Pediatric Guideline Adherence and Outcomes- Argentina

Last updated: January 8, 2025
Sponsor: University of Washington
Overall Status: Completed

Phase

N/A

Condition

Neurologic Disorders

Treatment

PEGASUS Program for Care

Clinical Study ID

NCT03896789
STUDY00005629
1R01NS106560-01A1
  • Ages < 17
  • All Genders

Study Summary

Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Mechanism or head CT consistent with TBI

  • <18 years old

  • Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motorGCS≤5 if intubated

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 505
Treatment Group(s): 1
Primary Treatment: PEGASUS Program for Care
Phase:
Study Start date:
September 09, 2019
Estimated Completion Date:
December 31, 2023

Study Description

Specific Aim 1: Determine the relationship between PEGASUS program implementation and TBI guideline adherence (Aim 1a), and assess system, provider, patient, implementation and guideline factors associated with TBI guideline adherence (Aim 1b). Hypothesis: Centers that receive the PEGASUS program have higher TBI guideline adherence (main outcome), as well as better discharge survival and 3-month Glasgow Outcome Scale-Extended (GOSE) score (secondary outcomes) than centers who receive usual care.

Specific Aim 2: Create a value stream map (VSM) to identify value-added processes of care associated with TBI guideline adherence. Hypothesis: ICU activity flows of TBI care during the first 72 hours will reveal value-added as well as non-value-added processes in severe TBI care. PEGASUS program implementation will result in more value-added TBI care processes and better TBI guideline adherence.

Specific Aim 3: Use computer simulation to develop and disseminate a real-world best practices blueprint for TBI guideline adherence. Hypothesis: This model will identify the impact of the PEGASUS program on key performance indicators (KPIs), outcomes (Aim 1), and process activities (Aim 2). Iterative computer simulations will then demonstrate the relationship among PEGASUS program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in TBI care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines.

Connect with a study center

  • Hospital el Cruce

    Florencio Varela, Buenos Aires
    Argentina

    Site Not Available

  • Hospital el Cruce

    Florencio Varela, Buenos Aires
    Argentina

    Site Not Available

  • Hospital Sor Ludovica

    La Plata, Buenos Aires
    Argentina

    Site Not Available

  • Hospital Interzonal Especializado Materno Infantil

    Mar Del Plata, Buenos Aires
    Argentina

    Site Not Available

  • Hospital Municipal del Nino de San Justo

    San Justo, Buenos Aires
    Argentina

    Site Not Available

  • Hospital de Ninos Eva Peron

    San Fernando Del Valle De Catamarca, Catamarca
    Argentina

    Site Not Available

  • Hospital Materno Infantil Dr. Hector Quintana

    San Salvador De Jujuy, Jujuy
    Argentina

    Site Not Available

  • Hospital Regional Reconquista

    Reconquista, Santa Fe
    Argentina

    Site Not Available

  • Hopital Victor J. Vilela

    Rosario, Santa Fe
    Argentina

    Site Not Available

  • Hospital del Nino Jesus

    San Miguel De Tucumán, Tucuman
    Argentina

    Site Not Available

  • Hospital de La Santisima Trinidad

    Cordoba,
    Argentina

    Site Not Available

  • Hospital Humberto Notti

    Mendoza,
    Argentina

    Site Not Available

  • Hospital Publico Materno Infantil

    Salta,
    Argentina

    Site Not Available

  • Hospital Alassia

    Santa Fe,
    Argentina

    Site Not Available

  • Centro Provincial de Salud Infantil Eva Peron

    Santiago Del Estero,
    Argentina

    Site Not Available

  • Hospital Carlos Van Buren

    Valparaíso,
    Chile

    Site Not Available

  • Hospital de Trauma Manuel Giagni

    Asuncion,
    Paraguay

    Site Not Available

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