Practice Based Research Networks:

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• Practice Based Research Networks
• Application Tools and Infrastructure Measures

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• Elizabeth Joy MD, MPH
• Network Director
• eajslc_at_aol.com 801-585-9075
• Steve Alder, PhD
• Assoc. Director, Public Health Program
• Steve.alder_at_utah.edu 801-587-3332
• Susanne Cusick
• Network Research Manager
• Susanne.cusick_at_utah.edu 801-587-5842
• Jerilin Nunu, MPH
• Practice-Based Research Associate 801-585-6116
• j.nunu_at_utah.edu

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Presentation Outline

• Overview of UHRN
• Development function
• Building an Effective Board of Directors
• Project Application Approval Process
• PBR Methodologies and Infrastructure
• Developing Resources for Infrastructure Support

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Brief History of PBRNs

• Around for 35 years 1st est in 1970s
• 1999 Congressional reauthorization of AHRQ
  includes mandate to support primary care PBRNs
• 24 primary care PBRNs in US in 2000, 110 PBRNS by
  2004
• In 2002 , AHRQ established a National Resource
  Center
• 2003 set-asides for PBRNs appear in NIH RFAs

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(No Transcript)
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UHRN Staff Structure

• Director- Liz Joy M.D.
• Direct oversight of network staff budget/fund
  raising
• Executive Committee
• Network expansion
• Communication within and outside University
• Grant writing
• Research Manager- Susanne Cusick
• Day to Day oversight of network operations
• Aid PIs through application process
• Project Reporting and Close Out
• Budget/Accounting/Grants Administration
• Research Associate- Jerilin Nunu
• Patient Recruiting
• Aids PIs with IRB protocols
• Study implementation
• Communication with network clinicians
• Manuscript Prep and Editing

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What is a PBRN?

• Group of ambulatory practices devoted
  principally to the primary care of patients, and
  affiliated in their mission to investigate
  questions related to community-based practice and
  to improve the quality of primary care. AHRQ
• Involve practicing clinicians in asking and
  answering clinical and organizational questions
  about primary health care
• Link relevant clinical questions with rigorous
  research methods in community settings to produce
  scientific information that is externally valid,
  and, in theory, assimilated more easily into
  everyday practice.

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Practice-Based Research Networks (PBRNs)

• Groups of community practices devoted to patient
  care, affiliated for research
• Often partner with academic or professional
  organizations
• Comprised of clinicians on the frontlines of
  patient care
• Produce findings that are generalizable,
  transportable readily translated into practice
• http//ahrq.gov/research/pbrnfact.htm

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• The Utah Health Research Network is a
  practice-based research network linked by a
  shared clinical and educational mission.
• 10 University of Utah Community Clinics (12 by
  the end of 2006)
• 127 clinicians
• 80 primary care providers
• 45 Family Medicine, 11 Pediatrics
• 300,000 patient visits per year
• 100,000 unique patients
• EPIC Electronic Medical Record (EMR)
• Salt Lake Community Health Centers (3)
• Family Medicine providers
• Majority of patients on Medicaid or uninsured
• 80 Hispanic/Latino

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• Mission
• The purpose of the Utah Health Research Network
  is to promote research in the network by
  developing the interface between researchers and
  patients, and supporting network-driven research
  projects that will benefit clinical practice and
  advance knowledge in primary care and population
  health.

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UUHSC-CPG Research Committee Promote Research
Collaboration UUHSC, CPG, CC
2005
2007
2001

• Fulltime staff of 2 (since July 2006)
• Part time administrative assistant
• 11 ongoing projects
• 2 NIH grants in development

• 37 Studies (5 NIH)
• 2.3 million direct expenses
• 25 PIs (DFPM, IM, Peds, Surgery, HCI,
  CON, COP)

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UHRN Board of Directors

• Department of Family and Preventive Medicine
• Liz Joy, M.D., M.P.H.
• Steve Alder, Ph.D.
• Michael Magill, M.D.
• George White, Ph.D.
• Peter Catinella, M.D., M.P.H.
• Rod Larson, Ph.D.
• Community Clinics
• Julie Day, M.D., Redwood Clinic
• Susan Terry, M.D., Greenwood Clinic
• Rob Lloyd, Administration
• Information Technology
• Ken Gondor, ITS
• Randy Baker

• Pediatric Administration
• Paul Young, M.D.
• Nursing
• Pat Murphy, Dr.PH.
• College of Health
• Pharmacy
• Diana Brixner, Ph.D.
• Biomedical Informatics
• Scott Narus, Ph.D.
• OB/GYN
• Michael Varner, M.D.
• Eccles Health Sciences Library
• Alice Weber, R.N., MLS

Denotes Executive Committee Member
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UHRN Board

• Meet monthly at SOM
• Executive Committee meets weekly
• Agenda
• Announcements
• Introductions
• Ongoing Projects
• Projects in Development
• Research Presentation
• Proposed project
• Completed project
• Project Approval
• CQI Update
• Database Committee Report
• Funding and finances

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UHRN

• Understanding the Resource
• Preferred Contact Study
• Each clinician within the network was asked their
  preferred mechanism of contact (email, page,
  phone call, memo, newsletter) for various types
  of information related to research within UHRN
• 80 response rate
• 71 respondents prefer email
• 68 interested in receiving clinically relevant
  information generated from UHRN patient data
• 77 respondents prefer disease surveillance
  information by email 2X/week
• Barriers to Research Study
• FM Faculty at Madsen and Sugarhouse have been
  interviewed to identify current barriers to
  participating in clinical research
• Priority Preventive Services in Primary Care
• Using survey instruments, this study will compare
  and contrast priorities and attitudes of primary
  care physicians and of patients visiting the
  University Community Clinics with regard to
  preventive services

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UHRN

• Developing its Identity
• Kim Wirthlin (University of Utah Vice President
  for Government Relations and Associate Vice
  President for Marketing and Communications UUHSC)
  
• Plaques denote PBRN member
• The Madsen Family Health Clinic is proud to be a
  member of the Utah Health Research Network
  (UHRN), dedicated to improving the lives of our
  patients through innovative clinical research.
• UHRN Newsletter (July 2007)
• Seed grant money directed toward research within
  the network

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UHRN

• Spreading the Word
• Dec 2005 Community Clinics Leadership Team
• Jan 2006 Department of Family and Preventive
  Medicine Grand Rounds
• Feb 2006 Department of Pediatrics Research
  Forum
• Feb 2006 HCI Cancer Control Program
• Sept 2006 Department of Pediatrics Grand
  Rounds
• Oct 2006 Intermountain Pediatric Research
  Consortium
• April 2007 Center on Aging
• May 2007 Obstetrics and Gynecology Research
  Group
• May 2007 Center for Healthcare and Business
• Summer 2007 Community Clinics Leadership Team

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• Ensuring Financial Viability
• Charge a fee for use of the EPIC database
• Hourly Consultant fee
• IRB submissions
• Research Coordination
• Data Management
• Biostatistical support
• Grant funding
• Development/Foundation funds

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The Future

• Strengthen existing partnerships
• Continue to seek out and identify new
  partnerships within and outside the University of
  Utah
• Increase awareness of UHRN within the University
  and the community
• Develop projects within UHRN
• Partner with ongoing research and clinical
  efforts within the University
• National Childrens Study
• Center of Excellence in Womens Health
• University of Utah Wellness Program
• HCI Cancer Control Program
• Utah Urban Systems Research Program
• CTSA Grant

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• The Nuts and Bolts of Research in the
• Utah Health Research Network
• Research Application and Approval
• Project Implementation and Completion Process
• PBR Methodologies and Infrastructure
• Developing Resources for Infrastructure Support

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Research Application Package

• Letter to investigators..\Application
  Packet\Application_Packet_Cover_Letter.doc
• ..\Application Packet\UHRN_Project_Application_Ap
  proval_Flow_Sheet_(Final).doc
• Outlines UHRN sites and statistics
• What to expect
• Research Application..\Application
  Packet\UHRN_Application_Form.doc
• Completed Application
• IRB protocol
• Survey Instruments ( if applicable)
• Research Timeline
• Research Funding

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Research Application Cont.

• Fee for Service Model
• ..\Application Packet\FFS_narritive.doc
• IRB assistance, data fees, subject recruitment,
  grants management, and publication assistance.
• Project Flow Chart
• Start to finish what is expected of the
  investigator

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Project Approval Process
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Project Implementation and Completion Process
Practice research associate works with PI to
assure IRB approval is suitable prior to
implementing research project within clinic(s)
PI is scheduled with each clinics provider
meeting to presents project at necessary to
applicable providers (medical directors, lab
directors, etc.)
PI and research practice associate receives
direction from clinic providers on how best to
implement research project for specific clinic
Adjustments to protocol made if necessary for
each specific clinic
Practice research coordinator maintains monthly
contact with PI and reports project status to
UHRN Board
Clinic staff members are introduced and oriented
to the research project by practice research
associate and PI
Upon completion of project PI presents Executive
Summary to UHRN Board
Practice research associate disseminates PIs
Executive Summary to clinicians through EPIC
email system
Practice research associate and research manager
include highlights from research project in
bi-annual UHRN Newsletter
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PBRN Methodologies Research Infrastructure

• Research and Statistical Collaboration
• Link between Clinical Questions
• Evidence-based Answers

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Role of Research Infrastructure

• Collaboration Partnering with clinicians and
  clinical scientists appreciation of clinical
  environment and nature of question
• Technical Accomplishing the practical tasks that
  allow the process to proceed

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Research Infrastructure Facilitates

• Conceptualization
• Design
• Sample size
• IRB / HIPPA
• Implementation
• Engagement of network
• Engagement of community
• Instrument development

• Data collection
• Primary data
• IT resources
• Data management analysis
• Interpretation of results
• Research education within the network

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The WHO of Research

• Principal investigator
• Clinical experts
• Research director
• Biostatistician
• Epidemiologist
• Information Technologist / Informaticist

• Data manager
• Clinical liaison / Research nurse
• Technical writer
• Research assistant

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Methodological Approaches to PBRN Research

• Descriptive studies
• Observational studies
• Case-control studies
• Cohort studies
• Intervention studies
• RCTs variants

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Accessing Research Resources

• Internal PBRN resources
• Partner resources
• University (clinical research, public health,
  biostatistics, epidemiology)
• Partner PBRNs
• Health system resources
• Externally hired resources
• Private consultants
• Temporary employees

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Assessing Feasibility

• Representation of Smoking-related Concepts in an
  Electronic Health Record
• Mollie R. Poynton, PhD, APRN1,2,
• Lewis Frey, PhD2, Hongying Tang2
• ¹University of Utah College of Nursing, Salt Lake
  City, UT
• ²University of Utah School of Medicine,
  Department of Biomedical Informatics, Salt Lake
  City, UT

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Background

• Knowledge Discovery in Databases (KDD) process
  (Fayyad, Piatetsky-Shapiro, Smyth, 1996)

?
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Purpose/ Aims

• (1) Assess the feasibility of a knowledge
  discovery project related to smoking cessation
  using warehoused data from a group of outpatient
  clinics, AND
• (2) Map strengths and gaps in the representation
  of smoking cessation related concepts in a common
  electronic health record system (EHR), EpicCare
  EMR.

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Concept Representation Strengths

• Prescribed medications
• ICD9 code tobacco use disorder8
• Willingness to quit
• Quit date
• Presence and type of tobacco use
• Arrangement of follow up
• Demographic information
• Family history/ pedigree

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Concept Representation Gaps

• Advice/counseling to quit
• Educational intervention
• Self-help materials
• Referral to external counseling/ treatment
  programs
• Type/ characteristics of program
• OTC nicotine replacement
• Social support

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Conclusions

• Coded attributes capture some (but not all)
  concepts relevant to smoking.
• Data assay indicates substantial data quality
  issues in coded data elements related to smoking
  cessation.
• Free text patient notes necessary to assess/
  describe primary care management of smoking/
  tobacco use. (Coded data not sufficient).

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Examples of UHRN Projects

• Time to Pregnancy in Normal Fertility, Joe
  Stanford, MD, MSPH (DFPM)
• Impact of Electronic Reminders on Screening for
  Colon Cancer, Randy Burt, MD (HCI) Michael
  Magill, MD (DFPM)
• Genital Herpes Prevention Study, Maria Reyes, MS
  (Infectious Diseases, SOM)
• Determinants of Exercise in Obese and Non-obese
  Sedentary Pregnant Women, Elizabeth Joy, MD
  (DFPM) Elizabeth Dranow, PhD (DFPM)
• Pharmacological Mechanisms of Falls and Sway in
  the Elderly, Ginnette Pepper, RN, PhD (CON)
• Asthma Guideline Adherence Implications for
  Cost, Qayyim, Said, PhD (Pharm) Diana Brixner,
  RPh, PhD (Pharm)

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Research Infrastructure Summary

• Research infrastructure is a key element of a
  successful PBRN
• Collaboration
• Technical support
• Accessing personnel and resources are important
  considerations in PBRN research
• Broad research expertise allows greater
  flexibility in addressing clinical questions

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Infrastructure Support

• Intramural Funding
• Vice Presidents Office for Health Sciences
• Academic Home Support
• Outside Departments
• Utilization-Fee for Service Model
• Grants
• Federal
• Foundation
• Corporate/ Pharma
• Donor Development

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Senior Vice President for Health Sciences

• Start-Up Package with 4 years of funding
• Stipulations
• Must submit 3 Federal Grants
• Must obtain financial support from other
  Colleges/Departments on Campus

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Academic Home Support

• Dept. of Family and Preventive Medicine
  isUHRNs academic home
• Salary Support
• Director
• Research Manager
• Practice Based Research Associate
• Financial Management/Grants Administration
• Space

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Fee for Service Model

• Could not be a barrier to research
• Created and approved by the Board of Directors
• A charge to PIs for using UHRNs services
• Negotiated with PIs up-front
• Signed contract for services rendered
• Student projects
• Still in negotiation

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Fee for Service Model

• Charge a flat fee of 50.00/hour for
• IRB protocol work, submission, and revisions
• Study participant recruitment
• Data queries
• Funding Searches
• Manuscript Preparation/Editing
• Funding Proposal Development
• Grants Administration
• Biostatistician Consulting- billed at 95.00/hour
• 10 discount is applied when 3 or more services
  are used.

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Federal Grants

• AAUPC
• Funded provides salary support
• Colorectal Cancer Screening
• R21 FUNDED-salary support
• Clinical Translational Science Award (CTSA)
• submitted Jan 2007
• 60,000/year in support to the network
• Validity and Reliability of the Physical Activity
  Vital Sign
• R21 submitted to NHLBI -Feb 2007
• The Impact of Physical Activity on Mood and
  Maternal-Infant Interactions During Pregnancy and
  the Postpartum
• RO1- Submitted to NIMH June 2007

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Corporate/ PHARMA Grants

• Novartis
• Clinical Trials
• Wyeth
• Network characterization research
• Sanofi Aventis
• Muscoskeletal Diseases and the Aging population
• Glaxo Smith Kline
• Asthma characterization in the network
• CME about new asthma care guidelines

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Donor Development

• Currently working with our Hospital and Health
  Sciences Development Staff to identify potential
  local corporate and individual donors.

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Infrastructure Support
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Financial Goals

• Goal 1 Diversify Funding
• Individual Donor Support
• Foundation Grants
• Corporate/PHARMA Money
• Goal 2 Two NIH Funded Grants
• Goal 3 Four NIH/AHRQ proposals submitted
• Goal 4 Fee for Service fully implemented