Recruiting

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Recruiting Retaining Racial and Ethnic
Minority Participants for Clinical Research

• Facilitators
• Kate Cronin, MPH.
• Earlise Ward, Ph.D.
• CIPP Scientific Writing Workshop
• November 4, 2004

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Agenda

• Introduction
• Recognition of contributors
• Recruiting and Retaining Racial and Ethnic
  Minorities (REMs) for Research
• Cultural competence
• Awareness and knowledge of barriers
• Case review
• Overcoming barriers
• Strategies to successfully recruit and retain
  REMs
• Conceptual Model for recruiting and retaining
  REMs
• Wrap up

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Objectives

• Gain a basic understanding of the concept of
  cultural competence and why it is important to
  discuss at this stage of your research career.
• Increase knowledge and understanding of barriers
  related to recruiting and retaining REMs.
• Learn about strategies to successfully recruit
  and retain REMs.
• Learn about one conceptual model for recruiting
  and retaining REMs.

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Cultural Competence

• Cultural competence is defined as having the
  necessary self-awareness, cultural knowledge, and
  skills to foster culturally effective and ethical
  communications, interactions, and relationships
  with people of various cultural backgrounds.

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Reality Check

• Evidence of racial and ethnic disparities in
  healthcare is, with few exceptions, remarkably
  consistent across a range of illnesses and
  healthcare services. Racial and ethnic
  minorities tend to receive a lower quality of
  healthcare than non-minorities, even when
  access-related factors, such as patients
  insurance status and income, are controlled.
• (Unequal Treatment, IOM Report)
• Wisconsin Data
• For the period 1996-2000, the number of infant
  deaths for African Americans in Wisconsin
  translates into an infant death rate of 16.3.
  This was almost 3 times greater than the white
  infant death rate (5.7) and well above the infant
  death rate in all other racial/ethnic groups.
• (The Health of Racial and Ethnic Populations in
  Wisconsin 1996-2000.)

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Dimensions of Cultural Competence

• Self-awareness
• Awareness of your values, beliefs, preconceived
  notions, assumptions and biases, and how they
  influence your perceptions about people.
• Knowledge
• Having knowledge of how age, gender, race,
  ethnicity, national origin, religion, sexual
  orientation, disability, language, sociopolitical
  history and socioecomonic status provides the
  context in which we understand human behavior
  (Hasen, Rockwell, Greene, 2000).
• Skills
• Involves having the clinical and research skills
  necessary to work effectively and ethically with
  culturally diverse individuals, groups, and
  communities (Hasen, Rockwell, Greene, 2000).

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Characteristics of a Culturally Competent
Researcher

• Self-awareness (know thyself)
• Aware of his or her own assumptions about human
  behavior, values, biases, preconceived notions,
  limitations and so forth.
• Understands his/her own worldview, how his/her
  worldview is a product of his/her cultural
  upbringing, and how it may be reflected in
  his/her interactions with other people.
• know thyself is important because it prevents
  us from allowing our biases, values and other
  hang-ups to interfere with our ability to
  effectively communicate, interact and work with
  people.

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Characteristics of a Culturally Competent
Researcher

• Knowledge
• A culturally skilled researcher understands and
  has knowledge about sociopolitical influences
  that impinge upon the life of racial and ethnic
  minorities (slavery, discrimination, racism,
  poverty etc.)
• A culturally skilled researcher possesses
  specific knowledge and information about the
  particular group (s) he or she wants to work with
  (prevalence of diabetes, chronic illness, cancer
  etc).
• The researcher is aware of the life experiences,
  cultural heritage, and historical background of
  their culturally diverse sample.
• Knowledge that immigration issues, acculturation,
  poverty, racism, stereotyping, and powerlessness
  all leave major scars that may influence
  participants motivation to participate in
  research.

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Characteristics of a Culturally Competent
Researcher

• Skills / Strategies
• Actively develops and practices appropriate,
  relevant, and sensitive strategies / skills in
  working with culturally different individuals
• design study, develop strategies to recruit and
  retain REMs, build partnerships with REM
  communities, effectively communicate with REMs,
  present findings to REM communities etc.
• Uses modalities that are consistent with the life
  experiences and cultural values of the
  individuals he or she is working with
• flexible hours to participate in the research,
  make accommodations for childcare and
  transportations, collaborate with REMs
  researchers.

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Becoming Culturally Skilled Is

• An on-going process
• An active process
• A process that never reaches an end point

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Barriers

• Fear and distrust of research enterprise (i.e.
  university, hospitals, clinics, white
  researchers, medical profession etc.)
• Lack of knowledge about research (lack of
  information about informed consent, role in the
  study, lab rat, negative perception of research
  and outcomes)
• Unappealing recruitment advertisements
• Interference with work and family
  responsibilities
• Subject burden as a result of participation in
  clinical study
• Lack of transportation
• Financial cost

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Case Study 1

• Recruiting Retaining Racial and Ethnic
  Minority Participants for Clinical
  ResearchProjects Case Study 1
• Researcher JM decides to write an R-01 proposal
  to the National Institute of Mental Health. In
  her proposal Researcher JM would like to compare
  the reliability of scoring methods to diagnose
  clinical depression between human interviewers
  and computer based interpretation of voice
  recordings. Researcher JM contacts a colleague at
  Pfizer who has the necessary equipment to analyze
  voice recordings and creates a collaborative
  agreement in which it is outlined that Researcher
  JM will be the Principal Investigator and in her
  proposal will
• request funding for her Pfizers colleagues
  time spent analyzing the voice recordings.
• Researcher JM decides to recruit subjects from
  two Dane County Mental Health clinics, where she
  has identified two physicians who will refer
  subjects to her research project. Researcher JM
  will supplement this by using advertising in
  local papers to recruit subjects. Researcher JM
  consults with her departments biostatistician to
  determine the appropriate sample size for
  statistical significance. She learns that she
  will need to recruit 200 subjects.
• Researcher JM goes to the U.S. Census Bureaus
  website and learns that Dane County has a total
  population of 426,526. Of the total population,
  89 is identified as white, 4 is identified as
  Black or African American, 0.29 is identified as
  American Indian/Alaska Native, 3.5 is identified
  as Asian, 0.01 is identified as Native Hawaiian
  or Other Pacific Islander, 1.4 is identified as
  Some Other Race, and 1.8 is identified as Two or
  More Races. Under Ethnic Category, 3.4 of Dane
  Countys populations is identified as Hispanic or
  Latino (of any race). The population of Dane
  County is 50.5 female.

Using this information, Researcher JM completes
the Targeted/Planned Enrollment Table as
follows Study Title Reliability of Depression
Scoring Methods Total Planned Enrollment200
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Case Study 1 Discussion Questions

• Pick one spokesperson who will summarize your
  case study and report out on the following
  questions
• What do you think the potential is for this study
  to recruit REMs from the information provided?
• What might you do differently?
• Is there other information that you think JM
  should or could include in the proposal to
  describe the target population and address
  possible recruiting issues?
• Do you think this project should be funded?

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Case Study 2

• Recruiting and Retaining Minority Participants
  into Clinical Research Projects Case Study 2
• Researcher KL agrees to be a site PI and
  participating site in a large scale Phase III
  breast cancer prevention clinical trial. The
  clinical trial is a randomized control trial
  seeking to recruit postmenopausal women at
  increased risk for breast cancer. Each
  participating site agrees to recruit 200 women
  over a two year period. The women will be
  followed in the study for a total of five years.
  Researcher KL knows that African American women,
  especially, are significantly represented in this
  target group, thus, participation in the trial is
  both potentially beneficial to the scientific
  community and to African American women.
• Researcher KL develops a short synopsis of the
  trial and sends it out to a group of physicians
  she knows are providing care to older women,
  including women of color. Researcher KL has
  attended local health fairs, health symposiums
  and local conferences in order to meet health
  care providers and develop a network of local
  physicians who are interested in participating in
  clinical research. Researcher KL frequently
  invites this group to seminars and lectures at
  the University and regularly forwards medical
  updates and links to articles published in
  professional journals.
• The trial sponsor has developed promotional
  materials which Research KL distributes to her
  physician group and to clinics at her
  institution. In addition to the existing
  promotional materials, research KL develops
  materials designed to increase awareness of
  breast cancer risk for African American women to
  distribute in conjunction with the promotional
  information. Researcher KL uses some of her start
  up funds from the sponsor to advertise in the
  local papers, including the Wisconsin State
  Journal, Isthmus, Madison Times, and UMOJA
  African-American News for the Madison Area.
• Researcher KL also contacts the project director
  of a local faith-based breast and cervical cancer
  health education project to see if she would be
  interested in including information about the
  clinical trial in her educational sessions.
  Researcher KL also asks the project director if
  she would be willing to introduce KL to local
  clergy who could then be asked to relay
  information about the trial to their
  congregations.
• Researcher KL meets with her research staff and
  discusses with them the need for flexibility in
  scheduling the screening and annual visits, and
  the importance of providing or arranging for
  childcare if necessary. She stresses that
  whenever possible visits should be scheduled to
  coincide with existing medical appointments.
  Researcher KL also works out a system where the
  study will cover any out of pocket expenses for
  the annual mammograms required by the study
  protocol.
• Once the trial has begun, Researcher KL makes
  arrangements to present an annual update of the
  trials progress. All study participants,
  Researcher KLs community physician group, the
  director of the breast and cervical cancer health
  education project, and clergy who were contacted
  about promoting the trials are invited to attend.

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Case Study 2 Discussion Questions

• Pick one spokesperson who will summarize your
  case study and report out on the following
  questions
• What do you think the potential is for this study
  to recruit REMs from the information provided?
• What strategies does KL use that you think might
  help recruit and retain REMs?
• Specific to this study?
• General strategies?
• Are there additional outreach activities you
  might add?

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Overcoming Barriers

• Five Elements of Outreach
• Understand the study population
• Establish an explicit outreach plan
• Achieve agreement on research plans
• Design and conduct evaluations
• Establish and maintain communication

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Strategies for Recruiting and Retaining REMs

• Involve the community, build relationship with
  the community
• Involve the participants, build relationship with
  the potential participants
• Staff the team right, minority representation
  on the research team
• Make sure the issue (s) you are studying is
  relevant to the REM community

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Strategies for Recruiting and Retaining REMs

• Recruit right
• Local community organizations, churches, hair
  salons, word of mouth, African American Studies
  Dept., race gender specific
• Address logistical and financial needs
• Convenient location, flexible time, safe zone
• Incentives/motivators
• Altruism, monetary compensation, access to
  specialty care, family history or other risk,
  race gender specific
• Improve communication
• Effective communication of results can help build
  trust. Publication in research journals, while
  important, does not necessarily meet the
  communication needs of the community. Present
  findings to community (oral written)

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Cultural Competence Model for Design and Conduct
of Clinical Research
1. Identify Research Topic is there interest
from the community?
2. Determine Research Questions does the
community have insights/additions?
Cultural Competence Awareness, Knowledge
Skills Community Partnerships
3. Who will your sample consist of? Do you know
how to reach this group?
4. Clinical trial, cross-sectional correlation,
qualitative etc

• 6. Did you collect data from REMs for demographic
  use only?
• Did you collect data from REMs to meet NIH
  quota/requirement?
• Analyze data by race and ethnicity
• Understand the implications of your findings
  for REMs

5. Recruit participants what are the most
effective methods to recruit REMs? Community
Partnership Outreach - Data collection
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References and Resources

• US Department of Health Human Services, Public
  Health Service, National Institutes of Health.
  Outreach Notebook, For the Inclusion, Recruitment
  and Retention of Women and Minority Subjects in
  Clinical Research. NIH Publication No. 03-7036
  (http//www4.od.nih.gov/orwh/outreach.pdf)
• Science of Inclusion, Recruiting and Retaining
  Racial and Ethnic Elders in Health Research. Ed.
  by Curry, L., Jackson, J. The Gerontological
  Society of America, 2003.
• Multicultural Competence Criteria and Case
  Examples. Nancy Hasen, Fran Pepitone-Arreola-Rockw
  ell, Anthony Greene. Professional Psychology
  Research and Practice, 0735-7028, December 2000,
  Vol.31, Issue 6.
• Research Participation in African American
  Women. Presentation. Juliet Rogers, Yolanda
  Smith, Lisa Newman, Leatrice Shacks, August
  2004.
• Unequal Treatment Confronting Racial and Ethnic
  Disparities in Healthcare. Institute of Medicine.
  National Academies Press 2003
• The Health of Racial and Ethnic Populations in
  Wisconsin 1996-2000. Wisconsin Department of
  Health and Family Services, Division of Public
  Health, Minority Health Program (PPH 0281 07/04).
  Madison, Wisconsin Department of Health and
  Family Services. http//dhfs.wisconsin.gov/health/
  minorityhealth
• Corbie-Smith G, Thomas SB, St George DM.
  Distrust, race, and research. Arch Intern Med.
  2002 Nov 25162(21)2458-63.
• The Spirit Catches You and You Fall Down
  Fadiman, Anne. Farrar, Straus and Giroux, 1997.