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Completed

NCT Number: NCT03896789

Pediatric Guideline Adherence and Outcomes- Argentina

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.

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sor Ludovica, La Plata, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEGASUS Program for Care

Other

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.

Primary outcomes

  1. First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall

    Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

    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).

Secondary outcomes

  1. Clinical Pathway Adoption

    Time frame: Started within 24 hours of patient eligibility (at admission or deterioration)

    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.

  2. Glasgow Outcome Scale (GOS) Score at Discharge

    Time frame: 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.

    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.

  3. Discharge Survival

    Time frame: 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.

    Number of survivors at intervention and control sites (descriptive and not powered for this outcome).

  4. Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)

    Time frame: 3 months post-admission

    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)

  5. Mortality, 3-Month

    Time frame: 3 months post admission

    We will examine participants' mortality at 3 months post discharge

Other outcomes

  1. Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status

    Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

    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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Centro de Informática e Investigación Clínica (CIIC)
  • Children's National Research Institute
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Washington State University

Registry information

Official study title

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

Acronym: PEGASUS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2019
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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