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. We’re the ones that benefit from research”

11. Lack of Concern about the Needs and Interests of the Community • “We don’t 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 don’t trust the science, the scientists, we don’t trust the doctors, and we definitely don’t 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, there’s 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 don’t relate to us. They don’t … I mean, they’re about another nationality. They’re not really for African Americans. And they don’t 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

17. 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

19. 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)

20. 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 Alzheimer’s 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

23. Wisconsin Registry forAlzheimer’s 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

24. Understanding Health Disparities from the Community’s Perspective Race demographics Age demographics Socioeconomic status Health status Values and belief systems Traditions customs and social norms Territorial boundaries Turf issues Neighborhood demographics

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

26. What Did the Community Require?

27. 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

29. 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

30. WRAP African American Participation

31. Putting “Words” into Action

32. 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

35. 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

36. Mistrust “ We don’t trust the science, the scientists, we don’t trust the doctors, and we definitely don’t 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, there’s 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, it’s not going to benefit black people anyhow. So there’s no real … I don’t 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 ?”

38. Issues of Informed Consent

39. 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 don’t 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

47. 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

48. 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.

49. 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

50. 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