Low-value Pre-operative InvestigationsNCT03610152
Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Ambulatory Surgery
A study testing Hospital Policy change in people with Low-value Pre-operative Investigations, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The Institute of Medicine (IOM) suggests that up to 30% of healthcare is considered low-value, defined as 'a test or treatment for which there is no evidence of benefit to the patient or where there is evidence of more harm than benefit'. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low-value Pre-operative Investigations
- What is being tested?
- Hospital Policy change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitals in the 26th - 100th percentile for routine preoperative tests
Who cannot join
- Hospitals in the 0 - 25th percentile for routine preoperative tests
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Kyle Kirkham, M.D, 416-790-0103, kyle.kirkham@uhn.ca
Regina Fraser, M.Sc, 416-603-5800 ext. 5216, regina.fraser@uhnresearch.ca
About this study
The Institute of Medicine (IOM) suggests that up to 30% of healthcare is considered low-value, defined as 'a test or treatment for which there is no evidence of benefit to the patient or where there is evidence of more harm than benefit'. The investigators have previously found that more than 31% of Ontario patients, who go home the same day as their surgery, receive unnecessary cardiac testing and/or chest x-rays. In addition, the investigators identified an almost 30-fold variability in how tests are ordered between different hospitals. While identification of low-value care is an important first step, additional efforts are required to reduce this waste. The investigators previously explored the reasons behind low value test ordering through a qualitative study of surgeons and anesthesiologists. This work has informed the development of a theory-based intervention to reduce wasteful ordering. The proposed project will conduct a hospital level randomized controlled trial to determine if preoperative testing ordered by anesthesiologist and supported by a focused implementation strategy can decrease the use of low-value investigations before elective surgery where patients will go home the same day.
Read the 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.
- Conditions
- Low-value Pre-operative Investigations
- Being tested
- Hospital Policy change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Policy changeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Hospitals made aware of Choosing Wisely Canada recommendations and Health Quality Ontario data. |
| Hospital wide policy | Experimental | 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. Receives: Behavioral: Hospital Policy change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-value preoperative investigations received
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.
Measured: 12-months
Secondary outcomes (4)
Overnight admissions
Hospital rates of overnight admissions
Measured: 12-months
Re-operation in 24-hours
Hospital rates of re-operation in 24 hours
Measured: 12-months
All-cause mortality from the date of surgery
Hospital rates of 30-day all-cause mortality from the date of surgery
Measured: 12-months
Patients who receive ECG, EKG, Chest X-ray and Cardiac stress test
The proportion of patients receiving each of the above pre-operative tests individually
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Oct 2019 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-value Pre-operative InvestigationsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Kirkham, M.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610152
- Sponsor's protocol ID
- 17-5108
- Status last verified
- Jul 2019
- First submitted
- 23 May 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT03610152
- Acronym / sponsor ID
- 17-5108
- Conditions
- Low-value Pre-operative Investigations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Institute of Medicine (IOM) suggests that up to 30% of healthcare is considered low-value, defined as 'a test or treatment for which there is no evidence of benefit to the patient or where there is evidence of more harm than benefit'. The investigators have previously found that more than 31% of Ontario patients, who go home the same day as their surgery, receive unnecessary cardiac testing and/or chest x-rays. In addition, the investigators identified an almost 30-fold variability in how tests are ordered between different hospitals. While identification of low-value care is an important first step, additional efforts are required to reduce this waste. The investigators previously explored the reasons behind low value test ordering through a qualitative study of surgeons and anesthesiologists. This work has informed the development of a theory-based intervention to reduce wasteful ordering. The proposed project will conduct a hospital level randomized controlled trial to determine if preoperative testing ordered by anesthesiologist and supported by a focused implementation strategy can decrease the use of low-value investigations before elective surgery where patients will go home the same day.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Hospitals made aware of Choosing Wisely Canada recommendations and Health Quality Ontario data. |
| Hospital wide policy | Experimental | Behavioral: Hospital Policy changeA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitals in the 26th - 100th percentile for routine preoperative tests
Key exclusion criteria (1 listed)
- Hospitals in the 0 - 25th percentile for routine preoperative tests
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 |
|---|---|---|
| Hospital Policy changeImplementation 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. | Behavioural | Hospital wide policy |
Primary outcome
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.
4 secondary outcomes
Overnight admissions
Time frame: 12-months
Re-operation in 24-hours
Time frame: 12-months
All-cause mortality from the date of surgery
Time frame: 12-months
Patients who receive ECG, EKG, Chest X-ray and Cardiac stress test
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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.
Kyle Kirkham, M.D. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital Policy change in people with Low-value Pre-operative Investigations, run by University Health Network, Toronto 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 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyle Kirkham, M.D. (416-790-0103, Kyle.Kirkham@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-value preoperative investigations received (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.