Engaging Communities of Color in Aging Research

Giselle Corbie-Smith, MDUniversity of North Carolina –Chapel Hill

Program on Health DisparitiesSheps Center for Health Services Research

NC Translational and Clinical Science Institute

Overview

• How did we get to mandated inclusion?

• Are older minorities underrepresented in research?

• Influences on participation of older minorities

• Role of community engagement

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

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

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”

Minority Enrollment for NIH Extramural Phase III Research Protocols

(Reported in FY 2003)

0

10

20

30

40

50

60

Amer.Indian/

AlaskanNative

Asian Black Hawaiian/Pacific

Islander

White More thanone race

Unknown/Other

UnknownMaleFemale

Dept. of Health and Human Services, (2004). Comprehensive Report: Tracking of Human Subjects Research Reported in FY 2002 and FY 2003.Dept. of Health and Human Services, (2004). Comprehensive Report: Tracking of Human Subjects Research Reported in FY 2002 and FY 2003.

# of protocols = 5153

n = 9,378,140

# of protocols = 5153

n = 9,378,140

Per

cen

tag

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erce

nta

ge

Enrollment of nonwhites in heart failure Enrollment of nonwhites in heart failure randomized controlled trials randomized controlled trials

Heiat A, Gross CP, Krumholz HM. Arch Intern Med. 2002; 162(15):1684.

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– Study’s 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. 2005Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005

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. 2005Ford, Howerton, Bolen, et al. AHRQ Evidence Report. 2005

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

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 2002Corbie-Smith et al, Archives of Internal Medicine, Nov 2002

Social and Health Priorities of Older African Americans and

Latinos• 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

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

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 participant’s convenience.

Dilworth-Anderson and Williams, J Aging Health 2004; 16; 137S

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 Winter;9(1):10-21 Resnicow et al, Ethn Dis. 1999 Winter;9(1):10-21

Suggestions for Effective Recruitment and Retention

• “Stop by when you don’t 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

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.2006Wendler et al. PLoS Med.2006

“If you're targeting minority groups, you have a lot of community issues that you've got to work through…buy 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

Role of Community Involvement

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

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

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

 “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?”

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

How Can Investigators Ensure That Participation in Research Translates

Into Tangible Benefits for Minority Communities?

 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

“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

“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  

Types of Engagement

• Investigator Initiated Community Based Research

• Research Collaborations– One on one– Multiple organizations

• Community Advisory Boards• Community Based Participatory

Research

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 processSource: hsc.unm.edu/som/fcm/cpr/docs/CBPR_Intro.ppt

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 Scholar’s Program (2001)

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_Intro.ppt

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

Health Concerns Identified

Study Designed and Funding Sought

Participants recruited and retention systems implemented

Measurement instruments designed and data collected

Intervention designed and implemented

Data analyzed and interpreted

Translation of findings

C. helps identify key issues

Incr. motivation to participate

Traditional Research Approach

C. helps with study design, budget, proposal submission

Incr. acceptability and “buy-in”

Issues selected from Epid. data

Design: science and feasibility

Budget: research expenses

Community-Based Participatory Research

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

Researchers report findings from analysis and publish in peer review journals

Intervention designed by researchers based on literature and theory

Measures adopted or adapted from other studies, psychometric testing

Recruitment and Retention based on science and “best guesses”

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

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

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

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

Project GRACE: Building and sustaining effective CBPR partnerships to address

HIV disparities

Giselle Corbie-Smith, Principal Investigator

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

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 1993;8(3):417-32.

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

Who is at the Table?

• The “Community”

– Subcontractors

– Agency/CBO Representation

– Grassroots Representation

– Individual Representation

Stage 2: Establish Organizational Structure

Project GRACE Consortium

Comprised of **51** organizations and **43** individuals

Membership & By-Laws Sub-Committee

Events Planning Sub-Committee

Research Design Sub-Committee

Fiscal/ Budget Sub-Committee

Nominations Sub-Committee

Communications & Publications Sub-Committee

Steering CommitteeArea L AHEC (Comm Outreach Spec) Nash Co. Health Dept.Better Days Ahead Nash Health Care SystemsCEO (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 MinistriesFreedom Hill Community Health Center Visions, Inc. (Process Consultants)Heritage Hospital Wright Center, Inc.NAACP, Edgecombe County UNC-Chapel Hill (Project Coordinator, PI)

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

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

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

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

Summary

• Multiple factors influence participation in research

• Effective strategies are – Multidimensional – Engage target populations – Address community concerns and expectations

NC TraCS and Community Engagement in Translational

Research

Giselle Corbie-Smith, MD, MSc

Deputy Director, NC TraCS InstituteDirector, Community Engagement CoreDirector, Program on Health Disparities

Sheps Center

www.tracs.unc.edu(866) 705-4931

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

CTSA Network 2009

To date, 46 institutions have received CTSA funding, the total is expected to reach 60 by 2010

 

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.

 

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

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 Principles:

Two-way Exchange Bi-directional between university and community

Participatory Approaches Co-learning , shared decision making, mutual ownership of products and processes

Education and Training Specific capacity building for all partners – community, investigators and health care providers

Regional TraCS Campus (RTC)

Clinical Coordinator

Community Based

Organizations

Community Research Network

Clinical Research Network

CommunityOutreachSpecialist

Healthy Carolinians

Local Community

Advisory Board

Community Practices

Practice Based Research Network

University Researchers

Regional TraCS Campuses

57

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.)• Coordination of community meetings• Identification of community-based organizations• Identification of clinical practices• Data entry• Report summaries

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

Bioinformatics

Career Development Resources

Education

Consultation Services

Clinical Trials Resources

Core Facilities

Dissemination

Grant & IRB Assistance

60

NC NC TraCS Pilot Grant Program Pilot Grant Program• TraC$2K

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.

• TraC$10K

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

 Questions?

www.tracs.unc.edu

(866) 705-4931

Additional CBPR Resources

• CBPR Curriculum– http://www.cbprcurriculum.info/

• CBPR Toolkits– http://www.shepscenter.unc.edu/research_programs/aging/publications/CEAL-U

NC%20Manual%20for%20Community-Based%20Participatory%20Research-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

How Can We Move the Field Forward

• Don’t 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

Hutchins LF, Unger JM, Crowley JJ et al. N Engl J Med 1999;341:2061-7.).

Proportion of Blacks Enrolled in Trials of the Southwest Oncology Proportion of Blacks Enrolled in Trials of the Southwest Oncology Group (SWOG) as Compared with the Proportion of Blacks in the U.S. Group (SWOG) as Compared with the Proportion of Blacks in the U.S. Population of Patients with Cancer, According to the Type of CancerPopulation of Patients with Cancer, According to the Type of Cancer