- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01339702
The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines (EPIC)
August 25, 2018 updated by: Daniel Spaite, University of Arizona
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
26873
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona Emergency Medicine Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospital length of stay
Time Frame: discharge from hospital
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This parameter will be the number of days that the patients spend in their initial, acute hospitalization.
An average of 3 weeks is expected.
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discharge from hospital
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Intensive care unit length of stay
Time Frame: admission to ICU to transfer from ICU
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This parameter will be the number of days that the patients spend in the ICU.
An average of 1 week is expected.
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admission to ICU to transfer from ICU
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ventilator days
Time Frame: during hospitalization
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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.
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during hospitalization
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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)
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hospital discharge
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel W Spaite, MD, University of Arizona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
August 1, 2017
Study Completion (ACTUAL)
August 1, 2017
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
April 20, 2011
First Posted (ESTIMATE)
April 21, 2011
Study Record Updates
Last Update Posted (ACTUAL)
August 28, 2018
Last Update Submitted That Met QC Criteria
August 25, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPIC-NINDS-R01NS071049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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