NCT04869878

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

April 26, 2021

Last Update Submit

November 12, 2021

Conditions

Keywords

Inter-rater reliabilityClinical Frailty ScaleFrailty assessmentFrailtyObserver variationEmergency service

Outcome Measures

Primary Outcomes (1)

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

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

    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)

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

    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

  • Agreement between CFS and clinical judgement (frail/not frail)

    The clinical judgement is made just before the assessment with CFS

Other Outcomes (1)

  • Difference in measures for Inter-rater reliability, expressed as Intraclass Correlation Coefficient, between care teams with emergency physicians in relation to care teams with interns/residents from other specialties.

    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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akutmottagningen US Östergötland

Linköping, Östergötland County, 58185, Sweden

Location

Related Publications (8)

  • 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.

    PMID: 31146300BACKGROUND
  • 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.

    PMID: 22881367BACKGROUND
  • 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/

    PMID: 29697231BACKGROUND
  • 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.

    PMID: 30448693BACKGROUND
  • 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.

    PMID: 32336486BACKGROUND
  • 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.

    PMID: 32141671BACKGROUND
  • 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.

    PMID: 16129869BACKGROUND
  • 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.

    PMID: 22833776BACKGROUND

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 3, 2021

Study Start

May 3, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations