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CompletedNCT03354546Updated Sep 23, 2024Results posted

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

An observational study in Frail Elderly Syndrome, Surgery and Outcomes, sponsored by Ottawa Hospital Research Institute. Completed. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Ottawa Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
511,285
Ages
66 Years and older
Sex
All
01

Study 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.

Read the 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,

02

Conditions studied

  • Frail Elderly Syndrome
  • Surgery
  • Outcomes
  • Predictive Value of Tests

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03

Who can participate

Ages eligible
66 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Having elective or emergency noncardiac surgery

Exclusion criteria

Exclusion Criteria:

  • no provincial health insurance number
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
511,285 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testFrailty 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.

05

What researchers measure

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

    Time frame: Date of surgery to 365 days after surgery

Secondary outcomes

  1. Institutional Discharge

    Discharge to long term care or continuing care facility at the time of hospital discharge

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

06

Results

Posted Sep 23, 2024
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.

Participant flow

Participant flow — Overall Study
MilestoneElectiveEmergency
Started41570495581
Completed41570495581
Not completed00

Outcome measures

PrimarySurvival 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

Time frame:
Date of surgery to 365 days after surgery
Reported as:
Count of participants · Participants
Survival for One Year After Surgery
ParticipantsElective SurgeryEmergency Surgery
Survival for One Year After Surgery3961640
SecondaryInstitutional Discharge

Discharge to long term care or continuing care facility at the time of hospital discharge

Time frame:
Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first)
Reported as:
Count of participants · Participants
Institutional Discharge
ParticipantsElective SurgeryEmergency Surgery
Institutional Discharge576660

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Elective Noncardiac Surgery19,540/415,704 (4.7%)——
Emergency General Surgery———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Elective SurgeryEmergency SurgeryTotal
Frail76 ± 676 ± 676 ± 6
Not Frail73 ± 673 ± 673 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)Elective SurgeryEmergency SurgeryTotal
Frail — Female589532142080373
Frail — Male608711861879489
Not Frail — Female16569330493196186
Not Frail — Male13018725050155237
07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Registry details

Key details

Study ID
NCT03354546
Lead sponsor
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Apr 1, 2002
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016
Results posted
Sep 23, 2024
Last update
Sep 23, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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