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

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment?

Research shows that audit and feedback can improve trauma care by identifying areas for improvement, leading to reduced preventable deaths and complications. For example, in some U.S. regions, the preventable death rate after injury decreased significantly after implementing audit processes. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles do not provide specific safety data for the treatment 'Reducing Unnecessary Care for Traumatic Injury' or its related interventions. They focus on monitoring adverse events and improving surgical safety, but do not directly address the safety of the treatment in question. ^{6 7 8 9 10}

How does this treatment for traumatic injury differ from other treatments?

This treatment is unique because it focuses on reducing unnecessary care through a multifaceted intervention, which includes quality improvement teams and performance-linked accreditation, rather than relying solely on traditional medical interventions. It aims to de-implement low-value clinical practices in trauma care, which is different from standard treatments that primarily focus on direct medical interventions. ^{2 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Trauma audit and quality improvement. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A randomised fractional factorial screening experiment to predict effective features of audit and feedback. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

['Clinical auditing', a novel tool for quality assessment in surgical oncology]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Audit and feedback: effects on professional practice and healthcare outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Implementing an integrated in-situ coaching, observational audit, and story-telling intervention to support safe surgery. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Trauma registry data validation: Essential for quality trauma care. [2022]

10. England pubmed.ncbi.nlm.nih.gov

An alternative strategy for studying adverse events in medical care. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a multifaceted intervention to reduce low-value care in adults hospitalized following trauma: a protocol for a pragmatic cluster randomized controlled trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Outcomes and costs of blunt trauma in England and Wales. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Quality improvement data analysis of a mass casualty event. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

A trauma outreach program provided by a level I trauma center is an effective way to initiate peer review at referring hospitals and foster process improvements. [2019]