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Reducing Low-value Care for Trauma Admissions

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05744154
Enrollment
29
Registered
2023-02-24
Start date
2023-06-30
Completion date
2026-12-31
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma Injury

Keywords

Low-value care, Multifaceted intervention, De-implementation, Trauma system

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALAudit & feedback with educational outreach and facilitation

As in arm descriptions

BEHAVIORALSimple audit & feedback (usual practice)

As in arm descriptions

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Local trauma committees will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of the intervention. Data extractors and analysts will be blinded to group allocation. Due to the nature of the intervention, it will not be possible to blind the investigators to allocation groups.

Intervention model description

We will conduct a parallel arm, pragmatic cluster randomized trial (CRT) embedded in the provincial trauma quality assurance program. As the trial will be based on routinely collected data that are available at no extra cost, we will use a baseline observation period pre-randomization to increase study power. We will randomize at the hospital level because quality programs operate at the local trauma committee level in each hospital. A stepped wedge design will not be used as the minimum one-year roll-out period is unacceptably long for stakeholders and parallel arm CRTs have fewer risks of bias than stepped wedge CRTs. The trial is pragmatic as the intervention will be embedded in the 2023 evaluation cycle of the provincial quality assurance program.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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) \-

Design outcomes

Primary

MeasureTime frameDescription
Low-value initial diagnostic imaging18-month interval (6 to 24 months) after implementationProportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department

Secondary

MeasureTime frameDescription
Low-value specialist consultation18-month interval (6 to 24 months) after implementationProportion of low-risk patients who receive neurosurgical or spine surgery consultation
Pre-transfer imaging18-month interval (6 to 24 months) after implementationProportion of patients with a clear indication to transfer who receive imaging in referral center
Repeat post-transfer imaging18-month interval (6 to 24 months) after implementationProportion of patients with imaging in referral center with no disease progression who are re-imaged in receiving center following transfer

Other

MeasureTime frameDescription
Intensive care unit stay18-month interval (6 to 24 months) after implementationMean intensive care unit stay in days for all patients admitted to the intensive care unit
Mortality18-month interval (6 to 24 months) after implementationProportion of patients admitted who die in hospital
Incremental Cost-Effectiveness Ratios0 to 24 months after implementationEconomic evaluation
Complications18-month interval (6 to 24 months) after implementationProportion 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
Unplanned readmission18-month interval (6 to 24 months) after implementationProportion of patients discharged alive with an unplanned readmission within 30 days of discharge
Missed injuries18-month interval (6 to 24 months) after implementationProportion of patients admitted for whom an injury was missed in the emergency department and later detected as an inpatient
Hospital stay18-month interval (6 to 24 months) after implementationMean hospital length of stay in days for all hospital admissions

Countries

Canada

Contacts

Primary ContactLynne Moore, PhD
lynne.moore@fmed.ulaval.ca4186490252
Backup ContactMélanie Bérubé, PhD
melanie.berube@fsi.ulaval.ca4186490252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026