Frailty Assessment in Vascular OUtpatients Review (FAVOUR Trial) - Comparing Feasibility and Prognostic Value of Commonly Used Assessments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Frailty assessment completion rates
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (aged 18 years or older)
- •Attending Vascular Hot Clinic
排除标准
- •Lacking capacity to provide informed consent
- •Parent clinical team feel frailty assessment not suitable
- •Non-English speaker without qualified translator present
- •Prisoners
结局指标
主要结局
Frailty assessment completion rates
时间窗: 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.
Feasibility of implementing routine frailty assessment in a vascular clinic setting
时间窗: During participant recruitment, over up to 4 months.
Proportion of patients recruited (Number of recruited patients/\[number of patients attending clinic - number of ineligible patients\]).
Frailty assessment completion time
时间窗: During participant recruitment, over up to 4 months.
Time taken to complete assessments (presented in seconds). The less time taken, the better.
次要结局
- 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 (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 (Readmission)(30-days from primary intervention offered following recruitment to study.)
- 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 (Length of stay)(30-days and 1 year from primary intervention offered following recruitment to study.)
- Assessing the peri-operative prognostic value of selected frailty assessment tools (Non-home discharge)(30-days from primary intervention offered following recruitment to study.)
- Assessing the peri-operative prognostic value of selected frailty assessment tools (Home time)(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)(30-days from primary intervention offered following recruitment to study.)
研究者
Silje Welsh
Principle Investigator
University of Glasgow