Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Ambulatory Surgery
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|ClinicalTrials.gov Identifier: NCT03610152|
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low-value Pre-operative Investigations||Behavioral: Hospital Policy change||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Ambulatory Surgery|
|Estimated Study Start Date :||August 2, 2019|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
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.
Behavioral: Hospital Policy change
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.
- 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.
- Overnight admissions [ Time Frame: 12-months ]Hospital rates of overnight admissions
- Re-operation in 24-hours [ Time Frame: 12-months ]Hospital rates of re-operation in 24 hours
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610152
|Contact: Kyle Kirkham, M.D.||416-790-0103||Kyle.Kirkham@uhn.ca|
|Contact: Regina Fraser, M.Sc||416-603-5800 ext email@example.com|
|Toronto Western Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Kyle Kirkham, M.D 416-790-0103 firstname.lastname@example.org|
|Contact: Regina Fraser, M.Sc 416-603-5800 ext 5216 email@example.com|
|Sub-Investigator: Duminda Wijeysundera, M.D|
|Sub-Investigator: Sacha Bhatia, M.D.|
|Principal Investigator:||Kyle Kirkham, M.D.||University Health Network, Toronto|