Trial record 3 of 497 for:    Open Studies | "Brain Injuries"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
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
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).
Other Names:
  • Brain Trauma Foundation TBI Guidelines
  • National Association of EMS Physicians TBI Guidelines

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014