Condition category
Musculoskeletal Diseases
Date applied
12/07/2017
Date assigned
27/09/2017
Last edited
27/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Richard Pugh

ORCID ID

http://orcid.org/0000-0002-2848-4444

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 228370

Study information

Scientific title

Frailty Assessment Reliability in the Intensive Care Unit

Acronym

FAR-ICU

Study hypothesis

The inter-rater reliability of bedside frailty assessment is unclear.

Ethics approval

Wales Research Ethics Committee 4, 07/06/2017, 17/WA/0168

Study design

Multi-centre observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

See additional files

Condition

Frailty

Intervention

Potential 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 type

Behavioural

Phase

Drug names

Primary outcome measures

1. 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 measures

1. 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 trial start date

01/11/2016

Overall trial end date

01/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admitted to Critical Care units
2. Aged 60 years and over
3. Anticipated stay greater than 24 hours

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. 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

Recruitment start date

01/10/2017

Recruitment end date

01/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glan Clwyd Hospital
Rhuddlan Road
Bodelwyddan
LL18 5UJ
United Kingdom

Trial participating centre

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Drive
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Morriston Hospital
Heol Maes Eglwys Morriston Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom

Trial participating centre

Prince Charles Hospital
Gurnos Road
Merthyr Tydfil
CF47 9DT
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Sponsor information

Organisation

Betsi Cadwaladr University Health Board

Sponsor details

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Betsi Cadwaladr University Health Board

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol will be available on request. Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The 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).

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes