The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines (EPIC)
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|ClinicalTrials.gov Identifier: NCT01339702|
Recruitment Status : Recruiting
First Posted : April 21, 2011
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment|
|Brain Injuries, Traumatic Injuries, Acute Brain TBI (Traumatic Brain Injury)||Other: The National Prehospital TBI Management 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.
|Study Type :||Observational|
|Estimated Enrollment :||20000 participants|
|Official Title:||Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
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.
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).
- Survival [ Time Frame: hospital discharge ]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 length of stay [ Time Frame: discharge from hospital ]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 ]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 ]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 ]where the patient was discharged or transferred to (e.g., skilled nursing facility, home, rehabilitation hospital) (average 3 weeks)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339702
|Contact: Daniel W Spaite, MD||520-626-8819||Dan@aemrc.arizona.edu|
|United States, Arizona|
|Arizona Emergency Medicine Research Center||Recruiting|
|Phoenix, Arizona, United States, 85004|
|Contact: Daniel W Spaite, MD 520-626-8819 email@example.com|
|Principal Investigator:||Daniel W Spaite, MD||University of Arizona|