The PIONEER Comparative Effectiveness Study - Project 2

Conditions

• Head Injury Trauma
• Traumatic Brain Injury, Mild

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clinical pathway 1: Guidelines plus biomarkers — DIAGNOSTIC_TEST
  Patients will be managed using an algorithm that integrates the Canadian Head CT Rule (CHCR) with iSTAT whole-blood GFAP and UCH-L1 testing. Patients who meet CHCR criteria for CT imaging and those whose CT imaging decision-making is not covered by CHCR (e.g., no loss of consciousness or amnesia) will receive iSTAT testing. Sites will be assigned to one of three implementation waves, with two sites transitioning to the Guidelines + Biomarkers phase every six months. Prior to their assigned transition, sites will continue to use guidelines alone. Once a site transitions to the Guidelines + Biomarkers phase, the integrated biomarker-guided algorithm will become the standard-of-care protocol at that site for eligible patients and will remain the standard of care for the remainder of the study.
• Clinical guidelines only — DIAGNOSTIC_TEST
  During the baseline phase, sites will rely solely on established clinical guidelines to guide brain CT utilization in patients with suspected TBI. Specifically, providers will apply the Canadian CT Head Rule, a validated decision instrument that identifies patients at high risk for clinically important brain injury who require CT imaging. All sites will begin in this Guidelines-Only baseline phase and will continue using this approach until their assigned transition to the Guidelines + Biomarkers phase. Sites will transition in three waves, with two sites transitioning every six months.

Study Details

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.

Key Dates

First listed

Sep 18, 2026

Start date

Oct 1, 2026

Status verified

Sep 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

3,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Clinical Pathway 2: Clinical Guidelines Only
  Clinical Guidelines Only (Canadian Head CT Decision Rule)
• Experimental: Clinical Pathway 1: Guidelines + Biomarkers
  Canadian Head CT Decision Rule plus whole blood Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) measurement using the iSTAT.

Primary Outcome Measure

The proportion of eligible Emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging. [ Time Frame: Initial Emergency room visit (approximately 24 hours) ]

Central Contacts

• Devon Newman, MS
  734-652-9679
  [email protected]

Locations (6)

Find similar trials in Sylmar, CA

Related Studies

• Screening Emotions in Adolescents at the Hospital for mTBI
  Recruiting · University of California, Davis · Sacramento, California
• Osteopathic Manipulative Treatment RCT and Computational Modeling for Head Injuries in Mixed Martial Artists
  Recruiting · New York Institute of Technology · Greenvale, New York