Clinical trial NCT06040658: Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value
Official title: Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Frail Elderly Syndrome
Surgery
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All referrals to vascular hot clinic are eligible for inclusion, preferentially recruiting new referrals. As frailty is related to age, but does not directly correlate with it, no age cut-off has been defined. As this is primarily a study of feasibility, patients will not be excluded/included based on presenting symptom or diagnosed pathology.

A proxy (relative/friend/carer), if present, will also be invited to participate and assist with frailty assessments of the patients, where suitable. The participation of the proxy is dependent on the patient providing written consent agreeing to their participation, as well as the proxy being eligible to participate, according to the same inclusion/exclusion criteria set out for patients below.

Brief summary: A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).

Detailed description: This single-centre prospective cohort study of feasibility, is conducted in a rapid-referral vascular surgery clinic, serving a population of 2 million. Capax adults (\>18years), attending clinic for any reason are eligible for inclusion. Five frailty assessments are completed at the clinic by patient (Rockwood Clinical Frailty Scale \[CFS\] and Frail NonDisabled Questionnaire \[FiND\]), clinician (CFS, Health care Improvement Scotland FRAIL Scale and 'Initial Clinical Evaluation') and researcher (11-item modified Frailty Index, mFI-11). Consistent with feasibility objectives, outcome measures include recruitment rates, frailty assessment completion rates, time-to-complete assessments and inter-rater variability. Electronic follow-up at 30-days and 1-year will assess home-time and mortality as prognostic indicators. Patients treated surgically/endovascularly will undergo additional 30-day and 1-year post-operative follow-up, outcome measures include: surgical procedure, mortality, complications (according to Clavien-Dindo Classification), length-of-stay, readmission rates, non-home discharge, home-time, higher social care requirements on discharge and amputation-free survival. Prognostic value will be compared by area under Receiver operator characteristic (ROC) curves. Continuous outcome variables will be analysed using Spearman's rank correlation coefficient. Inter-user agreement will be compared by percentage agreement in Cohen's Kappa coefficient.

Eligibility criteria: Inclusion Criteria:

* Adults (aged 18 years or older)
* Attending Vascular Hot Clinic

Exclusion Criteria:

* Lacking capacity to provide informed consent
* Parent clinical team feel frailty assessment not suitable
* Non-English speaker without qualified translator present
* Prisoners

Primary outcomes:
measure: Feasibility of implementing routine frailty assessment in a vascular clinic setting
timeFrame: During participant recruitment, over up to 4 months.
measure: Frailty assessment completion time
timeFrame: During participant recruitment, over up to 4 months.
measure: Frailty assessment completion rates
timeFrame: During participant recruitment, over up to 4 months.
Secondary outcomes:
measure: Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)
timeFrame: 30-days and 1 year from recruitment/clinic attendance
measure: Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)
timeFrame: 30-days and 1 year from recruitment/clinic attendance
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)
timeFrame: 30-days and 1 year from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)
timeFrame: 30-days and 1 year from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)
timeFrame: 30-days and 1 year from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)
timeFrame: 30-days from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)
timeFrame: 30-days from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)
timeFrame: 30-days and 1 year from primary intervention offered following recruitment to study.
measure: Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)
timeFrame: 30-days from primary intervention offered following recruitment to study.
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Lanarkshire
Study officials:
affiliation: University of Glasgow
name: Quinn
role: STUDY_DIRECTOR
References: