Pediatric Guideline Adherence and Outcomes- Argentina

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Other: PEGASUS Program for Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel cluster RCT following a baseline data collection period when all sites are in the 'control/usual care state'.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>All sites will collect usual care data from 9 months to 21 months. | |
| Experimental: PEGASUS Program (Intervention)<br>This arm (half of the sites) will receive the PEGASUS program (intervention) from 21 months to 57 months. | Other: PEGASUS Program for Care<br>* 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.<br>|
| No Intervention: Usual Care (Control)<br>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 data collection (57 months) period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pathway Adoption | This outcome will be measured as yes/no for each eligible patient at intervention centers. | within 24 hours of patient admission | 
| 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 | 
| 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 | 
| Mortality | We will examine participants' mortality at 3 months post discharge | 3 months post discharge | 
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guideline adherence, implementation fidelity