CLINICAL & TRANSLATIONAL SCIENCE AWARDS The Importance of Community Engagement J. Lloyd Michener, MD Professor and Chair Director, Duke Center for Community

CLINICAL & TRANSLATIONAL SCIENCE AWARDSCLINICAL & TRANSLATIONAL SCIENCE AWARDS

The Importance of Community EngagementThe Importance of Community Engagement

J. Lloyd Michener, MDProfessor and Chair

Director, Duke Center for Community ResearchDepartment of Community and Family Medicine

Duke University School of Medicine

Ohio State UniversityDepartment of Family Medicine

January 22, 2009

Re-engineering Clinical ResearchRe-engineering Clinical Research

BenchBench BedsideBedside PracticePractice

Building Blocks and Pathways•Molecular Libraries•Bioinformatics•Computational Biology•Nanomedicine

TranslationalResearchInitiatives

• Integrated Research Networks• Clinical Research Informatics • NIH Clinical Research Associates• Clinical Outcomes

Interdisciplinary Research Innovator Award

Public-Private Partnerships

Cross-cutting: Harmonization, Training

NIH Clinical and Translational Science Awards NIH Clinical and Translational Science Awards . . . and Beyond. . . and Beyond

Catalyze change - break silos, break barriers, and break conventions

Advance the new intellectual discipline of clinical and translational science

Integrate resources and training

Identify and remove impediments to clinical and translational science

Clinical and Translational Science Award (U54)

Trans-NIH collaboration

First RFA released October, 2005

reviewed in summer of 2006 for October 2006 funding

U54 mechanism

Cooperative agreement between awardee academic institution and NIH

Multi-faceted research program

Complex award mechanism: Combined U54, T32 and K12

5 year award

MT

WY

ID

WA

OR

NV

UT

CA

AZ

ND

SD

NE

CO

NM

TX

OK

KS

AR

LA

MO

IA

MNWI

IL IN

KY

TN

MS AL GA

SC

VAWV

MI

PANJ

MA

ME

VTNH

AK

HI

UC, Davis

Duke

UCSF

University of Rochester

OHSU

UT, Houston

Mayo Clinic

Columbia

Yale

OH

University of Washington

Emory

University of Iowa

University of Michigan

Washington University, St. Louis

Vanderbilt

Weill Cornell

FL

Since 2007

Since 2006

University of Chicago

RockefellerUniversity of Pennsylvania

Johns Hopkins

UT Southwestern

Case Western Reserve

NY

University of Wisconsin

Participating Institutions

University of Pittsburgh

Building a National CTSA Consortium

Stanford

Scripps

Univ. of Utah

Univ. of Colorado

HarvardBoston UniversityTufts University

OSU

UNC

Univ of Alabama at Birmingham

Indiana University

Northwestern

UT San Antonio

Albert Einstein

Since 2008

Trial Design

Advanced Degree-Granting

Programs

Participant& CommunityInvolvement

RegulatorySupport

Biostatistics

ClinicalResources

BiomedicalInformatics

ClinicalResearch

Ethics

CTSAAcademic Center

NIH & other government

agencies

Healthcare organizations

IndustryIndustry

Key Functions

Strategic Planning

Goal One: Enhancing National Clinical and Translational Research Capability

clinical research management research infrastructure phenotyping - human and preclinical models

Goal Two: Enhancing the Training and Career Development of Clinical and Translational Scientists

Strategic Planning

Goal Three: Enhancing Consortium-Wide Collaborations

National Resource Inventory Data Sharing Network Social Networking Initiative

Goal Four: Enhancing the Health of Our Communities and the Nation

National Model for Community Engagement Inform Public Health Policy Through Research

Consortium Governance & Organization

Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf

Recent CTSA Community Engagement Activities

Established 4 topic-based workgroups:

Community-Based Academic and Practice partnership Workgroup

Education Workgroup Resource Development Regional Workshops Workgroup

Workshop May 9, 2008 in Bethesda, MD: “Accelerating the Dissemination and Translation of Clinical Research into Practice”

May 14-15, 2009 NIH workshop: “Improving Health WITH Communities: The Role of Community Engagement in Clinical and Translational Research”

5 Regional Workshops 2008 Jointly Sponsored by NCRR and APTR/CDC:

http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf

Supplemental ProjectsConsultation Service

Provide consultation for each CTSA to strengthen community practice links

PRIMER

Practice network research infrastructure needs among CTSAs

Recent CTSA Community Engagement Activities

CTSAWeb.org

The Duke Center for Community Research (DCCR)Moving the Community from Subject to

Collaborative Partner Goal:

Improve the health of the community through:

Community engagement in research

Integration of practices into research structure

Linking communities, practices, researchers

Components:

1. Community Research Liaison Center

2. Community Health Research Training Center

3. Electronic Health Record

4. Demonstration Projects

DTMI Faculty Leadership

DTMI Administration

DCCRDCRIDTRI

Oddone (K30), Bastian (T32), Hamilton (K12)

McKinney, Burks, McHutchison, Turner

Cuffe, McKinney, Szczech

St. Geme, Li, Benjamin

Cooke-Deegan, Beskow

George

Pietrobon, Krishnan, Ahmad, Cuttechia

Ginsburg, Weinhold, Kurtzberg, Guilak, Charles, Dewhirst, Toone, Hauser

Gilliss

Sullenger Harrington, Schulman, Peterson, McHutchison

Michener, Yaggy,Gilliss, Miranda

DTMI Administration

DCCRDCRIDTRI






George



Gilliss



DTMI Administration

DCCRDCRIDTRI

Education and Training

DCRU

Duke as a Site

Pediatrics

Ethics

Biostatistics

Biomedical Informatics

Core Laboratories

Nursing

New molecule

Preclinical dev.

First-in-human

Phase II/III

Application in the communityNew molecule

Preclinical dev.

First-in-human

Phase II/III

Application in the community

DTMI Organizational Structure DTMI Faculty Leadership

DTMI Administration

DCCRDCRIDTRI






George



Gilliss



DTMI Administration

DCCRDCRIDTRI






George



Gilliss



DTMI Administration

DCCRDCRIDTRI

Education and Training

DCRU

Duke as a Site

Pediatrics

Ethics

Biostatistics

Biomedical Informatics

Core Laboratories

Nursing

New molecule

Preclinical dev.

First-in-human

Phase II/III

Application in the communityNew molecule

Preclinical dev.

First-in-human

Phase II/III

Application in the community

DTMI Organizational Structure

Regulatory Affairs

Project Leaders and the Portal Office

1. Community Research Liaison Center The connection between Duke and local

communities, practices, and organizations

A virtual library:

For researchers to learn about communities

For community groups to learn about themselves

For practices to identify opportunities for improvement Outreach and training to assist communities with data and to

connect communities with researchers

Status: 23 grants funded, submitted or under development

14 community-wide health committees staffed

2. Community Health Research Training Center

Train and prepare researchers and learners to work successfully with communities

• Electronic training modules

• On-site training programs

Status: required training for clinicians and researchers begun with online modules and classes (2500 trained to date)

www.aamc.org/mededportalgo to “Find Resources”; enter keyword: community engaged research

http://www.aamc.org/mededportal

3. Electronic Health Record Covers citizens of Durham County

Captures data for Durham County

Develop analytic techniques

Data capture and co-variates

Meshing advanced laboratory data with long term outcomes

Produce improvement of community health status

Status: Implemented in Duke practices, data analyses underway with community partners

4. Demonstration Projects Pilot projects to see if teams of community groups,

clinicians, and researchers can improve health

$ 1 million for 1 year for planning

RFA for pilot projects released Summer 2008. Requirements:

Input, support, and commitment from community Well-integrated design for prevention/care; Budget that demonstrates effective use of resources; Evaluation plan that establishes measurable markers

Project Status

Projects: Adolescent Health Asthma Breast Cancer Cancer Cardiovascular Disease Chronic Kidney Disease Diabetes Diabetes HIV/AIDS Insurance for Small Businesses Maternal/child health

Obesity (0-5) Obesity (Latinos) Obesity and Wellness Organ Donation Pain Management Prostate Cancer Seniors (Aging in Place) Seniors (Fall Prevention) Substance Abuse Substance Abuse (Youth) Youth Violence

Number of Proposals Received: 22Number of Team Members: 413

•Duke affiliated: 237 (57%)•Durham: 176 (43%)

Number of Community Agencies, Organizations, and Businesses Represented: 90

More information:

CTSA: http://www.ctsawiki.org/wiki Community Engagement Training Modules:

www.aamc.org/mededportal

go to “Find Resources”; enter keyword: community engaged research

Durham Projects: http://forms.dukehealth.org/dccr/dtmi.nsf/rfp

Michener JL, Yaggy S, Lyn M. Warburton S, Champagne M, Black MA, Cuffe M, Califf R, Gilliss C, Williams RS, Dzau VJ. Improving the Health of the Community: Duke’s Experience with Community Engagement. Acad Med. 2008; 83:408-413

Principles of Community Engagement CDC/ATSDR Committee on Community Engagement Centers for Disease Control and Prevention Public www.cdc.gov/phppo/pce

http://www.ctsawiki.org/wiki

http://www.aamc.org/mededportal

http://forms.dukehealth.org/dccr/dtmi.nsf/rfp

New Challenges Require New Solutions…

…Solutions that Combine Innovation with Community Engagement

Documents

CLINICAL & TRANSLATIONAL SCIENCE AWARDS The Importance of Community Engagement J. Lloyd Michener, MD Professor and Chair Director, Duke Center for Community