Trial Outcomes & Findings for Anticholinergic Risk Scale and Resource Use After Elective Noncardiac Surgery (NCT NCT03151616)

NCT ID: NCT03151616

Last Updated: 2025-01-10

Results Overview

Number of days in hospital after surgery

• Recruitment status: COMPLETED
• Target enrollment: 244976 participants
• Primary outcome timeframe: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
• Results posted on: 2025-01-10

Participant Flow

Participant milestones

Measure	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 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Overall Study STARTED	173522	38127	33327
Overall Study COMPLETED	173522	38127	33327
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anticholinergic Risk Scale and Resource Use After Elective Noncardiac Surgery

Baseline characteristics by cohort

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	Total n=244976 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION 6 • n=5 Participants	74 years STANDARD_DEVIATION 6 • n=7 Participants	75 years STANDARD_DEVIATION 6 • n=5 Participants	74 years STANDARD_DEVIATION 6 • n=4 Participants
Sex: Female, Male Female	86587 Participants n=5 Participants	23257 Participants n=7 Participants	20063 Participants n=5 Participants	129907 Participants n=4 Participants
Sex: Female, Male Male	86935 Participants n=5 Participants	14870 Participants n=7 Participants	13264 Participants n=5 Participants	115069 Participants n=4 Participants

PRIMARY outcome

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

Number of days in hospital after surgery

Outcome measures

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Hospital Length of Stay	6.8 Days Standard Deviation 9.7	7.8 Days Standard Deviation 11.4	7.5 Days Standard Deviation 11.3

SECONDARY outcome

Timeframe: date of surgery up to 90 days after surgery

Costs related to medical care paid for by the provincial health insurance system

Outcome measures

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Costs of Care	21528 Canadian Dollars Standard Deviation 21645	24108 Canadian Dollars Standard Deviation 23342	24610 Canadian Dollars Standard Deviation 24679

SECONDARY outcome

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

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)

Outcome measures

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Institutional Discharge	34724 Participants	8885 Participants	7371 Participants

SECONDARY outcome

Timeframe: from day of surgery up to 90 days after surgery

death from any cause

Outcome measures

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Mortality	3515 Participants	1154 Participants	939 Participants

SECONDARY outcome

Timeframe: From the date of hospital discharge to 30 days after the date of discharge

Acute hospital readmission after discharge from index hospitalization

Outcome measures

Measure	No Anticholinergic Exposure n=173522 Participants People with an anticholinergic risk scale score of 0	Moderate Anticholinergic Exposure n=38127 Participants People with an anticholinergic risk scale score of 1-2 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure	High Anticholinergic Exposure n=33327 Participants People with an anticholinergic risk scale score of \>=3 anticholinergic risk scale: Risk summation scale for grading and studying anticholinergic medication exposure
Hospital Readmission	10905 Participants	2981 Participants	2666 Participants

Adverse Events

No Anticholinergic Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3515 deaths

Moderate Anticholinergic Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1154 deaths

High Anticholinergic Exposure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 939 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel McIsaac

The Ottawa Hospital

Phone: 613-761-4940

Email: dmcisaac@toh.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place