NCT03896789

Pediatric Guideline Adherence and Outcomes- Argentina

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-09
• Primary completion: 2023-09-26
• Completion: 2023-12-31
• First posted: 2019-04-01
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

16 sites across 3 countries: Argentina, Chile, Paraguay