Working with Underserved Populations for Research- Challenges and Successful

MethodsDorothy Farrar Edwards PhD

Professor and ChairDepartment of Kinesiology-Occupational Therapy

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

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

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

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

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

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

Recruitment Challenges

• Attitudes and beliefs of the community

• Structural barriers- study design

• Investigator attitudes, beliefs & behaviors

Community Attitudes are Complex and MultifacetedNo 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

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”

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

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

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

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

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

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

Structural Factors Affecting Participation

• Limited Access– Transportation– Information– Health literacy

• Demands of Participation– Time– Location– Cost

• Inclusion and Exclusion Criteria

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

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)

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)

Strategies to Increase Participation

• Community Investment Models of Recruitment– Collaborative “win-win” approaches

• Social Marketing Methods

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

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

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

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

What Did the Community Require?

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

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

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

WRAP African American Participation

0

5

10

15

20

25

30

35

2006 2007 2008 2009 2010

Putting “Words” into Action

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

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

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

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

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”

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 ?”

Issues of Informed Consent

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

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

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

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

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

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

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”

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

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

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.

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

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

Social Marketing and Study Recruitment

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

Social Marketing

• Product: Study participation – What do we want the potential participant

to do ?– What does he/she stand to gain by

participation

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

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

Social Marketing

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

STROKE DISPARITIES PROGRAM

Principal Investigator:Chelsea S. Kidwell, MD

Professor of Neurology, Georgetown UniversityMedical Director, Georgetown University Stroke Center

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

Which Study Would You Volunteer For ?

• The Stroke Disparities Project ?

• The Triumph Over Stroke Study ?

Acute Hospital Recruitment

• Hemorrhagic Stroke Study (n=210)– Longitudinal study of microbleeds and

stroke outcome

• PROTECTDC (n=216)– RCT of Navigator assisted secondary

prevention

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

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

Mean SD RangePROTECT DC Approaches In-Person Contacts

2.732.55

1.651.56 1 - 10

DECIPHER Approaches In-Person Contacts

3.152.40

2.011.54 1 - 13

Recruitment Log Data

Social MarketingPrice• 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

Place: Community Education and Awareness

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

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