The Development of the electronic Primary Care Research Network ePCRN

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The Development of the electronic Primary Care
Research Network (ePCRN)

• NIH Roadmap Award, BAA-RM-004-23
• Re-Engineering the Clinical Research Enterprise
• Feasibility of Integrating and Expanding Clinical
  Research Networks
• Federation of Practice-Based Research Networks
• University of Minnesota Department of Family
  Medicine and Community Health
• American Academy of Family Physicians, CHIT

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Outline

• The NIH Roadmap
• Next generation of RCTs
• Translation of research into practice
• Information system applications
• Practice Based Research Networks
• ePCRN
• NECTAR
• CCR implementation in the ePCRN architecture
• Data warehouse
• Integral to communication
• EHR interoperability
• Questions and discussion

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Outline

• The use of the CCR in
• Next generation of RCTs
• Problems of existing RCTs
• Why the Roadmap is necessary
• Differences with the next generation of RCTs
• Involvement of the National Clinical Research
  Associates
• Translation of research into practice
• Why this has not occurred in the past
• Infrastructure problems
• The technology to support highly distributed
  datasets
• Commitment of the National Institutes of Health /
  Development by the NIH
• 2.2 billion
• Practice Based Research Networks
• ePCRN
• NECTAR
• The development of a data standard is essential
  to support these broad initiatives.
• CCR implementation in the ePCRN architecture
• Integral to the construction of the data
  warehouse
• Integral to communication

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The NIH Roadmap for Medical Research
www.nihroadmap.nih.gov

• Purposes
• Accelerate the pace of discoveries
• Develop more rapid translation from laboratories
  to patients and back
• Position NIH to address evolving public health
  challenges

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Research Teams of the Future
New Pathways to Discovery
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Research Teams of the Future
New Pathways to Discovery
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Research Teams of the Future
New Pathways to Discovery
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Research Teams of the Future
New Pathways to Discovery
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Research Teams of the Future
New Pathways to Discovery
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Commitment of the NIH

• 2.2 Billion over 6 years
• Practice Based Research Networks
• Electronic Primary Care Research Network (ePCRN)
• NECTAR
• The development of a communication standard is
  essential to support these broad initiatives

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NIH Roadmap Award, BAA-RM-004-23Re-Engineering
the Clinical Research Enterprise Feasibility of
Integrating and Expanding Clinical Research
Networks

• Stuart Speedie PhD
• Division of Health Computer Sciences
• Laboratory Medicine and Pathology
• University of Minnesota
• IdaSim, MD, PhD
• MED-GIM
• University of California, San Francisco
• David Kibbe MD
• Center for Health Information and Technology
• American Academy of Family Physicians
• John Hickner, MD, MS, FAAFP
• Dept of Family Medicine
• University of Chicago

• Kevin A. Peterson MD, MPH, FRCS(Ed), FAAFP
• Principal Investigator
• University of Minnesota Medical School, Dept of
  Family Medicine
• Chair, Federation of Practice Based Research
  Networks
• Richard Hobbs, MB, ChB, FRCGP, FRCP,FMedSci, FESC
• Birmingham University
• Birmingham, England
• Steve Cawley, Associate Vice President
• Office of Information Technology Associate Vice
  President
• University of Minnesota

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NIH Roadmap Award, BAA-RM-004-23Re-Engineering
the Clinical Research Enterprise
Participating Networks

• Patricia Fontaine, MD
• Minnesota Academy of Family Physicians Research
  Network
• Martin L. Kabongo, MD, PhD
• San Diego Unified Research in Family Medicine
  Network
• Jim Mold, MD
• Oklahoma Physicians Resource/Research Network
• Wilson Pace, MD
• AAFP National Research Network/Colorado Research
  Network
• John G. Ryan, DrPHSouth Florida Primary Care
  Practice-Based Research Network

• Alan Adelman, MD, MS
• Penn State Ambulatory Research Network
• Debra Allen, MD
• Indiana Family Practice Research Network
• Chet Fox, MD
• The Upstate New York Practice Based Research
  Network
• Walter Calmbach, MD
• South Texas Ambulatory Research Network
• Myra Crawford, MD
• Alabama Practice Based Research Network

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Distribution of Office Visits by Physician
SpecialtyUnited States, 2001
Total 880,487 visits
Source U.S. Department of Health and Human
Services, Public Health Service, Centers for
Disease Control and Prevention, National Center
for Health Statistics, 2001 data.
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In an average month
1000 people
800 have symptoms
327 consider seeking medical care
217 visit a physicians office 113 visit primary
care physicians office
65 visit CAM provider
21 visit a hospital outpatient clinic
14 receive home health care
13 visit an emergency department
8 are in a hospital
New Ecology of Medical Care - 2000
lt1 is in an academic health center hospital
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The Next Generation of Clinical Trials

• Very highly multi-centered
• Rapid turnaround
• Accessibility
• National Clinical Research Associates
• 50,000 to 100,000 practice based research
  associates
• Certified and trained for participation with NIH
• NECTAR

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Principle Goals of the electronic Primary Care
Research Network (ePCRN)

• Build an electronic infrastructure that
• facilitates the performance of randomized
  controlled trials in primary care practices
  anywhere in the United States
• facilitates recruitment of subjects
• promotes the rapid integration of new research
  findings into primary care

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Primary Care Practice-Based Research
Networks(PBRN)

• are
• clinical laboratories
• for primary care research
• and dissemination

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Federation of Practice-based Research Networks

• Established in 1998
• 52 networks (PBRNs) representing over 6500
  physicians
• Potential patient population of over 16 million
• the most promising infrastructure development
  that the committee could find to support better
  science in primary care.
• Committee on the Future of Primary Care
• Institute of Medicine 1999

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Birmingham University, UK

• eScience Centre for the National Health Service
• Extensive networking involving nearly all NHS
  clinics
• Research Centre for primary care trials
• Adopting existing successful Citrix-based RCT
  software

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Univ. California, San Francisco

• Abilene backbone
• Clinical Trials Database
• Existing gigapop
• Existing active PBRN

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Research Objective

• To establish a secure primary care web-portal
• enable primary care practices anywhere in the
  United States to link with researchers in
  academic centers and the NIH
• existing technology
• facilitate recruitment, entry, and follow-up of
  multidisciplinary randomized controlled trials

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Web Portal Function - Schematic
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Security precautions

• 24 hour monitored security cameras
• Argon gas fire protection
• Environmentally controlled

• Restricted and monitored access
• Secure identification card swipes

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Security precautions

• Class 5 security
• Additional limited access using swipe card id

• Environmental and access alarms

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Translation Objective

• To establish a clinic-based registry in primary
  care
• interfaces with the web portal solution
• promotes translation of research findings into
  practice
• standardized dataset (CCR) promotes clinical
  information exchange

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Clinical perspective
Research
Long term potential benefit?
Additional clinical burdens
Primary care clinic
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Clinical perspective
Translation
Primary care clinic
Quality Improvement
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Clinical perspective
Research
ePCRN
Primary care clinic
Quality Improvement
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Creation of a Registry What does it do for a
clinic?
The registry provides

• Focus on quality improvement
• Interface between EHRs
• Snapshot of current values
• Standard measures across the US
• Snowmed-CT codes (all diagnoses)

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Comparison of EHR and Registry
EHR
Registry

• Flexible user interface
• Individual history across time
• Maximize billing potential
• Improves clinical communication

• Strictly defined fields
• Aggregated patient groups by disease at one time
• Interfaces with NIH

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Laboratory
Billing
ePCRN implementation
Data Warehouse
ePCRN
CCR
Disidentified
Clinic host
CCR
EHR
Pay for Performance reports
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Integration of the CCR

• Input into the local data warehouse at the clinic
  (EHR)
• Import into the EHR/ disease registry
• Opportunistic identification of research subjects
• Real time identification of eligibility for
  research trials

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Laboratory
Billing
ePCRN implementation
Data Warehouse
ePCRN
CCR
Disidentified
EMDI
CCR
EHR
Pay for Performance reports
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Studies underway

• Demonstration 250 physicians
• 1st RCT 100 clinics
• 2nd RCT 500 clinics
• Translation dataset 1 million lives

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Development

• Looking for EHR partners
• Parsers for intermediate data set and data
  warehouse
• Defining standard data set
• Examining tools population of the local dataset

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Technical Objective

• To port the combined solution to open source
  Internet-2 components that will allow additional
  functionality
• real time opportunistic identification of
  subjects (OGSA)
• enhanced security
• warehousing of trial data emphasizing provenance
  and ontology of data

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Access Grid Node

• Testing Internet-2 connectivity
• Promoting better communication between partners

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Additional functionality

• Real time video conferencing
• training of 10,000 40,000 PC researchers
• HIPPA
• Human subjects protection
• Remote training
• Patient safety, decision support
• Remote instrumentation
• New Security tools (Abilene)
• Large collaborative national studies
• The foundation for a revolution in clinical
• research and primary care

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Future of Family Medicine Recommendation 7
Enhancing the Science of Family Medicine

• Practice-based research will be integrated
  into the values, structures, and processes of
  family medicine practices

Annals of Fam Med, 2(supp 1) s29,
March/April, 2004