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

This study is currently recruiting participants.
Verified January 2013 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Daniel Spaite, University of Arizona
ClinicalTrials.gov Identifier:
NCT01339702
First received: April 15, 2011
Last updated: January 12, 2013
Last verified: January 2013

April 15, 2011
January 12, 2013
September 2011
November 2015   (final data collection date for primary outcome measure)
Survival [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01339702 on ClinicalTrials.gov Archive Site
  • hospital length of stay [ Time Frame: discharge from hospital ] [ Designated as safety issue: No ]
    This parameter will be the number of days that the patients spend in their initial, acute hospitalization. An average of 3 weeks is expected.
  • Intensive care unit length of stay [ Time Frame: admission to ICU to transfer from ICU ] [ Designated as safety issue: No ]
    This parameter will be the number of days that the patients spend in the ICU. An average of 1 week is expected.
  • ventilator days [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
    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.
  • Patient disposition [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
    where the patient was discharged or transferred to (e.g., skilled nursing facility, home, rehabilitation hospital) (average 3 weeks)
  • hospital length of stay [ Time Frame: discharge from hospital ] [ Designated as safety issue: No ]
    This parameter will be the number of days that the patients spend in their initial, acute hospitalization. An average of 3 weeks is expected.
  • Intensive care unit length of stay [ Time Frame: admission to ICU to transfer from ICU ] [ Designated as safety issue: No ]
    This parameter will be the number of days that the patients spend in the ICU. An average of 1 week is expected.
  • ventilator days [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]
    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.
  • Patient disposition [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
    where the patient was discharged or transfered to (e.g., skilled nursing facility, home, rehabilitation hospital) (average 3 weeks)
Not Provided
Not Provided
 
The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

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.

  • 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.
Observational
Observational Model: Cohort
Not Provided
Not Provided
Probability Sample

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.

  • Brain Injuries, Traumatic
  • Injuries, Acute Brain
  • TBI (Traumatic Brain Injury)
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).
Other Names:
  • Brain Trauma Foundation TBI Guidelines
  • National Association of EMS Physicians TBI Guidelines
  • Pre-implementation cohort ("before")
    This cohort is a combination of retrospective and some prospective severe TBI patients cared for in the EMS systems of Arizona BEFORE implementation of the national prehospital TBI management guidelines
  • Post-implementation cohort ("after")
    This cohort is a comprised of prospective severe TBI patients cared for in the EMS systems of Arizona AFTER training EMS providers in the implementation of the national prehospital TBI management guidelines. It is intended that these patients will receive the "bundle" of care specified in the TBI Guidelines.
    Intervention: Other: The National Prehospital TBI Management Guidelines
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
February 2016
November 2015   (final data collection date for primary outcome measure)

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).
Both
Not Provided
No
Contact: Daniel W Spaite, MD 520-626-8819 Dan@aemrc.arizona.edu
United States
 
NCT01339702
EPIC-NINDS-R01NS071049
No
Daniel Spaite, University of Arizona
University of Arizona
Not Provided
Principal Investigator: Daniel W Spaite, MD University of Arizona
University of Arizona
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP