Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05566327 |
| Other study ID # |
22-1173 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
September 2022 |
| Source |
University of Calgary |
| Contact |
Yamile Jasaui |
| Phone |
403-210-7074 |
| Email |
yjasauic[@]ucalgary.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Low value preoperative testing does not improve patient outcomes or reduce adverse events.
Low value preoperative testing costs patients and healthcare systems without benefit. In a
previous study, the investigators identified the systems-level and individual-level drivers
of low value preoperative testing.
In this study, the investigators will use these drivers of low value testing to design and
implement a bundled intervention to reduce low value preoperative testing in Alberta, Canada.
The investigators will measure the impact of this intervention on the number of low value
tests, adverse events (ICU admissions, length of stay, 30-day readmissions), and patient
costs. The investigators will also interview healthcare providers on their experiences with
the intervention.
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. Choosing Wisely Canada (CWC) is
a professionally led campaign that rallies medical professional to address the issue of low
value care. For example, the CWC anaesthesiology recommendations produced by the Canadian
Anaesthesiologists' Society recommends against baseline ordering of pre-operative tests.
Whilst the identification of potential areas of low-value care is an important first step in
addressing this problem, the issue of implementing Choosing Wisely (CW) like recommendations
has not received adequate attention
In the investigators previous study based on the Theoretical Domains Framework (TDF)
(REB18-1097), they identified the factors that influence test ordering before low-risk
surgical procedures. 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
primarily responsible for ordering of tests and strengthens accountability within hospitals.
The next phase involves evaluating the theory-informed intervention.
The investigators will conduct a cluster randomized controlled trial in 20 hospitals in
Alberta, Canada to evaluate whether the theory-based intervention to improve accountability
can decrease the use of low-value tests before non-urgent surgery in otherwise healthy
patients
Objectives The overall aim of this trial is to evaluate whether a theory-based intervention
that addresses barriers and facilitators of persistent low value test ordering reduces
low-value preoperative test (ECGs and CXRs) in patients undergoing low risk surgery.
The specific objectives are to:
1. Evaluate whether the intervention leads to a decrease in low-value preoperative test
ordering compared to the control arm (standard of care).
2. Conduct a process evaluation to determine whether the intervention is delivered as
designed (fidelity); to determine whether any changes in low-value preoperative test
ordering are mediated through changes to the perceived barriers/enablers (mechanism of
action); and to understand healthcare workers and patients experiences of the
intervention.
3. Evaluate whether the intervention offers good value for money from the perspective of
Canada's publicly funded health care system.
METHODS This pragmatic parallel arm cluster randomized controlled trial with pre- and
post-intervention measurements will be conducted in hospitals that perform preoperative
assessments (preadmission clinics, PACs) in Alberta, Canada. The intervention will be
delivered to anaesthesiologists, surgeons, internists, pre-admission clinic nurses, and
administrative staff responsible for the care for patients who are over 18 years of age and
undergoing low-risk surgical procedures, defined as procedures with less than 1% mortality or
cardiac events, including but not limited to endoscopy, ophthalmologic surgery, knee
arthroscopy, hernia repair.
OBJECTIVE 1 Interventions Eligible hospitals will be randomly allocated to the intervention
(multi-component intervention) and control arm (standard of care).
Intervention description The intervention will focus on increasing accountability for
preoperative test ordering to reduce the number of inappropriate tests ordered for patients
having ambulatory surgeries. A multi-component approach will be used to address the
accountability of who should order preoperative tests for patients undergoing ambulatory
surgery.
- Changing PAC and Hospital Policies
- Identification of a Local Champion
- Delivering an Education Workshop
- Restructuring Patient Flow and Responsibility
OBJECTIVE 2 The investigators will conduct a mixed-methods theory-based process evaluation
alongside the trial. The evaluation will be performed through mechanistic sub-study (to
determine whether our interventions activated the hypothesized mediating pathways and if so,
was this sufficient to lead to implementation) and fidelity evaluation (to understand
participants' experiences of being in a trial, and to determine whether the content of
interventions was delivered as designed).
OBJECTIVE 3 The investigators will conduct a cost-effectiveness analysis from the perspective
of Alberta Health. The total costs will include the costs of the intervention and observed
harms associated with preoperative assessment (hospital admissions and re-operations).
