The reliability of frailty assessment in intensive care

ISRCTN ISRCTN17509500
DOI https://doi.org/10.1186/ISRCTN17509500
IRAS number 228370
Secondary identifying numbers IRAS 228370
Submission date
12/07/2017
Registration date
27/09/2017
Last edited
14/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
As national populations age, the proportion of older patients among those admitted to critical care has risen in many regions. Age unfortunately has negative prognostic implications for the outcome of critical illness and if faced with poor likelihood of a good outcome many older people may express a wish "not to be kept alive on life support". For an individual facing critical illness age by itself may be a fairly blunt indicator of likely outcome, and it seems that assessing "frailty" may in future help discussions between clinicians, patients and their relatives about the potential benefits of critical care treatments - and identify those who may need extra support with their longer-term recovery. The reliability of assessing frailty at the bedside in critical care (i.e. how closely do two separate assessments made by two different clinicians match each other?) needs research. The aim of this study is to determine the reliability of bedside frailty assessments.

Who can participate?
Adults aged 60 and older who are admitted to a critical care unit for 24 hours or more.

What does the study involve?
Participants take part in two interviews on the same day by two different members of the research team. The interview consists of unscripted questions to assess frailty, based on fitness, chronic disease, activity of daily living, dependence, mobility, and life expectancy. If participants are unable to participant due to severe illness, a proxy (a carer who is in contact with them on a regular basis and has known them for over five years) may be interviewed. The results from each frailty assessment are compared. The follow up consists of data that is collected for 30 days.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
This study is being run by the Betsi Cadwaladr University Health Board (UK) and takes place in eight health centres in the UK.

When is the study starting and how long is it expected to run for?
November 2016 to May 2018

Who is funding the study?
Betsi Cadwaladr University Health Board (UK)

Who is the main contact?
Dr Richard Pugh

Contact information

Dr Richard Pugh
Public

Department of Anaesthetics
Glan Clwyd Hospital
Bodelwyddan
LL18 5UJ
United Kingdom

ORCiD logoORCID ID 0000-0002-2848-4444

Study information

Study designMulti-centre observational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet ISRCTN17509500_PIS_05Apr17_V1.docx
Scientific titleFrailty Assessment Reliability in the Intensive Care Unit
Study acronymFAR-ICU
Study objectivesThe inter-rater reliability of bedside frailty assessment is unclear.
Ethics approval(s)Wales Research Ethics Committee 4, 07/06/2017, 17/WA/0168
Health condition(s) or problem(s) studiedFrailty
InterventionPotential participants (whether patient or proxy) are screened for eligibility, approached for participation and ask to provide consent to participate during at time of ICU admission.

Following consent participants take part in two interviews each conducted by a different member of the clinical team. Each interview takes less than 15 minutes. The interviews are conducted during the ICU admission, typically both on the same day, but by different clinicians. The interview consists of unscripted questions that enable the clinician to assess frailty according to the Dalhousie Clinical Frailty Scale – which relies on an interpretation of fitness, chronic disease, activities of daily living, dependence, mobility, resilience to acute illness and life expectancy.

Some critically ill patients who are not be able to participate in these discussions because of the severity of their illness are allowed, under these circumstances, a proxy (somebody who has known them for a long time [>5 years] and is in contact with them on a regular basis, for example, a close member of family) may agree to be interviewed.

The comparisons are made between the CFS assessments made by two groups of clinicians (a “senior” and a “junior” group, depending on the relative number of years of post-registration experience of each of the two clinicians making the assessment).

Follow-up is done in the form of routinely collected data, censored at 30 days and there is no direct participant involvement in follow-up.
Intervention typeBehavioural
Primary outcome measure1. Inter-rater reliability of frailty assessment (comparing the assessment of two groups of clinicians using the Clinical Frailty Scale) is measured using the kappa statistic after the interviews.
2. Frailty is measured using the clinical frailty scale at time of interview.
Secondary outcome measures1. Hospital mortality is measured using collected data at 30 days
2. Critical care length of stay is measured using routinely collected data at 30 days.
Overall study start date01/11/2016
Completion date01/05/2018

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants100
Total final enrolment101
Key inclusion criteria1. Admitted to Critical Care units
2. Aged 60 years and over
3. Anticipated stay greater than 24 hours
Key exclusion criteria1. Aged less than 60 years
2. Anticipated Critical Care stay or survival less than 24 hours
3. Where patient's condition prevents them from being interviewed and there are no other individuals qualified to act as proxy
4. No capacity to consent to participation nor anyone able to act as personal consultee
Date of first enrolment01/10/2017
Date of final enrolment01/11/2017

Locations

Countries of recruitment

  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Glan Clwyd Hospital
Rhuddlan Road
Bodelwyddan
LL18 5UJ
United Kingdom
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
Royal Infirmary of Edinburgh
51 Little France Drive
Edinburgh
EH16 4SA
United Kingdom
Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Morriston Hospital
Heol Maes Eglwys
Morriston
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom
Prince Charles Hospital
Gurnos Road
Merthyr Tydfil
CF47 9DT
United Kingdom
Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Sponsor information

Betsi Cadwaladr University Health Board
Hospital/treatment centre

Ysbyty Gwynedd
Bangor
LL57 2PW
Wales
United Kingdom

ROR logo "ROR" https://ror.org/03awsb125

Funders

Funder type

Hospital/treatment centre

Betsi Cadwaladr University Health Board

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planStudy protocol will be available on request. Planned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Richard Pugh (richard.pugh@wales.nhs.uk).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V1 05/04/2017 27/09/2017 No Yes
Results article results 01/06/2019 14/06/2019 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN17509500_PIS_05Apr17_V1.docx
Uploaded 27/09/2017

Editorial Notes

14/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.