Polypharmacy and Outcomes After Elective Noncardiac Surgery

December 4, 2024 updated by: Ottawa Hospital Research Institute

Association of Polypharmacy With Outcomes After Elective Noncardiac Surgery: a Population-based Cohort Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multilevel multivariable regression analysis will be used to investigate the adjusted association between preoperative polypharmacy and postoperative outcomes and healthcare resource utilization. Sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Study Type

Observational

Enrollment (Actual)

266499

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:

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Polypharmacy
People taking >=5 unique prescription drugs in the 3 months prior to surgery
Drug: Polypharmacy
Patients who are taking >=5 unique prescription drugs in the 3 months prior to surgery
No polypharmacy
People taking <5 unique prescription drugs in the 3 months prior to surgery

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: From day of surgery to day of hospital discharge, up to 365 days after surgery
Patient with a complication based on clusters of ICD-10 Type 2 codes collected in the hospital record
From day of surgery to day of hospital discharge, up to 365 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2002

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DM5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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