Under Title VI of the 1964 Civil Rights Act, it is required that “no person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” However, despite this federal requirement, the health disparity among minority populations continues to persist. CLAS standards can be applied to minority recruitment for clinical trials as a way of establishing trusting relationships with culturally diverse participants.
In 2001, the Office of Minority Health established the National Standards of Culturally and Linguistically Appropriate Services in Health Care as an official protocol for the implementation of culturally appropriate care. The CLAS standards consists of 4 mandates (legal Federal requirements), 9 guidelines (standards suggested for adoption as mandates), and 1 recommendation (suggestions) centered around 3 central themes of culturally competent care, language access services, and organizational supports for cultural competence.
Since its release, the CLAS standards have been implemented in various stages at healthcare institutions in the United States. A core goal of the CLAS standards is the establishment of a trusting and long-lasting relationship between health professionals and patients, a crucial step to achieving culturally competent care.
First of all: What is CLAS?
CLAS is an expansion of The Civil Rights Act of 1964, Title VI. The 14 CLAS Standards aim to meet the increasingly diverse demographics by requiring healthcare organizations to provide culturally competent care.
The CLAS Standards
…are comprised of 14 standards and 3 themes.
The 14 standards include:
- 4 mandates that are required by law
- 9 guidelines
- and 1 recommendation
The 3 themes are:
- Culturally Competent Care Awareness
- Language Access Services
- and Organizational Support for Cultural Competence
And now, a closer look at the CLAS themes:
With Culturally Competent Care Awareness, organizations need to recruit and train staff members to provide culturally congruent and linguistically appropriate care.
Language Access Services requires health organizations to provide bilingual staff and provide interpreter services at the patient’s request. In language medical materials must be readily available.
Organizational Support for Cultural Competence means healthcare organizations should integrate information about participant demographics into their medical records for future use and healthcare organizations should work towards building community networks with the population it serves.
Why are the CLAS standards important to clinical trials?
The CLAS standards provide a systematic way to integrate culturally competent care into clinical trials.
The adoption of the CLAS standards makes it possible to obtain true informed consent, establish an intimate relationship between researcher and participant, and allow for better treatment adherence and outcomes.
Now in the next case study: we will see how the CLAS Standards can be applied
Mohammad Kochi is a 63-year-old Afghanistani whose family immigrated to the United States in 1988. He is a devoted Muslim and a well-respected member of the community. He was previously diagnosed with gastric cancer and had the tumor removed via surgery. However, following surgery, his doctor recommended chemotherapy to eradicate the remaining cancerous cells. Mr. Kochi has consistently refused chemotherapy. During his visits, Mr. Kochi is accompanied by a family member or friend who serves as his translator. No hospital translator is provided.
Things to Consider:
What role does language play in the development of a researcher- participant relationship? What implications can the lack of adequate language services have on a participant’s willingness to consider enrolling in a clinical trial?
This video identifies the gaps in cross-cultural communication that exists in health-care today and the frustration that can result from miscommunication between researcher and participant in the absence of adequate language services:
- Mr. Kochi’s family neglected to tell him that the surgery did not remove all of the tumor mass.
- Mr. Kochi confused chemotherapy treatment with “the pump” believing that it was the only treatment available.
- Dr. Fisher did not understand that, due to religious practices, “the pump” was not an acceptable treatment option.
- Because of this misunderstanding, Mr. Kochi’s treatment was delayed 6-months.
Ensuring there is no miscommunication because of a language barrier is not just good practice, it’s the law!
Any healthcare organization receiving federal funding is required to:
- Provide language services at no cost to patient with limited English proficiency at all visits and point of contact.
- Provide patients written and verbal notices informing them of their rights to receive language assistance services in their preferred language
- Access and assure the competence of language assistance provided to the patient
- And make available easily understood patient-related materials, including signs, consent forms, medical information, etc.
In summary, here is what you should do:
Ask yourself: How well does your current clinical trials recruitment and retention efforts adhere to CLAS standards?
Take the CLAS self-assessment quiz to identify gaps in your service and ways to improve your adherence to CLAS standards at www.culturecareconnection.org
Know, that in order to implement the CLAS standards, it is crucial to
…recruit and train bilingual/bicultural staff and translate necessary research materials such as the consent forms, educational materials, and research protocols. Please take into account the literacy rate of your target population reading level. You can use the SMOG tool found at www.wordscount.info. Also, engage the community in the development of research material via focus groups or community forums.
In the Recruitment and training of bilingual/bicultural staff
- Regularly train staff in cultural competency and CLAS standards.
- Assess staff on their skills and comfort level of cultural terms and or references
For the Translation of Necessary Materials
- Use “I Speak” cards
- Translate consent forms
- Provide in-language education materials
- Translate clinic signs
Case Study: Facing Growing Diversity
Like other healthcare organizations, AnMed Health must face the growing diversity in the population by finding an effective and low-cost way to provide language services to its patient. This video highlights the success of their partnership with the language service provider, MedVerse, that resulted in the deployment of medical translators for patients as well as training on cultural competency for the hospital staff
Things to Consider
What value does language interpretation add to the understanding of study protocols for non-English speaking patients?
What aspects does a language interpreting program need in order to successfully follow the CLAS standards?
Successful application of the CLAS standards has evidence of:
- Culturally and linguistically appropriate services being integrated into each step of the clinical trial process
- Engagement in community capacity development
- Programs that are community driven and community controlled
- Trust and communication between researcher and the targeted population
You can learn more about the CLAS standards from these resources:
- The Office of Minority Health online at http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=11
- National Standards for Culturally and Linguistically Appropriate Services in Health Care: Executive Summary. U.S. Department of Health and Human Services, OPHS, Office of Minority Health. (2001) http://minorityhealth.hhs.gov/assets/pdf/checked/executive.pdf
- Betancourt JR, Green AR, Carrillo JE. (2002) Cultural Competence in Health Care: Emerging Frameworks and Practical Approaches. The Commonwealth Fund. www.cmwf.org.
- Vigil A, Hotrum K, Rodriguez D, Sutin J, Armitage K. Culturally and Linguistically Appropriate Services (CLAS) Toolkit. Department of Health, New Mexico. http://nmdohcc.org/files/DRCLAS%20instrument%20final%208-18-09.pdf