Clinical trial NCT01339702: The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Official title: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries, Traumatic
Injuries, Acute Brain
TBI (Traumatic Brain Injury)
Keywords: Traumatic Brain Injury
TBI
Head Trauma
Acute Traumatic Brain Injury
Trauma, Brain
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 26873
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and children of all ages with acute, moderate or severe TBI cared for in the participating EMS systems of Arizona who are taken to a Level 1 Trauma Center (either directly by EMS or transfered by EMS). This will include approximately 4 years of retrospective cases and 4.5 years of prospective cases.

Brief summary: Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.

Detailed description: * 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Survival
timeFrame: hospital discharge
Secondary outcomes:
measure: hospital length of stay
timeFrame: discharge from hospital
measure: Intensive care unit length of stay
timeFrame: admission to ICU to transfer from ICU
measure: ventilator days
timeFrame: during hospitalization
measure: Patient disposition
timeFrame: hospital discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Emergency Medicine Research Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Daniel W Spaite, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spaite DW, Bobrow BJ, Stolz U, Sherrill D, Chikani V, Barnhart B, Sotelo M, Gaither JB, Viscusi C, Adelson PD, Denninghoff KR. 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. Acad Emerg Med. 2014 Jul;21(7):818-30. doi: 10.1111/acem.12411. Epub 2014 Aug 11.
citation: Spaite DW, Hu C, Bobrow BJ, Barnhart B, Chikani V, Gaither JB, Denninghoff KR, Bradley GH, Rice AD, Howard JT, Keim SM. Optimal Out-of-Hospital Blood Pressure in Major Traumatic Brain Injury: A Challenge to the Current Understanding of Hypotension. Ann Emerg Med. 2022 Jul;80(1):46-59. doi: 10.1016/j.annemergmed.2022.01.045. Epub 2022 Mar 24.
citation: Gaither JB, Spaite DW, Bobrow BJ, Keim SM, Barnhart BJ, Chikani V, Sherrill D, Denninghoff KR, Mullins T, Adelson PD, Rice AD, Viscusi C, Hu C. Effect of Implementing the Out-of-Hospital Traumatic Brain Injury Treatment Guidelines: The Excellence in Prehospital Injury Care for Children Study (EPIC4Kids). Ann Emerg Med. 2021 Feb;77(2):139-153. doi: 10.1016/j.annemergmed.2020.09.435. Epub 2020 Nov 11.
citation: Spaite DW, Bobrow BJ, Keim SM, Barnhart B, Chikani V, Gaither JB, Sherrill D, Denninghoff KR, Mullins T, Adelson PD, Rice AD, Viscusi C, Hu C. Association of Statewide Implementation of the Prehospital Traumatic Brain Injury Treatment Guidelines With Patient Survival Following Traumatic Brain Injury: The Excellence in Prehospital Injury Care (EPIC) Study. JAMA Surg. 2019 Jul 1;154(7):e191152. doi: 10.1001/jamasurg.2019.1152. Epub 2019 Jul 17.
citation: Spaite DW, Hu C, Bobrow BJ, Chikani V, Barnhart B, Gaither JB, Denninghoff KR, Adelson PD, Keim SM, Viscusi C, Mullins T, Sherrill D. The Effect of Combined Out-of-Hospital Hypotension and Hypoxia on Mortality in Major Traumatic Brain Injury. Ann Emerg Med. 2017 Jan;69(1):62-72. doi: 10.1016/j.annemergmed.2016.08.007. Epub 2016 Sep 28.