Working with Underserved Populations for Research- Challenges and Successful Methods

1
Working with Underserved Populations for
Research- Challenges and Successful Methods

• Dorothy Farrar Edwards PhD
• Professor and Chair
• Department of Kinesiology-Occupational Therapy

2
Moving from Health Disparities to Health Equity

• Examination of all aspects of research process
• Recruitment strategies
• Consent procedures
• Assessment process
• Involvement of minority investigators
• Cultural and community attitudes

3
Growing Attention to Minority Recruitment

• Greater awareness of disparities
• Questions of generalizability of findings and
  interventions to women and minorities
• NIH regulations introduced in 1993
• Increased pressure to move beyond
  descriptive/screening studies to clinical trials

4
NIH Mandate

• In 1994 NIH mandated greater inclusion of women
  and underrepresented ethnic and racial minorities
  in NIH funded studies
• Minority recruitment and retention efforts are
  carefully monitored by NIH
• Efforts have led to a growing literature
  examining barriers and facilitators of minority
  research participation

5
Minority Participation in Biomedical Research

• Communities of color remain underrepresented in
  biomedical research
• Limited enrollment affects our full understanding
  of the complex etiology of the disease
  generalizability of study findings and
• Inequities in research participation reflect
  disparities in health and healthcare utilization

6
Examination of Minority Research Participation

• Majority of studies have examined African
  American participation
• Fewer studies of Latino/Hispanic communities and
  effects of language differences
• Virtually no data on American Indians and Alaskan
  Natives

7
Challenges of African American Recruitment

• Recruitment and retention of African Americans
  has been described as
• Difficult
• Expensive
• Minimal return on investment
• Little empirical evidence to guide development
  and implementation of successful recruitment and
  retention methods

8
Recruitment Challenges

• Attitudes and beliefs of the community
• Structural barriers- study design
• Investigator attitudes, beliefs behaviors

9
Community Attitudes are Complex and Multifaceted

• No single, simple cause for nonparticipation
• Distrust
• Research/Researchers
• Medical institutions, clinics, providers and
  universities
• Negative experiences and disparities in care
• Lack of Investigator Accountability
• Tuskegee
• Henrietta Lacks
• Johns Hopkins Lead Studies
• Confusion about informed consent
• Fear of Adverse Effects
• Failure to Form Relationships with the Community

10
Community Attitudes are Both Positive and Negative

• Overall, participants believe research to be
  important to study and cure disease, to make
  discoveries about new medicines or techniques,
  and to improve health.
• I would volunteer because research benefits us.
  Were the ones that benefit from research

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Lack of Concern about the Needs and Interests of
the Community

• We dont want to work with those drive by
  researchers
• They come and get what they want and we never
  hear from them again
• Ballard et al, 2010

12
Mistrust of Government Funded Studies

• We dont trust the science, the scientists, we
  dont trust the doctors, and we definitely dont
  trust the government
• The government, you can hardly trust them.
• Scharf et al, 2010

13
Mistrust of Government Funded Studies

• I think you have a lot of people who mistrust
  the government. You start looking at a lot of
  medical centers, theres always going to be some
  link up the chain to some government entity.
• Scharf et al, 2010

14
Lack of Trust

• Doctors will say things just to get people to
  agree to the research. But you never know whether
  they will actually keep their word.
• Williams et al, 2010

15
No Perceived Benefit

• And it goes back, if you find something, are we
  ever going to see it? So truly, why does my
  participation really matter for anything? If it's
  not going to produce a product that I'm going to
  see, why should I be one of the study
  participants?
• I think the deception is when we read studies,
  they dont relate to us. They dont I mean,
  theyre about another nationality. Theyre not
  really for African Americans. And they dont
  apply to us.
• Williams et al, 2010

16
Structural Factors

• Recruitment Issues
• African Americans may not be asked
• AAAPS -85 of participants screened had never
  been approached to participate in a study
  (Gorelick et al, 2003)
• Active vs Passive Strategies
• Active Face to face contact, direct mailings
  telephone calls may be less effective
• Passive Announcements at churches and meetings,
  Flyers, Newspaper ads, Information/education
  programs appear to be more effective
• Participants recruited through mainstream
  strategies may belong as much to the majority
  culture as the culture of their minority group

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Structural Factors Affecting Participation

• Limited Access
• Transportation
• Information
• Health literacy
• Demands of Participation
• Time
• Location
• Cost
• Inclusion and Exclusion Criteria

18
Investigator Attitudes and Beliefs

• Awareness of Tuskegee Cultural Competence
• Need for an immediate response
• Few/no attempts to recruit
• Insensitive to community customs and traditions

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New Perspectives on Recruitment and Retention of
African Americans for AD Studies

• Less likely to participate (past and/or present
  state) does not equate to less willing to
  participate (present and/or future state)
• Ballard, Gwyther Edmonds (2010)

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How do we Increase Participation?

• The mindset and behaviors of the investigator and
  research staff are the most important criterion
  for the success of recruitment and retentio
• Recruitment efforts grounded in programs designed
  to increase resources and access to care are more
  likely to be successful (Williams et al, 2011)

21
Strategies to Increase Participation

• Community Investment Models of Recruitment
• Collaborative win-win approaches
• Social Marketing Methods

22
Milwaukee Alzheimers Prevention Program

• Established in 2006
• Outreach, Education , Care Management and Memory
  Diagnostic Clinic
• Supports WRAP and ADRC
• Funded By
• Wisconsin Partnership Program
• CUPH/Aurora Sinai
• ICTR
• Helen Bader Foundation
• NIA

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Wisconsin Registry forAlzheimers Prevention
(WRAP)

• November, 2001
• Adult children (aged 40-65) of persons with
  verified AD
• Agree to follow-up testing (4 year intervals) and
  to participate in clinical, epidemiological and
  genetic research in the area of AD prevention
• 1650 currently enrolled

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Understanding Health Disparities from the
Communitys Perspective

• Values and belief systems
• Traditions customs and social norms
• Territorial boundaries
• Turf issues
• Neighborhood demographics

• Race demographics
• Age demographics
• Socioeconomic status
• Health status

25
Community Identified Obstacles to Health Parity

• Awareness
• Education
• Economic Status
• Preparedness
• Transportation
• Access to qualified providers
• Poor Health Status

• Systemic Discrimination
• Unhealthy Lifestyles
• Myths
• Stigma
• Stereotypes
• Mistrust

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What Did the Community Require?
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Community Education

• Staff participate in 300 community events per
  year
• Sponsor 15 AD education events
• Co sponsor 20 additional health education events
  with emphasis on brain health
• Radio spots and public access tv

28
Community Service

• Home-based evaluation and care consultation
• AD training for community health and social
  service providers
• Physician and health professional training
• Memory Clinic network

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Memory Diagnostic Clinic

• Worked with Milwaukee Health Services Inc (FQHC)
  to create a weekly memory diagnostic clinic
• Based on a medical home model
• Staffed by Geriatric Nurse Practitioner and
  Geriatrician
• Evaluates 2-3 patients per week
• Supportive Social Services
• Working on documentation and billing to increase
  revenue to MHSI

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WRAP African American Participation
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Putting Words into Action
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Retention Strategies

• Flexible times and locations offered for
  appointments
• Contacting participants during evenings and
  weekends when necessary
• Keeping control participants engaged (monthly
  phone calls)
• Allowing participants to take breaks from the
  study (vs. withdrawing)
• Working with additional contacts to locate
  participants
• Making withdrawal decisions based on individual
  cases (vs. solely on phone calls or time
  limits)
• Demonstration appreciation and respect for time
  and effort of participants and their family
  members

33
Rationale for Research Participation (Hamilton et
al, 2006)

• Willingness to participate differed by age
• Older Adults
• Desire and willingness to help others
• Value opportunity to improve medical treatments
• Opportunity to increase personal knowledge or
  improve understanding of health condition
• Particularly important if disease is prevalent in
  Black community

34
Rationale for Research Participation (Hamilton et
al, 2006)

• Young Adults
• Financial incentives
• Desire to help others
• Personal interest and increased knowledge
• Religious commitment to help others
• Specific help for family members affected by
  disease
• Both groups emphasized
• Minority investigators and staff
• Oversight from a prominent authority or
  recognized entity

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Summary of NIMH Focus Group Themes Facilitators

• Clear description of procedure and willingness to
  answer questions one on one or in small groups
• Continuous engagement in the community
• Bringing findings back to the community
• Education from trusted sources
• Information presented in honest but positive way
• Varieties of options for participation
• Minimize wear and tear on participants
• Transportation, flexible hours, stipends, home
  testing

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Mistrust

• We dont trust the science, the scientists, we
  dont trust the doctors, and we definitely dont
  trust the government
• The government, you can hardly trust them.
• I think you have a lot of people who mistrust
  the government. You start looking at a lot of
  medical centers, theres always going to be some
  link up the chain to some government entity

37
Mistrust about Benefits of Participation

• And then if it went the other way, extreme, its
  not going to benefit black people anyhow. So
  theres no real I dont have any faith in it
  ..the research
• And it goes back, if you find something, are
  we ever going to see it? And I'm like, I may
  never see anything of this. So truly, why does my
  participation really matter for anything? If it's
  not going to produce a product that I'm going to
  see and I'm one of the study participants ?

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Issues of Informed Consent
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Challenges to Informed Consent

• Common for participants to forget, deny or
  misunderstand consent information
• VA Study (1998)
• 72 unaware that they were participating in a
  study
• Of these, 75 believed that the study treatment
  would be beneficial
• Need for more consistent, simpler presentation
  and discussion with potential participants

40
Informed Consent Process Ethical Demands on the
Investigator

• Process of informed consent requires some
  reasonable attempt on the part of the
  investigator to help potential participants
  understand what is being asked of them
• Commitment to helping potential subjects gain
  enough information to assure autonomous and
  voluntary participation

41
Studies of the Process of Consent in Clinical
Trials

• Repeatedly demonstrate that regulatory
  requirements are met-but the consent documents
  have little impact on patient knowledge or
  decisions about participation
• Problems with understanding of the concept of
  informed consent
• Difficulty understanding and interpreting the
  language of the consent forms

42
Language and Comprehension Issues

• Difference between knowing and understanding
• Recent study of 114 US medical school web sites
  examined consent form templates and found that
  the majority of IRB provided texts failed to meet
  the recommended reading standards

43
Issues of Informed Consent in African Americans
(Corbie-Smith et al. 1999)

• Many barriers to recruitment and retention of
  African Americans for clinical research
• Historic mistrust of doctors, scientists and the
  government
• Concerns about ethical conduct of clinicians and
  investigators when poor and minority patients
  involved

44
Lack of Trust

• Language used in consent forms may have very
  different meanings to others.
• For example the word trial seems emotionally
  neutral-but potential participants report that
  this means they will be treated like a person on
  trial-the anticipated study experience
• They will be questioned and cross-examined as if
  not telling the truth

45
Limited Understanding of the Consent Process

• Participants believed that the purpose of the
  consent document was to protect doctors and
  hospitals from any legal responsibility.
• If you give consent you dont have any legal
  rights. When you sign that paper, you sign all of
  your rights away, because they have disclaimers
  all neatly typed up, reviewed by their lawyers to
  protect themselves from being sued

46
Lack of Trust

• Doctors will say things just to get people to
  agree to the research. But you never know whether
  they will actually keep their word.
• Language used in consent forms may have very
  different meanings to others. For example the
  word trial seems emotionally neutral-but
  potential participants may think that they will
  be treated like a person on trial-questioned and
  cross-examined as if not telling the truth

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Improving the consent process

• Establish a relationship and gain the trust of
  the community
• Seek input and advice about the language and
  format of the consent form and process
• Use multiple forms of information (written,
  audio, video) and allow time for review and
  questions
• Acknowledge the importance of significant others
  in the decision making process

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Summary of Findings

• The primary and fundamental reason for African
  Americans lack of participation research is
  pervasive mistrust of the healthcare system.
• Negative perceptions of healthcare providers and
  health care infrastructure persist due to
  historical events, institutional racism, and
  healthcare disparities.
• Adverse perceptions of health professionals
  extend to perceptions of clinical researchers.
• Other barriers to research participation
  included
• Fear of the unknown and adverse effects
• Insufficient dissemination of information in the
  African American community
• Inconvenience
• Reputation of the researcher/research
  institution.

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Summary of Findings-

• Enhancing African American Participation
• Honest respectful communication
• Engagement with community
• Contact with physician investigators
• Use of additional media to explain the research
• Extra time for participant to confer with family
  and friends
• Financial incentives
• Sharing findings with the community

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Social Marketing

• Social marketing uses the principles of product
  marketing to encourage people to change their
  behavior for a social good
• Social marketing techniques have been used in
  public health to promote health behavior change

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Social Marketing and Study Recruitment

• Investigators apply principles to increase
  recruitment and retention
• Product
• Price
• Promotion
• Place

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Social Marketing

• Product Study participation
• What do we want the potential participant to do ?
• What does he/she stand to gain by participation

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Social Marketing

• Price- What are the costs to participation ?
• Tangible
• Time
• Discomfort
• Study related expenses
• Intangible
• Changes in beliefs or habits
• Questions from family and friends
• Loss of privacy

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Social Marketing

• Promotion- How to we convey our message ?
• Information about study goals and procedures
• Who delivers the message
• How is participation presented recruitment
  message

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Social Marketing

• Place where does recruitment take place
• The way the request is made
• Where the research occurs

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STROKE DISPARITIES PROGRAM

• Principal Investigator
• Chelsea S. Kidwell, MD
• Professor of Neurology, Georgetown University
• Medical Director, Georgetown University Stroke
  Center

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Scientific Research Goals of Projects Address 3
Key Areas of Stroke Disparities

• IV tPA Utilization
• An intervention study to demonstrate tPA
  utilization can be increased
• Secondary Stroke Prevention
• A randomized trial of hospital-initiated
  secondary prevention plus navigation to increase
  compliance
• Intracerebral Hemorrhage
• A longitudinal observation study of microbleeds
  in primary intracerebral hemorrhage

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Which Study Would You Volunteer For ?

• The Stroke Disparities Project ?
• The Triumph Over Stroke Study ?

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Acute Hospital Recruitment

• Hemorrhagic Stroke Study (n210)
• Longitudinal study of microbleeds and stroke
  outcome
• PROTECTDC (n216)
• RCT of Navigator assisted secondary prevention

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Recruitment Based on Social Marketing

• Product
• Emphasize the impact of stroke on the community
• Ask for help in improving stroke care and
  decreasing stroke related mortality and morbidity

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Recruitment Based on Social Marketing

• Promotion
• Inclusive recruitment materials
• Tailored recruitment scripts
• Motivational interviewing training for research
  staff
• Involve family in the discussion
• Careful documentation of each encounter

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Recruitment Log Data
Mean SD Range
PROTECT DC Approaches In-Person Contacts 2.73 2.55 1.65 1.56 1 - 10
DECIPHER Approaches In-Person Contacts 3.15 2.40 2.01 1.54 1 - 13
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Social Marketing

• Price
• Decreased the costs of participation
• Provide transportation
• Some data collected via home visits
• No additional insurance charges
• Schedule visits when convenient for participant/
  family
• Participant handbook

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Place Community Education and Awareness
66
Conclusions

• Important to be aware of community attitudes and
  beliefs
• Important for investigators to identify and
  address barriers
• Recruitment/retention is based on developing
  relationships with communities and study
  participants

67
Conclusions

• Be prepared to spend more time than you indicated
  in your funding application
• Develop a realistic budget
• Engage the community and value their expertise

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