Clinical trial NCT05526495: Reducing Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery
Official title: Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Anesthesiology
Keywords: Electrocardiographs
Preoperative testing
Chest X-rays
Low Risk Surgical Procedures
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-09-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible hospitals (cluster) within the 26-100th centile for routine preoperative tests will be parallel randomized into two study arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: The study intervention will target hospitals, anesthesiologists, surgeons, pre-admission clinic nurses, and administrative staff.

Cluster (Hospital) Level Inclusion Criterion:

1. Hospitals in Ontario, Canada
2. within the 26-100th centile for routine preoperative tests for 2019

The study will recruit anesthesiologist and surgeons taking care of patients that meet the following criterion:

Patient Level Inclusion Criterion:

1. ≥18 age
2. undergoing low risk surgeries such as:

   * endoscopy
   * ophthalmologic surgery
   * knee arthroscopy
   * hernia repair

Exclusion Criteria:

* emergency elective chest X-rays and/or electrocardiogram

Primary outcomes:
measure: Pre-operative testing
timeFrame: within 60 days before surgery
Secondary outcomes:
measure: Overnight admission
timeFrame: within 24 hours from the date of surgery
measure: Re-operation events
timeFrame: within 24 hours
measure: All-cause mortality
timeFrame: 30-day from the date of surgery
measure: Preoperative tests
timeFrame: 6 months
measure: Mechanistic sub-study
timeFrame: 6 months
measure: Economic Evaluation
timeFrame: 6 months
measure: Fidelity evaluation
timeFrame: 1 month
Other outcomes:
Locations:
city: Muskoka
country: Canada
facility: Muskoka Algonquin Healthcare
state: Onario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: London
country: Canada
facility: St.Joseph'S Health Care
state: Ontario
city: Stratford
country: Canada
facility: Stratford General Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Jeremy Grimshaw, PhD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesia, Toronto Western Hospital, University of Toronto
name: Kyle Kirkham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kirkham 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.
citation: Patey 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.