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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in Canada

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.

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 groups in NCT03610152
Study groupRoleWhat they receive
ControlNo interventionHospitals made aware of Choosing Wisely Canada recommendations and Health Quality Ontario data.
Hospital wide policyExperimentalA 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.

  1. 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)
  1. Overnight admissions

    Hospital rates of overnight admissions

    Measured: 12-months

  2. Re-operation in 24-hours

    Hospital rates of re-operation in 24 hours

    Measured: 12-months

  3. All-cause mortality from the date of surgery

    Hospital rates of 30-day all-cause mortality from the date of surgery

    Measured: 12-months

  4. 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.

  1. First posted1 Aug 2018
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

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)
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

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.

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