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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04931472
Other study ID # 2021-00875FAA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 8, 2021
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source University Hospital, Linkoeping
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 emergency care context.


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: A. 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. B. 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. C. 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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Has been in clinical work at the ED for the period of the current study Exclusion Criteria: - Unwilling to provide informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Akutmottagningen US Östergötland Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Completion rate Proportion of completed Clinical Frailty Scale assessments in relation to the number of eligible patients During a period of six weeks
Secondary 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. 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 Patient related characteristics correlated to completion rate Age, gender, arrival mode, triage priority and discharge destination compared between the screened and not screened patients From admission to discharge from the Emergency department, up to 24 hours.
Secondary Organisational related characteristics correlated to completion rate Day and time of arrival compared between the screened and not screened patients From admission to discharge from the Emergency department, up to 24 hours
Secondary 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 ? Questionnaire that can be answered within five weeks
Secondary 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? Questionnaire that can be answered within five weeks
Secondary 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 " Questionnaire that can be answered within five weeks
Secondary 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". Questionnaire that can be answered within five weeks
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