- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03610152
Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Ambulatory Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Institute of Medicine's (IOM) quality improvement framework includes the three pillars of underuse, overuse and misuse, though misuse and underuse have largely been the historical focus of quality improvement efforts (1). More recently, there is increasing recognition of the problem of overuse relating to "low-value care", defined as 'a test or treatment for which there is no evidence of patient benefit or where there is evidence of more harm than benefit'. The IOM suggests that as much as 30% of healthcare qualifies as low-value, which can lead to: poor patient outcomes due to adverse events of treatments or secondary unwarranted tests (with potential for over-treatment of incidental findings); and inefficient use of scarce healthcare resources threatening the sustainability of healthcare systems. In the context of Ontario, this would equate to over $15 billion wasted on low-value care in 2014 representing a major threat to the sustainability of the Ontario healthcare system. Unfortunately, recent studies have demonstrated similar levels of low-value care in Ontario currently, and suggest that there are considerable opportunities to reduce this waste within the province. For example, the investigators found previously that approximately 30% of patients received unnecessary cardiac testing and/or chest x-rays prior to ambulatory surgery (with almost 30-fold variability in ordering between institutions) (2,3).
Within Canada, provincial governments have made reducing low-value care a priority. Choosing Wisely Canada (CWC) (4,5) is a professionally led campaign to rally the medical professional to address this issue and make declarative statements about low-value care that physicians and patients should avoid or question across a broad range of specialties. To date, 37 Canadian medical specialty societies have developed over 150 recommendations pertaining to unnecessary tests, treatments and procedures.
Whilst the identification of potential areas of low-value care is an important first step in addressing this problem, additional efforts are required to ensure implementation of CWC recommendations. Before now, internationally and in Canada, the issue of implementing Choosing Wisely like recommendations has not received adequate attention. This project directly addresses this key priority for healthcare systems bringing together Ontarian experts from CWC, implementation science, relevant clinical content areas and knowledge users to develop and evaluate programs to implement CWC recommendations. The investigators will use state-of-the-art approaches from implementation science to develop and evaluate a major initiative to reduce low-value care in Ontario. Knowledge users include Health Quality Ontario, the Ontario Hospital Association and Choosing Wisely Canada.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kyle Kirkham, M.D.
- Phone Number: 416-790-0103
- Email: Kyle.Kirkham@uhn.ca
Study Contact Backup
- Name: Regina Fraser, M.Sc
- Phone Number: 5216 416-603-5800
- Email: regina.fraser@uhnresearch.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
Contact:
- Regina Fraser, M.Sc
- Phone Number: 5216 416-603-5800
- Email: regina.fraser@uhnresearch.ca
-
Contact:
- Kyle Kirkham, M.D
- Phone Number: 416-790-0103
- Email: kyle.kirkham@uhn.ca
-
Sub-Investigator:
- Duminda Wijeysundera, M.D
-
Sub-Investigator:
- Sacha Bhatia, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Hospitals in the 26th - 100th percentile for routine preoperative tests
Exclusion Criteria:
• Hospitals in the 0 - 25th percentile for routine preoperative tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Hospitals made aware of Choosing Wisely Canada recommendations and Health Quality Ontario data.
|
|
Experimental: Hospital wide policy
A hospital-wide policy will be implemented whereby medically necessary preoperative tests for patients undergoing ambulatory surgery will be ordered at the discretion of the consulting anesthesiologists based on their clinical assessment of the patient.
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Implementation of a hospital wide policy whereby medically necessary preoperative tests for patients undergoing ambulatory surgery will be ordered at the discretion of the consulting anesthesiologist based on their clinical assessment of the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-value preoperative investigations received
Time Frame: 12-months
|
The proportion of patients that receive low-value preoperative investigations such as ECG, EKG, Chest X-Rays and chest stress testing within 60-days before surgery at each enrolled institution.
Pooled data will be collected from administrative data source.
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overnight admissions
Time Frame: 12-months
|
Hospital rates of overnight admissions
|
12-months
|
Re-operation in 24-hours
Time Frame: 12-months
|
Hospital rates of re-operation in 24 hours
|
12-months
|
All-cause mortality from the date of surgery
Time Frame: 12-months
|
Hospital rates of 30-day all-cause mortality from the date of surgery
|
12-months
|
Patients who receive ECG, EKG, Chest X-ray and Cardiac stress test
Time Frame: 12-months
|
The proportion of patients receiving each of the above pre-operative tests individually
|
12-months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kyle Kirkham, M.D., University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-5108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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