Pediatric Guideline Adherence and Outcomes- Argentina

Not Applicable

Completed

Conditions: TBI (Traumatic Brain Injury)

Interventions: Other: PEGASUS Program for Care

Registration Number: NCT03896789

Lead Sponsor: University of Washington

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 505

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEGASUS Program (Intervention)	PEGASUS Program for Care	This arm (half of the sites) will receive the PEGASUS program (intervention) from 21 months to 57 months.

Primary Outcome Measures

Name	Time	Method
First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall	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 Outcome Measures

Name	Time	Method
Clinical Pathway Adoption	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.
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.	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.
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.	Number of survivors at intervention and control sites (descriptive and not powered for this outcome).
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)	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)
Mortality, 3-Month	3 months post admission	We will examine participants' mortality at 3 months post discharge

Trial Locations

Locations (16): Hospital Sor Ludovica
🇦🇷
La Plata, Buenos Aires, Argentina
Hospital el Cruce
🇦🇷
Florencio Varela, Buenos Aires, Argentina
Hospital Interzonal Especializado Materno Infantil
🇦🇷
Mar Del Plata, Buenos Aires, Argentina
Hospital Municipal del Nino de San Justo
🇦🇷
San Justo, Buenos Aires, Argentina
Hospital Regional Reconquista
🇦🇷
Reconquista, Santa Fe, Argentina
Hospital del Nino Jesus
🇦🇷
San Miguel De Tucumán, Tucuman, Argentina
Hospital Humberto Notti
🇦🇷
Mendoza, Argentina
Hospital de La Santisima Trinidad
🇦🇷
Cordoba, Argentina
Hospital Publico Materno Infantil
🇦🇷
Salta, Argentina
Centro Provincial de Salud Infantil Eva Peron
🇦🇷
Santiago Del Estero, Argentina
Hospital Carlos Van Buren
🇨🇱
Valparaíso, Chile
Hospital de Trauma Manuel Giagni
🇵🇾
Asuncion, Paraguay
Hopital Victor J. Vilela
🇦🇷
Rosario, Santa Fe, Argentina
Hospital Materno Infantil Dr. Hector Quintana
🇦🇷
San Salvador De Jujuy, Jujuy, Argentina
Hospital de Ninos Eva Peron
🇦🇷
San Fernando Del Valle De Catamarca, Catamarca, Argentina
Hospital Alassia
🇦🇷
Santa Fe, Argentina