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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03133182
Other study ID # DM5
Secondary ID
Status Completed
Phase N/A
First received April 18, 2017
Last updated April 25, 2017
Start date April 2002
Est. completion date March 2014

Study information

Verified date April 2017
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200000
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Intermediate to high risk elective non-cardiac surgery

- Age >=66 on day of surgery

Exclusion Criteria:

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality death from any cause from day of surgery up to 90 days after surgery
Secondary Complications 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
Secondary 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 Costs of care Costs related to medical care paid for by the provincial health insurance system date of surgery up to 90 days after surgery
Secondary Institutional discharge 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
Secondary Hospital readmission Acute hospital readmission after discharge from index hospitalization From the date of hospital discharge to 30 days after the date of discharge
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