SURGICAL PROCEDURES, OPERATIVENCT02975375

The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery

An observational study of SURGICAL PROCEDURES, OPERATIVE and Aged, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: SURGICAL PROCEDURES, OPERATIVE, Aged, Epidemiology
What is being tested?: Preoperative geriatric consult or assessment and No Preoperative geriatric consult or assessment
Type of treatment: Surgery or procedure
How many people: 266,499 participants
Where: 1 siteCanada
Study dates: Apr 2002to Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

Read the detailed 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.

Conditions: SURGICAL PROCEDURES, OPERATIVE, Aged, Epidemiology, Mortality
Being tested: Preoperative geriatric consult or assessment, No Preoperative geriatric consult or assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preoperative geriatric consult or assessmentProcedure or surgery
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 assessmentProcedure or surgery
No assessment or consult billed in the 4 months before surgery

Study groups in NCT02975375
Study group	Role	What they receive
Preoperative geriatric consult or assessment		Patients who have a geriatric assessment of consult billed in the 4 months before surgery Receives: 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 Receives: Procedure: No Preoperative geriatric consult or assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With All-Cause Mortality at 90-days
Death from any cause in the 90 days after surgery
Measured: date of surgery to 90 days after surgery

Secondary outcomes (4)

Patient Safety Event
Any Type 2 diagnostic code for a patient-safety event
Measured: From surgery to hospital discharge (on average 6 to 7 days)
Hospital Length of Stay
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Non-independent Discharge Location
Discharge disposition from hospital record that is not a home discharge without support
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
30-day Hospital Readmission
New acute care hospitalization within 30-days of discharge from the index hospitalization
Measured: Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2002Nov 2016

First posted29 Nov 2016 (estimated)
Study startApr 2002
Primary completionMar 2014
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SURGICAL PROCEDURES, OPERATIVEStudies of the same condition, open and under way.
More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 266,499 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02975375
Sponsor's protocol ID: DM4
Status last verified: Feb 2025
First submitted: 17 Nov 2016
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery
ClinicalTrials.gov ID: NCT02975375
Acronym / sponsor ID: DM4
Conditions: SURGICAL PROCEDURES, OPERATIVE, Aged, Epidemiology, Mortality
Study type: Observational
Recruitment status: Completed
Enrolment: 266,499 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: Apr 2002
Primary completion: Mar 2014 (actual)
Study completion: Nov 2016 (actual)
First posted: 29 Nov 2016 (estimated)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Preoperative geriatric consult or assessment	–	Procedure: Preoperative geriatric consult or assessmentPatients who have a geriatric assessment of consult billed in the 4 months before surgery
No Preoperative geriatric consult or assessment	–	Procedure: No Preoperative geriatric consult or assessmentPatients who do not have a geriatric assessment of consult billed in the 4 months before surgery

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Individuals >65 years of age on the day of the potential participant's first elective non-cardiac surgery in the study period

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Preoperative geriatric consult or assessmentA 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.	Procedure or surgery	Preoperative geriatric consult or assessment
No Preoperative geriatric consult or assessmentNo assessment or consult billed in the 4 months before surgery	Procedure or surgery	No Preoperative geriatric consult or assessment

Primary outcome

Number of Participants With All-Cause Mortality at 90-days
Time frame: date of surgery to 90 days after surgery
Death from any cause in the 90 days after surgery

4 secondary outcomes

Patient Safety Event
Time frame: From surgery to hospital discharge (on average 6 to 7 days)
Hospital Length of Stay
Time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Non-independent Discharge Location
Time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
30-day Hospital Readmission
Time frame: Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Preoperative Geriatric Consult or Assessment	7,352	7,352
No Preoperative Geriatric Consult or Assessment	259,147	259,147

Primary outcome: Number of Participants With All-Cause Mortality at 90-days

Time frame: date of surgery to 90 days after surgery. Count of participants. Unit: Participants

Measure	Preoperative Geriatric Consult or Assessment n = 7352	No Preoperative Geriatric Consult or Assessment n = 259147
Value	103	6172

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preoperative Geriatric Consult or Assessment	0 of 0	0 of 0	103 of 7,352
No Preoperative Geriatric Consult or Assessment	0 of 0	0 of 0	6,172 of 259,147

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of SURGICAL PROCEDURES, OPERATIVE and Aged, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All-Cause Mortality at 90-days (time frame: date of surgery to 90 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.