NCT06040658

Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of Glasgow · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Frailty
• Frail Elderly Syndrome
• Surgery

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Frailty assessment	Rockwood Clinical Frailty Scale
DIAGNOSTIC_TEST	Frailty assessment	Frail NonDisabled Questionnaire (FiND)
DIAGNOSTIC_TEST	Frailty assessment	Clinician's subjective 'end-of-bed' test
DIAGNOSTIC_TEST	Frailty assessment	Healthcare Improvement Scotland FRAIL Scale
DIAGNOSTIC_TEST	Frailty assessment	11-item modified Frailty Index (mFI-11)

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-07-17
• Completion: 2024-11-01
• First posted: 2023-09-15
• Last updated: 2023-09-15

Locations

1 site across 1 country: United Kingdom