- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151616
Anticholinergic Risk Scale and Resource Use After Elective Noncardiac Surgery
November 22, 2024 updated by: Dan McIsaac, Ottawa Hospital Research Institute
Association of Anticholinergic Risk Scale and Healthcare Resource Use After Elective Noncardiac Surgery: a Population-based Cohort Study
This study investigates the association of preoperative anticholinergic medication exposure with healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative Anticholinergic Risk Scale and postoperative healthcare resource utilization.
Sensitivity analyses will be used to evaluate the robustness of the primary analysis.
Study Type
Observational
Enrollment (Actual)
244976
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, K1Y4E9
- 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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Population-based sample of people having their first eligible surgery during the study period
Description
Inclusion Criteria:
- at least 66 years old on the day of surgery
- Intermediate to high risk elective noncardiac surgery
Exclusion Criteria:
-
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 |
|---|---|
|
No anticholinergic exposure
People with an anticholinergic risk scale score of 0
|
|
|
Moderate anticholinergic exposure
People with an anticholinergic risk scale score of 1-2
|
Risk summation scale for grading and studying anticholinergic medication exposure
|
|
High anticholinergic exposure
People with an anticholinergic risk scale score of >=3
|
Risk summation scale for grading and studying anticholinergic medication exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Length of Stay
Time Frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
Number of days in hospital after surgery
|
date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: from day of surgery up to 90 days after surgery
|
death from any cause
|
from day of surgery up to 90 days after surgery
|
|
Costs of Care
Time Frame: date of surgery up to 90 days after surgery
|
Costs related to medical care paid for by the provincial health insurance system
|
date of surgery up to 90 days after surgery
|
|
Institutional Discharge
Time Frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
A discharge location at the end of the surgical episode of care that is not back to the patient's original residence (specifically respite or long term care)
|
date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
|
|
Hospital Readmission
Time Frame: From the date of hospital discharge to 30 days after the date of discharge
|
Acute hospital readmission after discharge from index hospitalization
|
From the date of hospital discharge to 30 days after the date of discharge
|
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 (Actual)
April 1, 2003
Primary Completion (Actual)
March 31, 2014
Study Completion (Actual)
March 31, 2014
Study Registration Dates
First Submitted
May 10, 2017
First Submitted That Met QC Criteria
May 11, 2017
First Posted (Actual)
May 12, 2017
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
November 22, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM6
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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