NCT05526495

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

August 5, 2022

Last Update Submit

October 31, 2023

Conditions

Keywords

ElectrocardiographsPreoperative testingChest X-raysLow Risk Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Pre-operative testing

    Proportion of patients receiving one or more low-value preoperative tests within 60 days before surgery

    within 60 days before surgery

Secondary Outcomes (7)

  • Overnight admission

    within 24 hours from the date of surgery

  • Re-operation events

    within 24 hours

  • All-cause mortality

    30-day from the date of surgery

  • Preoperative tests

    6 months

  • Mechanistic sub-study

    6 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Reducing preoperative low-value test ordering

Comparator

NO INTERVENTION

Standard of care

Interventions

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

De-implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • emergency elective chest X-rays and/or electrocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Muskoka Algonquin Healthcare

Muskoka, Onario, Canada

RECRUITING

Grand River Hospital

Kitchener, Ontario, Canada

RECRUITING

St.Joseph'S Health Care

London, Ontario, Canada

RECRUITING

Stratford General Hospital

Stratford, Ontario, Canada

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32029572BACKGROUND
  • 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.

    PMID: 26032314BACKGROUND
  • 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.

    PMID: 22682612BACKGROUND

Study Officials

  • Jeremy Grimshaw, PhD

    Ottawa Hospital Research Institute

    STUDY DIRECTOR
  • Kyle Kirkham, MD

    Department of Anaesthesia, Toronto Western Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Ortiz, MSc

CONTACT

Andrea Patey, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Eligible hospitals (cluster) within the 26-100th centile for routine preoperative tests will be parallel randomized into two study arms.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 5, 2022

First Posted

September 2, 2022

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 31, 2025

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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.

Locations