Reducing Unnecessary Care for Traumatic Injury

Overseen By Mélanie Bérubé, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Level IV centers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance care for people hospitalized after injury by reducing unnecessary medical tests and procedures. It focuses on helping hospitals adopt better practices to avoid low-value care, where treatments or tests don't provide enough benefit to justify their cost or potential harm. The trial compares a new approach involving detailed feedback and educational support (audit & feedback with educational outreach and facilitation) with the current standard practice of simple feedback in trauma centers. This research is particularly relevant for trauma centers in Québec that handle many injury cases. Participants include adult trauma centers in Québec, except those with low patient volume. As an unphased trial, this study offers a unique opportunity to improve healthcare practices in trauma centers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for reducing unnecessary care in traumatic injury?

Research has shown that audit and feedback methods are generally safe for patients. These methods help healthcare providers improve by identifying areas needing change. Studies have found that audit and feedback can reduce mistakes and enhance patient care, especially in trauma situations. The audit and feedback process itself poses no direct risk to patients. The goal is to improve healthcare by sharing information with medical teams. This approach is well-accepted because it focuses on enhancing healthcare providers' practices rather than involving patients in any risky procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to streamline the care process for traumatic injuries by reducing unnecessary procedures. The trial compares two approaches: a simple audit and feedback (A&F) model, which is standard in many trauma systems, and an enhanced model that incorporates educational outreach and facilitation. This enhanced model not only provides performance feedback but also includes educational materials, virtual meetings, and follow-up facilitation visits to guide healthcare teams in implementing changes. By focusing on education and strategic action planning, this approach hopes to improve adherence to high-value care, potentially leading to better patient outcomes and more efficient resource use.

What evidence suggests that this trial's interventions could be effective in reducing unnecessary care for traumatic injury?

This trial compares two approaches to improving trauma care. One arm receives "Audit & feedback with educational outreach and facilitation," which includes educational visits and support to enhance the feedback process. Research has shown that this combined approach helps medical teams follow best practices and reduce unnecessary tests and procedures. Evidence suggests it could be cost-effective, saving money while improving care quality. The other arm receives "Simple audit & feedback," which has shown some success in previous studies, but adding educational elements may lead to better results. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult trauma centers in Québec's Trauma Care Continuum, specifically levels I-III. It aims to improve care for patients hospitalized with injuries by reducing unnecessary medical procedures. Level IV centers are excluded due to low patient volumes.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the multifaceted intervention including audit & feedback, educational materials, and virtual facilitation visits

6 months

2 virtual facilitation visits

Follow-up

Participants are monitored for the effectiveness of the intervention in reducing low-value care practices

18 months

Evaluation

Evaluation of primary and secondary outcomes including low-value imaging and specialist consultations

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Audit & feedback with educational outreach and facilitation
• Simple audit & feedback (usual practice)

Trial Overview The study tests two approaches to reduce low-value clinical practices: usual practice with simple audit & feedback versus enhanced audit & feedback combined with educational outreach and facilitation. The goal is to see which method better reduces unnecessary tests and treatments.

How Is the Trial Designed?

Group I: Simple audit & feedback Experimental Treatment 1 Intervention

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.

Group II: Audit & feedback with educational outreach and facilitation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Trauma Association of Canada

Collaborator

Trials

1

Recruited

30+

Health Standards Organisation

Collaborator

Trials

1

Recruited

30+

Audit & Feedback Metalab

Collaborator

Trials

1

Recruited

30+

Institut national de la pertinence des actes médicaux

Collaborator

Trials

1

Recruited

30+

Institut national en santé et services sociaux

Collaborator

Trials

1

Recruited

30+

Choosing Wisely Canada

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study of 3,807 surgical patients over 22 months, 30.9% experienced adverse events, with 6.9% of admissions linked to errors, highlighting a significant incidence of complications in surgical care.

Implementing continuous data collection on adverse events led to a reduction in error rates from 11.1% to 4.5%, demonstrating that systematic monitoring can enhance patient safety and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. Rebasa, P., Mora, L., Luna, A., et al.[2022]

The Trigger Tool (TT) identified 89.9% of adverse events (AEs) in patients undergoing general surgery, compared to only 28.48% detected by the Minimum Basic Data Set (MBDS), highlighting TT's superior effectiveness in AE detection.

The study found a high prevalence of AEs at 36.8% among surgical patients, indicating that the risk of complications in general surgery may be greater than previously estimated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. Pérez Zapata, AI., Gutiérrez Samaniego, M., Rodríguez Cuéllar, E., et al.[2018]

A systematic review of 140 studies found that audit and feedback can lead to a small but significant increase (4.3%) in healthcare professionals' compliance with desired practices, particularly when baseline performance is low.

The effectiveness of audit and feedback is enhanced when it is delivered multiple times, by a supervisor or colleague, and includes both verbal and written formats along with clear targets and action plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audit and feedback: effects on professional practice and healthcare outcomes. Ivers, N., Jamtvedt, G., Flottorp, S., et al.[2022]

In a study involving 40 internal medicine teams, intensive audit and feedback methods, including daily data dashboards and weekly performance reviews, significantly improved the completion of discharge metrics (79.3% vs. 63.2% in the control group, P<0.0001).

The effectiveness of the intensive feedback diminished after the intervention ended, indicating that continuous and timely feedback is crucial for maintaining improved performance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial. Patel, S., Rajkomar, A., Harrison, JD., et al.[2019]

The intervention at University College London Hospitals, which included in-situ coaching and observational audits, successfully educated theatre teams on the Five Steps to Safer Surgery, leading to improved safety practices.

There was a 68% increase in near miss reporting and a reduction in surgical harm incidents, indicating that the intervention effectively enhanced behavioral reliability and overall surgical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an integrated in-situ coaching, observational audit, and story-telling intervention to support safe surgery. Carthey, J., McCormack, K., Coombes, J., et al.[2018]

In a study of 1047 patients at a large teaching hospital, 17.7% experienced serious adverse events, with longer hospital stays increasing the likelihood of such events by about 6% for each additional day.

The majority of adverse events were linked to individual errors (37.8%) or interactive causes (15.6%), highlighting the need for healthcare providers to focus on these areas for proactive error prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative strategy for studying adverse events in medical care. Andrews, LB., Stocking, C., Krizek, T., et al.[2022]

In a study involving 1241 participants from five UK National Clinical Audits, no single feedback modification independently improved clinicians' intention to enact audit standards, indicating that the effectiveness of audit feedback may depend on how different modifications interact rather than on individual features alone.

The research revealed that certain combinations of feedback modifications, such as using multimodal feedback, recommending specific actions, and incorporating the patient voice, could significantly enhance the intention to follow audit standards, highlighting the importance of thoughtful design in feedback interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised fractional factorial screening experiment to predict effective features of audit and feedback. Wright-Hughes, A., Willis, TA., Wilson, S., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-wounds-and-injuries-5-2023-df038

Reducing Unnecessary Care for Traumatic Injury What data supports the effectiveness of this treatment? Research shows that audit and feedback can improve trauma care by identifying areas for improvement, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38632593

Implementation of an audit and feedback module targeting ... A&F module targeting LVPs is associated with higher costs and higher effectiveness than status quo and has the potential to be cost-effective.

3. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-023-01279-y

Evaluating the effectiveness of a multifaceted intervention to ... While simple Audit & Feedback (A&F) has shown modest effectiveness in reducing low-value care, there is a knowledge gap on the effectiveness ...

4. researchgate.net researchgate.net/publication/358431620_The_Feedback_Form_and_Its_Role_in_Improving_the_Quality_of_Trauma_Care

The Feedback Form and Its Role in Improving the Quality ... The purpose of the study was to evaluate the effect of feedback on the quality of trauma care. Methods: Retrospective cohort study comprising ...

5. injuryjournal.com injuryjournal.com/article/S0020-1383(24)00179-7/abstract

Effect of trauma quality improvement initiatives on ... This review summarizes the available evidence based on the type of QI interventions and outcomes studied (patient, process, provider, costs).

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK549284/

Audit and Feedback as a Quality Strategy - NCBI - NIH Audit and feedback is a strategy that intends to encourage professionals to change their clinical practice. An audit is a systematic review of professional ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002961024002642

Review Article Enhancing patient safety in trauma ... This study aimed to investigate adverse events (AEs) in trauma resuscitation, evaluate contributing factors, and assess methods, such as trauma video review ( ...

8. americanjournalofsurgery.com americanjournalofsurgery.com/article/S0002-9610(24)00264-2/pdf

Enhancing patient safety in trauma Objectives: This study aimed to investigate adverse events (AEs) in trauma resuscitation, evaluate contributing factors, and assess methods, such as trauma ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7286246/

The impact of trauma systems on patient outcomes - PMC Beyond the clinical care continuum, a trauma system also prioritizes outreach, education and advocacy, data collection through registries ...