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

Surgery Clinical Trial

— FAVOUR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040658
• Other study ID #: GN23CE014
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2023
• Source: University of Glasgow
• Contact: Welsh
• Phone: 07786123590
• Email: silje.welsh[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2024
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty
• Surgery

Intervention

Diagnostic Test:
• Frailty assessment
Rockwood Clinical Frailty Scale
• Frailty assessment
Frail NonDisabled Questionnaire (FiND)
• Frailty assessment
Clinician's subjective 'end-of-bed' test
• Frailty assessment
Healthcare Improvement Scotland FRAIL Scale
• Frailty assessment
11-item modified Frailty Index (mFI-11)

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)	'Home time': this describes the number of full days at home (not as a hospital inpatient) over the follow up periods. All recruited patients will undergo this follow-up.	30-days and 1 year from recruitment/clinic attendance
Secondary	Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)	Mortality: this will be calculated from date of recruitment. All recruited patients will undergo this follow-up.	30-days and 1 year from recruitment/clinic attendance
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)	For patients offered endovascular/surgical/hybrid intervention: mortality. Proportion of patients dead at follow up.	30-days and 1 year from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)	For patients offered endovascular/surgical/hybrid intervention: post-operative complications (according to the Clavien-Dindo Classification).	30-days and 1 year from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)	For patients offered endovascular/surgical/hybrid intervention: length of hospital stay (full days). Calculated as number of full days as inpatient following admission for index procedure.	30-days and 1 year from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)	For patients offered endovascular/surgical/hybrid intervention: readmission rates (to any speciality). This will be calculated by the proportion of patients readmitted to hospital following index procedure/the number of patients undergoing surgical/endovascular treatment.	30-days from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)	For patients offered endovascular/surgical/hybrid intervention: non-home discharge. This will be calculated by the proportion of patients who are discharged to place of residence differing from their preoperative residence/total number of patients undergoing surgical/endovascular treatment. For example, from private residence preoperatively to care home.	30-days from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)	For patients offered endovascular/surgical/hybrid intervention: home time. See outcome 4.	30-days and 1 year from primary intervention offered following recruitment to study.
Secondary	Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)	For patients offered endovascular/surgical/hybrid intervention: discharge with a higher level of social care requirements. This will be presented as the proportion of patients discharged with greater social care requirements than before their index admission/'total number of patients offered surgical or endovascular treatment. E.g., a patient is admitted preopertively with three times daily package of care and discharged with four times daily package of care	30-days from primary intervention offered following recruitment to study.