The Importance of Communication and Cultural Competence in Enhancing Research Participant Recruitment and Retention

Transcription

1 The Importance of Communication and Cultural Competence in Enhancing Research Participant Recruitment and Retention Lisa A. Cooper, MD, MPH Professor of Medicine Johns Hopkins University School of Medicine Welch Center for Prevention, Epidemiology, and Clinical Research

2 Objectives Describe barriers and promoters to full participation in research studies by diverse groups at the following levels: Research participant Investigator Institutional Funder Define patient-centeredness and cultural competence and describe their roles in overcoming healthcare disparities Discuss how improving interpersonal and institutional communication/patient-centeredness and cultural competence can be used to enhance research participation

3 Barriers and Promoters to Full Participation in Research

4 Origins of Mistrust in Medical Care and Research African Americans Legacy of slavery and racial discrimination The Tuskegee Syphilis Study Civil Rights Era Persistent disparities in healthcare Other Ethnic Minority Populations Legacy of discrimination Lack of cultural sensitivity in research practices Persistent disparities in healthcare

5 Tuskegee Syphilis Study Observational study conducted in Tuskegee, Alabama by the U.S. Public Health Service. Recruited 400 black men with evidence of syphilis and 200 Black men without the disease Aimed to evaluate the natural progression of syphilis in black men, believed to be different than in white men Grassroots recruitment methods used, attractive incentives offered True objectives of the study were not communicated to study participants; those with syphilis were told they had bad blood Jones JH. Bad Blood: the Tuskegee Syphilis Experiment. New York: The Free Press; 1993.

6 Tuskegee Syphilis Study Treatment of participants was withheld even after penicillin became standard of care in 1943 Study terminated after exposure to the media in 1972 Led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections Also led to federal regulation requiring Institutional Review Boards (IRBs) for protection of human subjects in studies involving human subjects The Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services Jones JH. Bad Blood: the Tuskegee Syphilis Experiment. New York: The Free Press; 1993.

7 Health Disparities Policy Timeline Minority Health and Health Disparities Research and Education Act of 2000 Healthy People Tuskegee Syphilis Study becomes public NIH Revitalization Act of 1993 establishes the Office of Research on Minority Health 1985 DHHS Heckler Report on Black and Minority Health 2003 IOM Report Unequal Treatment and first National Healthcare Disparities Report published Healthcare reform bill passed

8 Definitions Health disparity population: "a population where there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. 1 Health disparities: Differences in health that occur by gender, race or ethnicity, income or education, disability, living in a rural locality, or sexual orientation Minority Health and Health Disparities Research and Education Act of Healthy People 2010

9 A Framework for Understanding Relationships between Race and Health RACE Biologic factors Cultural factors Socioeconomic factors Environmental factors Health risk behavior Access to healthcare Quality of healthcare HEALTH

10 NIH Policy on the Inclusion of Women and Minorities in Clinical Research NIH Revitalization Act adopted 1993 Created to ensure that women and minorities and their subpopulations are included in all human subjects research Encourages inclusion with adequate numbers to conduct subgroup analyses Requires official documentation of inclusion to facilitate monitoring demographic data of all NIHfunded research

11 NIH Policy on the Inclusion of Women and Minorities in Clinical Research Updated guidelines (2001) address issues beyond the scope of participant enrollment Emphasize better planning, conducting, and reporting of subgroup analyses If prior evidence suggests outcome differences by subgroups, research plan must include specific details on how data will be analyzed Encourages investigators to report subgroup analyses in publications

12 Framework to Achieve Full Participation in Clinical Research Investigator s Role Participant s Reasons Full Participation Awareness Opportunity Enrollment Retention Ethics Funder s Role Institution s Role Adapted from Powe NR, Gary TL. Clinical Trials, in Race and Research: Perspectives on Minority Participation in Health Studies, Editor Bettina M. Beech (APHA publications, released Spring 2004).

13 Moderators/ Sociodemographic Factors Race/Ethnicity Age Gender Geography Language Income Social Ties Education Culture Awareness Barriers/ Promoters Knowledge Attitudes/ Beliefs Self-Efficacy Organizational Environment Health Literacy Opportunity Barriers/ Promoters Provider knowledge Provider attitudes/beliefs Eligibility/ Exclusions by design Access Medical Insurance Advanced Disease Co-Morbidity Organizational Environment Acceptance/ Refusal Barriers/ Promoters Perceived harms/ benefits Trust in sponsor/ investigator Self-Efficacy Altruism Religious beliefs Personal experience No cost treatment Financial incentives Timing Opportunity Awareness Acceptance/ Refusal Conceptual Framework of Barriers and Promoters of Participation of Underrepresented Minorities in Clinical Trials. Adapted from Ford et al., AHRQ Tech Report, 2005

14 Participant Barriers to Full Participation in Clinical Research Barrier Awareness Recruitment Retention Limited opportunity to learn about studies Recruitment schemes Lack of medical resources in community Ineffective staff communication X X X Language barriers X X X Mistrust Prior negative experience in healthcare Family and friends influence X X X X X X X Adapted from Powe NR, Gary TL. Clinical Trials, in Race and Research: Perspectives on Minority Participation in Health Studies, Editor Bettina M. Beech (APHA publications, Spring 2004).

15 Participant Barriers to Full Participation in Clinical Research Barrier Awareness Recruitment Retention Concerns about changing treatment X X Fatalistic attitudes X X Beliefs/moral values, including religion X X Use of alternative medicine X X Caring for children or other ill relatives X X Working multiple jobs X X Transportation problems X X Lack of feedback X X Adapted from Powe NR, Gary TL. Clinical Trials, in Race and Research: Perspectives on Minority Participation in Health Studies, Editor Bettina M. Beech (APHA publications, Spring 2004).

16 PERCEPTION ALIGNMENT UTILIZATION CULTURAL PREFERENCES HEALTH BELIEFS TRADITIONAL & ALTERNATIVE HEALTHCARE Poor Health Dissatisfaction HEALTH & ILLNESS UTILIZATION OF BIOMEDICAL HEALTHCARE ACCESS TO & COST OF BIOMEDICAL HEALTHCARE RESEARCH PARTICIPATION Ethno-Medical Model of Research Participation. Calderón et al, Med Gen Med 2006;8:23

17 Barriers to Research Participation SHARED BARRIERS TO RESEARCH PARTICIPATION Fear of experimentation/harm Research for disease with current Rx Transportation Lack of financial resources Time conflicts Need for childcare Number of visits required DISTINCT BARRIERS TO RESEARCH PARTICIPATION Immigrant Latinos African Americans Fear of deportation Racism in healthcare Lack of information about free care Mistrust of healthcare systems Lack of information about health Mistrust of medical research Lack of information about research Differential treatment because of race Poor communication Language barriers Need for healthcare Calderón et al, Med Gen Med 2006;8:23

18 Motivators to Research Participation SHARED MOTIVATORS TO RESEARCH PARTICIPATION Fear of experimentation/harm Research for disease with current Rx Transportation Lack of financial resources Time conflicts Need for childcare Number of visits required DISTINCT MOTIVATORS TO RESEARCH PARTICIPATION Immigrant Latinos African Americans Burden of disease in family Adequate remuneration Burden of disease in community Self having disease at a severe stage Susceptibility to a disease Access to healthcare Access to medicines Access to health information Spanish-speaking research staff Calderón et al, Med Gen Med 2006;8:23

19 Attitudes and Beliefs of African Americans toward Participation in Medical Research Objective: To describe barriers to participation of African Americans in research Design: Five Focus group interviews Patients: 33 African-American adults presenting to an urban public hospital for outpatient medical care Measurements: African-American patients' attitudes toward medical research Main results: Mistrust of doctors, scientists, and the government was reported consistently by the participants Corbie-Smith G et al. J Gen Intern Med 1999; 14:537-46

20 Results, cont d Many participants described concerns about the ethical conduct of clinicians and investigators and cited examples of exploitation and conspiracy theories as supporting evidence for their mistrust of the medical establishment While participants were clear about the violation of human rights in the Tuskegee Syphilis Study, all were misinformed of the historical facts Few participants understood the concept of informed consent; they saw signing the document as relinquishing their autonomy and as a legal protection for physicians Corbie-Smith G et al. J Gen Intern Med 1999; 14:537-46

21 Participant Recommendations More honest and respectful communication from physicians and other research personnel Provision of complete information about risks and benefits of the study Generally speaking, a need for greater promotion of, and awareness about, the purpose and importance of research and opportunities to participate Corbie-Smith G et al. J Gen Intern Med 1999; 14:537-46

22 Investigator Barriers to Full Participation in Clinical Research Barrier Awareness Recruitment Retention Methods to increase awareness unknown Lack of community liaison efforts X X Ineffective guidance to study staff Recruitment based on convenience Study run-in periods/selection processes Stereotypes/attitudes of investigators Ineffective informed consent process Ineffective study staff communication X X Limited knowledge of retention methods Lack of appropriate participant incentives Lack of feedback Adapted from Powe NR, Gary TL. Clinical Trials, in Race and Research: Perspectives on Minority Participation in Health Studies, Editor Bettina M. Beech (APHA publications, Spring 2004). X X X X X X X X X

23 Institution and Funder Barriers to Full Participation in Clinical Research Barrier Awareness Recruitment Retention Lack of investigator incentives Lack of participant incentives X X Limited control over actions of particular institutions Institutional stereotypes/attitudes Relationship with community X X X Institution s minority status X X X X X X X Adapted from Powe NR, Gary TL. Clinical Trials, in Race and Research: Perspectives on Minority Participation in Health Studies, Editor Bettina M. Beech (APHA publications, Spring 2004).

24 Patient-centeredness and Cultural Competence: Lessons from Healthcare Studies Definitions Effectiveness Link to Healthcare Disparities

25 Access to Health Care for Racial and Ethnic Groups Barriers Personal/Family acceptability cultural language/literacy attitudes, beliefs preferences involvement in care health behavior education/income Structural availability appointments how organized transportation Financial insurance coverage reimbursement levels public support Health Care Processes Use of Services Mediators Outcomes Visits primary care specialty emergency Procedures preventive diagnostic therapeutic Quality of providers cultural competence communication skills medical knowledge technical skills bias/stereotyping Appropriateness of care Efficacy of treatment Patient adherence Health Status mortality morbidity well-being functioning Equity of Services Patient Views of Care experiences satisfaction effective partnership Modified From Access to Health Care in America (1993, Millman M, ed). Cooper LA, Hill MN, and Powe NR. JGIM 2002;

26 Definition of Patient-centered Care Providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions *Institute of Medicine, Crossing the Quality Chasm, 2001

27 The doctor I have now is great. He s nice and calm. And he asks a lot of questions. He is very, very sharp I think, whatever this guy tells me for the most part, if it sounds sensible, I ll give it a try. African American man, age 41, about his primary care physician

28 Organizational and Interpersonal Patient-Centeredness Within Health Care Organizations Services aligned to meet patient needs/ preferences: Coordinated/ integrated/ continuous Convenient/ easily accessible Attendant to health promotion/physical comfort Patient- Centered Health Care Systems Patient- Centered Health Care Interactions Within Interpersonal Interactions Clinician understands each patient as a unique human being: Uses biopsychosocial model Views patient as person Shares power and responsibility Builds effective relationship Is aware of the doctor as person Saha S, Beach MC, Cooper LA. J Natl Med Assoc 2008;100:

29 CMS Evaluation of Standards for Patient-centered Medical Homes Access and communication Patient tracking and registry functions Care management Patient self-management support Electronic prescribing Test tracking Referral tracking Performance reporting and improvement Advanced electronic communications

30 Training in Patient-centered Communication Skills is Effective Patient knowledge and recall of information Patient adherence Patient satisfaction Clinical outcomes Pain reduction (11 of 25 trials) Depression resolution Blood glucose control (1 of 3 trials) Blood pressure control (1/4 trials) Patient trust Griffin SJ, et al Ann Fam Med. 2004; 2(6):

31 Students without Patient-centered Attitudes Perform More Poorly with African American Patients Beach MC et al. Acad Med Feb;82(2):193-8.

32 Ethnic Minorities Rate Their Visits with Physicians as Less Participatory P=0.007 P=0.05 PDM scores range from A higher score means visit is more participatory. Cooper-Patrick L, JAMA 1999;282:

33 Physicians Communicate More Poorly with African-American Patients Communication measure Whites Blacks n=202 n=256 p-value* Physician verbal dominance <0.01 Patient-centeredness ratio Patient positive affect** <0.01 Physician positive affect** Adjusted for: patient age, gender, education level, and self-rated health status; and physician gender, race, time since completing training, and report of how well he/she knows each patient. *p-value from linear regression with GEE.** Patient and physician affect scores are derived from audiotape coders impressions of the overall emotional tone of the medical visit. Johnson RL, Roter DL, Powe NR, Cooper LA. Am J Public Health 2004; 94:

34 Definitions of Cultural Competence Interpersonal Cultural Competence The ability of individual health care professionals to establish effective interpersonal and working relationships with patients (and each other) that supercede cultural differences 1 Health System Cultural Competence The ability of health care providers and organizations to understand and respond effectively to the cultural and linguistic needs brought by patients to the health care encounter 2 1 Cooper & Roter, Unequal Treatment, IOM, Office of Minority Health 2001

35 I think it is more difficult to manage someone from a different culture. They may have different values. I often do wonder if there s something else that either he [the patient] hasn t told me, or that I m not understanding White primary care physician, about his African American patient with uncontrolled hypertension

36 Organizational and Interpersonal Within Health Care Organizations: Ability of the health care organization to meet needs of diverse groups of patients: Cultural Competence Culturally Competent Health Care Systems Within Interpersonal Interactions: Ability of a provider to bridge cultural differences to build an effective relationship with a patient: Understands the meaning culture Is knowledgeable about different cultures Appreciates diversity Diverse workforce reflecting patient population Facilities convenient to Culturally community Competent Language assistance for Is aware of health Health Care patients with limited disparities and English proficiency Interactions discrimination affecting Staff training regarding minority groups delivery of culturally and Effectively uses interpreter linguistically appropriate services when needed services Culturally appropriate health education materials Saha S, Beach MC, Cooper LA. J Natl Med Assoc 2008;100:

37 # of Studies Cultural Competence Training is Beneficial* Knowledge 1 1 Benefit No Effect Mixed Harm Attitudes Skills Satisfaction Adherence Beach et al. Med Care 2005;43: *34 studies: 2 RCTs, 12 CCTs, 20 Pre/Post.

38 Culturally Targeted Health Care is Effective Systematic review showed 23/38 interventions were effective at increasing patient knowledge, improving access, and enhancing clinician cultural competence Interventions that modified health behaviors of individual patients of color Typically tapped community members expertise to shape programs Interventions that increased access of communities of color to the existing health care system Involved screening programs, incorporating patient navigators and lay educators Interventions that modified the health care system to better serve patients of color and their communities Focused on the roles of nurses, counselors, and community health workers to deliver culturally tailored health information Fisher TL. Med Care Res Rev. 2007; 64(5 Suppl): 243S 282S.

39 Resident Physicians Report Low Cross Cultural Skill Levels Weissman JS et al. JAMA. 2005;294:

40 The Implicit Association Test A computer-based, indirect measure of social cognition Measures the time it takes for a respondent to match representatives of social groups to certain attributes The Race Attitude IAT asks participants to sort and pair African American and European American facial images with the value categories of good vs. bad using right and left keys as they appear rapidly on a computer screen Premise: individuals will link concepts that are strongly associated more quickly than those that are not The IAT score is derived from the difference in average response time on two sorting tasks Greenwald, McGhee, Schwartz, 1998

41 Clinicians Have Implicit Racial Bias Favoring Whites Percent of respondents with each score Strong preference for Whites Moderate preference for Whites Slight preference for Whites Little to no preference Slight preference for Blacks Moderate preference for Blacks Strong preference for Blacks 14% 26% 26% 10% 14% 5% 5% 66% Cooper LA et al, Clinicians Implicit Race Attitudes and Stereotypes and Quality of Interpersonal Care, manuscript under review

42 Ethnic Minorities Report Biased Treatment by Health Professionals White Black Hispanic Asian Perception of Treatment N=3488 N=1037 N=1153 N=621 Percent of patients I would have received better care if I were different race/ethnicity I was treated unfairly based on my race or ethnicity I was treated unfairly based on how I speak English p-values for all race/ethnicity comparisons <0.001 Johnson RL, Saha S, Arbelaez J, Beach MC, Cooper LA. J Gen Intern Med 2004;19:

43 Race-concordant Visits are Longer with Slower Speech and More Positive Patient Emotional Tone P= P= P= P=0.19 concordant discordant Visit duration, minutes Speech speed per minute Patient positive affect Physician positive affect Adjusted for patient age, race, gender, and health status, physician gender & yrs in practice Cooper LA et al, Ann Intern Med 2003;139:

44 Mean Score/Probability Patients In Race-concordant Relationships Rate Their Physicians Better 76.1 P= concordant discordant P<.01 Participatory Decision-making Overall Satisfaction Recommend MD to a friend Analyses adjusted for patient gender, race, age, and health status, physician gender, years in practice, and patient-centered communication. 51 P= Cooper LA et al, Ann Intern Med 2003;139:

45 Summary Findings regarding patient-clinician interactions in healthcare are applicable to participation in research by diverse groups Lack of patient-centeredness (e.g., communication problems), harboring of biases, and lack of cultural competence among health professionals and institutions contribute to healthcare disparities and participant willingness to enroll in research studies

46 Improving Interpersonal and Institutional Communication and Cultural Competence to Enhance Research Participation

47 Relationships and Communication in Minority Participation in Research One-to-One, Interpersonal Communication Short-term, study-related Recruitment facilitators Technical advisors Long-term, extending beyond a project Mentoring relationships Technical aspect of recruitment Sounding board Acting as mentor Corbie-Smith G et al, J Natl Med Assoc 2007; 99:

48 Relationships and Communication in Minority Participation in Research One-to-Many, Community-Level Communication Short-term, study-related Community advisors Investigator visibility Building trust Long-term, extending beyond a project Sharing insights Forming networks Investigator obligations Corbie-Smith G et al, J Natl Med Assoc 2007; 99:

49 Community-based Participatory Research (CBPR) Research that focuses on social, structural, and physical environmental inequities through active involvement of community members, organizational and institutional representatives, and researchers in all aspects of the research process All partners contribute their expertise to enhance understanding of a given phenomenon and to integrate the knowledge gained with action to benefit the community involved Israel BA et al. Annu Rev Public Health. 1998;19:

50 Community-based Participatory Research (CBPR) The process of working together in planning, intervention development and implementation, evaluation, dissemination and policy development has the potential to bridge the cultural gap between researchers and communities and empower traditionally marginalized communities through the acquisition of new knowledge A culturally sensitive and potentially effective and sustainable approach to research Israel BA et al. Annu Rev Public Health. 1998;19:

51 Checklist for Planning and Instituting Studies with Diverse Populations Establish and maintain community involvement and liaisons and relationships throughout study Train personnel in ethics, communication, and cultural sensitivity Obtain IRB approval Employ recruitment coordinator; consider culturally concordant staff Communicate respectfully throughout study

52 Checklist for Planning and Instituting Studies with Diverse Populations Use culturally and linguistically appropriate materials for recruitment, data collection, and interventions Allocate sufficient funds for incentives Use outreach programs and advertisements Support community events and participate in political process regarding health concerns Involve local churches and community organizations

53 Checklist for Planning and Instituting Studies with Diverse Populations Launch targeted publicity campaigns Consider participant needs, such as convenient hours, study-supplied transportation or reimbursement for transportation costs, and the location of the study Use role models/lay health workers Door-to-door canvassing Become willing to make changes to study design

54 Acknowledgments David M. Levine, MD, ScM, MPH Lee R. Bone, RN, MPH Chidinma A. Ibe, BA Crystal Evans, MS Shardai Thomas ICTR Community Research Advisory Board members

55 Patient-centeredness and Cultural Competence: Additional Resources Measurement Training Targets

56 Measuring Patient-centeredness Self-report by clinician, investigator, or staff Attitudes (e.g., patient-provider orientation scale*) Behaviors Patient or research participant report Listening Spending enough time Explaining things clearly Participatory decision-making Direct observation Observer present Audiotape or videotape *Krupat E, Patient Educ Couns 2000 Jan;39(1):49-59.

57 Communication Skills Training Targets Data-gathering Using open-ended questions to probe patients perspectives Educating and counseling Providing information in short, clear statements with opportunities for patients to ask questions Rapport-building Making emotional connections and giving support to patients Partnering with patients to share diagnostic and treatment decisions Soliciting and listening to patients views; using participatory strategies to solve problems and resolve differences Roter D, Health Expect. 2000; 3:17-25

58 Communication Skills Training Targets/Methods Study-specific communication skills Skills specific to informed consent process Disease or condition-oriented proficiencies Behavior-oriented proficiencies (e.g., motivational interviewing) Population-specific proficiencies (e.g., low health literacy, limited English proficiency) Methods Lectures, films Small group discussion Role-playing Clinical experience Interactive media, web-based tools

59 Measuring Cultural Competence Self-assessment Attitudes Explicit importance of culture, social justice Implicit biases and stereotypes Preparedness to deliver cross-cultural care, frequency of behaviors, self-reported skill Patient or research participant report Unbiased care Respectful communication Objective measurement Knowledge General concepts of culture Health disparities facts Skills Communication in race-discordant encounters Appropriate use of interpreters Performance audit

60 Cultural Competence Training Targets/Domains General cultural concepts and cultural awareness Specific cultural information Bias, racism and stereotyping Patient-physician relationships/communication Health care access Socioeconomic status Language and literacy issues Methods Lectures Community activities Small-group discussions Clinical experience Cultural immersion Smith W et al, Ann Intern Med ;147:654-65