Pediatric Guideline Adherence and Outcomes- Argentina

NCT03896789 | Completed Results

• 2 other identifiers: STUDY000056291R01NS106560-01A1
• Study Type: interventional
• Target: 505
• Locations: 3 countries
• Sites: 16

Brief 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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

guideline adherence; implementation fidelity; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical Pathway Adoption

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

• Glasgow Outcome Scale (GOS) Score at Discharge

  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

  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)

  3 months post-admission

• Mortality, 3-Month

  3 months post admission

Other Outcomes (1)

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

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

Study Arms (2)

Usual Care, then Usual Care (Control)

NO INTERVENTION

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.

Usual Care, then PEGASUS Program (Intervention)

EXPERIMENTAL

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

Interventions

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.

Usual Care, then PEGASUS Program (Intervention)

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- none

Sponsors & Collaborators

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

Study Sites (16)

Hospital Sor Ludovica

La Plata, Buenos Aires, Argentina

Location

Hospital Interzonal Especializado Materno Infantil

Mar del Plata, Buenos Aires, Argentina

Location

Hospital el Cruce

San Juan Bautista, Buenos Aires, Argentina

Location

Hospital Municipal del Nino de San Justo

San Justo, Buenos Aires, Argentina

Location

Hospital de Ninos Eva Peron

Catamarca, Catamarca Province, Argentina

Location

Hospital Materno Infantil Dr. Hector Quintana

San Salvador de Jujuy, Jujuy Province, Argentina

Location

Hospital Regional Reconquista

Reconquista, Santa Fe Province, Argentina

Location

Hopital Victor J. Vilela

Rosario, Santa Fe Province, Argentina

Location

Hospital del Nino Jesus

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Hospital de La Santisima Trinidad

Córdoba, Argentina

Location

Hospital Humberto Notti

Mendoza, Argentina

Location

Hospital Publico Materno Infantil

Salta, Argentina

Location

Hospital Alassia

Santa Fe, Argentina

Location

Centro Provincial de Salud Infantil Eva Peron

Santiago del Estero, Argentina

Location

Hospital Carlos Van Buren

Valparaíso, Chile

Location

Hospital de Trauma Manuel Giagni

Asunción, Paraguay

Location

Related Publications (1)

• Velonjara J, Mills B, Lujan S, Petroni G, Bell MJ, Guadagnoli N, Mock C, Hughes JP, Vavilala MS, Rowhani-Rahbar A; PEGASUS Argentina Study Group. The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial. Trials. 2022 Dec 5;23(1):980. doi: 10.1186/s13063-022-06938-x.

  PMID: 36471399 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Monica S. Vavilala
• Organization: University of Washington

vavilala@uw.edu

206-744-7235

Study Officials

• Monica Vavilala, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine: Anesthesiology and Pain Medicine

Model Details: Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: April 1, 2019
• Study Start: September 9, 2019
• Primary Completion: September 26, 2023
• Study Completion: December 31, 2023
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Monthly as available

Locations

PA (1); AR (14); CL (1)