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.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-04-01
• Study Start: 2019-09-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

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

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Exclusion Criteria

• none

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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
TBI guideline adherence	ICU Stay, approximately up to 2 weeks	The main outcome will be measured as the sum of indicators to which care was adhered by the number of relevant adherence indicators for a given patient during ICU stay.

Secondary Outcome Measures

Name	Time	Method
GOSE-Peds. Pediatric Version of the Glasgow Outcome Scale-Extended	3 months post discharge	We will examine participants' Pediatrics Glasgow Outcome Scale-Extended (GOSE-Peds).; GOS-E PEDS Score: 8-Death 7- Vegetative State (VS) 6- Lower Severe Disability (Lower SD) 5- Upper Severe Disability (Upper SD) 4- Lowe Moderate Disability (Lower MD) 3- Upper Moderate Disability (Upper MD) 2- Lower Good Recovery (Lower GR); 1-Upper Good Recovery (Upper GR); -Higher scores represent an increasing level of disability.
Mortality	3 months post discharge	We will examine participants' mortality at 3 months post discharge
Clinical Pathway Adoption	within 24 hours of patient admission	This outcome will be measured as yes/no for each eligible patient at intervention centers.
Discharge Survival	At Hospital Discharge, approximately up to 5 weeks	We will examine the number of survivors between intervention and control centers (descriptive and not powered for this outcome).
DIBQ (Determinants of Implementation Behaviors Scale)	Baseline, and quarterly during year 1 after randomization; then once annually through study completion, approximately 3 years, for intervention sites.	This questionnaire measures the constructs found in the TDF (Theoretical Domain Framework). We will use the short version with 41 items.
Value added processes assessed by Organizational Questionnaire for Participant Hospitals	Baseline and annually through study completion, approximately 3 years	We will ask participant sites to answer a Hospital, Unit and Medical Staff Information, Quality of Care, Medication and Culture of Safety questionnaire developed by Monica S. Vavilala, Bryan Weiner and Silvia Lujan for this study.
Changes in patient outcomes from time in - to time out- of the system based on manipulations of KPIs	during ICU care, approximately up to 2 weeks	We will examine the behavior of TBI care processes. We will evaluate the effect of interventions on key guideline indicators, adherence to Guidelines, and GOSE-Peds (described in out come 4). Inputs from parameter estimates from the regression models (Aim 1) and inputs from VSMs (Aim 2) will be used to develop computer simulation models using commercially available discrete event modeling and simulation software (e.g., SIMIO®, Simio LLC, Sewickley, PA). Parameter estimates from the regression models will then be used to model the distribution of the 15 indicators from the Pediatric Guidelines that are already integrated in the process flow. This provides a way to observe changes in patient outcomes from time-in to time-out of the system based on manipulations of KPIs. Each KPI will be initially "weighted" based on the parameter estimates obtained from the regression models.

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