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

NCT06040658 | Unknown

• 1 other identifier: GN23CE014
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Frailty; Frail Elderly Syndrome; Surgery

Outcome Measures

Primary Outcomes (3)

• Feasibility of implementing routine frailty assessment in a vascular clinic setting

  Proportion of patients recruited (Number of recruited patients/\[number of patients attending clinic - number of ineligible patients\]).

  During participant recruitment, over up to 4 months.

• Frailty assessment completion time

  Time taken to complete assessments (presented in seconds). The less time taken, the better.

  During participant recruitment, over up to 4 months.

• Frailty assessment completion rates

  Proportion of assessments with non-completion. Calculated by: number of incomplete frailty assessments/total number of recruited patients, the lower the value the better.

  During participant recruitment, over up to 4 months.

Secondary Outcomes (9)

• Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)

  30-days and 1 year from recruitment/clinic attendance

• Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)

  30-days and 1 year from recruitment/clinic attendance

• Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)

  30-days and 1 year from primary intervention offered following recruitment to study.

• Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)

  30-days and 1 year from primary intervention offered following recruitment to study.

• Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)

  30-days and 1 year from primary intervention offered following recruitment to study.

Study Arms (1)

Vascular 'hot' clinic.

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.

Diagnostic Test: Frailty assessment

Interventions

Frailty assessment DIAGNOSTIC_TEST

Rockwood Clinical Frailty Scale

Vascular 'hot' clinic.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, Lanarkshire, G51 4TF, United Kingdom

RECRUITING

Related Publications (1)

• Welsh SA, Hussey K, Brittenden J, Orr DJ, Quinn T. Frailty Assessment in Vascular OUtpatients Review (FAVOUR) protocol: single-centre prospective cohort study comparing feasibility and prognostic value of commonly used frailty assessment tools. BMJ Open. 2023 Dec 9;13(12):e079387. doi: 10.1136/bmjopen-2023-079387.

  PMID: 38070914 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Quinn

  University of Glasgow

  STUDY DIRECTOR

Central Study Contacts

Welsh

CONTACT

07786123590; silje.welsh@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 15, 2023
• Study Start: March 15, 2023
• Primary Completion: July 17, 2023
• Study Completion: November 1, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

GB (1)