NCT03354546

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511,285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

May 1, 2024

Enrollment Period

14 years

First QC Date

November 17, 2017

Results QC Date

November 15, 2023

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival for One Year 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 Outcomes (1)

  • Institutional Discharge

    Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)

Study Arms (2)

Elective noncardiac surgery

Individuals having major noncardiac surgery following an elective hospital admission

Diagnostic Test: Frailty index

Emergency general surgery

Individuals having general surgery following an urgent hospital admission

Diagnostic Test: Frailty index

Interventions

Frailty indexDIAGNOSTIC_TEST

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.

Elective noncardiac surgeryEmergency general surgery

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Having elective or emergency noncardiac surgery

You may not qualify if:

  • no provincial health insurance number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Limitations and Caveats

Some variables underlying the pFI, such as pharmacy and home-support care data, may not be available in all data systems. Additionally, while the ACG system is the most widely used population-risk software in the world, it is not universally available, and diagnostic codes underlying its clusters are not openly disseminated. Our results represent associations, not causal relationships.

Results Point of Contact

Title
Dr. Daniel McIsaac
Organization
The Ottawa Hospital

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 28, 2017

Study Start

April 1, 2002

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

September 23, 2024

Results First Posted

September 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share