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

University of Glasgow

Status: Enrolling

Conditions: Surgery; Frailty; Frail Elderly Syndrome

Treatments: Diagnostic Test: Frailty assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06040658

GN23CE014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Vascular 'hot' clinic.

Description:

All adults (aged \> 17 years) referred to an urgent-referral, consultant-led, Vascular Surgery outpatient clinic, who have capacity, will be eligible for inclusion in this study.

Treatment:

Diagnostic Test: Frailty assessment

Diagnostic Test: Frailty assessment

Diagnostic Test: Frailty assessment

Diagnostic Test: Frailty assessment

Diagnostic Test: Frailty assessment