Engaging Communities of Color in Aging Research

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Engaging Communities of Color in Aging Research

• Giselle Corbie-Smith, MD
• University of North Carolina Chapel Hill
• Program on Health Disparities
• Sheps Center for Health Services Research
• NC Translational and Clinical Science Institute

2
Overview

• How did we get to mandated inclusion?
• Are older minorities underrepresented in
  research?
• Influences on participation of older minorities
• Role of community engagement

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How Did We Arrive at Mandated Inclusion?

• Public reports of ethical misconduct raised
  concerns about vulnerability in research
• Nuremberg Trials
• Willowbrook Study
• Jewish Chronic Disease Hospital
• US Public Health Study at Tuskegee
• Belmont Report reinforced the need to protect
  groups considered vulnerable by physical, mental
  or social and economic circumstances

4
How Did We Arrive at Mandated Inclusion?

• Little public pressure to enter clinical research
  due to perception of high risk and low benefit
• HIV/AIDS became a pivotal event in research
  participation
• Research seen as offering best and least costly
  hope to victims
• AIDS victims campaigned to gain admission to
  clinical studies
• Shift in clinical research being considered a
  risky burden to a prized benefit from which no
  one should excluded

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Why Worry About Minority Inclusion in Clinical
Research

• 1993 NIH Revitalization Act
• Participation of racial and ethnic minorities in
  clinical trials is critical for understanding and
  eliminating racial and ethnic health disparities
• to better understand disparities in health
• to improve the generalizability of research
  findings
• Clinical research drives advances in medical care
• You gotta be in it to win it

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Minority Enrollment for NIH Extramural Phase III
Research Protocols(Reported in FY 2003)
Percentage
of protocols 5153 n 9,378,140
Dept. of Health and Human Services, (2004).
Comprehensive Report Tracking of Human Subjects
Research Reported in FY 2002 and FY 2003.
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Enrollment of nonwhites in heart failure
randomized
controlled trials
Heiat A, Gross CP, Krumholz HM. Arch Intern Med.
2002 162(15)1684.
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Barriers to Accrual

• Barriers to awareness
• Lack of education about trials
• Lack of dissemination of study opportunities to
  patients/providers
• Lack of knowledge about the origins of cancer
• Barriers to opportunity
• Cost
• Functional status
• Studys duration and visit structure
• Time commitment
• Lack of or inadequate health insurance
• Lack of transportation
• Provider attitudes

• Barriers to acceptance
• Perceived harms of clinical trial participation
• Mistrust of research, researchers, and the
  medical system
• Fear
• Family considerations

Ford, Howerton, Bolen, et al. AHRQ Evidence
Report. 2005
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Promoters of accrual

• Promoters of awareness
• Education programs for community physicians
• Adequate knowledge about study
• Workshop on trials
• Promoters of opportunity
• Culturally relevant education about trials
• Providing transportation
• Promoters of acceptance
• Altruism
• Perceived benefits of trial participation
• Incentives

Ford, Howerton, Bolen, et al. AHRQ Evidence
Report. 2005
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Distrust and African Americans

• Thought to stem from the history of racial
  discrimination and exploitation
• US Public Health Service Syphilis Study at
  Tuskegee
• Experiences extending back to slavery
• Medical and surgical experimentation on slaves
• Robbery of Black graves for cadavers in medical
  education
• Current fear of hospitalization

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African Americans and Distrust

• Distrust exists among both Blacks and Whites
• African Americans more likely to believe
• doctors would ask them to participate in harmful
  research or expose them to unnecessary risks
• doctors would not explain research or would treat
  them as part of an experiment without their
  consent
• African Americans had 5 times odds of having
  highest distrust scores
• Differences persisted after controlling for
  markers of socioeconomic status
• Still need to explore the contributions of
  interpersonal and societal trust
• Demonstrating our trustworthiness one important
  step in improving minority participation

Corbie-Smith et al, Archives of Internal
Medicine, Nov 2002
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Social and Health Priorities of Older African
Americans andLatinos

• Focus group with older Latinos and African
  Americans, and survey of community-based
  organizations serving older African Americans or
  Latinos
• Affordable housing, enough money to meet their
  needs, adequate transportation, and safer
  neighborhoods were urgent priorities for older
  Latinos and African Americans and superseded
  their health concerns
• Distrust of researchers, lack of information,
  caregiver obligations, fear of experimentation,
  and lack of benefits were identified as barriers
  to research participation
• Willing to participate if fully informed,
  perceive tangible benefits and congruence between
  the objectives of researchers and participants
• Nápoles-Springer et al. Research on Aging 2000
  22 668

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Consumer Centered Models in Mental Health
Research in Older Minorities

• Consult with community opinion leaders,
  gatekeepers, and representative consumers when
  designing their research
• focus groups and advisory boards made up of
  members from the target community
• improves research groups ability to understand
  community-specific recruitment/retention
• collaboratively develop methods for overcoming
• Include staff members who are ethnically similar
  to, have experience working with, or are members
  of the target population
• may also be more sensitive to participants
  reactionsand can provide feedback
• Method of anticipating respondent burden to
  minimize attrition
• Provide feedback to the target community
• Arean, The Gerontologist, 2003

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Success in longitudinal studies of aging

• Use of a culturally grounded approach to
  recruitment and retention
• Assign the same interviewers to communicate with
  and interview study participants for each wave of
  data collection.
• Ensure that all interviewers are knowledgeable of
  cultural values and norms, possible family
  dynamics, and social issues within the African
  American community.
• Provide a mechanism by way of the toll-free
  number for all study participants to contact the
  project staff at their convenience.
• Allow flexibility in scheduling and/or
  rescheduling interviews at the participants
  convenience.
• Dilworth-Anderson and Williams, J Aging Health
  2004 16 137S

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Surface Structure vs. Deep Structure Recruitment
Strategies

• Surface Structure
• PSAs on minority radio stations
• PSAs on television
• Advertisements in minority newspapers

• Deep Structure
• Radio interview with a credible host in the
  target market, coupled with traditional PSAs
• Station viewed by the target market, particular
  hours, and use of cable channels
• Include a story written about the study and
  investigators in credible print media, coupled
  with ads

Resnicow et al, Ethn Dis. 1999 Winter9(1)10-21
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Suggestions for Effective Recruitment and
Retention

• Stop by when you dont want something
• Community involvement in research infrastructure
• Use appropriate channels of communication
• Demonstrate an appreciation for barriers
• Offer an incentive that is meaningful to
  participants
• Provide feedback and disseminate findings
• Ask people to participate

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What Happens When You Ask?

• Widely claimed that minority groups are less
  willing than non-Hispanic whites to participate
  in health research
• Examined 20 health research studies
• Small differences by race/ethnicity in
  willingness to participate
• non-intervention studies African Americans had
  slightly lower consent rates Clinical and
  surgical interventions slightly higher consent
  rates than non-Hispanic whites

Wendler et al. PLoS Med.2006
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Role of Community Involvement
If you're targeting minority groups, you have a
lot of community issues that you've got to work
throughbuy in from churches, local, opinion
leaders I think you've got a lot more foot work
to do and discussions to occur so that the
community is fully aware of what the project is
about because misperceptions can really destroy a
study. Even if the study is done, everything is
perfect, the IRB completely agrees and it's been
reviewed. The study can be destroyed by
misperception. Investigator, stroke clinical
trials in minority communities
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Why Involve Communities?

• Investigators bring technical knowledge about
  topic and expertise in research methodology
• Community members bring in depth knowledge of
  community concerns, needs, values, and priorities
  
• Providing the framework for study questions,
• Identifying ethical concerns about the project,
• Suggesting how to modify the study to increase
  acceptance of the research in the community,
• Assuring that data collection instruments are
  culturally appropriate,
• Promoting enrollment and retention in the study.
• Input from community members can be important for
  understanding risks research poses and
  identifying most acceptable methods of
  ameliorating them
• Enhances ability of community groups to use
  research results in advocating for social change

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Examining Ethical Principles

• Due to social, historical and economic contexts,
  ethical principles need to be examined in
  underserved communities
• Respect for persons Informed consent may need to
  be examined if participants are vulnerable in
  many ways and live in communities that lack
  economic and political power
• Beneficence Participants and community
  representatives may have a markedly different
  assessment of benefits and risks of research than
  researchers or IRBs
• Justice Often focuses on equitable selection of
  subjects in communities where there may be
  multiple vulnerabilities additional issues of
  power, responsibility, trust, context, and
  history must be considered

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Approaches to Community Involvement

• Range of involvement from none to passive to
  active to partner/collaborators
• Investigators consult with individuals at the
  periphery of community cultural systems
• Investigators consult with influential community
  members for endorsement and support, but not
  advice or guidance
• Investigators consult with influential community
  members for support, advice, and guidance,
  usually through an advisory board
• Investigators partner with the community to
  define problem, identify potential solutions, and
  conduct research -- community as collaborator --
  negotiating goals and conduct of study and
  analysis and use of findings
• Potential for manipulation especially when
  involvement is limited and decision-making power
  of community members is absent

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 If I do all of this and it benefits society
given the way brothers are treated in this
country how is it going to help me?
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Perceptions of Research Participation

• Doubt and distrust about research participation
• Not sure if research participation will lead to
  improved health for them or their community
• Aware of the disparities in health and access to
  care
• Experiences in clinical care inform their
  expectation of research participation

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How Can Investigators Ensure That Participation
in Research Translates Into Tangible Benefits for
Minority Communities?
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 Rethinking Benefit

• Expected outcome of participation is benefit
• Potential direct benefits of receiving a
  particular intervention in a clinical study
• Collateral benefits of study participation such
  as free medical care
• Societal benefits that accrues to others in
  greater society

King NMP. The Journal of Law, Medicine and Ethics
2000
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Societal Benefit and Minority Communities

• Disparities in health are in part determined by
  social and environmental inequities
• Consider ways to affect socioeconomic factors
• Build capacity among community leaders
• Creating opportunities for employment and
  training
• Building and supporting infrastructure
• Provide the results of study findings
• Take cues from international efforts
• HIV/AIDS trials
• NBAC guidelines on conducting trials in resource
  poor countries
• Other nations as examples New Zealand and Maori

Corbie-Smith, et al, Archives of Internal
Medicine, 2004
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Societal Benefit and Minority Communities

• Need a deliberate multidimensional approach
• Opportunity to demonstrate our trustworthiness
• Close the circle between inclusion of minorities
  in clinical research and disparate health
  outcomes
• So that research participation is not another
  example of inequities so evident in this country  

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Types of Engagement

• Investigator Initiated Community Based Research
• Research Collaborations
• One on one
• Multiple organizations
• Community Advisory Boards
• Community Based Participatory Research

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Why CBPR?

• Complex health and social problems ill-suited to
  outside expert research
• Increasing community and funder demands for
  community-driven research
• Disappointing results in intervention research
• Increasing understanding of importance of local
  and cultural context
• Increasing interest in use of research to improve
  best practices/best process
• Source hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.p
  pt

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Definition of CBPR

• CBPR is a collaborative approach to research
  that equitably involves all partners in the
  research process and recognizes the unique
  strengths that each brings. CBPR begins with a
  research topic of importance to the community
  with the aim of combining knowledge and action
  for social change to improve community health and
  eliminate health disparities.
• W.K. Kellogg Community Scholars Program (2001)

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What is and is not CBPR?

• CBPR is an orientation to research
• a collaborative approach that changes the role of
  researcher and researched
• CBPR is an applied approach
• Goal is to influence change in community health,
  systems, programs, or policies
• CBPR is not a method or set of methods
• Source See hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intr
  o.ppt

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Perspectives on CBPR extremes of a continuum
Community Research as imposing on or using vs.
benefiting or involving the community
Academia Community participation as largely
incompatible with rigorous research
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Community-Based Participatory Research
C. helps identify key issues ? Incr. motivation
to participate
C. helps with study design, budget, proposal
submission ? Incr. acceptability and buy-in
C. gives guidance re recruitment and retention ?
Enhanced recruitment and retention
C. helps with measures development and testing ?
Increased reliability and validity
C. helps guide intervention development ? Greater
relevance and likelihood for success
C. helps with data interpretation and
publications ? Enhanced potential for translation
and dissemination
Data analyzed and interpreted Translation of
findings
Study Designed and Funding Sought
Participants recruited and retention systems
implemented
Measurement instruments designed and data
collected
Health Concerns Identified
Intervention designed and implemented
Intervention designed by researchers based on
literature and theory
Issues selected from Epid. data
Design science and feasibility Budget research
expenses
Measures adopted or adapted from other studies,
psychometric testing
Recruitment and Retention based on science and
best guesses
Researchers report findings from analysis and
publish in peer review journals
Traditional Research Approach
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Principles of CBPR

• Acknowledges community as a unit of identity
• Builds on strengths and resources within the
  community
• Facilitates a collaborative, equitable
  partnership in all phases of research, involving
  an empowering and power-sharing process that
  attends to social inequalities

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Principles of CBPR

• Fosters co-learning and capacity building among
  all partners
• Seeks balance between knowledge generation and
  intervention (research and action)
• Focuses on the local relevance of public health
  problems and pays attention to the multiple
  determinants of health

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Principles of CBPR

• Involves a cyclical and iterative process
• Disseminates results to all partners and involves
  them in the wider dissemination of results
• Involves a long-term process, relationship and
  commitment to sustainability
• Source Israel, Eng, Schulz, and Parker 2005

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CBPR Tools and Approaches

• Focus groups
• Interviews
• Windshield Tours
• Community Capacity Inventory
• Community Asset Maps
• Risk Mapping
• Community Dialogues
• Photovoice
• Source Minkler and Wallerstein, 2008

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• Project GRACE Building and sustaining effective
  CBPR partnerships to address HIV disparities
• Giselle Corbie-Smith, Principal Investigator

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How Project GRACE Started

• NIH Request for Application
• National Center for Minority Health and Health
  Disparities (NCMHD)
• Community-Based Participatory Research (CBPR)
• Goal to reduce/eliminate health disparities
• 3 year needs assessment
• Pilot intervention

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Planned Approach to Partnership Development

• Stage 1 Initial mobilization
• Stage 2 Establishment of organizational
  structure
• Stage 3 Capacity building for action
• Stage 4 Planning for action

Source Florin P, Mitchell R, Stevenson J.
Identifying training and technical assistance
needs in community coalitions a developmental
approach. Health Educ Res 19938(3)417-32.
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Stage 1 Initial Mobilization Writing the
Grant

• University of North Carolina at Chapel Hill
  invites the community to the table at the outset
• Community-based organization (CBO) liaison
• Assembled a group of CBOs to provide input
• Components developed by working committees
• Presentation to the larger community

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Who is at the Table?

• The Community
• Subcontractors
• Agency/CBO Representation
• Grassroots Representation
• Individual Representation

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Stage 2 Establish Organizational Structure
Project GRACE Consortium Comprised of 51
organizations and 43 individuals
Steering Committee Area L AHEC (Comm Outreach
Spec) Nash Co. Health Dept. Better Days
Ahead Nash Health Care Systems CEO (Youth LHA
Supv) New Sources, Inc. (Parent LHA
Supv) Citizens of Edgecombe Co. Project
Momentum, Inc. (COC) East Tarboro-Princeville
CDC Rocky Mount OIC (Interviewer
Supv) Edgecombe Co. Health Dept. Sozo
Ministries Freedom Hill Community Health Center
Visions, Inc. (Process Consultants) Heritage
Hospital Wright Center, Inc. NAACP, Edgecombe
County UNC-Chapel Hill (Project Coordinator, PI)
Communications Publications Sub-Committee
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The Consortium

• Mission
• To improve the health of minority and/or
  high-risk populations by establishing
  collaborative structures and processes that
  respond to, empower, and facilitate communities
  in defining and solving their own problems.
• Includes volunteers from many fields, including
• -HIV/STI prevention and/or care services
  -Recreation
• -Edgecombe County and City Government -Private
  Business
• -Health Care Services -Mental Health Services
  Support
• -Education Educational Support for Youth
  -Character and Life Skills Training
• -Daycare Services -Employment assistance
• -Housing Assistance -Religious/Spiritual
  Support
• -Legislative Representation
• -Education Educational Support for Young Adults
  and Adults
• -Local History/Genealogy for African Americans

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Stage 3 Capacity Building for Action

• Initial and ongoing multicultural isms training
• Process consultants at each community meeting
• Annual process evaluation
• Coalition building sessions

• Periodic retreats to address concerns, progress
  and strategic planning

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Stage 4 Planning for Action

• Identify community needs and assets to plan
  intervention
• 11 focus groups conducted
• 37 stakeholder interviews
• Intervention mapping to plan intervention
• Pre-test curriculum pieces
• Pilot test intervention

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Lessons Learned

• Planned approach has resulted in effective
  engagement of community members
• Consortium membership increased from 15 to 57
• Representation from 51 community agencies and 43
  individuals
• 82 of steering committee reside or work in the
  two counties
• Community members chair 5 of the 6 working
  committees
• Over 100 people attended community forums

• Need for flexibility in by-laws, organizational
  structure and processes
• Paying close attention to organizational
  structure, developing by-laws and focusing on
  process have been crucial

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Summary

• Multiple factors influence participation in
  research
• Effective strategies are
• Multidimensional
• Engage target populations
• Address community concerns and expectations

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NC TraCS and Community Engagement in
Translational Research

• Giselle Corbie-Smith, MD, MSc
• Deputy Director, NC TraCS Institute
• Director, Community Engagement Core
• Director, Program on Health Disparities
• Sheps Center
• www.tracs.unc.edu
• [phone]

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Clinical and Translational Science Awards (CTSA)

• A national consortium of medical research
  institutions, working together and sharing a
  common vision to
•  
• Improve the way biomedical research is conducted
  across the country
•  
• Reduce the time it takes for laboratory
  discoveries to become treatments for patients
•  
• Engage communities in clinical research efforts
•  
• Train the next generation of clinical and
  translational researchers

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CTSA Network 2009
To date, 46 institutions have received CTSA
funding, the total is expected to reach 60 by
2010
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NC Translational and Clinical Sciences (TraCS)
Institute

• Our mission
• transform all activities relating to clinical and
  translational research
• create new programs and pathways that make it
  easier for research to be performed at UNC and
  throughout the State of North Carolina.

 
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NC TraCS Community Engagement Core

• focused on conducting T2 research and ensuring
  community input and outreach
• Increased acceptance of and adherence to
  effective medical interventions
• Improved recruitment and retention
• Dissemination of culturally appropriate
  health-related information

 
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Community Engagement Core (CEC)Giselle
Corbie-Smith, MD, MSc - Director
CEC Purpose Create permanent research
structures Regional TraCS campuses-local
community boards, single connection portal and
core resources with stable research staff so that
population research dictated by community needs
can proceed rapidly and successfully. Guiding
PrinciplesTwo-way Exchange Bi-directional
between university and community Participatory
Approaches Co-learning , shared decision
making, mutual ownership of products and
processesEducation and Training Specific
capacity building for all partners community,
investigators and health care providers
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Regional TraCS Campus (RTC)
Community Outreach Specialist
Clinical Coordinator
University Researchers
Community Based Organizations
Community Practices
Local Community Advisory Board
Healthy Carolinians
Practice Based Research Network
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Regional TraCS Campuses
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The CEC provides consultation on a range of
services, including

• Connection Portal
• Identify potential community and university
  partners for collaboration
• Map service areas of research efforts
• Education and Training
• Training community and clinical audiences
• Identify potential community and university
  partners for collaboration
• Technical assistance at community level for pilot
  application process
• Regional TraCS Campuses
• Local research staff
• Identification of meeting space
• Dissemination of study results
• Assistance with study implementation/data
  collection (i.e. interviewing, focus groups,
  screening potential study participants, survey
  administration, etc.)

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NC TraCS Services
Providing the infrastructure to increase the
safety, speed, and rigor of patient-oriented
research
TraCS Research Inquiry Desk Research
Navigators IND/IDE Specialists Research Subject
Advocates Recruitment Specialists Strategic
Opportunities
Data Management Biostatistics Ethics/Regulatory Bi
oinformatics Career Development Resources
Education Consultation Services Clinical Trials
Resources Core Facilities Dissemination Grant
IRB Assistance
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NC TraCS Pilot Grant Program

• TraC2K
• TraCS offers up to 2,000 grants to assist
  researchers implement a proposed study, or move a
  research project forward by providing rapid
  access to funds that will support almost any
  aspect of promising and innovative research.
• TraC10K
• TraCS offers up to 10,000 grants to support
  researchers with the early development of a
  research idea, or to expand an existing study
  beyond the original scope into promising new
  directions.
• Large Pilot Program
• The TraCS Large Pilot Grant serves as a stimulus
  for new research initiatives aimed at obtaining
  sufficient preliminary data to allow new
  applications for extramural funding.
• Each of these pilot programs will be offered
  multiple times within the first year of the CTSA.
  For specific program guidelines and application
  due dates, please visit our website
  www.tracs.unc.edu

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 Questions? www.tracs.unc.edu [phone]
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Additional CBPR Resources

• CBPR Curriculum
• http//www.cbprcurriculum.info/
• CBPR Toolkits
• http//www.shepscenter.unc.edu/research_programs/a
  ging/publications/CEAL-UNC20Manual20for20Commun
  ity-Based20Participatory20Research-1.pdf
• Books
• Israel BA, Eng E, Schulz AJ, Parker EA. (Eds.)
  (2005). Methods in Community-Based Participatory
  Research for Health. San Francisco Jossey-Bass.
• Minkler, M, Wallerstein, E. (Eds.) (2008)
  Community-Based Participatory Research for
  Health From Process to Outcomes. San Francisco
  Jossey- Bass.
• NIH Summer Institute on CBPR
• http//conferences.thehillgroup.com/si2009/agenda.
  html

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How Can We Move the Field Forward

• Dont assume that others (or you) know what you
  mean by race
• Explicit definitions of race
• More careful in invoking either biological or
  social constructions of race
• Statement on the theory that might explain
  differences in health outcomes

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Proportion of Blacks Enrolled in Trials of the
Southwest Oncology Group (SWOG) as Compared with
the Proportion of Blacks in the U.S. Population
of Patients with Cancer, According to the Type of
Cancer
Hutchins LF, Unger JM, Crowley JJ et al. N Engl
J Med 19993412061-7.).