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

Brain Injuries, Traumatic Clinical Trial

— EPIC  

Official title:

Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339702
• Other study ID #: EPIC-NINDS-R01NS071049
• Status: Completed
• Start date: September 2011
• Est. completion date: August 2017

Study information

• Verified date: August 2018
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26873
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Injuries, Acute Brain
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Other:
• The National Prehospital TBI Management Guidelines
In the post-implementation (after) cohort, implementation of the entire "bundle" of the TBI treatment guidelines with special emphasis on prevention and treatment of hypotension (IV crystalloids), prevention and treatment of hypoxia (pre-oxygenation with high-flow O2 via non-rebreather mask, bag-valve-mask, extraglottic airways/intubation when basic maneuvers have failed), and prevention of hyperventilation (in intubated patients) and prevention/treatment of hypoventilation (in all patients).

Locations

Country	Name	City	State
United States	Arizona Emergency Medicine Research Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Participants will be followed for the duration of hospital stay. The average time from admission to either discharge or death is expected to be approximately 3 weeks.	hospital discharge
Secondary	hospital length of stay	This parameter will be the number of days that the patients spend in their initial, acute hospitalization. An average of 3 weeks is expected.	discharge from hospital
Secondary	Intensive care unit length of stay	This parameter will be the number of days that the patients spend in the ICU. An average of 1 week is expected.	admission to ICU to transfer from ICU
Secondary	ventilator days	When applicable, the number of days a patient is on a ventilator. This is expected to be an average of 2 days among all patients and 1 week among the subgroup of patients who are placed on a ventilator.	during hospitalization
Secondary	Patient disposition	where the patient was discharged or transferred to (e.g., skilled nursing facility, home, rehabilitation hospital) (average 3 weeks)	hospital discharge