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The PIONEER Comparative Effectiveness Study - Project 2

a study on Head Injury Trauma Brain Injury Concussion Traumatic Brain Injury

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Breena Taira, MD, MPH (ucla)Kabir Yadav, MD, MS, MHSH (ucla)
Headshot of Kabir Yadav
Kabir Yadav

Description

Summary

This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.

Official Title

Comparing the Effectiveness of a Biomarker-plus-clinical Guidelines Algorithm Versus Clinical Guidelines Only for Safely Decreasing Brain Computed Tomography Utilization During Brain Injury Evaluations: The PIONEER Comparative Effectiveness Study

Keywords

Head Injury Trauma, Traumatic Brain Injury, Mild, Emergency department, Struck by or against an object, traumatic brain injury, TBI, CT imaging, head CT, brain CT, biomarkers, clinical decision rule, implementation study, gfap, UCH-L1, glial fibrillary acidic protein, Ubiquitin Carboxy-terminal hydrolase L1, Brain Concussion, Emergencies, Traumatic Brain Injuries, Clinical pathway 1: Guidelines plus biomarkers, Clinical guidelines only

Eligibility

For people ages 18 years and up

Inclusion

  • Age ≥18 years at the time of the emergency department visit.
  • Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury/head trauma/head strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury.
  • Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration/deceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury.
  • Glasgow Coma Scale (GCS) score of 13-15 at presentation.
  • Presentation to the emergency department within 24 hours of injury.

Exclusion Criteria:

  • Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative.
  • Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban [Eliquis], rivaroxaban [Xarelto]), Clopidogrel, Ticagrelor.
  • Presentation >24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.

Locations

  • UCLA-Olive View Medical Center
    Sylmar California 91342 United States
  • Harbor-UCLA Medical Center
    Torrance California 90502 United States

Lead Scientists at University of California Health

  • Breena Taira, MD, MPH (ucla)
    Professor Of Clinical, Emergency Medicine, Medicine. Authored (or co-authored) 78 research publications
  • Kabir Yadav, MD, MS, MHSH (ucla)
    Kabir Yadav, MDCM, MS, MSHS, FACEP, is the Vice Chair for Research & Academic Affairs and Professor of Emergency Medicine at Harbor-UCLA Medical Center. He completed emergency medicine residency at Kings County Hospital Center/ SUNY Downstate Medical Center, followed by a clinical research fellowship at Jacobi Medical Center with a Masters in Clinical Research Methods.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT07829107
Study Type
Interventional
Participants
Expecting 3000 study participants
Last Updated