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Measure of Frailty in Perioperative Setting

Completed
Conditions
Frailty
Interventions
Other: Modified Frailty Index (MFI)
Other: Hopkins Frailty Score (HFS)
Registration Number
NCT02838511
Lead Sponsor
The Cleveland Clinic
Brief Summary

Though most physicians believe they can identify frail patients, frailty is a poorly characterized and complex clinical syndrome. Frailty has been categorized four dimensions by de Vries et al: 1) physical (physical activity, nutrition, mobility, strength and energy); 2) biochemical (nutritional and inflammatory biomarkers); 3) psychological (cognition and mood); and, 4) social (social contact and support). 1 However, the pathophysiology of frailty remains unclear. Two broad hypotheses have been proposed.

Deficit accumulation model: This hypothesis assumes that frailty occurs due to accumulation and additive effect of multiple deficits, which occur across various domains. The more deficits a person has, the more likely that person is to be frail. Frailty in this paradigm is thus measured by identifying the number of positive factors/ deficits from a list. This is used to create a proportional index of deficits, expressed as the ratio of deficits present to the total number of deficits considered.

Many studies have used a modified frailty index (MFI) with 11 factors, which has shown to correlate well with patient outcomes after surgery.

Phenotype model: Fried et al in 2001 proposed a phenotype based model, in which she identified various clinical features that define frailty as a clinical syndrome. This criterion, known as Fried index, consists of 5 factors- shrinking, weakness, exhaustion, slowness, and low physical activity level. The Fried index is the most commonly used phenotype-based assessment tool to evaluate frailty. An advantage is its ease-of use during preoperative visits. Measurement of these factors in a perioperative setting was further characterized by Makary et al in 2010, and was the basis for the Hopkins Frailty Score (HFS).

Currently, there exists no gold standard for assessment of frailty, especially in the perioperative setting. In the absence of a well-accepted gold standard, a measurement of frailty which would predict adverse postoperative outcomes would be useful. However, no study has compared the prognostic abilities of HFS and MFI, after non-cardiac surgery.

All adult patients presenting to pre anesthesia evaluation clinic (PACE) at Cleveland Clinic main campus will be included in the this prospective observational cohort study. Frailty would be evaluated prospectively using HFS and components of MFI will be obtained from Cleveland Clinic Perioperative Health Documentation System registry (PHDS).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1190
Inclusion Criteria
  • adult patients (18-100 years of age)
  • patients presenting to the PACE clinic for non cardiac surgery
Exclusion Criteria
  • children (under 18 years of age)
  • patients presenting to the PACE clinic for cardiac surgery

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Non-cardiac surgeryModified Frailty Index (MFI)Hopkins Frailty Score (HFS) or Modified Frailty Index (MFI) will be obtained during during pre anesthesia evaluation
Non-cardiac surgeryHopkins Frailty Score (HFS)Hopkins Frailty Score (HFS) or Modified Frailty Index (MFI) will be obtained during during pre anesthesia evaluation
Primary Outcome Measures
NameTimeMethod
Days in Hospital30 days after non-cardiac surgery

total number of days spent by patient in the hospital within 30 days of non-cardiac surgery

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

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