The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

- Significance: Approximately 1.4 million victims of Traumatic Brain Injury (TBI) are seen
in emergency departments each year in the U.S. and, of those, 50,000 die and 235,000 are
hospitalized. A least 2% of the U.S. population has a TBI-related long-term need for
help to perform activities of daily living. There is growing evidence that the
management of TBI in the early minutes after injury profoundly impacts outcome. This has
led to the promulgation of evidence-based TBI treatment guidelines by authoritative
national and international scientific bodies. Reports on guideline implementation in the
hospital setting are very promising. However, no studies have evaluated their impact in
the prehospital setting. While randomized prehospital trials to identify the
effectiveness of the guidelines would clearly be optimal, the strong indirect evidence
currently precludes withholding guideline therapy because of ethical considerations.
Thus a large, prospective, historically controlled, observational study is the best
methodology currently available to evaluate the effectiveness of implementing the
guidelines in the prehospital setting.

- Specific Aim: To test the hypothesis that implementation of the TBI guidelines in a
statewide EMS system will reduce mortality and improve non-mortality outcomes in adults
and children with moderate to severe TBI.

- Objective #1: Implement the nationally-vetted TBI guidelines across a broad variety of
EMS systems (urban, suburban and rural) throughout the State of Arizona. This will be
accomplished through the statewide collaboration between the University of Arizona, the
Arizona Department of Health Services, and local EMS agencies responding to 85% of the
state's population. This will mirror the approach that has been successfully employed to
study and document a tripling of patient survival from out-of-hospital cardiac arrest in
the state.

- Objective #2: Collect prehospital EMS and trauma center data on severe TBI patients
cared for by participating EMS agencies to determine pre-implementation and
post-implementation injury severity/risk-adjustment measures and outcomes.

- Objective #3: Evaluate the impact of prehospital guideline implementation on the
following outcomes: 1) Overall mortality (primary outcome), 2) mortality among patients
who are intubated prior to hospital arrival, and 3) non-mortality outcomes such as
hospital/intensive care unit length of stay, ventilator days, and patient disposition.

- Relevance/health impact: The societal burden of TBI is immense. While the potential for
dramatically reducing morbidity and mortality by early treatment appears to be great,
the effectiveness of the prehospital guidelines remains unproven. Demonstrating the
impact of guideline therapy would potentially lead to widespread implementation of the
effective interventions. This could dramatically reduce morbidity and mortality from
this major public health problem. On the other hand, if the guidelines are not effective
despite confirmed implementation across a wide variety of EMS systems throughout the
entire state, this would provide the ethical basis for conducting future randomized
trials.

Inclusion Criteria:

- Adults and children with physical trauma who: 1) are transported directly to or are
transferred to a level I TC by participating EMS agencies, 2) have hospital
diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes
TBI), and 3) meet at least one of the following definitions for severe TBI: a) last
prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of ≥3, c) CDC
Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy.

Exclusion Criteria:

- Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2)
choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g.,
hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5)
intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute
neurological emergencies (e.g., bacterial meningitis).