Brain Injuries, TraumaticEPICNCT01339702

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

An observational study of Brain Injuries, Traumatic and Injuries, Acute Brain, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Brain Injuries, Traumatic, Injuries, Acute Brain, TBI (Traumatic Brain Injury)
What is being tested?: The National Prehospital TBI Management Guidelines
Type of treatment: Injection or infusion
How many people: 26,873 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Aug 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Arizona Emergency Medicine Research Center
Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

Read the 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.

Conditions: Brain Injuries, Traumatic, Injuries, Acute Brain, TBI (Traumatic Brain Injury)
Being tested: The National Prehospital TBI Management Guidelines
Keywords: Traumatic Brain Injury, TBI, Head Trauma, Acute Traumatic Brain Injury, Trauma, Brain
Medical subject headings: Brain Injuries, Traumatic, Brain Injuries, Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The National Prehospital TBI Management GuidelinesOther
Also called Brain Trauma Foundation TBI Guidelines, National Association of EMS Physicians TBI 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).

Study groups in NCT01339702
Study group	Role	What they receive
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. Receives: Other: The National Prehospital TBI Management Guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival
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.
Measured: hospital discharge

Secondary outcomes (4)

hospital length of stay
This parameter will be the number of days that the patients spend in their initial, acute hospitalization. An average of 3 weeks is expected.
Measured: discharge from hospital
Intensive care unit length of stay
This parameter will be the number of days that the patients spend in the ICU. An average of 1 week is expected.
Measured: admission to ICU to transfer from ICU
ventilator days
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.
Measured: during hospitalization
Patient disposition
where the patient was discharged or transferred to (e.g., skilled nursing facility, home, rehabilitation hospital) (average 3 weeks)
Measured: hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Aug 2017

First posted21 Apr 2011 (estimated)
Study startSep 2011
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 26,873 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01339702
Sponsor's protocol ID: EPIC-NINDS-R01NS071049
Acronym: EPIC
Status last verified: Aug 2018
First submitted: 15 Apr 2011
Last updated: 28 Aug 2018
Results posted: No
Data monitoring committee: No

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.
PubMed 25112451
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.
PubMed 35339285
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.
PubMed 33187749
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.
PubMed 31066879
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.
PubMed 27692683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Brain Injuries, Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
ClinicalTrials.gov ID: NCT01339702
Acronym / sponsor ID: EPIC / EPIC-NINDS-R01NS071049
Conditions: Brain Injuries, Traumatic, Injuries, Acute Brain, TBI (Traumatic Brain Injury)
Keywords: Traumatic Brain Injury, TBI, Head Trauma, Acute Traumatic Brain Injury, Trauma, Brain
Study type: Observational
Recruitment status: Completed
Enrolment: 26,873 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Study start: Sep 2011
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 21 Apr 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
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")	–	Other: The National Prehospital TBI Management GuidelinesThis 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The National Prehospital TBI Management GuidelinesAlso: Brain Trauma Foundation TBI Guidelines, National Association of EMS Physicians TBI GuidelinesIn 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	Post-implementation cohort ("after")

Primary outcome

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.

4 secondary outcomes

hospital length of stay
Time frame: discharge from hospital
Intensive care unit length of stay
Time frame: admission to ICU to transfer from ICU
ventilator days
Time frame: during hospitalization
Patient disposition
Time frame: hospital discharge

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Background: PubMed 25112451Spaite 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.
Derived from this study: PubMed 35339285Spaite 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.
Derived from this study: PubMed 33187749Gaither 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.
Derived from this study: PubMed 31066879Spaite 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.
Derived from this study: PubMed 27692683Spaite 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel W Spaite, MD principal investigator

University of Arizona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries, Traumatic and Injuries, Acute Brain, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01339702, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.