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

May 28, 2024 updated by: Ottawa Hospital Research Institute

Creation, Evaluation and Validation of a Preoperative Frailty Index Using Health Administrative Data: a Population-based Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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,

Study Type

Observational

Enrollment (Actual)

511285

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

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All individuals 66 years of older on the day of their surgery

Description

Inclusion Criteria:

  • Having elective or emergency noncardiac surgery

Exclusion Criteria:

  • no provincial health insurance number

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Outcome is binary, exposure is per 0.1 unit increase
Date of surgery to 365 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)

Collaborators and Investigators

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

Sponsor

Ottawa Hospital Research Institute

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)

April 1, 2002

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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