Pediatric Guideline Adherence and Outcomes- Argentina (PEGASUS)

Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Other: PEGASUS Program for Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina
    • Hospital de La Santisima Trinidad
  • Mendoza, Argentina
    • Hospital Humberto Notti
  • Salta, Argentina
    • Hospital Público Materno Infantil
  • Santa Fe, Argentina
    • Hospital Alassia
  • Santiago Del Estero, Argentina
    • Centro Provincial de Salud Infantil Eva Peron
  • Buenos Aires
    • Florencio Varela, Buenos Aires, Argentina
      • Hospital El Cruce
    • La Plata, Buenos Aires, Argentina
      • Hospital Sor Ludovica
    • Mar Del Plata, Buenos Aires, Argentina
      • Hospital Interzonal Especializado Materno Infantil
    • San Justo, Buenos Aires, Argentina
      • Hospital Municipal del Nino de San Justo
  • Catamarca
    • San Fernando Del Valle De Catamarca, Catamarca, Argentina
      • Hospital de Ninos Eva Peron
  • Jujuy
    • San Salvador De Jujuy, Jujuy, Argentina
      • Hospital Materno Infantil Dr. Hector Quintana
  • Santa Fe
    • Reconquista, Santa Fe, Argentina
      • Hospital Regional Reconquista
    • Rosario, Santa Fe, Argentina
      • Hopital Victor J. Vilela
  • Tucuman
    • San Miguel De Tucumán, Tucuman, Argentina
      • Hospital del Niño Jesús
• Chile
  • Valparaíso, Chile
    • Hospital Carlos Van Buren
• Paraguay
  • Asuncion, Paraguay
    • Hospital de Trauma Manuel Giagni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mechanism or head CT consistent with TBI
• <18 years old
• Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated

Exclusion Criteria:

- none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care, then Usual Care (Control); All sites will collect usual care data during the baseline and post-randomization study periods. This arm (half of the sites) will maintain usual care. They will receive the opportunity for the PEGASUS program training (intervention) at the end of study.
Experimental: Usual Care, then PEGASUS Program (Intervention); All sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care.	Other: PEGASUS Program for Care; This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall	Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention).	ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pathway Adoption	This outcome will be measured as yes/no for each participant at intervention sites to assess intervention delivery. In essence, the intervention started (use of PEGASUS program clinical pathway) within 24 hours of their eligibility and enrollment. Due to our intention-to-treat analysis plan, participants who enrolled after randomization but before intervention implementation at intervention sites are included in the analysis. Although they could not have implemented the intervention, sites were aware of their allocation status and were preparing and training during this interval.	Started within 24 hours of patient eligibility (at admission or deterioration)
Glasgow Outcome Scale (GOS) Score at Discharge	Participants' GOS score at hospital discharge from medical record: Death-1 (worse) Vegetative State-2 Severe Disability-3 Moderate Disability-4 Good Recovery-5 (better) The timing varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.	Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Discharge Survival	Number of survivors at intervention and control sites (descriptive and not powered for this outcome).	Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)	We will examine participants' recovery using GOSE-Peds scores. These were assessed by site study staff either in-person, by telephone, or from medical record approximately 3 months after the admission date. Death-8 (worse) Vegetative State-7 Severe Disability lower-6 Severe Disability upper-5 Moderate Disability lower-4 Moderate Disability upper-3 Good Recovery lower-2 Good Recovery upper-1 (better)	3 months post-admission
Mortality, 3-Month	We will examine participants' mortality at 3 months post discharge	3 months post admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status	Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention). Here, we stratified by extracranial injury status (isolated TBI vs. TBI and ext	ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Washington State University; Children's National Research Institute; Centro de Informática e Investigación Clínica (CIIC)
• Investigators: Principal Investigator: Monica Vavilala, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; guideline adherence; implementation fidelity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: STUDY00005629; 1R01NS106560-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with Co-Investigators
• IPD Sharing Time Frame: Monthly as available
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No