SurgeryPre-OpNCT05526495
Reducing Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery
A study testing Reducing preoperative low-value test ordering in people with Surgery and Anesthesiology, run by Ottawa Hospital Research Institute at 4 sites in Canada.
Trial summary
The purpose of this study is to evaluate if a multi-component behavioral intervention given to anesthesiologists and surgeons is associated with decreasing low value preoperative testing orders in patients undergoing low risk surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Anesthesiology
- What is being tested?
- Reducing preoperative low-value test ordering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jan 2024to 31 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- emergency elective chest X-rays and/or electrocardiogram
Trial locations and contacts
4 sites in 1 country.
Andrea Patey, PhD contact
Canada4 sites, 4 recruiting
- Recruiting
Grand River Hospital
Kitchener, Ontario
Magid Morgan, M.D, magidmorgan@yahoo.com
- Recruiting
St.Joseph'S Health Care
London, Ontario
Hussein Sadkhan, MD, Hussein.Sadkhan@lhsc.on.ca
- Recruiting
Muskoka Algonquin Healthcare
Muskoka, Onario
Lisa Allen, RN, lisa.allen@mahc.ca
Hector Roldan, MD, hectorroldan@cogeco.ca
- Recruiting
Stratford General Hospital
Stratford, Ontario
SHANKAR MANICKAVASAGAM, M.D, shankar.manickavasagam@hpha.ca
LAURIE ROBERTS, RC, laurie.roberts@hpha.ca
About this study
Official title: Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery?
The purpose of this study is to evaluate if a multi-component behavioral intervention given to anesthesiologists and surgeons is associated with decreasing low value preoperative testing orders in patients undergoing low risk surgery.
The objectives of this trial are to evaluate a) the overall rate of low-value preoperative test (electrocardiogram and chest X-ray) in patients undergoing low risk surgery, b) to conduct an economic and c) process evaluation of the implementation The investigators will assess these outcomes in a sample of 22 Hospitals in Ontario, Canada.
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.
Within Canada, provincial governments have made reducing low-value care a priority. Choosing Wisely Canada (CWC) is a professionally led campaign that rallies medical professionals to address the issue of low-value care. The CWC makes declarative statements about low-value cares that should be avoided in practice across a broad range of specialties. To date, over 70 Canadian medical specialty societies have developed over 350 recommendations pertaining to unnecessary tests, treatments, and procedures.
Successful de-implementation of low value care require key actors (patients, healthcare providers, managers and policymakers) to change their behaviours and/or decisions while working in complex healthcare environments. Interventions to translate evidence into practice can be effective with the application of behavioural approaches. Behavioural sciences have informed methods for identifying factors that explain and influence behaviour, selecting techniques to address the barriers, and reporting behaviour change interventions. These approaches have yet to be explicitly applied in a systematic and theory-based manner to inform interventions for reducing low-value care.
To address this gap, Grimshaw and colleagues developed the Choosing Wisely De-Implementation Framework (CWDIF), a systematic process framework that uses tools from behavioural science to guide the design, evaluation, and scalability of interventions to reduce low-value care. The CWDIF consists of five phases: Phase 0, identification of potential areas of low-value healthcare; Phase 1, identification of local priorities for implementation of CWC recommendations (i.e., de-implementing low-value care); Phase 2, identification of barriers to implementing CWC recommendations and potential interventions to overcome these; Phase 3, rigorous evaluations of CWC implementation programmes; and Phase 4, spread of effective CWC implementation programmes.
In Canada, CWC provides a list of items that are considered low-value care for each medical specialty and provincial CWC campaigns have prioritized the items that are relevant to each province (Phase 0). The Canadian Anesthesiologists Society made 3 CWC recommendations against routine pre-operative tests prior to low risk surgery. In 2015, CWC and Health Quality Ontario co-hosted a stakeholder event of 60 key health system leaders in Ontario who identified low value preoperative testing, such as electrocardiographs and chest X-rays prior to low risk surgery as a key priority (Phase 1). Having identified the local priorities, it is important to identify determinants (barriers and enablers) of the particular low-value care that can be address by intervention (Phase 2). A theory-based qualitative study with Ontario anesthesiologists and surgeons used the Theoretical Domains Framework to understand individual, socio-cultural, and environmental factors that influence behaviour in specific contexts. 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 the primary focus for ordering of tests and strengthens accountability within hospitals.
The next phase of the framework requires the evaluation of the theory-informed intervention (Phase 3).This study is a cluster randomized controlled trial in 22 hospitals in Ontario, Canada to determine if preoperative testing ordered by anesthesiologist and supported by a focused implementation strategy can decrease the use of low-value preoperative tests in patients undergoing low risk surgeries.
- Conditions
- Surgery, Anesthesiology
- Being tested
- Reducing preoperative low-value test ordering
- Keywords
- Electrocardiographs, Preoperative testing, Chest X-rays, Low Risk Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing preoperative low-value test orderingBehavioural
A multi-component approach will be used:1) An administrative change will be implemented whereby medically necessary preoperative tests for patients undergoing non-urgent surgery will be ordered at the discretion of an anesthesiologist based on their clinical assessment. Adoption of the policy change will be facilitated by a local champion using an engagement and education program for anesthesiologists, surgeons, pre-admission clinic nurses and administrative staff; 2) The workshop program will include rationale for the policy, discussion of perceived local barriers to implementation and mitigation strategies. A train-the-trainer model will be used; 3) The departments will commit to supporting the change in policy. Nurses within preoperative clinic will be coached to feel comfortable calling the anesthesiologist about any pre-op tests ordered, and the Pre-Admission Unit will have the authority to cancel tests that deem unnecessary. Check boxes will be removed from medical order forms
| Study group | Role | What they receive |
|---|---|---|
| De-implementation | Experimental | A multi-behaviour technique will be used along with theoretical domains framework.
Clinicians will be provided with continuing multi-behaviour component intervention to increase accountability for preoperative test ordering in patients having low risk surgeries. Receives: Behavioral: Reducing preoperative low-value test ordering |
| Comparator | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative testing
Proportion of patients receiving one or more low-value preoperative tests within 60 days before surgery
Measured: within 60 days before surgery
Secondary outcomes (7)
Overnight admission
proportions of patients with overnight admission
Measured: within 24 hours from the date of surgery
Re-operation events
rate of re-operation within 24 hours after primary surgery
Measured: within 24 hours
All-cause mortality
30-day all-cause mortality from the date of surgery
Measured: 30-day from the date of surgery
Preoperative tests
proportions of patients receiving each of the included preoperative investigations individually
Measured: 6 months
Mechanistic sub-study
We will test whether changes in healthcare providers' behaviour are mediated through changes in hypothesized mechanisms using bootstrapped multiple mediation models controlling for hospital clustering and baseline response
Measured: 6 months
Economic Evaluation
We will compare the total costs of the intervention to the total costs of the control group. Results will be presented as an incremental cost per one preoperative test avoided. The monetary cost will be estimated using micro-costing technique by measuring monetary costs associated with perioperative assessment, hospital admissions and re-operations will be derived from ICES databases, and patient out-of-pocket costs and time missed from work because of attending pre-op tests such as chest x-rays and echocardiographs
Measured: 6 months
Fidelity evaluation
In the intervention arm only we will conduct a fidelity check-intervention checklist to assess: low; medium; high risk, with a semi-structured interview with physicians in the intervention arm. De-identified interviews will be analyzed by two independent researchers using the content analysis. A descriptive analysis will be used to summarize all data and a fidelity score will be calculated from a 7 point Likert scale (1:strongly agree; 7: strongly disagree).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Model description
- Eligible hospitals (cluster) within the 26-100th centile for routine preoperative tests will be parallel randomized into two study arms.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jeremy Grimshaw, Ottawa Hospital Research Institute
- Investigators
- Jeremy Grimshaw, PhD, Study director, Ottawa Hospital Research InstituteKyle Kirkham, MD, Principal investigator, Department of Anaesthesia, Toronto Western Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526495
- Sponsor's protocol ID
- Reducing Low-Value Pre-Op
- Acronym
- Pre-Op
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available at the moment. Aggregated cluster level data may be share upon reasonable request once the study has been published.
Publications
Grimshaw JM, Patey AM, Kirkham KR, Hall A, Dowling SK, Rodondi N, Ellen M, Kool T, van Dulmen SA, Kerr EA, Linklater S, Levinson W, Bhatia RS. De-implementing wisely: developing the evidence base to reduce low-value care. BMJ Qual Saf. 2020 May;29(5):409-417. doi: 10.1136/bmjqs-2019-010060. Epub 2020 Feb 6.
PubMed 32029572Kirkham KR, Wijeysundera DN, Pendrith C, Ng R, Tu JV, Laupacis A, Schull MJ, Levinson W, Bhatia RS. Preoperative testing before low-risk surgical procedures. CMAJ. 2015 Aug 11;187(11):E349-E358. doi: 10.1503/cmaj.150174. Epub 2015 Jun 1.
PubMed 26032314Patey AM, Islam R, Francis JJ, Bryson GL, Grimshaw JM; Canada PRIME Plus Team. Anesthesiologists' and surgeons' perceptions about routine pre-operative testing in low-risk patients: application of the Theoretical Domains Framework (TDF) to identify factors that influence physicians' decisions to order pre-operative tests. Implement Sci. 2012 Jun 9;7:52. doi: 10.1186/1748-5908-7-52.
PubMed 22682612
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. 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 Low Risk Surgery?
- ClinicalTrials.gov ID
- NCT05526495
- Acronym / sponsor ID
- Pre-Op / Reducing Low-Value Pre-Op
- Conditions
- Surgery, Anesthesiology
- Keywords
- Electrocardiographs, Preoperative testing, Chest X-rays, Low Risk Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Sep 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.
The purpose of this study is to evaluate if a multi-component behavioral intervention given to anesthesiologists and surgeons is associated with decreasing low value preoperative testing orders in patients undergoing low risk surgery.
The objectives of this trial are to evaluate a) the overall rate of low-value preoperative test (electrocardiogram and chest X-ray) in patients undergoing low risk surgery, b) to conduct an economic and c) process evaluation of the implementation The investigators will assess these outcomes in a sample of 22 Hospitals in Ontario, Canada.
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.
Within Canada, provincial governments have made reducing low-value care a priority. Choosing Wisely Canada (CWC) is a professionally led campaign that rallies medical professionals to address the issue of low-value care. The CWC makes declarative statements about low-value cares that should be avoided in practice across a broad range of specialties. To date, over 70 Canadian medical specialty societies have developed over 350 recommendations pertaining to unnecessary tests, treatments, and procedures.
Successful de-implementation of low value care require key actors (patients, healthcare providers, managers and policymakers) to change their behaviours and/or decisions while working in complex healthcare environments. Interventions to translate evidence into practice can be effective with the application of behavioural approaches. Behavioural sciences have informed methods for identifying factors that explain and influence behaviour, selecting techniques to address the barriers, and reporting behaviour change interventions. These approaches have yet to be explicitly applied in a systematic and theory-based manner to inform interventions for reducing low-value care.
To address this gap, Grimshaw and colleagues developed the Choosing Wisely De-Implementation Framework (CWDIF), a systematic process framework that uses tools from behavioural science to guide the design, evaluation, and scalability of interventions to reduce low-value care. The CWDIF consists of five phases: Phase 0, identification of potential areas of low-value healthcare; Phase 1, identification of local priorities for implementation of CWC recommendations (i.e., de-implementing low-value care); Phase 2, identification of barriers to implementing CWC recommendations and potential interventions to overcome these; Phase 3, rigorous evaluations of CWC implementation programmes; and Phase 4, spread of effective CWC implementation programmes.
In Canada, CWC provides a list of items that are considered low-value care for each medical specialty and provincial CWC campaigns have prioritized the items that are relevant to each province (Phase 0). The Canadian Anesthesiologists Society made 3 CWC recommendations against routine pre-operative tests prior to low risk surgery. In 2015, CWC and Health Quality Ontario co-hosted a stakeholder event of 60 key health system leaders in Ontario who identified low value preoperative testing, such as electrocardiographs and chest X-rays prior to low risk surgery as a key priority (Phase 1). Having identified the local priorities, it is important to identify determinants (barriers and enablers) of the particular low-value care that can be address by intervention (Phase 2). A theory-based qualitative study with Ontario anesthesiologists and surgeons used the Theoretical Domains Framework to understand individual, socio-cultural, and environmental factors that influence behaviour in specific contexts. 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 the primary focus for ordering of tests and strengthens accountability within hospitals.
The next phase of the framework requires the evaluation of the theory-informed intervention (Phase 3).This study is a cluster randomized controlled trial in 22 hospitals in Ontario, Canada to determine if preoperative testing ordered by anesthesiologist and supported by a focused implementation strategy can decrease the use of low-value preoperative tests in patients undergoing low risk surgeries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible hospitals (cluster) within the 26-100th centile for routine preoperative tests will be parallel randomized into two study arms.
| Arm | Type | Receives |
|---|---|---|
| De-implementation | Experimental | Behavioral: Reducing preoperative low-value test orderingA multi-behaviour technique will be used along with theoretical domains framework. Clinicians will be provided with continuing multi-behaviour component intervention to increase accountability for preoperative test ordering in patients having low risk surgeries. |
| Comparator | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- emergency elective chest X-rays and/or electrocardiogram
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 |
|---|---|---|
| Reducing preoperative low-value test orderingA multi-component approach will be used:1) An administrative change will be implemented whereby medically necessary preoperative tests for patients undergoing non-urgent surgery will be ordered at the discretion of an anesthesiologist based on their clinical assessment. Adoption of the policy change will be facilitated by a local champion using an engagement and education program for anesthesiologists, surgeons, pre-admission clinic nurses and administrative staff; 2) The workshop program will include rationale for the policy, discussion of perceived local barriers to implementation and mitigation strategies. A train-the-trainer model will be used; 3) The departments will commit to supporting the change in policy. Nurses within preoperative clinic will be coached to feel comfortable calling the anesthesiologist about any pre-op tests ordered, and the Pre-Admission Unit will have the authority to cancel tests that deem unnecessary. Check boxes will be removed from medical order forms | Behavioural | De-implementation |
Primary outcome
Pre-operative testing
Time frame: within 60 days before surgery
Proportion of patients receiving one or more low-value preoperative tests within 60 days before surgery
7 secondary outcomes
Overnight admission
Time frame: within 24 hours from the date of surgery
Re-operation events
Time frame: within 24 hours
All-cause mortality
Time frame: 30-day from the date of surgery
Preoperative tests
Time frame: 6 months
Mechanistic sub-study
Time frame: 6 months
Economic Evaluation
Time frame: 6 months
Fidelity evaluation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 32029572Grimshaw JM, Patey AM, Kirkham KR, Hall A, Dowling SK, Rodondi N, Ellen M, Kool T, van Dulmen SA, Kerr EA, Linklater S, Levinson W, Bhatia RS. De-implementing wisely: developing the evidence base to reduce low-value care. BMJ Qual Saf. 2020 May;29(5):409-417. doi: 10.1136/bmjqs-2019-010060. Epub 2020 Feb 6.
- Background: PubMed 26032314Kirkham KR, Wijeysundera DN, Pendrith C, Ng R, Tu JV, Laupacis A, Schull MJ, Levinson W, Bhatia RS. Preoperative testing before low-risk surgical procedures. CMAJ. 2015 Aug 11;187(11):E349-E358. doi: 10.1503/cmaj.150174. Epub 2015 Jun 1.
- Background: PubMed 22682612Patey AM, Islam R, Francis JJ, Bryson GL, Grimshaw JM; Canada PRIME Plus Team. Anesthesiologists' and surgeons' perceptions about routine pre-operative testing in low-risk patients: application of the Theoretical Domains Framework (TDF) to identify factors that influence physicians' decisions to order pre-operative tests. Implement Sci. 2012 Jun 9;7:52. doi: 10.1186/1748-5908-7-52.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available at the moment. Aggregated cluster level data may be share upon reasonable request once the study has been published.
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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.
Andrea Patey, PhD contact
Jeremy Grimshaw, PhD study director
Ottawa Hospital Research Institute
Kyle Kirkham, MD principal investigator
Department of Anaesthesia, Toronto Western Hospital, University of Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing preoperative low-value test ordering in people with Surgery and Anesthesiology, run by Ottawa Hospital Research Institute at 4 sites 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 0 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Alfonso Ortiz, MSc (613-929-8423, lortiz@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative testing (time frame: within 60 days before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526495, which also lists 3 linked publications.
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 1 Nov 2023.