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NCT Number: NCT05744154

Reducing Low-value Care for Trauma Admissions

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.

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Key information

Conditions

Trauma Injury Accidental Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université Laval

Québec, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

-

Treatment and study plan

Audit & feedback with educational outreach and facilitation

Behavioral

As in arm descriptions

Simple audit & feedback (usual practice)

Behavioral

As in arm descriptions

Primary outcomes

  1. Low-value initial diagnostic imaging

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department

Secondary outcomes

  1. Low-value specialist consultation

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of low-risk patients who receive neurosurgical or spine surgery consultation

  2. Pre-transfer imaging

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of patients with a clear indication to transfer who receive imaging in referral center

  3. Repeat post-transfer imaging

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of patients with imaging in referral center with no disease progression who are re-imaged in receiving center following transfer

Other outcomes

  1. Mortality

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of patients admitted who die in hospital

  2. Unplanned readmission

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of patients discharged alive with an unplanned readmission within 30 days of discharge

  3. Missed injuries

    Time frame: 18-month interval (6 to 24 months) after implementation

    Proportion of patients admitted for whom an injury was missed in the emergency department and later detected as an inpatient

  4. Hospital stay

    Time frame: 18-month interval (6 to 24 months) after implementation

    Mean hospital length of stay in days for all hospital admissions

  5. Intensive care unit stay

    Time frame: 18-month interval (6 to 24 months) after implementation

    Mean intensive care unit stay in days for all patients admitted to the intensive care unit

  6. Complications

    Time frame: 18-month interval (6 to 24 months) after implementation

    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

  7. Incremental Cost-Effectiveness Ratios

    Time frame: 0 to 24 months after implementation

    Economic evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Lynne Moore, PhD

CONTACT

[email protected]

4186490252 ext. 63366

Mélanie Bérubé, PhD

CONTACT

[email protected]

4186490252 ext. 66600

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Audit & Feedback Metalab
  • Choosing Wisely Canada
  • Health Standards Organisation
  • Institut national de la pertinence des actes médicaux
  • Institut national en santé et services sociaux
  • Trauma Association of Canada

Registry information

Official study title

A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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