1

Involving Diverse Communities in Clinical Research

Anna Nápoles-Springer, Ph.D.

May 9, 2006

2

Outline

NIH mandate Introduce recruitment issues in diverse groups Review framework and critical questions for

designing recruitment approaches Involving communities in research

3

Background:History of Research Abuse and Neglect

1960’s elderly cancer patients in Jewish Chronic Disease Hospital in Brooklyn, NY injected with live cancer cells to measure immunologic reactions

Tuskegee Syphilis Study in Alabama 1932-1972: untreated progression of syphilis in hundreds of poor Black men

1980’s Women’s movement pushed for more involvement in research-aspirin study to determine efficacy in reducing heart attack risk-1982-men only

4

Background:NIH Mandate to Recruit Minorities

1993 NIH Revitalization Act: women and minorities must be included in clinical research supported by NIH

For clinical trials, recruitment methods must yield sufficient numbers to allow valid evaluation of ethnic differences

Need to provide scientific evidence to inform health policy or standard of care that is relevant for major ethnic groups

5

4 Basic Recruitment Issues in Diverse Groups

Mismatch between priorities of researchers and communities

Barriers to participation include historical, social, financial and attitudinal factors

Need for more evidence as to what works Requires special strategies, additional

resources and flexibility

6

Mismatch in priorities

7

Identifying Community Priorities and Attitudes about Research

Survey: conducted a mail survey of 117 San Francisco and Oakland CBOs serving African Americans and Latinos, identified through community resource listings and prior outreach efforts

Focus groups: conducted 4 focus groups with 36 low-income residents (aged 58-84) of Bayview Hunters Point, Western Addition and Mission District

8

CBO Survey Unmet Needs of African American and Latino Elders

Percent NeedingLots/Huge

Rank Unmet Need Amount of Help1 Affordable housing 712 Enough money to meet needs 703 Transportation 604 Safer neighborhoods 605 Medical care 536 Help with household tasks 457 Care for depression or anxiety 45

Nápoles-Springer A et al., Research on Aging. 2000;22(6):668-691.

.

9

Focus GroupsSocial Priorities

Urban isolation and vulnerability Racism and discrimination in housing

and health care Social impotence, hopelessness

Personal safety of elders

Affordable and easy access to housing

10

Focus GroupsHealth Priorities

Need for community-based health centers Access to new prevention and treatment

options Better communication with physicians Better insurance coverage

11

Historical, financial, and attitudinal barriers

12

CBO SurveyTrust in Researchers

% Neither

% Agree A nor D % Disagree

L and AA do not take part due to distrust 65 29 6

L and AA afraid due to discrimination 43 39 18

Studies guard health of participants 41 45 14

Researchers protect rights of participants 35 55 10

Participants treated as guinea pigs 30 46 24

Good reason not to trust health researchers 25 43 32

Researchers are condescending to minorities 25 62 13

13

Focus GroupsBarriers to Participation in Research

Distrust of doctors, researchers, institutions Lack of information Lack of follow-up if adversely affected

Inconvenience Lack of transportation

Caregiver obligations 31% of African Americans and 95%

of Latinos agreed to be re-contacted

14

Focus GroupsExperimentation

“They don’t know if people are tellin’ the truth. You know, they will tell you you’re gonna get in this research. Well, what IS this research? Are you REALLY gonna do what you say you’re gonna do? Or are you gonna tell me, are you puttin’ me, and then injectin’ me with the AIDS virus, or a syphilis virus, or something else, and I’m not aware? …People are afraid. They just don’t know enough about these programs.”

15

Focus GroupsBenefits of Research

Advance scientific knowledge

To preserve one’s health

To learn more about a specific disease

To teach researchers about cultural differences

Access to new treatments

16

Focus GroupsLack of Tangible Benefits

“Me, I would have to know that the information they get is gonna benefit the community, as well as me, in some way. If I knew…the findings would benefit the community, and something would be DONE with those findings. They’ve got researchers from UC everywhere, have been out here to research the soil, the air, everything. And then after, they go, that’s the last we hear of it.”

17

Researchers Working For Communities

CBO respondent

“Researchers need to spend time in agencies and in community or clients’ homes to develop trust. Paying people and providing transportation is not enough to increase participation. The study has to have some intrinsic worth to the research participant. Communicating the results back to the agency and participants is crucial to developing trust.”

18

Conclusions Need to improve fit between the priorities of

researchers and those of the community

AA & L community members place a great value on knowledge, especially if it improves their health or their communities’ health

AA & L are willing to participate if:

– we openly address their concerns

– we reduce barriers to participating

19

Lack of evidence on recruitment

20

Lack of Evidence on Recruitment

Diverse groups underrepresented in research

Studies that do include minorities seldom present recruitment by ethnicity

Rigorous studies and reporting of recruitment effectiveness seldom conducted

21

Lack of Evidence on Recruitment

65 recruitment studies (‘93-95) + all articles with human subjects from NEJM and Circulation (‘95)

– 59% of studies reported ethnicity of enrolled subjects vs. 91% reporting on age and 80% on gender

Ness R. 1997AEP,7:7; 472-8

22

Lack of Evidence cont.

Of 600 articles 1970-2003 on community-level obesity-lifestyle interventions in general population, only 5 presented ethnic-specific data

Yancey AK, et al. 2004. Prev Chronic Disease, 1:1-18

23

Lack of Evidence on Recruitment

Review of U.S. Phase III cancer prevention and treatment trials, 1990-2000 with at least 100 participants: 205 treatment and 56 prevention

Age/gender reported in ≈ 92% R/E reported in 35% of tx and 54% of prevention

RCTs No tx RCTs used R/E as selection criteria while

gender specified in 44% and age in 29%

Swanson GM,2002 Cancer:95(5); 950-9.

24

When Consent Rates are Available by Race/ethnicity…

…minorities may be just as willing to participate

…Latinos may be slightly more likely than Whites: OR=1.33 (95% CI 1.08, 1.65)

- Reviewed NHIS 2000, NHANES 2000, NIS2000, 10 clinical interventions studies, and 7 surgical trials

Wendler D, et al., 2006. PLoS Med;3(2):e19

25

Recruitment Effectiveness

Very few experimental studies of methods by ethnic subgroups

Observational data indicate:– Whites may refuse at higher rates– AA and Latinos require greater efforts to enroll– Personal and media approaches in combination

yield good results– Community involvement is key

26

Recruitment Framework

Recruitment Factors Sampling frame Individual/family

factors Study characteristics Recruitment methods Personnel

characteristics

Stages of Participation Invitation to

participate Establishing contact

and eligibility Initial response Study retention and

completion

27

Sampling Strategies

Use lists and identify surnames– 80% sensitive and specific for Latinos– Very sensitive and specific for Vietnamese

Target census tracts based on high-density areas for subpopulations

Budget additional $ to screen for ethnicity if not available in sampling frame

Allow for misclassification of ethnicity Harder (more $) to recruit older adults

28

Factors and Stages of Recruitment: Critical Questions

Stage 1: Invitation to participate Is sampling frame likely to yield representative sample

of targeted subgroups (adequate coverage)? Does initial contact method account for literacy,

culture, education, language, familiarity with and acceptance of research?

Are messages appealing to targeted audience? Are there pre-recruitment strategies that might help

(e.g., radio ads, outreach)?

29

Factors and Stages of Recruitment: Critical Questions

Stage 2: Establishing Contact and Eligibility How accurate is the contact information? Is ethnicity available/accurate? When is the best time to attempt contact? Do I have to obtain the consent of other family

members? Is no response a soft refusal? Will poor health/high mortality affect recruitment? Are eligibility criteria a barrier?

30

Factors and Stages of Recruitment: Critical Questions

Stage 3: Responding How do I deal with those who do not respond? How do I deal with refusals? Is the respondent burden reasonable? Are there tangible benefits to participating? Are the setting, approach and personnel welcoming? Is the research relevant and interesting to participants?

31

Factors and Stages of Recruitment: Critical Questions

Stage 4: Study Completion How do participants feel about the study? How do I retain people in the study? How can I maintain current contact information? Is the respondent burden reasonable? Are there tangible benefits to participating? Are the setting, approach and personnel welcoming? How do I feed back the results to participants and the

communities involved?

32

Aims of IPC Recruitment Study

Achieve equal representation of 4 ethnic-language groups in a telephone survey of the

interpersonal processes of care (communication with MD, decision making,

interpersonal style of MD) Assess response status at various stages by ethnic-language group Assess effectiveness of ethnically-tailored letter on minority recruitment

33

Recruitment Methods

General approach: Initial contact letter with phone follow-up to patients in clinic database» Pre-testing of envelopes, letters for clarity,

readability, appeal» Bilingual materials and personnel

Randomized trial of ethnically-tailored initial contact letters for African Americans and Latinos

Enhanced follow-up protocol with Latinos due to smaller numbers; ↑ no. of calls, search for wrong phone nos.

34

Initial Contact LetterProject Logo

Your Opinions MatterHelp Us Improve CommunicationBetween Doctors and PatientsPlease Consider Taking Part In This Study

Ethnically-tailored initial contact letters for non-Whites referred to:– shortage of ethnic concordant MDs– need for input of patients from their

ethnic group

35

IPC Recruitment Results

61

71

79

58

0

10

20

30

40

50

60

70

80

90

100

AfricanAmerican

English-speaking

Latino

Spanish-speaking

Latino

Non-LatinoWhite

Established Contact with Household

36

IPC Recruitment Results

21

23

6

15

35

20

127

20

41

14

11

10

16

49

17

29

8

15

31

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

AfricanAmerican

English-speaking

Latino

Spanish-speaking

Latino

Non-LatinoWhite

Incorrect phone No answerIneligible RefusedCompleted survey

37

IPC Response Rates by Letter Type

6772

6968 74

76

7072

0

10

20

30

40

50

60

70

80

90

100

AfricanAmerican

English-speaking

Latino

Spanish-speaking

Latino

Total Non-White

General Ethnically-tailored

38

Summary of IPC Recruitment Results

Primary subject loss is prior to contact– Unable to contact: bad numbers, no household

contact, no individual contact– Ranged from 27% (LS) to 48% (W)

» Most noncontact of W due to no household contact (e.g., answering machines, no answer)

Once contacted, response rates are fairly high– Higher in LS (75%) and AA (70%)– Lower in LE (68%) and W (66%)

39

Recruitment: General Guidelines

Develop strategies to avoid or deal with incorrect contact information

Develop strategies for “soft refusals” (no answer, individual not at home, busy right now)

Design methods and materials to be culturally sensitive; pretest

Anticipate barriers to extent possible Develop recruitment tracking system Obtain community support for project

40

What Works and What Doesn’t?

Use multiple strategies, personal approaches, community involvement, tangible benefits, culturally similar research personnel

Address language, economic, transportation, childcare needs

Openly address issues of distrust and fear Set recruitment goals, track on-going results,

adjust methods as needed

41

Practical Recruitment Advice

Build credibility of research institution through community service– address issues of distrust

Increase awareness of resources available at the research institution for the community– lectures, medical and referral services, translations,

health screenings, clinical trials, grant writing Increase access to research information

– community forums, outreach, convenience, newsletters, responsiveness to community priorities

42

Practical Recruitment Advice

Budget for time to develop recruitment strategies Pretest recruitment messages and strategies

– e.g. pre-test ethnically tailored flyers, contact letters, envelopes

Ongoing monitoring of recruitment results is critical, adjust as necessary

Report results by ethnicity– to build evidence of effectiveness of methods

43

Why an Increased Focus on Communities?

To broaden our models of health to include individual, social and environmental influences

Expansion of outcomes from morbidity and mortality to include well-being and QoL

Managed care focus on enrolled populations and health maintenance

Challenges of addressing health disparities

44

IOM Concept of Primary Care: New Facets

Integrated, accessible health care services Attend to wide range of individual needs Long-term partnership with clients Attend to broader family and community context of health

care - social and economic factors affecting the health and well-being of individuals, families and communities

Utilizes specific community-based empowering strategies, e.g. use community assets to improve health

Primary Care America’s Health in a New Era, IOM, 1996.

45

Working with Communities to Conduct Health Disparities Research

Expands our perspective Shifts focus from how to recruit minority

populations and how to engage/interest them in research… to ……

having minority communities involved as partners in research from the beginning

46

Key Principles of Community-based Participatory Research (CBPR)

Recognizes community as an important aspect of individual and collective identity

Builds on strengths and resources of community to improve health

Facilitates collaborative partnerships through all phases of research

Integrates knowledge and action for mutual benefit of all partners

(Israel B. Annu Rev Public Hlth. 1998. 19:173-202)

47

Key Principles of CBPR

Shared learning and empowering to address social inequalities

Iterative process: partnership development and maintenance, assessment, goal-setting, development of methods, data collection, interpretation, dissemination, policy, action, sustainability

Positive and ecological perspective of health Dissemination of findings to all partners

(Israel B. Annu Rev Public Hlth. 1998. 19:173-202)

48

Methodological Issues

Flexibility to tailor methods to objectives, context, and interests of community

Involve community members in all stages Conduct community assessment Develop training and educational opportunities Involve partners in dissemination Interdisciplinary research teams

49

Other Issues

Community individuals and agencies often volunteer their time (as do research staff)

CBPR may not carry same promotional weight in academia as other types of research

More difficult to obtain funding Lack of support for relationship building and facilitating

community change Need for more in-depth publications of processes and

outcomes of CBPR

50

Conclusions

Recruitment requires special attention when conducting research with minority and lower-SES populations

Working closely with minority communities in all phases of research can facilitate– research that is relevant to their perspectives– enhanced recruitment– using community resources and strengths in combination

with health care interventions to improve health