NCT03151616

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244,976

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2003

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

October 1, 2024

Enrollment Period

11 years

First QC Date

May 10, 2017

Results QC Date

November 22, 2024

Last Update Submit

November 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    Number of days in hospital after surgery

    date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first

Secondary Outcomes (4)

  • Costs of Care

    date of surgery up to 90 days after surgery

  • Institutional Discharge

    date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first

  • Mortality

    from day of surgery up to 90 days after surgery

  • Hospital Readmission

    From the date of hospital discharge to 30 days after the date of discharge

Study Arms (3)

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

Other: anticholinergic risk scale

High anticholinergic exposure

People with an anticholinergic risk scale score of \>=3

Other: anticholinergic risk scale

Interventions

Risk summation scale for grading and studying anticholinergic medication exposure

High anticholinergic exposureModerate anticholinergic exposure

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population-based sample of people having their first eligible surgery during the study period

You may qualify if:

  • at least 66 years old on the day of surgery
  • Intermediate to high risk elective noncardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y4E9, Canada

Location

Limitations and Caveats

The data used were not initially collected for research purposes and could be subject to misclassification bias. Our findings are at risk of unmeasured confounding. Administrative data do not accurately capture delirium, so we were unable to provide estimates of the association of the ARS with delirium rates. We chose to use the ARS as our measure of anticholinergic exposure; however, several anticholinergic scales have been described and effect sizes vary.

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 12, 2017

Study Start

April 1, 2003

Primary Completion

March 31, 2014

Study Completion

March 31, 2014

Last Updated

January 10, 2025

Results First Posted

January 10, 2025

Record last verified: 2024-10

Locations