NCT03133182

Brief Summary

This study investigates the association of preoperative polypharmacy with outcomes and healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program

Trial Health

100
On Track

Trial Health Score

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

Enrollment
266,499

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
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
7.7 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

December 1, 2024

Enrollment Period

11.9 years

First QC Date

April 18, 2017

Results QC Date

December 4, 2024

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    death from any cause

    from day of surgery up to 90 days after surgery

Secondary Outcomes (5)

  • Complications

    From day of surgery to day of hospital discharge, up to 365 days after surgery

  • Length of Stay

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

  • 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

  • Hospital Readmission

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

Study Arms (2)

Polypharmacy

People taking \>=5 unique prescription drugs in the 3 months prior to surgery

Drug: Polypharmacy

No polypharmacy

People taking \<5 unique prescription drugs in the 3 months prior to surgery

Interventions

Patients who are taking \>=5 unique prescription drugs in the 3 months prior to surgery

Polypharmacy

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:

  • Intermediate to high risk elective non-cardiac surgery
  • Age \>=66 on day of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • McIsaac DI, Wong CA, Bryson GL, van Walraven C. Association of Polypharmacy with Survival, Complications, and Healthcare Resource Use after Elective Noncardiac Surgery: A Population-based Cohort Study. Anesthesiology. 2018 Jun;128(6):1140-1150. doi: 10.1097/ALN.0000000000002124.

MeSH Terms

Interventions

Polypharmacy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsOvertreatmentMedical OveruseHealth Services MisuseHealth ServicesHealth Care Facilities Workforce and ServicesAttitude to HealthDelivery of Health CareHealth Care Quality, Access, and Evaluation

Limitations and Caveats

We are unable to fully account for unmeasured confounders and indication bias. We were not able to account for granular patient-level data. We used health administrative data that were not initially collected for research purposes; risk of misclassification bias should be considered. Our polypharmacy exposure did not account for the potential differing risk impacts or appropriateness of different drugs. We were unable to account for medication underutilization which could bias results.

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

April 18, 2017

First Posted

April 28, 2017

Study Start

April 1, 2002

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share