Pediatric Guideline Adherence and Outcomes- Argentina (PEGASUS)

University of Washington

Status: Completed

Conditions: TBI (Traumatic Brain Injury)

Treatments: Other: PEGASUS Program for Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03896789

STUDY00005629

1R01NS106560-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 505 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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505 participants in 2 patient groups

Usual Care, then Usual Care (Control)

No Intervention group

Description:

All sites will collect usual care data during the baseline and post-randomization study periods. 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.

Usual Care, then PEGASUS Program (Intervention)

Experimental group

Description:

All sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care.

Treatment:

Other: PEGASUS Program for Care