Results of the Pediatric Guideline Adherence and Outcomes (PEGASUS) Program Versus Usual Care Pragmatic Randomized Controlled Trial in Severe Traumatic Brain Injury

Objectives: High-quality approaches to increase evidence-based severe traumatic brain injury (TBI) practice is lacking. We examined whether a facilitated, multilevel program improves TBI guideline adherence in children with severe TBI, including extracranial injury patients. The primary outcome was first 3-day cumulative ICU TBI guideline adherence rate for all and stratified by extracranial injury. Design: This was an open-label, pragmatic, multicenter, phase 3, superiority, parallel cluster randomized controlled trial. Unadjusted and adjusted percent differences were based on intention-to-treat. Setting: Sixteen South American hospitals (14 Argentina, one Chile, and one Paraguay) regularly treating pediatric patients with severe TBI participated. Patients: Patient inclusion criteria were younger than 18 years, severe TBI (Glasgow Coma Scale GCS score ≤ 8 or, if intubated, motor GCS ≤ 5), and ICU admission. Interventions: Sites provided usual care ( n = 8) or the Pediatric Guideline Adherence and Outcomes (PEGASUS) intervention ( n = 8) to participating patients. The PEGASUS intervention included checklists, case reviews, and other components designed to improve adherence to Brain Trauma Foundation pediatric guidelines. Measurements and Main Results: Three hundred eighty-nine patients were enrolled (208 control and 181 intervention). Control patients had less extracranial injury than intervention patients (70.7% vs. 82.9%; p = 0.005). TBI guideline adherence rates were 83.7% for control and 84.4% for intervention arms. There was no overall difference in adjusted first 3-day cumulative guideline adherence rate between arms (0.1% –3.3% to 3.5%). Intervention sites achieved higher guideline adherence rates than control sites in patients with isolated severe TBI (7.9% 1.9–13.8%; p = 0.01). Conclusions: Implementing an evidence-based TBI program was not superior to usual care in increasing first 3-day cumulative ICU TBI guideline adherence rates in all children with severe TBI. However, implementation increased adherence rates in children with isolated severe TBI.