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FrailtyNCT04931472

Feasibility and Acceptability 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

The purpose of this study is to evaluate the feasibility and acceptability of the Clinical Frailty Scale (CFS). The scale can potentially be adopted for daily use in the Emergency Department (ED) and have been evaluated with regard to feasibility to a certain extent, but have so far not been evaluated in the Swedish… Read more about this study

Who is it for?
Any age
Conditions the study is for
Frailty
How many people
229 participants
Where
1 siteSweden
Study dates
8 Jun 2021to 31 Dec 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Physicians, registered nurses and assistant nurses working in the ED

Who may be able to join

  • Has been in clinical work at the ED for the period of the current study

Who cannot join

  • Unwilling to provide informed consent

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

The purpose of this study is to evaluate the feasibility and acceptability of the Clinical Frailty Scale (CFS).

The scale can potentially be adopted for daily use in the Emergency Department (ED) and have been evaluated with regard to feasibility to a certain extent, but have so far not been evaluated in the Swedish emergency care context.

Read the detailed description

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

CFS is a 9-point scale developed within the Canadian Study of Health and Aging, a pictograph and a clinical description aids to assign scores from very fit to terminally ill. The scale enable clinicians to stratify elderly people's degree of frailty with the help of questions and clinical assessment. However, even excellent tools will not be used if they are too difficult or time consuming. The amount of papers addressing issues regarding feasibility and acceptability of the CFS in a clinical ED-setting is still limited, and for Swedish EDs non-existent.

This study is part of a larger research project, data will be collected in three ways:

  1. All eligible patients who visit the ED for a period of six weeks will be enrolled, and subsequently assessed with CFS by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). The number of screened patients divided by the total number of eligible patients will yield the screening rate. Patient- and organisational related characteristics will be collected from the electronic health record.
  2. 100 patients will be assessed when someone from the research team is present to enrol patients and clock the assessments. 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 document the time to complete the assessment using CFS, which will give us the screening time.
  3. To assess acceptability, health-care professionals will be sent a questionnaire per email, including two reminders. The questionnaire will consist of Likert scales, multiple-choice questions and open textboxes with the aim to explore facilitators and barriers for screening completion.

Primary aim: To explore the feasibility and acceptability of the CFS in a Swedish Emergency care context.

Conditions
Frailty
Keywords
Frailty, Geriatric assessment, Emergency service, Feasibility studies, Geriatric emergency medicine
Medical subject headings
Frailty

What is being measured

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

  1. Completion rate

    Proportion of completed Clinical Frailty Scale assessments in relation to the number of eligible patients

    Measured: During a period of six weeks

Secondary outcomes (7)

  1. Duration of time to make the assessment

    Measured time from that the health care professionals begins to read the instructions until he/she notes the assigned score.

    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. Patient related characteristics correlated to completion rate

    Age, gender, arrival mode, triage priority and discharge destination compared between the screened and not screened patients

    Measured: From admission to discharge from the Emergency department, up to 24 hours.

  3. Organisational related characteristics correlated to completion rate

    Day and time of arrival compared between the screened and not screened patients

    Measured: From admission to discharge from the Emergency department, up to 24 hours

  4. Ease of use

    The proportion of distributed answers to alternatives 1 (Not at all easy) to 7 (Very easy) to the question: What is your experience of how it is to decide what CFS score a person has ?

    Measured: Questionnaire that can be answered within five weeks

  5. Relevance

    The proportion of distributed answers to alternatives 1 (Completely irrelevant) to 7 (Very relevant) to the question: How relevant or irrelevant do you experience that it is to use CFS in the emergency department?

    Measured: Questionnaire that can be answered within five weeks

  6. Facilitators to perform assessment

    Health care professionals descriptions of what facititates performance of frailty assessments, qualitative analysis of the respondents' written answers in a free text box "

    Measured: Questionnaire that can be answered within five weeks

  7. Barriers to perform

    The proportion of distributed answers to existing alternatives, and qualitative analysis of the respondents' written answers in the free text box "other reason".

    Measured: Questionnaire that can be answered within five weeks

Timeline

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

  1. First posted18 Jun 2021
  2. Study start8 Jun 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 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
Cohort
Time perspective
Prospective
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04931472
Sponsor's protocol ID
2021-00875FAA
Status last verified
May 2022
First submitted
10 Jun 2021
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Elliott A, Phelps K, Regen E, Conroy SP. Identifying frailty in the Emergency Department-feasibility study. Age Ageing. 2017 Sep 1;46(5):840-845. doi: 10.1093/ageing/afx089.

    PubMed 28541400

  • 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

  • Horlin E, Munir Ehrlington S, Toll John R, Henricson J, Wilhelms D. Is the clinical frailty scale feasible to use in an emergency department setting? A mixed methods study. BMC Emerg Med. 2023 Oct 26;23(1):124. doi: 10.1186/s12873-023-00894-8.

    PubMed 37880591

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 1 inclusion and 1 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 23 May 2022. 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?

Completion rate (time frame: During a period of six weeks). 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 NCT04931472, which also lists 4 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 23 May 2022.

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