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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02975375
Other study ID # DM4
Secondary ID
Status Completed
Phase N/A
First received November 17, 2016
Last updated December 6, 2016
Start date April 2002
Est. completion date November 2016

Study information

Verified date December 2016
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

The investigators will conduct a population-based study using health administrative data to evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older patients having elective, non-cardiac surgery


Description:

The investigators will use multilevel multivariable analyses to measure the association between preoperative geriatric assessment or consultation and outcomes after major elective non-cardiac surgery. Sensitivity analyses will be done to evaluate types and timing of geriatric care around surgery, as well as for effect modification based on patient and procedural factors.


Recruitment information / eligibility

Status Completed
Enrollment 200000
Est. completion date November 2016
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- >65

- Resident of Ontario

- Having elective non-cardiac surgery (inpatient admission)

Exclusion Criteria:

- Residing in a nursing home or long term care facility at baseline

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Preoperative geriatric consult or assessment
A preoperative geriatric consult or assessment will be considered to be present if such a consult or assessment is billed by a geriatrician for a patient in the cohort within 4 months preceding surgery. For the primary analysis we will collapse both geriatric consultations and comprehensive geriatric assessments into a single exposure level.
No Preoperative geriatric consult or assessment
No assessment or consult billed in the 4 months before surgery

Locations

Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 90-day survival Death from any cause in the 90 days after surgery date of surgery to day of death or 365 days after surgery, whichever comes first Yes
Secondary Patient safety event Any Type 2 diagnostic code for a patient-safety event as described by Southern et al, Medical Care 2016 surgery to hospital discharge, or up to 365 days after surgery Yes
Secondary Hospital length of stay date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first No
Secondary Non-independent discharge location Discharge disposition from hospital record that is not a home discharge without support date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first No
Secondary 30-day hospital readmission New acute care hospitalization within 30-days of discharge from the index hospitalization date of discharge to 30 days after discharge No
Secondary Health Utility Index A health utility index will be constructed, and used as an outcome if an adequate number of participants have required measures to support multivariable modelling in the 365 days following surgery No
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