Measure of Frailty in Perioperative Setting

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02838511
Collaborator
(none)
1,190
1
56
21.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Modified Frailty Index (MFI)
  • Other: Hopkins Frailty Score (HFS)

Study Design

Study Type:
Observational
Actual Enrollment :
1190 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Which is a Better Measure of Frailty in Perioperative Setting: Deficit Accumulation Model or Phenotype Model?
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Non-cardiac surgery

Hopkins Frailty Score (HFS) or Modified Frailty Index (MFI) will be obtained during during pre anesthesia evaluation

Other: Modified Frailty Index (MFI)
non-cardiac surgical patients will have frailty evaluated

Other: Hopkins Frailty Score (HFS)
non-cardiac surgical patients will have frailty evaluated

Outcome Measures

Primary Outcome Measures

  1. Days in Hospital [30 days after non-cardiac surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Study Chair: Daniel Sessler, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02838511
Other Study ID Numbers:
  • 14-1241
First Posted:
Jul 20, 2016
Last Update Posted:
Nov 4, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2019