Trial record 11 of 575 for:
Traumatic Brain Injury
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:
University of Arizona
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
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Purpose
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.
| Condition | Intervention |
|---|---|
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Brain Injuries, Traumatic Injuries, Acute Brain TBI (Traumatic Brain Injury) |
Other: The National Prehospital TBI Management Guidelines |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines |
Resource links provided by NLM:
Further study details as provided by University of Arizona:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 20000 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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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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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:
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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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339702
Contacts
| Contact: Daniel W Spaite, MD | 520-626-8819 | Dan@aemrc.arizona.edu |
Locations
| United States, Arizona | |
| Arizona Emergency Medicine Research Center | Recruiting |
| Phoenix, Arizona, United States, 85004 | |
| Contact: Daniel W Spaite, MD 520-626-8819 dan@aemrc.arizona.edu | |
Sponsors and Collaborators
University of Arizona
Investigators
| Principal Investigator: | Daniel W Spaite, MD | University of Arizona |
More Information
No publications provided
| Responsible Party: | Daniel Spaite, Professor of Emergency Medicine, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT01339702 History of Changes |
| Other Study ID Numbers: | EPIC-NINDS-R01NS071049 |
| Study First Received: | April 15, 2011 |
| Last Updated: | January 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Arizona:
|
Traumatic Brain Injury TBI Head Trauma Acute Traumatic Brain Injury Trauma, Brain |
Additional relevant MeSH terms:
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Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013