Tools for Building Research Infrastructure at Health Centers

Jonathan N. Tobin, PhDClinical Directors Network (CDN)

The Rockefeller University Center for Clinical & Translational Science

(CCTS)JNTobin@CDNetwork.org

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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N2 LEARNING COLLABORATIVE

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933 online viewers to dateVisit: www.CDNetwork.org933 online viewers to date

Visit: www.CDNetwork.org

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)

+ +

Access Community Health Network

(ACCESS)

+

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

www.hrsa.gov/data.htm

http://datawarehouse.hrsa.gov

http://quickfacts.census.gov/qfd/states/00000lk.html

www.CDNetwork.org/

CME accredited through AAFPCDE accredited through AGD

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

www.CDNetwork.org/NACHC

www.CDNetwork.org/NACHC

Step 1: Getting Started

www.CDNetwork.org/NACHC

Step 3: Asking the Right Questions

www.CDNetwork.orgwww.eClinician.org

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• 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.

1. Hatch J, Moss N, Saran A et al. Community research: Partnership in Black communities. American Journal of Preventive Medicine. 1993 Nov-Dec;9(6 Suppl):27-31; discussion 32-34.

Four-Stage Model of Community-Engaged Research