NCT02975375

Brief 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

Trial Health

87
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

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, 2002

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
8.3 years until next milestone

Results Posted

Study results publicly available

March 17, 2025

Completed
Last Updated

March 17, 2025

Status Verified

February 1, 2025

Enrollment Period

11.9 years

First QC Date

November 17, 2016

Results QC Date

November 25, 2024

Last Update Submit

February 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With All-Cause Mortality at 90-days

    Death from any cause in the 90 days after surgery

    date of surgery to 90 days after surgery

Secondary Outcomes (4)

  • Patient Safety Event

    From surgery to hospital discharge (on average 6 to 7 days)

  • Hospital Length of Stay

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

  • Non-independent Discharge Location

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

  • 30-day Hospital Readmission

    Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)

Study Arms (2)

Preoperative geriatric consult or assessment

Patients who have a geriatric assessment of consult billed in the 4 months before surgery

Procedure: Preoperative geriatric consult or assessment

No Preoperative geriatric consult or assessment

Patients who do not have a geriatric assessment of consult billed in the 4 months before surgery

Procedure: No Preoperative geriatric consult or assessment

Interventions

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.

Preoperative geriatric consult or assessment

No assessment or consult billed in the 4 months before surgery

No Preoperative geriatric consult or assessment

Eligibility Criteria

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

Individuals \>65 years of age on the day of the potential participant's first elective non-cardiac surgery in the study period

You may qualify if:

  • \>65
  • Resident of Ontario
  • Having elective non-cardiac surgery (inpatient admission)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Limitations and Caveats

This was an observational study, so we cannot prove causality. Unmeasured confounding is a risk to causal inference, but we were able to control for a large number of confounders, including mortality risk, diagnoses, preoperative healthcare use, and unmeasured hospital-level confounders. We were unable to study all possible pathways, such as improvements in medication appropriateness, that may be attributable to geriatric care.

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

November 17, 2016

First Posted

November 29, 2016

Study Start

April 1, 2002

Primary Completion

March 1, 2014

Study Completion

November 1, 2016

Last Updated

March 17, 2025

Results First Posted

March 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations