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Reducing Low-value Care for Trauma Admissions

Sponsor
Laval University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05744154
Collaborator
Institut national en santé et services sociaux (Other), Trauma Association of Canada (Other), Health Standards Organisation (Other), Choosing Wisely Canada (Other), Audit & Feedback Metalab (Other), Institut national de la pertinence des actes médicaux (Other)
29
Enrollment
1
Location
2
Arms
42
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Audit & feedback with educational outreach and facilitation
  • Behavioral: Simple audit & feedback (usual practice)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Triple (Participant, Care Provider, 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.
Primary Purpose:
Health Services Research
Official Title:
A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Audit & feedback with educational outreach and facilitation

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
As in arm descriptions
Other: Simple audit & feedback

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

Outcome Measures

Primary Outcome Measures

  1. Low-value initial diagnostic imaging [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 Outcome Measures

  1. Low-value specialist consultation [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 [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 [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 Outcome Measures

  1. Mortality [18-month interval (6 to 24 months) after implementation]

    Proportion of patients admitted who die in hospital

  2. Unplanned readmission [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 [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 [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 [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 [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 [0 to 24 months after implementation]

    Economic evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université Laval Québec Quebec Canada

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laval University
ClinicalTrials.gov Identifier:
NCT05744154
Other Study ID Numbers:
  • 113664
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 24, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laval University
Low-value care
Multifaceted intervention
De-implementation
Trauma system
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Feb 24, 2023