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Reducing Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery

Does a Theory-Based Intervention to Improve Accountability Reduce Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05526495
Acronym
Pre-Op
Enrollment
22
Registered
2022-09-02
Start date
2024-01-01
Completion date
2025-03-31
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesiology, Surgery

Keywords

Electrocardiographs, Preoperative testing, Chest X-rays, Low Risk Surgical Procedures

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.

Interventions

BEHAVIORALReducing preoperative low-value test ordering

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

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Eligible hospitals (cluster) within the 26-100th centile for routine preoperative tests will be parallel randomized into two study arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Pre-operative testingwithin 60 days before surgeryProportion of patients receiving one or more low-value preoperative tests within 60 days before surgery

Secondary

MeasureTime frameDescription
Re-operation eventswithin 24 hoursrate of re-operation within 24 hours after primary surgery
All-cause mortality30-day from the date of surgery30-day all-cause mortality from the date of surgery
Preoperative tests6 monthsproportions of patients receiving each of the included preoperative investigations individually
Overnight admissionwithin 24 hours from the date of surgeryproportions of patients with overnight admission
Economic Evaluation6 monthsWe 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
Fidelity evaluation1 monthIn 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).
Mechanistic sub-study6 monthsWe 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

Countries

Canada

Contacts

Primary ContactAlfonso Ortiz, MSc
lortiz@ohri.ca613-929-8423
Backup ContactAndrea Patey, PhD
apatey@ohri.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026