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

September 14, 2023 updated by: Silje Welsh, University of Glasgow

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of implementing routine frailty assessment in a vascular clinic setting
Time Frame: During participant recruitment, over up to 4 months.
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 Frame: During participant recruitment, over up to 4 months.
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
Time Frame: During participant recruitment, over up to 4 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the prognostic value of selected frailty assessment tools (Home time - all patients)
Time Frame: 30-days and 1 year from recruitment/clinic attendance
'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
Assessing the prognostic value of selected frailty assessment tools (Mortality - all patients)
Time Frame: 30-days and 1 year from recruitment/clinic attendance
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
Assessing the peri-operative prognostic value of selected frailty assessment tools (Mortality)
Time Frame: 30-days and 1 year from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Complications)
Time Frame: 30-days and 1 year from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Length of stay)
Time Frame: 30-days and 1 year from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Readmission)
Time Frame: 30-days from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)
Time Frame: 30-days from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)
Time Frame: 30-days and 1 year from primary intervention offered following recruitment to study.
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.
Assessing the peri-operative prognostic value of selected frailty assessment tools (Social care requirements)
Time Frame: 30-days from primary intervention offered following recruitment to study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Investigators

  • Study Director: Quinn, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

July 17, 2023

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN23CE014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pseudonymised research data will be uploaded to appropriate data registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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