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The PIONEER Comparative Effectiveness Study - Project 2

14. september 2026 opdateret af: Frederick Korley, MD, PhD, University of Michigan

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Sylmar, California, Forenede Stater, 91342
        • UCLA-Olive View Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Breena Taira, MD, MPH
      • Torrance, California, Forenede Stater, 90502
        • Harbor-UCLA Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Kabir Yadav, MD, MS, MHSH
    • Michigan
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Henry Ford Macomb (HFM)
        • Kontakt:
        • Ledende efterforsker:
          • Joseph Miller, MD, MS
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital (HFH)
        • Kontakt:
        • Ledende efterforsker:
          • Joseph Miller, MD, MS
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University (OHSU)
        • Kontakt:
        • Ledende efterforsker:
          • Bory Kea, MD, MCR
      • Portland, Oregon, Forenede Stater, 97216
        • Adventist Health Portland (AHP)
        • Kontakt:
        • Ledende efterforsker:
          • Bory Kea, MD, MCR

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Clinical Pathway 2: Clinical Guidelines Only
Clinical Guidelines Only (Canadian Head CT Decision Rule)
Diagnostisk test: Clinical guidelines only
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.
Eksperimentel: 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.
Diagnostisk test: Clinical pathway 1: Guidelines plus biomarkers
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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of eligible ED patients with suspected TBI who receive brain CT imaging and have a clinically significant traumatic lesion.
Tidsramme: Initial Emergency room visit (approximately 24 hours)
Initial Emergency room visit (approximately 24 hours)
Incidence of clinically significant missed traumatic intracranial injury diagnosed within 7 days of the index ED visit
Tidsramme: Within 7 days of the index/initial ED visit
Within 7 days of the index/initial ED visit
Incidence of Neurosurgical interventions within 7 days of the index ED visit, without a new traumatic event.
Tidsramme: Within 7 days of the index/initial ED visit
Within 7 days of the index/initial ED visit
ED length of stay
Tidsramme: Initial Emergency room visit (approximately 24 hours)
This will be measured in minutes.
Initial Emergency room visit (approximately 24 hours)
Initial and sustained provider adherence at 6 and 24 months post-implementation
Tidsramme: 6 and 24 months post-implementation
6 and 24 months post-implementation
Provider acceptability and feedback
Tidsramme: During implementation phase (months 9-32)
Providers will answer 17 questions regarding the implementation of the biomarker guided algorithm and acceptability. Information from this will be summarized.
During implementation phase (months 9-32)
Provider trust in biomarker-guided CT decision making as measured by the proportion of biomarker-negative patients who don't get a CT
Tidsramme: During implementation phase (months 9-32)
During implementation phase (months 9-32)
30-day ED revisits and hospitalizations
Tidsramme: 30 days following Initial Emergency room visit
30 days following Initial Emergency room visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

United States Department of Defense

Efterforskere

  • Ledende efterforsker: Frederick Korley, MD, PhD, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

14. september 2026

Først indsendt, der opfyldte QC-kriterier

14. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00278426
  • HT942524TBIPHRPFPA (Anden identifikator: Department of Defense)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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