Evaluation of the Impact of Implementing the Emergency Medical Services Traumatic Brain Injury Guidelines in Arizona: The Excellence in Prehospital Injury Care (EPIC) Study Methodology

Abstract

Traumatic brain injury (TBI) exacts a great toll on society. Fortunately, there is growing evidence that the management of TBI in the early minutes after injury may significantly reduce morbidity and mortality. In response, evidence-based prehospital and in-hospital TBI treatment guidelines have been established by authoritative bodies. However, no large studies have yet evaluated the effectiveness of implementing these guidelines in the prehospital setting. This article describes the background, design, implementation, emergency medical services (EMS) treatment protocols, and statistical analysis of a prospective, controlled (before/after), statewide study designed to evaluate the effect of implementing the EMS TBI guidelines—the Excellence in Prehospital Injury Care (EPIC) study (NIH/NINDS R01NS071049, “EPIC”; and 3R01NS071049-S1, “EPIC4Kids”). The specific aim of the study is to test the hypothesis that statewide implementation of the international adult and pediatric EMS TBI guidelines will significantly reduce mortality and improve nonmortality outcomes in patients with moderate or severe TBI. Furthermore, it will specifically evaluate the effect of guideline implementation on outcomes in the subgroup of patients who are intubated in the field. Over the course of the entire study (~9 years), it is estimated that approximately 25,000 patients will be enrolled.

Association of Out-of-Hospital Hypotension Depth and Duration With Traumatic Brain Injury Mortality

“…33–35 EPIC is evaluating the impact of implementing the EMS TBI guidelines 36–39 in patients with major TBI throughout Arizona using a before-after, controlled, multisystem, observational design 33 (ClinicalTrials.gov #NCT01339702). We obtained the necessary regulatory approvals for EPIC from the Arizona Department of Health Services (ADHS) and the State Attorney General.…”

“…In this secondary analysis we included patients 10 years of age or older with physical trauma who have trauma center (TC) diagnosis(es) consistent with TBI (isolated or multisystem trauma) and meet at least one of the following definitions for moderate or severe (“major”) TBI: a) Centers for Disease Control (CDC) Barell Matrix-Type 1, b) International Classification of Diseases-Version 9 (ICD-9) head region severity score ≥3, c) Abbreviated Injury Scale (AIS)-head region score ≥3. 33,34 We excluded cases with age <10 years, inter-facility transfer (or unknown), any SBP >200mmHg, SBP of 0 indicating traumatic arrest, missing important confounders/risk-adjusters, and zero or only one recorded out-of-hospital SBP with documented time between six hours before ED arrival to 10 minutes after ED arrival (excludes extreme or obviously-inaccurate time data). The patients with only one timed, recorded SBP measurement were excluded because at least two are needed to establish depth-duration dose.…”

“…33–35 The ASTR has detailed in-hospital data on all trauma patients taken to the state-designated level I TCs in Arizona. All cases from the ASTR that meet EPIC criteria are entered into the database.…”

“…The processes of case identification, linkage, data entry, and data quality management have been reported in detail. 33 We have enrolled over 20,000 cases into the EPIC study and the ASTR/EMS data linkage rate is well over 90%.…”

The Role of EMS in Regionalized Systems of Care

“…[15][16][17] The importance of developing regionalized systems is further supported by a number of national organizations in Canada and the United States. [18][19][20][21] Historically, the drivers of regionalized systems of care have been trauma and STEMI; however, other systems include stroke, traumatic brain injury (TBI) 22 , OHCA 4,23 , and burns…”