Length of StayNCT03151616

Anticholinergic Risk Scale and Resource Use After Elective Noncardiac Surgery

An observational study of Length of Stay and Anti Cholinergics, 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

This study investigates the association of preoperative anticholinergic medication exposure with healthcare resource utilization in a population-based sample of older patients enrolled in a universal pharmacare program Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Length of Stay, Anti Cholinergics, Surgical Procedure, Operative
What is being tested?: anticholinergic risk scale
How many people: 244,976 participants
Where: 1 siteCanada
Study dates: 1 Apr 2003to 31 Mar 2014
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: Population-based sample of people having their first eligible surgery during the study period

Who may be able to join

at least 66 years old on the day of surgery
Intermediate to high risk elective noncardiac surgery

Who cannot join

Trial locations and contacts

1 site in 1 country.

Canada1 site

Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y4E9

Other trials in Canada

About this study

Official title: Association of Anticholinergic Risk Scale and Healthcare Resource Use After Elective Noncardiac Surgery: a Population-based Cohort Study

Read the detailed description

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

Conditions: Length of Stay, Anti Cholinergics, Surgical Procedure, Operative, Aged, Epidemiology
Being tested: anticholinergic risk scale

What participants receive

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

anticholinergic risk scaleOther
Risk summation scale for grading and studying anticholinergic medication exposure

Study groups in NCT03151616
Study group	Role	What they receive
No anticholinergic exposure		People with an anticholinergic risk scale score of 0
Moderate anticholinergic exposure		People with an anticholinergic risk scale score of 1-2 Receives: Other: anticholinergic risk scale
High anticholinergic exposure		People with an anticholinergic risk scale score of >=3 Receives: Other: anticholinergic risk scale

What is being measured

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

Hospital Length of Stay
Number of days in hospital after surgery
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first

Secondary outcomes (4)

Costs of Care
Costs related to medical care paid for by the provincial health insurance system
Measured: date of surgery up to 90 days after surgery
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)
Measured: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
Mortality
death from any cause
Measured: from day of surgery up to 90 days after surgery
Hospital Readmission
Acute hospital readmission after discharge from index hospitalization
Measured: From the date of hospital discharge to 30 days after the date of discharge

Timeline

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

1 Apr 200331 Mar 2014

First posted12 May 2017
Study start1 Apr 2003
Primary completion31 Mar 2014
Study completion31 Mar 2014

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 Length of StayStudies 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: 244,976 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03151616
Sponsor's protocol ID: DM6
Status last verified: Oct 2024
First submitted: 10 May 2017
Last updated: 10 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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All Length of Stay trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Anticholinergic Risk Scale and Healthcare Resource Use After Elective Noncardiac Surgery: a Population-based Cohort Study
ClinicalTrials.gov ID: NCT03151616
Acronym / sponsor ID: DM6
Conditions: Length of Stay, Anti Cholinergics, Surgical Procedure, Operative, Aged, Epidemiology
Study type: Observational
Recruitment status: Completed
Enrolment: 244,976 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: 1 Apr 2003 (actual)
Primary completion: 31 Mar 2014 (actual)
Study completion: 31 Mar 2014 (actual)
First posted: 12 May 2017 (actual)
Results: Posted 10 Jan 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: 3

Arm	Type	Receives
No anticholinergic exposure	–	–People with an anticholinergic risk scale score of 0
Moderate anticholinergic exposure	–	Other: anticholinergic risk scalePeople with an anticholinergic risk scale score of 1-2
High anticholinergic exposure	–	Other: anticholinergic risk scalePeople with an anticholinergic risk scale score of >=3

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Population-based sample of people having their first eligible surgery during the study period

Key inclusion criteria (2 listed)

at least 66 years old on the day of surgery
Intermediate to high risk elective noncardiac surgery

Key exclusion criteria (1 listed)

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
anticholinergic risk scaleRisk summation scale for grading and studying anticholinergic medication exposure	Other	High anticholinergic exposure, Moderate anticholinergic exposure

Primary outcome

Hospital 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

4 secondary outcomes

Costs of Care
Time frame: 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
Mortality
Time frame: from day of surgery up to 90 days after surgery
Hospital Readmission
Time frame: From the date of hospital discharge to 30 days after the date of discharge

Results and safety

Results posted to the registry on 10 Jan 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
No Anticholinergic Exposure	173,522	173,522
Moderate Anticholinergic Exposure	38,127	38,127
High Anticholinergic Exposure	33,327	33,327

Primary outcome: Hospital Length of Stay

Time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first. Mean (Standard Deviation). Unit: Days

Measure	No Anticholinergic Exposure n = 173522	Moderate Anticholinergic Exposure n = 38127	High Anticholinergic Exposure n = 33327
Value	6.8 (9.7)	7.8 (11.4)	7.5 (11.3)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Anticholinergic Exposure	0 of 0	0 of 0	3,515 of 173,522
Moderate Anticholinergic Exposure	0 of 0	0 of 0	1,154 of 38,127
High Anticholinergic Exposure	0 of 0	0 of 0	939 of 33,327

Limitations and caveats (from the sponsor): The data used were not initially collected for research purposes and could be subject to misclassification bias. Our findings are at risk of unmeasured confounding. Administrative data do not accurately capture delirium, so we were unable to provide estimates of the association of the ARS with delirium rates. We chose to use the ARS as our measure of anticholinergic exposure; however, several anticholinergic scales have been described and effect sizes vary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Length of Stay

Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
RecruitingObservational study
The Effect of Perioperative Nutritional Care on Recovery After Knee and Hip Replacement Surgery
Postoperative Outcomes, Postoperative Complications
Active, not recruitingObservational study
AKI and Delirium Risk Prediction and Cost Burden Study
Acute Kidney Injury, Delirium
RecruitingObservational study
Patterns of Rehabilitation After Spinal Cord Injury
Spinal Cord Injury
Recruiting
Peripheral Venous Pressure (PVP) Trial
Congestive Heart Failure

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 Length of Stay and Anti Cholinergics, 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 2 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 10 Jan 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 10 Jan 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?

Hospital Length of Stay (time frame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first). 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 NCT03151616.

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 10 Jan 2025.