Surgery-ComplicationsNCT05566327
De-implementing Low Value Preoperative Care Wisely
A study testing De-implementation Bundle in people with Surgery-Complications and Anesthesia Complication, run by University of Calgary.
Trial summary
Low value preoperative testing does not improve patient outcomes or reduce adverse events. Low value preoperative testing costs patients and healthcare systems without benefit. In a previous study, the investigators identified the systems-level and individual-level drivers of low value preoperative testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery-Complications, Anesthesia Complication
- What is being tested?
- De-implementation Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jan 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low risk patient (no cancer, diabetes, or life-limiting disease)
- Undergoing a low-risk surgical procedure (a day surgery or any procedure with a less than 1% 30-day cardiac event or all-cause mortality)
- Adults
- Hospitals in the 26-100th centiles for low value preoperative test ordering
Who cannot join
- Has a life-limiting condition
- Pregnancy
- Younger than 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: De-implementing Wisely: Using a Theory-based De-implementation Intervention to Reduce Low-value Preoperative Testing in Alberta
Low value preoperative testing does not improve patient outcomes or reduce adverse events. Low value preoperative testing costs patients and healthcare systems without benefit. In a previous study, the investigators identified the systems-level and individual-level drivers of low value preoperative testing.
In this study, the investigators will use these drivers of low value testing to design and implement a bundled intervention to reduce low value preoperative testing in Alberta, Canada. The investigators will measure the impact of this intervention on the number of low value tests, adverse events (ICU admissions, length of stay, 30-day readmissions), and patient costs. The investigators will also interview healthcare providers on their experiences with the intervention.
Read the detailed description
Low-value care is 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. Choosing Wisely Canada (CWC) is a professionally led campaign that rallies medical professional to address the issue of low value care. For example, the CWC anaesthesiology recommendations produced by the Canadian Anaesthesiologists' Society recommends against baseline ordering of pre-operative tests.
Whilst the identification of potential areas of low-value care is an important first step in addressing this problem, the issue of implementing Choosing Wisely (CW) like recommendations has not received adequate attention
In the investigators previous study based on the Theoretical Domains Framework (TDF) (REB18-1097), they identified the factors that influence test ordering before low-risk surgical procedures. Barriers identified included conflict about who was responsible for the test-ordering (Social/professional role and identity), inability to cancel tests ordered by fellow physicians (Beliefs about capabilities and Social influences), and logistic problems with tests being completed before the anesthesiologists see the patient (Beliefs about capabilities and Environmental context and resources). There were also concerns that not testing might be associated with harms (Beliefs about Consequences). These findings led to the development of a theory-informed intervention that identifies anesthesiologists as primarily responsible for ordering of tests and strengthens accountability within hospitals. The next phase involves evaluating the theory-informed intervention.
The investigators will conduct a cluster randomized controlled trial in 20 hospitals in Alberta, Canada to evaluate whether the theory-based intervention to improve accountability can decrease the use of low-value tests before non-urgent surgery in otherwise healthy patients
Objectives The overall aim of this trial is to evaluate whether a theory-based intervention that addresses barriers and facilitators of persistent low value test ordering reduces low-value preoperative test (ECGs and CXRs) in patients undergoing low risk surgery.
The specific objectives are to:
- Evaluate whether the intervention leads to a decrease in low-value preoperative test ordering compared to the control arm (standard of care).
- Conduct a process evaluation to determine whether the intervention is delivered as designed (fidelity); to determine whether any changes in low-value preoperative test ordering are mediated through changes to the perceived barriers/enablers (mechanism of action); and to understand healthcare workers and patients experiences of the intervention.
- Evaluate whether the intervention offers good value for money from the perspective of Canada's publicly funded health care system.
METHODS This pragmatic parallel arm cluster randomized controlled trial with pre- and post-intervention measurements will be conducted in hospitals that perform preoperative assessments (preadmission clinics, PACs) in Alberta, Canada. The intervention will be delivered to anaesthesiologists, surgeons, internists, pre-admission clinic nurses, and administrative staff responsible for the care for patients who are over 18 years of age and undergoing low-risk surgical procedures, defined as procedures with less than 1% mortality or cardiac events, including but not limited to endoscopy, ophthalmologic surgery, knee arthroscopy, hernia repair.
OBJECTIVE 1 Interventions Eligible hospitals will be randomly allocated to the intervention (multi-component intervention) and control arm (standard of care).
Intervention description The intervention will focus on increasing accountability for preoperative test ordering to reduce the number of inappropriate tests ordered for patients having ambulatory surgeries. A multi-component approach will be used to address the accountability of who should order preoperative tests for patients undergoing ambulatory surgery.
- Changing PAC and Hospital Policies
- Identification of a Local Champion
- Delivering an Education Workshop
- Restructuring Patient Flow and Responsibility
OBJECTIVE 2 The investigators will conduct a mixed-methods theory-based process evaluation alongside the trial. The evaluation will be performed through mechanistic sub-study (to determine whether our interventions activated the hypothesized mediating pathways and if so, was this sufficient to lead to implementation) and fidelity evaluation (to understand participants' experiences of being in a trial, and to determine whether the content of interventions was delivered as designed).
OBJECTIVE 3 The investigators will conduct a cost-effectiveness analysis from the perspective of Alberta Health. The total costs will include the costs of the intervention and observed harms associated with preoperative assessment (hospital admissions and re-operations).
- Conditions
- Surgery-Complications, Anesthesia Complication
- Being tested
- De-implementation Bundle
- Keywords
- Low value preoperative testing, Choosing Wisely CAnada
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-implementation BundleBehavioural
A multicomponent intervention directed at the drivers of low value preoperative testing.
An administrative change will be implemented whereby medically necessary preoperative tests for patients undergoing scheduled surgery will be ordered at the discretion of a consulting anaesthesiologist only. Workshops will be delivered to surgical, internal medicine, and anaesthesia divisions. The workshop program will include rationale for the policy, discussion of perceived local barriers to implementation and mitigation strategies.The clinical departments will commit to supporting the change in policy. Nurses will be coached to feel comfortable calling the anesthesiologist about any preoperative tests ordered, and the PAC nurses will have the authority to cancel tests. Check boxes will be removed from surgeons' and family physicians' order forms to reduce to ease of ordering the tests.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Clinics in this arm will receive the usual information about low value preoperative testing. Staff at these hospitals may be aware of the Choosing Wisely Anaesthesia Guidelines for reducing unnecessary testing, the Ontario Anaesthesiology Toolkit to operationalize the Choosing Wisely guidelines. |
| Intervention Group | Active comparator | The intervention will focus on increasing accountability for preoperative test ordering to reduce the number of inappropriate tests ordered for patients having ambulatory surgeries. A multi-component approach will be used to address the accountability of who should order preoperative tests for patients undergoing ambulatory surgery. Receives: Behavioral: De-implementation Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low value preoperative testing
The proportion of patients undergoing one or more low value preoperative test (ECG, echocardiogram, chest x-ray or cardiac stress test) within 60-days of surgery
Measured: 1 year
Secondary outcomes (7)
Overnight admission
Proportion of patients who are admitted overnight to the hospital after low-risk surgery
Measured: 1 year
Re-operation
Proportion of patients who require a second procedure during their hospital admission
Measured: 1 year
ED Visits
Proportion of patients who represent to the emergency department within 30 days of their surgical discharge
Measured: 1 year
Readmissions
Proportion of patients who are readmitted to hospital within 30-days of their surgery
Measured: 1 year
ICU Admission
Proportion of patients who are admitted to an intensive care unit during their hospital admission
Measured: 1 year
Length of stay
The length of stay for the surgical admission
Measured: 1 year
Mortality
The proportion of patients who die from any cause within 30-days of their surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- 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
- Model description
- Randomized intervention trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, Ottawa Hospital Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566327
- Sponsor's protocol ID
- 22-1173
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-implementing Wisely: Using a Theory-based De-implementation Intervention to Reduce Low-value Preoperative Testing in Alberta
- ClinicalTrials.gov ID
- NCT05566327
- Acronym / sponsor ID
- 22-1173
- Conditions
- Surgery-Complications, Anesthesia Complication
- Keywords
- Low value preoperative testing, Choosing Wisely CAnada
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, Ottawa Hospital Research Institute
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 4 Oct 2022 (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.
Low value preoperative testing does not improve patient outcomes or reduce adverse events. Low value preoperative testing costs patients and healthcare systems without benefit. In a previous study, the investigators identified the systems-level and individual-level drivers of low value preoperative testing.
In this study, the investigators will use these drivers of low value testing to design and implement a bundled intervention to reduce low value preoperative testing in Alberta, Canada. The investigators will measure the impact of this intervention on the number of low value tests, adverse events (ICU admissions, length of stay, 30-day readmissions), and patient costs. The investigators will also interview healthcare providers on their experiences with the intervention.
Detailed description
Low-value care is 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. Choosing Wisely Canada (CWC) is a professionally led campaign that rallies medical professional to address the issue of low value care. For example, the CWC anaesthesiology recommendations produced by the Canadian Anaesthesiologists' Society recommends against baseline ordering of pre-operative tests.
Whilst the identification of potential areas of low-value care is an important first step in addressing this problem, the issue of implementing Choosing Wisely (CW) like recommendations has not received adequate attention
In the investigators previous study based on the Theoretical Domains Framework (TDF) (REB18-1097), they identified the factors that influence test ordering before low-risk surgical procedures. Barriers identified included conflict about who was responsible for the test-ordering (Social/professional role and identity), inability to cancel tests ordered by fellow physicians (Beliefs about capabilities and Social influences), and logistic problems with tests being completed before the anesthesiologists see the patient (Beliefs about capabilities and Environmental context and resources). There were also concerns that not testing might be associated with harms (Beliefs about Consequences). These findings led to the development of a theory-informed intervention that identifies anesthesiologists as primarily responsible for ordering of tests and strengthens accountability within hospitals. The next phase involves evaluating the theory-informed intervention.
The investigators will conduct a cluster randomized controlled trial in 20 hospitals in Alberta, Canada to evaluate whether the theory-based intervention to improve accountability can decrease the use of low-value tests before non-urgent surgery in otherwise healthy patients
Objectives The overall aim of this trial is to evaluate whether a theory-based intervention that addresses barriers and facilitators of persistent low value test ordering reduces low-value preoperative test (ECGs and CXRs) in patients undergoing low risk surgery.
The specific objectives are to:
- Evaluate whether the intervention leads to a decrease in low-value preoperative test ordering compared to the control arm (standard of care).
- Conduct a process evaluation to determine whether the intervention is delivered as designed (fidelity); to determine whether any changes in low-value preoperative test ordering are mediated through changes to the perceived barriers/enablers (mechanism of action); and to understand healthcare workers and patients experiences of the intervention.
- Evaluate whether the intervention offers good value for money from the perspective of Canada's publicly funded health care system.
METHODS This pragmatic parallel arm cluster randomized controlled trial with pre- and post-intervention measurements will be conducted in hospitals that perform preoperative assessments (preadmission clinics, PACs) in Alberta, Canada. The intervention will be delivered to anaesthesiologists, surgeons, internists, pre-admission clinic nurses, and administrative staff responsible for the care for patients who are over 18 years of age and undergoing low-risk surgical procedures, defined as procedures with less than 1% mortality or cardiac events, including but not limited to endoscopy, ophthalmologic surgery, knee arthroscopy, hernia repair.
OBJECTIVE 1 Interventions Eligible hospitals will be randomly allocated to the intervention (multi-component intervention) and control arm (standard of care).
Intervention description The intervention will focus on increasing accountability for preoperative test ordering to reduce the number of inappropriate tests ordered for patients having ambulatory surgeries. A multi-component approach will be used to address the accountability of who should order preoperative tests for patients undergoing ambulatory surgery.
- Changing PAC and Hospital Policies
- Identification of a Local Champion
- Delivering an Education Workshop
- Restructuring Patient Flow and Responsibility
OBJECTIVE 2 The investigators will conduct a mixed-methods theory-based process evaluation alongside the trial. The evaluation will be performed through mechanistic sub-study (to determine whether our interventions activated the hypothesized mediating pathways and if so, was this sufficient to lead to implementation) and fidelity evaluation (to understand participants' experiences of being in a trial, and to determine whether the content of interventions was delivered as designed).
OBJECTIVE 3 The investigators will conduct a cost-effectiveness analysis from the perspective of Alberta Health. The total costs will include the costs of the intervention and observed harms associated with preoperative assessment (hospital admissions and re-operations).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized intervention trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Clinics in this arm will receive the usual information about low value preoperative testing. Staff at these hospitals may be aware of the Choosing Wisely Anaesthesia Guidelines for reducing unnecessary testing, the Ontario Anaesthesiology Toolkit to operationalize the Choosing Wisely guidelines. |
| Intervention Group | Active comparator | Behavioral: De-implementation BundleThe intervention will focus on increasing accountability for preoperative test ordering to reduce the number of inappropriate tests ordered for patients having ambulatory surgeries. A multi-component approach will be used to address the accountability of who should order preoperative tests for patients undergoing ambulatory surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low risk patient (no cancer, diabetes, or life-limiting disease)
- Undergoing a low-risk surgical procedure (a day surgery or any procedure with a less than 1% 30-day cardiac event or all-cause mortality)
- Adults
- Hospitals in the 26-100th centiles for low value preoperative test ordering
Key exclusion criteria (3 listed)
- Has a life-limiting condition
- Pregnancy
- Younger than 18 years
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 |
|---|---|---|
| De-implementation BundleA multicomponent intervention directed at the drivers of low value preoperative testing. An administrative change will be implemented whereby medically necessary preoperative tests for patients undergoing scheduled surgery will be ordered at the discretion of a consulting anaesthesiologist only. Workshops will be delivered to surgical, internal medicine, and anaesthesia divisions. The workshop program will include rationale for the policy, discussion of perceived local barriers to implementation and mitigation strategies.The clinical departments will commit to supporting the change in policy. Nurses will be coached to feel comfortable calling the anesthesiologist about any preoperative tests ordered, and the PAC nurses will have the authority to cancel tests. Check boxes will be removed from surgeons' and family physicians' order forms to reduce to ease of ordering the tests. | Behavioural | Intervention Group |
Primary outcome
Low value preoperative testing
Time frame: 1 year
The proportion of patients undergoing one or more low value preoperative test (ECG, echocardiogram, chest x-ray or cardiac stress test) within 60-days of surgery
7 secondary outcomes
Overnight admission
Time frame: 1 year
Re-operation
Time frame: 1 year
ED Visits
Time frame: 1 year
Readmissions
Time frame: 1 year
ICU Admission
Time frame: 1 year
Length of stay
Time frame: 1 year
Mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided. To be determined
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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.
Questions about this trial
What is this clinical trial studying?
A study testing De-implementation Bundle in people with Surgery-Complications and Anesthesia Complication, run by University of Calgary.
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 4 inclusion and 3 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Yamile Jasaui (403-210-7074, yjasauic@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low value preoperative testing (time frame: 1 year). 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 10 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.