An interventional study of Audit & feedback with educational outreach and facilitation and Simple audit & feedback (usual practice) in Trauma Injury, sponsored by Laval University. Not yet recruiting at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Laval University · Not applicable, Interventional, and Health services research
In Canada, injury leads to more potential years of life lost and to greater costs than heart and stroke diseases combined. Furthermore, more than 50% of patients hospitalised following injury do not receive optimal care, 20% of injury deaths are estimated to be preventable, and significant variations in injury mortality and morbidity have been observed across trauma centers in Canada, the United Kingdom, Australia and the United States. Over the past decades, emphasis on adherence to evidence-based processes of care (rewards for doing more) and rapid innovation in imaging and therapeutic techniques has led to an exponential rise in unnecessary tests and procedures. Whole body computed tomography scan for single-system trauma is just one example. Low-value clinical practices, defined as "the common use of a particular intervention when the benefits don't justify the potential harm or cost" consume up to 30% of healthcare budgets. They expose patients to physical and psychological adverse events and put enormous pressure on healthcare budgets, thereby threatening accessible, universal health care. The objective of this research project is to evaluate the effectiveness of an intervention targeting reductions in low-value clinical practices for injury admissions. The results of this study should directly lead to improvements in the health systems across Canada and elsewhere. Medium and long-term advantages include an increase in healthcare efficiency and effectiveness, a reduction in costs, an increase in the availability of resources for patients who need them and a reduction in adverse events for patients hospitalized following injury.
RATIONALE: While simple Audit \& Feedback (A\&F) has shown modest effectiveness for reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Given the need to make rapid decisions in a context of multiple diagnostic and therapeutic options, trauma is a high-risk setting for low-value care. Furthermore, trauma systems are a favorable setting for de-implementation interventions as they have quality improvement teams with medical leadership, routinely collected clinical data, and performance linked to accreditation.
OBJECTIVES: We aim to evaluate the effectiveness of a multifaceted intervention for reducing low-value clinical practices in acute adult trauma care.
METHODS: We will conduct a pragmatic cluster randomized controlled trial. Level I-III trauma centers in an inclusive Canadian trauma system (n=29) will be randomized (1:1) to receive simple A\&F (control) or a multifaceted intervention (intervention). The multifaceted intervention, developed using extensive background work and United Kingdom Medical Research Council guidelines for the Development of Complex Interventions, includes an A\&F report, educational materials, virtual educational meetings, and virtual facilitation visits. The primary outcome will be patient-level use of low-value initial diagnostic imaging, assessed using routinely collected trauma registry data. Secondary outcomes will be low-value specialist consultation, low-value repeat imaging for transfers, unintended consequences, and Incremental Cost-Effectiveness Ratios.
IMPACT: This innovative, timely research project will advance knowledge on the incremental effectiveness of a multifaceted intervention over simple A\&F to de-implement low-value care. The intervention has a high probability of success because it targets a problem identified by stakeholders, is based on extensive background work, is low-cost, and is linked to accreditation. This intervention has the potential to reduce the adverse effects and indirect expenses of low-value trauma care for patients and families. It could also free up resources, reduce delays to care, and decrease healthcare professionals' workload, at a time of unprecedented strain on healthcare resources.
57 studies on the registry are indexed under Accidental Injuries; 30 are open to participants now.
This study's planned enrollment of 29 is below the median of 122 across 36 interventional studies indexed under Accidental Injuries.
Browse Accidental Injuries studies →Laval University is the lead sponsor of 380 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: All adult level I-III trauma centers in the Trauma Care Continuum of the province of Québec -
Exclusion Criteria: Level IV centers (patient volume too low)
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The intervention includes: 1) refinement with end users, 2) an A\&F report sent to local governing authorities presenting for each practice: performance compared to peers (simple A\&F), a summary message indicating if action is required and a list of potential actions, 3) educational materials (a clinical vignette; consequences of the practice; links to practice guidelines, clinical decision rules and shared decision-making tools; a case review tool), 4) virtual educational meetings with the local trauma Medical Director, trauma program manager and data analyst, and 5) two virtual facilitation visits 2 and 4 months after the transmission of the report to support committees in preparing their action plan.
Behavioral: Audit & feedback with educational outreach and facilitation
The control arm will receive the quality improvement intervention currently in place in the Québec Trauma Care Continuum (i.e. simple A\&F report presenting their performance compared to peers on quality indicators measuring adherence to high-value care and risk-adjusted outcomes) with the addition of quality indicators on low-value care (already planned by provincial authorities for the 2023 evaluation cycle). Simple A\&F was chosen for the control because it is standard practice in Québec and in most integrated trauma systems and the effectiveness of A\&F for de-implementation has been documented.
Behavioral: Simple audit & feedback (usual practice)
As in arm descriptions
As in arm descriptions
Low-value initial diagnostic imaging
Proportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department
Time frame: 18-month interval (6 to 24 months) after implementation
Low-value specialist consultation
Proportion of low-risk patients who receive neurosurgical or spine surgery consultation
Time frame: 18-month interval (6 to 24 months) after implementation
Pre-transfer imaging
Proportion of patients with a clear indication to transfer who receive imaging in referral center
Time frame: 18-month interval (6 to 24 months) after implementation
Repeat post-transfer imaging
Proportion of patients with imaging in referral center with no disease progression who are re-imaged in receiving center following transfer
Time frame: 18-month interval (6 to 24 months) after implementation
Mortality
Proportion of patients admitted who die in hospital
Time frame: 18-month interval (6 to 24 months) after implementation
Unplanned readmission
Proportion of patients discharged alive with an unplanned readmission within 30 days of discharge
Time frame: 18-month interval (6 to 24 months) after implementation
Missed injuries
Proportion of patients admitted for whom an injury was missed in the emergency department and later detected as an inpatient
Time frame: 18-month interval (6 to 24 months) after implementation
Hospital stay
Mean hospital length of stay in days for all hospital admissions
Time frame: 18-month interval (6 to 24 months) after implementation
Intensive care unit stay
Mean intensive care unit stay in days for all patients admitted to the intensive care unit
Time frame: 18-month interval (6 to 24 months) after implementation
Complications
Proportion of patients admitted with an event of deep vein thrombosis/pulmonary embolism, decubitus ulcers, delirium, pneumonia, or urinary tract infection during their in-patient stay
Time frame: 18-month interval (6 to 24 months) after implementation
Incremental Cost-Effectiveness Ratios
Economic evaluation
Time frame: 0 to 24 months after implementation
Plan to share: Yes — Individual patient data are held by provincial authorities and cannot be transmitted by study investigators. Supporting material will be made available through the study program website.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Six months after publication of all study results up to 10 years after study initiation
Access criteria: Supporting data will be made available on request. Patient-level data from the provincial trauma registry can be accessed on request through provincial authorities.
Start is estimated for Jun 2023; primary completion for Sep 2025, 27 months later.
Of 18 interventional studies with no phase under Accidental Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 59. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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