- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975375
The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery
February 24, 2025 updated by: Ottawa Hospital Research Institute
The investigators will conduct a population-based study using health administrative data to evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older patients having elective, non-cardiac surgery
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators will use multilevel multivariable analyses to measure the association between preoperative geriatric assessment or consultation and outcomes after major elective non-cardiac surgery.
Sensitivity analyses will be done to evaluate types and timing of geriatric care around surgery, as well as for effect modification based on patient and procedural factors.
Study Type
Observational
Enrollment (Actual)
266499
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- Ottawa Hospital Research Institute
-
-
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals >65 years of age on the day of the potential participant's first elective non-cardiac surgery in the study period
Description
Inclusion Criteria:
- >65
- Resident of Ontario
- Having elective non-cardiac surgery (inpatient admission)
Exclusion Criteria:
- Residing in a nursing home or long term care facility at baseline
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 |
|---|---|
|
Preoperative geriatric consult or assessment
Patients who have a geriatric assessment of consult billed in the 4 months before surgery
|
A preoperative geriatric consult or assessment will be considered to be present if such a consult or assessment is billed by a geriatrician for a patient in the cohort within 4 months preceding surgery.
For the primary analysis we will collapse both geriatric consultations and comprehensive geriatric assessments into a single exposure level.
|
|
No Preoperative geriatric consult or assessment
Patients who do not have a geriatric assessment of consult billed in the 4 months before surgery
|
No assessment or consult billed in the 4 months before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With All-Cause Mortality at 90-days
Time Frame: date of surgery to 90 days after surgery
|
Death from any cause in the 90 days after surgery
|
date of surgery to 90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Safety Event
Time Frame: From surgery to hospital discharge (on average 6 to 7 days)
|
Any Type 2 diagnostic code for a patient-safety event
|
From surgery to hospital discharge (on average 6 to 7 days)
|
|
Hospital Length of Stay
Time Frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
|
|
Non-independent Discharge Location
Time Frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
Discharge disposition from hospital record that is not a home discharge without support
|
date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
|
30-day Hospital Readmission
Time Frame: Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)
|
New acute care hospitalization within 30-days of discharge from the index hospitalization
|
Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
April 1, 2002
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 17, 2016
First Submitted That Met QC Criteria
November 28, 2016
First Posted (Estimated)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- DM4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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