Pediatric Emergency Care Applied Research Network PECARN

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James M. Chamberlain, MD Vice-Chair, PECARN
Steering Committee
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True or False Children with seizures are
better off if they receive medications before
reaching the hospital.
3
True or False Children with severe head injury
are better off if paramedics can insert an
endotracheal tube.
4
True or False Children with bleeding after a
motor vehicle accident are better off if they
receive IV fluids before they have surgery.
5
True or False Children with bronchiolitis do
better if treated with steroids.
6
Multiple choiceDoctors always/usually/often/som
etimes/rarely follow guidelines defining best
practice.
Why not?
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What is PECARN?

• A collaborative group of hospital emergency
  departments coordinated by a core research center
  unit and working with MCHB/HRSA and other Federal
  agencies to conduct multi-center randomized
  trials and observational studies on a variety of
  issues related to emergency medical services for
  children.

• 3-year cooperative agreement funded by
  HRSA/MCHB/EMSC in October 2001.
• 4 centers funded along with separate funding for
  a data coordinating center.
• Funding for the development of research
  infrastructure.

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Why PECARN is Needed

• Low incidence rates of pediatric emergency events
  require pooling of centers to conduct research.
• Large numbers of children are required to attain
  diverse and representative study samples.
• An infrastructure is needed to test the efficacy
  of treatments as well as the transport and care
  that children receive before coming to the ER.
• A mechanism is needed to study the process of
  transferring research results to treatment
  settings.

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PECARN Mission
The Pediatric Emergency Care Applied Research
Network (PECARN) is dedicated to improving health
care for ill and injured children.  PECARN will
perform meaningful and rigorous
multi-institutional research into the prevention
and management of acute illnesses and injuries in
children representing demographic and regional
diversity in order to promote their health in all
phases of care.  PECARN will also provide the
leadership and infrastructure needed to support
research collaboration among EMSC investigators
and informational exchanges between EMSC
investigators, providers, and the communities
they serve in order to significantly improve EMSC
care delivery.
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Structure of PECARN
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PECARN Subcommittees
PECARN Steering Committee
Grant Writing Publication Subcommittee (GAPS)
Protocol Concept Review Development
Subcommittee (PCRADS)
Data Analysis Management Subcommittee (DAMS)
Safety Regulatory Affairs Subcommittee (SRAS)
Quality Assurance Subcommittee (QAS)
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PECARN Nodes
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Academic Centers Research Node (ACORN)
Richard Ruddy, MD
Marc Gorelick, MD, MSCE
Nathan Kuppermann, MD, MPH PECARN Chair
David Jaffe, MD
Howard Corneli, MD, MS
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Chesapeake Applied Research Network (CARN)
Kraig Melville, MD
James M. Chamberlain, MD PECARN Vice-Chair
Allen Walker, MD
Christina Johns, MD PECARN Secretary
Diana Alexander, MD
David Monroe, MD
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Great Lakes Regional Node (GLRN)
Rachel Stanley, MD
Ronald F. Maio, DO, MS
Prashant Mahajan, MD, MPH
John Hoyle, Jr, MD
Donald Snowdon, MD
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Pediatric Emergency Department North East Team
(PEDNET)
Kathleen Lillis, MD
Michael Tunik, MD
Michael Gerardi, MD
Steven Miller, MD
John Brennan, MD
Julius Goepp, MD
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PECARN Strengths

• 25 Hospital Emergency Department Affiliates
• Serving 840,000 acutely ill and injured
  children
• Wide geographic and hospital representation
• Senior-level expertise in epidemiology,
  statistics, health services research, and ethics
• Senior-level PEM researchers and clinicians
• Strong ties with EMSC and MCHB

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PECARN Protocol Review and Work Flow
External investigators will be directed to a node
of their choosing for proposal submission and
will be given equal consideration by PECARN
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Ongoing PECARN Research Development

• Real-time bioterrorism surveillance
• Color coding for safety in bioterrorism
  pediatric medication
• Early recognition and treatment of bioterrorism
• C-Spine immobilization
• Steroids in acute bronchiolitis
• Acute asthma care in short-stay unit
• The burden of mental illness and psychiatric
  emergencies in the PED
• EMS data linkages
• Short-term ED follow-up mechanisms after acute
  pediatric illness

• Therapeutic hypothermia in pediatric
  cardiopulmonary arrest
• Characterizing a population within a
  research network
• Pre-hospital seizure management
• Pediatric pre-hospital arrest survival
  evaluation
• Acuity/Severity status scoring
• systems for profiling PED workload
• Quality assessment in the PED

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PECARN Core Data Project

• Aim
• Describe PECARNs patient population
• Collect in-depth information about asthma and
  long-bone fractures for future hypothesis
  generation.
• Evaluate PECARNs ability to collect, transfer
  and manage data in a secure and confidential
  fashion.
• Measure data accuracy and completeness by
  comparing electronic data and manual chart
  review.
• Provide ongoing data in the future for other
  studies.

• Methods
• 2 Phase Study
• Phase 1 Retrospective electronic data
• Phase 2 Prospective electronic and chart review
  data

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PCDP Progress

• Phase I data submitted from 20 sites
• Phase II data abstraction completed at 25 sites
• Phase II data entry completed at 25 sites
• Data Analysis starting in December
• Manuscripts will be written for publication
  2003-2004

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• Example Uses of PCDP Data
• Pilot data for grant applications
• GIS mapping
• Surveillance data (see graphs below)

Example of a GIS map created through PCDP data
Mechanism of Injury Reported for Patients
presenting to the ED (PCDP data from selected
hospitals)

• Length of stay for PECARN patients
• Mean 7.7 (? 22.1) hrs. median 2
• (PCDP data from selected hospitals)

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PECARN Grant Submissions

• All of the following projects have received
  endorsement from the PECARN steering committee.
• 1. Childhood Head Trauma A Neuroimaging Decision
  Rule
• By University of California-Davis (ACORN)
• Submitted concurrently February 1, 2003 to NIH
  (NICHD) March 1, 2003 to MCHB
• Amount 1,941,000 to NICHD 1,945,000 to MCHB
• Status Under NIH and MCHB review
• 2. Hypothermia for Cardiac Arrest Planning Grant
• By University of Michigan (Great Lakes)
• Status Funded July 1, 2003
• Amount 300,000
• Project has begun with data collection projected
  to be completed in 12 months.
• The planning grant will provide pilot data for a
  RCT.

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PECARN Grant Submissions

• 3. Bioterrorism Surveillance Using the PECARN
  Network
• By Childrens Hospital of Boston (PI Kenneth
  Mandl) originally funded by AHRQ to develop a
  biosurveillance program.
• This was the first PECARN proposal submitted by
  an external investigator not formally part of the
  network.
• In 2003, he received supplemental AHRQ funds to
  pilot a system with selected PECARN hospitals.
• 4. Benzodiazepines for the Prehospital Treatment
  of Pediatric Seizures
• By Childrens National Medical Center (CARN)
• Submitted to the Pediatric Epilepsy Foundation
  March 2003
• Amount 100,000
• Status Rejected

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PECARN Grant Submissions

• 5. Use of Lorazepam for the Treatment of
  Pediatric Status Epilepticus A Blinded
  Randomized Controlled Trial of Lorazepam versus
  Diazepam
• By Childrens National Medical Center (CARN)
• Submitted to the NIH (NICHD) in response to RFP
  July 14,2003
• Amount approx. 3,000,000
• Status recently submitted and under review
• 6. Disparities in Emergency Medical Services for
  Urgent Pediatric Conditions Incidence and
  Multi-level Contributors
• By Childrens National Medical Center (CARN)
• Submitted to AHRQ/NICHD October 1, 2003

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PECARN First Clinical Trial

• Oral dexamathasone versus placebo for the
  treatment of bronchiolitis in infants.
• - Bronchiolitis is the most common respiratory
  disease of infancy
• - There is no compelling evidence either way re
  steroids
• - RCT
• - Uses existing PECARN infrastructure
• - Starts Jan 2004
• - Competion April 2004

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Investigator Initiated Grant Applications

• All of the following projects have received
  endorsement from the PECARN steering committee.
• Childhood Head Trauma A Neuroimaging Decision
  Rule
• By University of California-Davis (ACORN)
• Submitted concurrently February 1, 2003 to NIH
  (NICHD) March 1, 2003 to MCHB
• Amount 1,941,000 to NICHD 1,945,000 to MCHB
• Status Under NIH and MCHB review
• Bioterrorism Surveillance Using the PECARN
  Network
• By Childrens Hospital of Boston (PI Kenneth
  Mandl) originally funded by AHRQ to develop a
  biosurveillance program.
• This was the first PECARN proposal submitted by
  an external investigator not formally part of the
  network.
• In 2003, he received supplemental AHRQ funds to
  pilot a system with selected selected PECARN
  hospitals.

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Response to RFP or RFA Grant Applications

• All of the following projects have received
  endorsement from the PECARN steering committee.
• Hypothermia for Cardiac Arrest Planning Grant
• By University of Michigan (Great Lakes)
• Status Funded July 1, 2003
• Amount 300,000
• Project has begun with data collection projected
  to be completed in 12 months.
• The planning grant will provide pilot data for a
  randomized clinical trial.
• Benzodiazepines for the Prehospital Treatment of
  Pediatric Seizures
• By Childrens National Medical Center (CARN)
• Submitted to the Pediatric Epilepsy Foundation
  March 2003
• Amount 100,000
• Status Under review

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Challenges

• Informed consent
• Rare diseases (e.g. C-spine injury)
• Training the next generation
• Translating research results into practice

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Conclusion

• PECARN is committed to collaboratively applying
  strengths and expertise to the study of the
  prevention and treatment of acutely ill and
  injured children and youth.
• We are forging strong collaborations between all
  Nodes of PECARN, the EMSC program, and MCHB/HRSA.
  
• We are confident that the strong commitment of
  all those involved will contribute towards the
  success of this novel and exciting network.
• Please join us in this important endeavor.

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Contact Information

• JChamber_at_CNMC.org