Pediatric Guideline Adherence and Outcomes- Argentina

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03896789
• Other study ID #: STUDY00005629
• Secondary ID: 1R01NS106560-01A
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Mechanism or head CT consistent with TBI

• <18 years old

• GCS (Glasgow Coma Scale) score =8 at any point during hospital admission

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

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.

Locations

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

Sponsors (5)

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

Countries where clinical trial is conducted

Argentina,  Chile,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBI guideline adherence	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.	ICU Stay, approximately up to 2 weeks
Secondary	Clinical Pathway Adoption	This outcome will be measured as yes/no for each eligible patient at intervention centers.	within 24 hours of patient admission
Secondary	Discharge Survival	We will examine the number of survivors between intervention and control centers (descriptive and not powered for this outcome).	At Hospital Discharge, approximately up to 5 weeks
Secondary	GOSE-Peds. Pediatric Version of the Glasgow Outcome Scale-Extended	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.	3 months post discharge
Secondary	Mortality	We will examine participants' mortality at 3 months post discharge	3 months post discharge
Secondary	DIBQ (Determinants of Implementation Behaviors Scale)	This questionnaire measures the constructs found in the TDF (Theoretical Domain Framework). We will use the short version with 41 items.	Baseline, and quarterly during year 1 after randomization; then once annually through study completion, approximately 3 years, for intervention sites.
Secondary	Value added processes assessed by Organizational Questionnaire for Participant Hospitals	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.	Baseline and annually through study completion, approximately 3 years
Secondary	Changes in patient outcomes from time in - to time out- of the system based on manipulations of KPIs	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.	during ICU care, approximately up to 2 weeks