tools for building research infrastructure at health centers jonathan n. tobin, phd clinical...
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Tools for Building Research Infrastructure at Health Centers
Jonathan N. Tobin, PhDClinical Directors Network (CDN)
The Rockefeller University Center for Clinical & Translational Science
(CCTS)[email protected]
www.CDNetwork.org/Rockefeller www.Rockefeller.edu/ccts/communityengagement
Presented at NACHC – CHI August 22, 2013 Chicago IL
CDN: Past, Present & Future
• An informal network of clinical leaders who practice as primary care clinicians in low-income and minority communities
• A research and educational organization• A means to translate clinical research into clinical practice
www.CDNetwork.org 2
Practice-based Research Clinical Leadership & Sustained Clinician Engagement Early & Significant Community Engagement
Education and Training Quality Improvement Professional Development PBRN Research Infrastructure
Primary Activities
Practice-based Research Network (PBRN) Primary Health Care Safety-net Practices& Center of Excellence
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NIH Roadmap Initiative Designated “Best Practice” Clinical Research Network (2006)
AHRQ Designated “Center of Excellence” (P30)For Practice-based Research and Learning (2012)
US Department of Health & Human Services Regional Health Administrator’s Award “Outstanding Contribution Toward the Elimination of Racial and Ethnic Disparities in Health” (2001)
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Accelerating Research Translation
Funded in part by AHRQ Grant #1 P30-HS-021667
NIH-National Center for Advancing Translational Sciences to The Rockefeller University (NIH-NCATS Grant #8 UL1 TR000043)
CTSA Administrative Supplement Award (2011) to The Rockefeller University Center for Clinical and Translational Science (CCTS)
and Clinical Directors Network (CDN)and by HRSA (CHARN)
www.CDNetwork.org
CDN N2-PRN Building a Network of Safety Net PBRNs
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A collaboration among:
Access Community Health Network (ACCESS)Alliance of Chicago (ALLIANCE)
Association of Asian Pacific Community Health Organization (AAPCHO)Center for Community Health Education Research and Service (CCHERS)
Clinical Directors Network (CDN)Community Health Applied Research Network (CHARN)
Fenway Institute (FENWAY)New York City Research and Improvement Group (NYCRING)
Oregon Community Health Information Network (OCHIN)
Funded by AHRQ Grant: P30 HS 021667Principal Investigator: Jonathan N. Tobin, PhD
Project Officer: Rebecca A. Roper, MS, MPHDirector, AHRQ PBRN Initiative
N2 LEARNING COLLABORATIVE
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933 online viewers to dateVisit: www.CDNetwork.org933 online viewers to date
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CDN N2-PBRN LEARNING COLLABORATIVE TRACK:
PBRN INTRODUCTION TO RESEARCH
Funded by: AHRQ; Grant No. 1 P30-HS-021667
Social Determinants of Health: Important Considerations for Medically Underserved Community Health Center PatientsFeatured PBRN: Association of Asian Pacific Community Health Organizations (AAPCHO) An Update on Community-Based HIV Prevention Research and ApplicationsFeatured PBRN: The Fenway Institute, Boston MA Integrating Patient Reported Outcomes into Clinical Care: HIV as a Case StudyFeatured PBRN: The Fenway Institute, Boston MA
Introduction to Collaborative Community-based ResearchFeatured PBRN: National Association of Community Health Centers (NACHC) and Lutheran Family Health Center (Incubator PBRNs) and Clinical Directors Network Inc., (CDN), NY, NY
Stakeholder Feedback on Community Engaged Research in the CTSA ProgramFeatured PBRN: Center for Community Health Education, Research and Service (CCHERS)Friday, August 9, 2013, 2:00-3:00pm EDT
Funded by: AHRQ; Grant No. 1 P30-HS-021667
Young African American Men and HIV: An Interactive Response to a Community Health IssueFeatured PBRN: Access Community Health Network, Chicago, ILThursday, June 27, 2013, 12:00-1:00pm EDT
The Bronx Ongoing Pediatric Screening (BOPS) Initiative: Lessons Learned from a Large Scale Initiative to Enhance Screening in Urban Primary CareFeatured PBRN: New York City Research and Improvement Group (NYC RING)
From Bench to Bedroom: Testing and Translating Behavioral Interventions from Research into PracticeFeatured PBRN: National Association of Community Health Centers (NACHC) (Incubator PBRN) and Clinical Directors Network Inc., (CDN), NY, NY
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Patient-Centered Medical Home: Using the EMR to facilitate PCMH TransformationFeatured PBRN: Alliance of Chicago Community Health ServicesThursday, Sept 12, 2013, 1:00-2:00pm EDT
Preparing for Meaningful Use Stage 2Featured PBRN: Alliance of Chicago Community Health ServicesTuesday, July 30, 2013, 2:00-3:00pm EDT
The Research Potential of an EHR-Based Network: Lessons from the OCHIN PBRNFeatured PBRN: Oregon Community Health Information Network (OCHIN)
Funded by: AHRQ; Grant No. 1 P30-HS-021667
CDN N2-PBRN
Community Health CentersHospitals
South Texas Ambulatory
Research Network (STARNet)
Clinical Directors Network
(CDN)
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Access Community Health Network
(ACCESS)
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Lutheran Family Health Centers
(LFHCs)Incubator PBRN
Hudson River
Health Care
Urban Health
Plan
Brookdale Family Care
Center
Open Door
Family Health Center
Manhattan Physician’s
Group – 95th Street
Manhattan Physician’s
Group -125th Street
Park Slope LFHC
Family Physician
LFHC
Kling Adult
Medicine
Madison Family Health
Trevino Family Clinic
University Health System
• National Association of Community Health Centers (NACHC)• Clinical and Translational Science Institute at Children’s National• George Washington University (GWU)• Clinical Directors Network (CDN)• Alexandria Neighborhood Health Services• Mission Life Center• Mary's Center for Maternal and Child Care• Unity Health Care
DC Research Collaborative Lutheran Family Health Center (LFHC)Brooklyn, NY
Research Training for Clinical Leaders
Epidemiology and StatisticsStudy Design and Implementation
Grant Writing and IRB
Team Intervention Projects:• Hepatitis C/HIV Screening• Childhood and Teen Obesity• Teen Pregnancy and Contraception• Diabetes Type II
Lutheran Medical CenterClinical Directors Network, Inc.
RESEARCH TRAINING FOR CLINICAL LEADERS 2012-2013
Goals:• To enable practicing clinicians to develop their research interests and skills,
through didactics on the scientific and statistical aspects of study design (quantitative and qualitative) as well as through hands-on experience in preparing and implementing a research project
• To provide technical assistance in grant-writing and identifying potential funding sources, including training exercises and assistance in developing budgets, staffing plans, work-scopes, and timelines
• To develop and provide oral and written research dissemination/presentation skills (scientific, clinical and lay) at local, regional and national forums
• Co-Directors: Nonkulie Dladla, MD, MS Lutheran Family HealthCare Jonathan N. Tobin, PhD CDN /The Rockefeller University Center for Clinical & Translational Science
• Facilitator: Maria Dziok, PhD, Clinical Directors Network, Inc. (CDN)
Research Training for Clinicians Course Goals
• Study Design and Implementation– To enable practicing clinicians to develop their research
interests and skills, through didactics on the scientific and statistical aspects of study design as well as through hands-on experience in preparing and implementing a research project
• Epidemiology and Biostatistics– To develop and provide oral and written research
dissemination/presentation skills at local, regional and national forums
• IRB/Human Subjects Protection– IRB Application– Informed Consent
• Grant Writing – To provide technical assistance in grant-writing and
identifying potential funding sources, including training exercises and assistance in developing budgets, staffing plans, work-scopes, and timelines
• 60 CME/CNE/CDE Credits for Participation
• Developing study questions and interventions• Calculating sample size• Identifying dependent and independent
variables, and covariates• Patient-centered, clinical, laboratory, public
health• Recruiting and retaining patients• Health disparities and cultural competence• Intervention and Fidelity Monitoring • Engaging Stakeholders• Interactive Experiences
• Participated in qualitative research/focus groups• Participated in the informed consent process
Study Design and Implementation
• Prevalence and Incidence• Odds Ratio (OR), Relative Risk or Risk Ratio (RR)• Significance Testing, p-values, Confidence
Intervals• Validity and Reliability• Bias and Confounding• Types of Analysis• Power, Sample Size, and Effect Size• Sensitivity and Specificity • Using Statistical Software (CDC EpiInfo)
Epidemiology and Biostatistics
A Review of Types of Study Designs• Prevalence/Surveys• Cross-sectional• Retrospective• Case Control• Prospective Cohort• Historical Cohort• Randomized Controlled Trial (RCT)
• Site level (Cluster RCT) vs. patient level• Comparative Effectiveness Research (CER) • Patient Centered Outcomes Research (PCOR)
• Qualitative/Focus Group• Mixed Methods (Qualitative/Quantitative)
A Review of Study Designs
http://sph.bu.edu/otlt/MPH-Modules/EP/EP713_AnalyticOverview/EP713_AnalyticOverview7.html
Biomedical Informatics
Biomedical Informatics Methods,Techniques, and Theories
Bioinformatics ImagingInformatics
Clinical Informatics
Public HealthInformatics
Molecular and
Cellular Processes
Tissues and
Organs
Individuals (Patients)
Populations and
Society
Basic Research
Applied Research
Grant Writing• Literature searches using PubMed• Patient Centered Outcomes Research Institute (PCORI)• Biosketch development• Drafting Specific Aims, Hypotheses, Analysis Plans• Identifying Funders – Using Foundation Center Resources• Grant development and submission
Human Subjects Protection & IRBs• Writing an Informed Consent Form• Conducting Informed Consent Interview (role play)• Preparing an IRB Application
Recommended TextsPrimary Text:SB Hulley, SR Cummings et al., Designing Clinical Research: An Epidemiologic Approach (NY: Lippincott Williams & Wilkins; 2nd Ed.
2001)
Additional/Supplemental Texts & Resources:• Leon Gordis Epidemiology (Philadelphia PA: Saunders Elsevier, 2009 4th Ed)• N Krieger Epidemiology for the People (New York NY: Oxford, 2010) • RS Greenberg, SR Daniels, WD Flanders, JW Eley, JR Boring III Medical
Epidemiology (4th Ed) (New York NY: Lange/McGraw Hill, 2005)• RM Merrill Introduction to Epidemiology (Boston MA: Jones and Bartlett,
2010, 5th Ed)• Univ of Pittsburgh - Epidemiology Super Course www.pitt.edu/~super1 • Univ of North Carolina – Epidemiology eText www.epidemiolog.net• CDN Clinical Research Track www.CDNetwork.org• Rockefeller Webcasts www.CDNetwork.org/Rockefeller
http://muse.jhu.edu/journals/progress_in_community_health_partnerships_research_education_and_action/toc/cpr.6.3.html
Building a Stronger Science of Community Engaged Research
Guest Editors:• Milton Eder, PhD (ACCESS Community Health Network)• Michelle Proser, MPP(NACHC)• Peter Shin, PhD(GWU)• Jonathan N. Tobin, PhD(CDN/Rockefeller Univ.)
Sponsors:• AHRQ• CDN• GWU• NACHC• RCHN• HENRY SCHEIN
NATIONAL CENTER FOR HEALTH STATISTICS (NCHS)
www.cdc.gov/DataStatisticswww.cdc.gov/nchs/data_access/ftp_data.htmwww.cdc.gov/nchs/dhcs/dhcs_surveys.htm • NATIONAL HOSPITAL DISCHARGE SURVEY (NHDS)
www.cdc.gov/nchs/nhds.htm • NATIONAL AMBULATORY MEDICAL CARE SURVEY (NAMCS)
www.cdc.gov/nchs/ahcd.htm • NATIONAL HEALTH EXAMINATION & NUTRITION SURVEY
(NHANES)www.cdc.gov/nchs/nhanes.htm
• NATIONAL HEALTH INTERVIEW SURVEY (NHIS)www.cdc.gov/nchs/nhis.htm
• BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM (BRFSS)• YOUTH BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM
(YBRFSS)
www.cdc.gov/brfss
www.CDNetwork.org
CDN Webcast Series• Health Care Acquired Infection Prevention for Ambulatory
Surgical Centers• Train-the-Trainer Workshop in Infection Prevention for
Ambulatory Surgical Centers • www.CDNetwork.org/HAI• The Rockefeller University Center for Clinical and Translational
Science (CCTS) Series• www.CDNetwork.org/Rockefeller• Howard University College of Medicine AIDS Education and
Training Center-National Multicultural Center Cultural Competence Series
• www.CDNetwork.org/AETCNMC • RCHN Community Health Foundation• www.CDNetwork.org/RCHN
CDN Resource Libraries & Toolkits
www.CDNetwork.org
• Improving Colorectal Cancer Screening Rates among NYC Russian Speaking Communities
• Sponsored by: NYC Dept. of Health and Mental Hygiene
• www.CDNetwork.org/RussianCRC• Online Guidelines & Clinical Decision Support Tools • Sponsored by: NYC Dept. of Health and Mental Hygiene
• eClinician.org•Research Training Catalog for Federally
Qualified Health Centers (FQHCs)• Sponsored by: NACHC, GWU, Children’s CTSI
•www.CDNetwork.org/NACHC
• CER Comparative Effectiveness Research
• PCOR Patient Centered Outcomes Research-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
• CEnR Community-Engaged Research
• CBPR Community-based Participatory Research-------------------------------------------------------------------------------------------------------------------------------------------------------------------------
• PBRN Practice-based Research Networks
Types of T2 T3 T4 Research
Models of Practice-Based Research
• Top-Down– Researcher-focused– Funder-focused
• Bottom-up– Clinician-focused (PBRN)– Patient-focused (CBPR)
• Mixed Model (Bi-directional)
Clinician Researcher38
CHALLENGES FOR PBRNSCHALLENGES FOR PBRNS
A common aim behind Comparative Effectiveness Research (CER) and Practice-based Research Network (PBRN)-conducted research is to produce new evidence-based medical knowledge that fills gaps between primary care practice realities and findings produced by academic/tertiary-care research and clinical trials
Less control over Patient characteristicsVariability in practice clinical and research capacityMultiple IRBs Significant resource problems that impede research
Other challenges include: selecting studies that meet network goals and objectivesworking within an adequate and sufficient budgetdeveloping study teams and agreements among team members training practice staff for participation
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SOURCE: Westfall, et al., “Practice-Based Research—“Blue Highways’ on the NIH Roadmap”JAMA 2007; 297: 403-406
Translational Research & NIH “Blue Highways”
T4T4PublicPublicHealth Health ImpactImpact
Stages of CBPR vs. Key Steps in PCTs
MacPherson H. Pragmatic clinical trials. Complementary Therapies in Medicine. 2004. 12:136-140.
CBPR PCTs (MacPherson)
1. Selecting a research question 1. Appropriate research question
2. Designing the study
2. Defining the patient group
3. Identify a comparison group
4. Defining the treatment protocol
3. Recruiting patients5. Ensuring adequate sample size
6. Referral, recruitment and randomisation
4. Conducting the study 7. Outcomes
5. Analyzing the data 8. Analysis
6. Publishing, presenting, and disseminating the results7. Spread and sustainability
9. Reporting and dissemination
Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool
Thorpe KE et al. A pragmatic-explanatory continuum indicator summary tool (PRECIS): a tool to help trial designers. CMAJ 2009; 180(10):E47-57.