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Development and Validation of a Preoperative Frailty Index Using Health Administrative Data

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ClinicalTrials.gov Identifier: NCT03354546
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Surgery Outcomes Predictive Value of Tests Diagnostic Test: Frailty index

Detailed Description:

The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.

Once derived the index will be tested to measure its association with outcomes, as well as its discrimination. Various representations of the frailty index will be tested (primary-as a continuous measure; secondary as a binary, categorical and fractional polynomial variable). Performance in subgroups will also be evaluated,

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Study Type : Observational
Actual Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Creation, Evaluation and Validation of a Preoperative Frailty Index Using Health Administrative Data: a Population-based Cohort Study
Actual Study Start Date : April 1, 2002
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Group/Cohort Intervention/treatment
Elective noncardiac surgery
Individuals having major noncardiac surgery following an elective hospital admission
Diagnostic Test: Frailty index
A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.

Emergency general surgery
Individuals having general surgery following an urgent hospital admission
Diagnostic Test: Frailty index
A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.




Primary Outcome Measures :
  1. Survival for one year after surgery [ Time Frame: Date of surgery to 365 days after surgery ]
    Still being alive (no death date) in the registered persons database


Secondary Outcome Measures :
  1. Institutional discharge [ Time Frame: Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first) ]
    Discharge to long term care or continuing care facility at the time of hospital discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All individuals 66 years of older on the day of their surgery
Criteria

Inclusion Criteria:

  • Having elective or emergency noncardiac surgery

Exclusion Criteria:

  • no provincial health insurance number
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03354546    
Other Study ID Numbers: DM8
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes