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Opportunities & Challenges for Comparative Effectiveness ResearchEngaging the Community to Enhance CER

Lucy A. Savitz, Ph.D., MBAJanuary 26, 2009lucy.savitz@imail.org

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Objectives

Participants will acquire a foundational knowledge of the policy implications and priorities for CER in the U.S.

Participants will be familiarized with the various steps across the research process--from development/design through dissemination--and strategies for actively engaging in CER activities

Participants will be provided with resources to support active engagement in CER.

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Value to Clinical Researchers

Clinicians represent a vital community to actively engage in comparative effectiveness research (CER) for3 primary reasons:

1. the quality of the CER is enhanced (meeting real clinical needs/priorities), strengthening the evidence base for practice;

2. there is direct translation of the research into practice; and

3. they see the direct utility of CER results.

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Institute of Medicine (IOM) ReportReleased June 30, 2009

      

The purpose of CER is to assist

consumers, clinicians, purchasers, and policy makers to make informed decisions thatwill improve health care at both the individual and population levels. Comparative Effectiveness Research (CER)

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IOM’s CER Working Definition

CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.

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100 Research Priorities Identified

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CER Challenges Which questions are most appropriately

answered by trials vs. which ones are best answered via observational study design?

How do observational studies extend RCTs?

What are the core team credentials & strategic issues required for winning awards?

Can we enhance the evidence base?Knowing What Works in Health Care (www.nap.edu)

What do various “community” members want and need to know?

How do we effectively engage the “community?”

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What is a “Community?”

A group of people linked by social ties who share common perspectives or interests, and may also share a geographic location (MacQueen et al)

Examples of communities• Utah County residents• Somali immigrants• Persons with AIDS • Primary care physicians in Southern Utah• And many others….

Communities are not homogeneous and seldom speak with a single voice

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CER Funding to Date Omnibus Appropriations Act, 2009

$50 million to AHRQ

American Recovery and Reinvestment Act (ARRA) of 2009 $1.1 billion• $300 million for AHRQ• $400 million for NIH• $400 million to Secretary

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Funding Mechanisms

Investigator Initiated

Indefinite Delivery/Indefinite Quantity (IDIQ) or Master Task Orders• DEcIDE

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DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network

University of Colorado Center for Health Outcomes is prime

AHRQ has indicated that they will distribute the bulk of CER $ via DEcIDE

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Rocky Mountain Center for CER University of Utah--CCTS CE

Intermountain Healthcare

SLC VA Medical Center

University of Colorado

Denver Health

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Clinical Translational Science Award or CTSA http://www.ctsaweb.org/

Funded by National Institutes of Health (NIH)

46 medical institutions in 26 states University of Utah Center for Clinical &

Translational Science (CCTS)•9 Core areas: Administration; Novel Clinical & Translational Methods; Biomedical Informatics; Biostatistics; Participant & Clinical Interactions; Patient Care; Community Engagement; Translational Technologies & Resources; Research Education, Training & Career Development

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CTSA Purpose

To improve the way biomedical research is conducted nationwide.

Consortium members share a common vision to reduce the time it takes for laboratory discoveries to become treatments for patients, to engage communities in clinical research efforts, and to train clinical and translational researchers.

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CE Core: Primary Functions

Serve as:• Collaboration liaison• Knowledge connector (bidirectional exchange)• Outreach service

GIVE ME A PLACE TO STAND AND I WILL MOVE THE EARTHGIVE ME A PLACE TO STAND AND I WILL MOVE THE EARTH

A remark of Archimedes quoted by A remark of Archimedes quoted by Pappus of Alexandria

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CCTS Community Engagement (CE) Core Leadership

• Lucy Savitz, Ph.D., MBA, Director• Louisa Stark, Ph.D., Associate Director• Steve Alder, Ph.D., Technical Advisor

Leveraging resources to support participatory research and training

Annual pilot projects & administrative supplements

Creation of the Rocky Mountain Center for Comparative Effectiveness Research

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CCTSCE

Core

NationalCTSA

Service

KnowledgeExchange

CommunityReps

OrgCommunity

RMCCER

OtherCCTSCores

DenverHealth

COHO

SLCVAMCInter-

mountain

COCTSI

National CTSA KFCs:

CE KFC

Community Partners Integration

Outcomes of CE

Educational Competencies

CTSA Strategic Goal 4a & 4b

Local Consults/Mentoring

AHRQ ACTION

AHRQ DEcIDE

Rocky Mountain Center for ComparativeEffectiveness Research (RMCCER)

COHO: Colorado Health Outcomes Program, University of Colorado at Denver

KFC: Key Function Committee

VAMC: Veterans Affairs Medical Center

DenverVAMC

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A regional, multi-state consortium of vertically integrated health care organizations and translational research programs designed to leverage state-of-the-art, existing QI and HIT capacities to support a collective goal of collaborative, comparative effectiveness research in diverse populations, health care settings, and information technology environments; actively bridging the participatory research perspective with:• state-of-the-art technology and •scrupulous adherence to rigorous application & advancing CER methods.

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CCTS Community Engagement 2010 Goals1. Serve as a connector to bring together academic, institutional,

governmental and community organizations that are working on complementary programs; submit at least one application for external funding to support this work.

2. Continue to build and sustain our regional CTSA collaboration via RMCCR; produce at least two funded projects and two manuscripts submitted for publication. 

3. Actively contribute to national CTSA activities via Key Function Committee participation and attendance at national and regional meetings.

4. Measurably provide consultation and technical assistance for translational research related to bi-directional community engagement.

5. Work with communities to identify meaningful and valuable knowledge exchange opportunities; implement at least 2 of

these “events”.  

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Research Training Resources

CER Certificate at the University of Utah (forthcoming)

K award proposal submitted by Carrie Byington (pending)

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Why are we talking about “community engagement?”

Deficiency in traditional research approaches

~98% of Americans receive their health care outside of academic medical centers

The challenge of “translational research”

• How to reach Dr. Smith and Billy in Delta, UT?

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The Translational Research Continuum

Basic BiomedicalDiscovery

Clinical Efficacy

ClinicalEffectivenessClinical Practice

T1

What works under controlled conditions?

(Up to phase III trials)

How can we change practice?(Dissemination and

Implementation Research)

What is the effect on population health?

(Outcomes research)T2

T3

T4

“Bench” “Bedside”

CommunityPractices

CommunityPractices

What works in real world settings?

(e.g., Comparative Effectiveness

Research)

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“Community engagement” as a key component of translational research

How to reach Dr. Smith and Billy?

• Include them in the research process

The NIH response• Roadmap, CTSA, etc.

Issues arise…• The ethics of conducting

research in communities - e.g., who benefits? unique needs/requirements?

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What is “Community Engagement”?

…community engagement is a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar situations to address issues affecting the well-being of the community of focus.

NIH Council of Public Representatives, October 2008

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Unpacking Community Engagement…

A broad framework that includes the full spectrum of approaches that involve the community in the research process

• Includes research ranging from that which incorporates only a few elements of community engagement with minimal collaboration to research in which community organizations and researchers are equal partners throughout the process

Builds on community strengths

Emphasis on partnerships and collaboration

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Traditional Research Approach

Researcher writes article, obtains academic rewards, thanks community (sometimes)

Researcher or funding source identifies problem

Researcher writes protocol, selects community to be studied, obtains funding

Researcher recruits subjects from the community

Researcher collects and analyzes data

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Community-engaged Research Approaches

Problem identified of interest and relevance to the community

Protocol tailored to specific community of interest, funding obtained and shared as appropriate

Community members are participants in research, not just subjects

Data analyzed and collected with community input as appropriate

Results disseminated to both the academic world and the community

Studies that recruit subjects in community settings are not necessarily community-engaged

CO

MM

UN

ITY

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Identifying research topic• Community members or researcher may make the initial

approach• Example – chronic pain in Native Americans

• Researcher and community may work together to refine

Plan developed and funding secured• Researcher contributes scientific expertise• Community also contributes;

• Ideas on logistics and recruitment• Advice on tailoring for community context

• Community receives research funds as appropriate

Examples of community-engaged research approaches

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Study conduct• Community members involved as appropriate

• e.g., hire study staff• Promote study within the community• Advice on study problems

Data analysis and reporting• Involvement of community as appropriate

Dissemination of results to the community and to the academic world

• Community determines appropriate/relevant media for their members

Examples of community-engaged research approaches

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Community-based Participatory Research (CBPR)

One end of the community-engaged research spectrum

Equitable partnership between researcher and community in all research phases

Community identifies the problem to be addressed

Aims at achieving meaningful changes that will directly improve community health

Requires major investments of time and energy in building the relationships necessary for successful partnerships

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Challenges of community-engaged research approaches

Requires considerable investment of time and energy to build relationships

• And any relationship has high and low points….• Trust is essential

Community priorities may not reflect your research priorities

Community may have little capacity/experience with research and follow a different timeline

Funding mechanisms/study sections may be unfamiliar with these approaches

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Benefits of community-engaged research approaches

Can improve reliability and validity of study tools and procedures

Helps recruitment and study flow

Results more likely to be relevant

May improve external validity

Minimizes translation burden

Expanded opportunities for funding• NIH expanding RFAs• Foundation funding

Relationships have their own rewards

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Successful Community-engaged Researchers…

View community partners as knowledgeableand important contributors to research

Acknowledge that they and community members bring their own beliefs to research

Think that the beliefs and values of community members should be recognized

Value relationships with the community as one of the benefits of research

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Value of Research Partnerships Research partnerships can engage multiple

entities to enhance the generalizability and potential for modeling and spread of results.

Successful partnerships are engaged beyond a one-time research opportunity and are able to keep the flame of change burning and build a critical mass for change

Interaction & engagement is bi-directional

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Definitions Research partnerships are broadly defined to

include inter-organizational relationships where resources are shared to advance a collective purpose—in this case, applied, participatory research.

Participatory research then “… is an approach that involves all potential users of the research and other stakeholders (as partners)

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Foundation for Participatory Research The rich tradition of participatory research is

anchored in community development and since the mid1960s, has been embraced in• social, educational, health services, and public health

research.

Therefore, the literature or evidence base for participatory research is dispersed

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Organizational-Based Participatory Research (OBPR)

a subset of CBPR

OBPR is distinctly culled out to describe collaborative work among organizational research partners are engaged around a shared problem or goal to improve the quality of care and, ultimately, patient outcomes.

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Framework for Assessing Partnership Strength

Leadership &Management

Critical Characteristicsof the Process

•IndividualEmpowerment•Social Capital•Synergy

CollaborativeProblemSolving

Learning fromDemonstrated Research Endeavors thatGenerate Evidence

Mapping Organizational Needs to Identified Collaborative Projects

Adapted from RD Lasker & ES Weiss, Journal of Urban Health, 2003—Model of Community Health Governance

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Evidence: Knowledge that is…

Explicit (codified)

Systematic (with transparent & explicit methods)

Replicable

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Framework for the Continuum of Translational Research

T1

T2

T3

T4

seeks to move a basic science discovery into a candidate health application

assesses value of application for health practice leading to development of EB guidelines

attempts to move EB guidelines into health practice

assesses "real world" health outcomes of application in practice

Increasing community engagement

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Conducting real-world, CER that engages the community.