured: The clinical judgement is made just before the assessment with CFS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start3 May 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04869878
Sponsor's protocol ID
2021-00875IRR
Status last verified
Nov 2021
First submitted
26 Apr 2021
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manfredi G, Midao L, Paul C, Cena C, Duarte M, Costa E. Prevalence of frailty status among the European elderly population: Findings from the Survey of Health, Aging and Retirement in Europe. Geriatr Gerontol Int. 2019 Aug;19(8):723-729. doi: 10.1111/ggi.13689. Epub 2019 May 30.

    PubMed 31146300

  • Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6.

    PubMed 22881367

  • Preston L, Chambers D, Campbell F, Cantrell A, Turner J, Goyder E. What evidence is there for the identification and management of frail older people in the emergency department? A systematic mapping review. Southampton (UK): NIHR Journals Library; 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK493681/

    PubMed 29697231

  • Lewis ET, Dent E, Alkhouri H, Kellett J, Williamson M, Asha S, Holdgate A, Mackenzie J, Winoto L, Fajardo-Pulido D, Ticehurst M, Hillman K, McCarthy S, Elcombe E, Rogers K, Cardona M. Which frailty scale for patients admitted via Emergency Department? A cohort study. Arch Gerontol Geriatr. 2019 Jan-Feb;80:104-114. doi: 10.1016/j.archger.2018.11.002. Epub 2018 Nov 8.

    PubMed 30448693

  • 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.

    PubMed 32336486

  • Lo AX, Heinemann AW, Gray E, Lindquist LA, Kocherginsky M, Post LA, Dresden SM. Inter-rater Reliability of Clinical Frailty Scores for Older Patients in the Emergency Department. Acad Emerg Med. 2021 Jan;28(1):110-113. doi: 10.1111/acem.13953. Epub 2020 Apr 2. No abstract available.

    PubMed 32141671

  • 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.

    PubMed 16129869

  • Hallgren KA. Computing Inter-Rater Reliability for Observational Data: An Overview and Tutorial. Tutor Quant Methods Psychol. 2012;8(1):23-34. doi: 10.20982/tqmp.08.1.p023.

    PubMed 22833776

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty, run by University Hospital, Linkoeping at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of inter-rater reliability regarding frailty as assessed by CFS (time frame: The assessment will be made in connection with the patient´s first meeting with the care team, i.e. within 1 hour from the patient´s arrival to the ED). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04869878, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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