Reducing Low-Value Preoperative Investigations in Patients Undergoing Low Risk Surgery (Pre-Op)

October 31, 2023 updated by: Jeremy Grimshaw, Ottawa Hospital Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alfonso Ortiz, MSc
  • Phone Number: 613-929-8423
  • Email: lortiz@ohri.ca

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: De-implementation

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.
Behavioral: Reducing 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
No Intervention: Comparator
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 60 days before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overnight admission
Time Frame: within 24 hours from the date of surgery
proportions of patients with overnight admission
within 24 hours from the date of surgery
Re-operation events
Time Frame: within 24 hours
rate of re-operation within 24 hours after primary surgery
within 24 hours
All-cause mortality
Time Frame: 30-day from the date of surgery
30-day all-cause mortality from the date of surgery
30-day from the date of surgery
Preoperative tests
Time Frame: 6 months
proportions of patients receiving each of the included preoperative investigations individually
6 months
Mechanistic sub-study
Time Frame: 6 months
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
6 months
Economic Evaluation
Time Frame: 6 months
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
6 months
Fidelity evaluation
Time Frame: 1 month
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).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Director: Jeremy Grimshaw, PhD, Ottawa Hospital Research Institute
  • Principal Investigator: Kyle Kirkham, MD, Department of Anaesthesia, Toronto Western Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Reducing Low-Value Pre-Op

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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