CLAS-ACT - Handbook

Culturally and Linguistically Appropriate Services And Clinical Trials
(CLAS-ACT)

CLAS-ACT SELF-STUDY Handbook

Developed by the

Chronic Disease Prevention and Control Research Center
at
Baylor College of Medicine

for the
Eliminating Disparities In Clinical Trials (EDICT) Project

The EDICT CLAS-ACT Project is funded under Cooperative Agreement Number MPCMP051006-03 from the U.S. Department of Health and Human Services Office of Minority Health to the Baylor College of Medicine Chronic Disease Prevention and Control Research Center.

The Office of Minority Health acknowledges the National Institutes of Health (NIH) National Center for Minority Health and Health Disparities for its financial contribution to this effort, and also to HHS Office on Women's Health for its support.

For more information about the CLAS-ACT Project, contact:

Larry Laufman, Ed.D.
EDICT CLAS-ACT Project Director
Chronic Disease Prevention and Control Research Center
Baylor College of Medicine
1709 Dryden ? Suite 1025
Houston, TX 77030
Tel: 713.798.5387
E-mail: llaufman@bcm.edu

INTRODUCTION

Background

Since the 19th century, the underprivileged were exploited for the ends of medical research. These groups have included women, racial and ethnic minorities, the poor, children and orphans, those without decisional capacity, and other groups. They were systematically forced or coerced into risky medical research without either their knowledge or informed consent. While some benefitted from the experimental interventions, many did not, most were harmed, and all were wronged. Fortunately, codes of conduct, laws, and regulations were passed in the second half of the 20th century to help prevent these wrongs.^1-5

Unfortunately, there has been a pendulum swing in the opposite direction, such that underprivileged and vulnerable populations in beneficial clinical trials are now, for the most part, under-represented in clinical trials. This contributes to health disparities in two ways. On the one hand, the newest techniques and drugs are kept out of reach for disadvantaged groups. On the other hand, approved drugs are more dangerous for these populations because the medications may not have been tested on a sufficiently diverse participant pool to detect population-specific contraindications.

EDICT⁶

Eliminating Disparities in Clinical Trials (EDICT) is a four-year project (2005-2009) of the Chronic Disease Prevention and Control Research Center (CDRC) at Baylor College of Medicine and the Intercultural Cancer Council (ICC).^7,8 The EDICT Project was designed to develop practical and realizable policy solutions to the problem of clinical trial disparities. The project will eventually attempt to initiate change at the federal, state, and institutional levels as well as in the public, private, and non-profit sectors. The project has two arms ? policy research and field research ? which provide both a theoretical and practical basis for policy recommendations.

National Standards on Culturally and Linguistically Appropriate Services (CLAS)⁹

The National Standards on Culturally and Linguistically Appropriate Services (CLAS) were developed by the Department of Health and Human Services (DHHS) Office of Minority Health (OMH) to help reduce health disparities as they impact racial and ethnic groups. The CLAS standards are primarily directed at health care organizations. However, individual providers are also encouraged to use the standards to make their practices more culturally and linguistically accessible. The principles and activities of culturally and linguistically appropriate services should be integrated throughout an organization and undertaken in partnership with the community.

National Standards on Culturally and Linguistically Appropriate Services (CLAS)⁹
http://www.omhrc.gov/templates/browse.aspx?lvl=2&lvlID=15

The CLAS standards are primarily directed at health care organizations; however, individual providers are also encouraged to use the standards to make their practices more culturally and linguistically accessible. The principles and activities of culturally and linguistically appropriate services should be integrated throughout an organization and undertaken in partnership with the communities being served.

The 14 standards are organized by themes: Culturally Competent Care (Standards 1-3), Language Access Services (Standards 4-7), and Organizational Supports for Cultural Competence (Standards 8-14). Within this framework, there are three types of standards of varying stringency: mandates, guidelines, and recommendations as follows:

CLAS mandates are current Federal requirements for all recipients of Federal funds (Standards 4, 5, 6, and 7).

CLAS guidelines are activities recommended by OMH for adoption as mandates by Federal, State, and national accrediting agencies (Standards 1, 2, 3, 8, 9, 10, 11, 12, and 13).

CLAS recommendations are suggested by OMH for voluntary adoption by health care organizations (Standard 14).

Standard 1.	Health care organizations should ensure that patients/consumers receive from all staff member's effective, understandable, and respectful care that is provided in a manner compatible with their cultural health beliefs and practices and preferred language.
Standard 2.	Health care organizations should implement strategies to recruit, retain, and promote at all levels of the organization a diverse staff and leadership that are representative of the demographic characteristics of the service area.
Standard 3.	Health care organizations should ensure that staff at all levels and across all disciplines receive ongoing education and training in culturally and linguistically appropriate service delivery.
Standard 4.	Health care organizations must offer and provide language assistance services, including bilingual staff and interpreter services, at no cost to each patient/consumer with limited English proficiency at all points of contact, in a timely manner during all hours of operation.
Standard 5.	Health care organizations must provide to patients/consumers in their preferred language both verbal offers and written notices informing them of their right to receive language assistance services.
Standard 6.	Health care organizations must assure the competence of language assistance provided to limited English proficient patients/consumers by interpreters and bilingual staff. Family and friends should not be used to provide interpretation services (except on request by the patient/consumer).
Standard 7.	Health care organizations must make available easily understood patient-related materials and post signage in the languages of the commonly encountered groups and/or groups represented in the service area.
Standard 8.	Health care organizations should develop, implement, and promote a written strategic plan that outlines clear goals, policies, operational plans, and management accountability/oversight mechanisms to provide culturally and linguistically appropriate services.
Standard 9.	Health care organizations should conduct initial and ongoing organizational Self-Studys of CLAS-related activities and are encouraged to integrate cultural and linguistic competence-related measures into their internal audits, performance improvement programs, patient satisfaction assessments, and outcomes-based evaluations.
Standard 10.	Health care organizations should ensure that data on the individual patient's/consumer's race, ethnicity, and spoken and written language are collected in health records, integrated into the organization's management information systems, and periodically updated.
Standard 11.	Health care organizations should maintain a current demographic, cultural, and epidemiological profile of the community as well as a needs assessment to accurately plan for and implement services that respond to the cultural and linguistic characteristics of the service area.
Standard 12.	Health care organizations should develop participatory, collaborative partnerships with communities and utilize a variety of formal and informal mechanisms to facilitate community and patient/consumer involvement in designing and implementing CLAS-related activities.
Standard 13.	Health care organizations should ensure that conflict and grievance resolution processes are culturally and linguistically sensitive and capable of identifying, preventing, and resolving cross-cultural conflicts or complaints by patients/consumers.
Standard 14.	Health care organizations are encouraged to regularly make available to the public information about their progress and successful innovations in implementing the CLAS standards and to provide public notice in their communities about the availability of this information.

CLAS-ACT

The CLAS standards were developed for the clinical care setting rather than research. However, in 2007, the OMH funded the CDRC to collaborate in developing approaches to combining CLAS And Clinical Trials ? thus, the CLAS-ACT Project.¹⁰ CLAS-ACT is designed to help researchers and organizations better implement CLAS standards to better meet the needs of research participants from various cultural backgrounds.

This CLAS-ACT Self-Study Handbook is designed to help you measure how well you and/or your institution currently addresses CLAS standards in clinical trials and other research. You can use the Handbook in several ways. To establish current baseline data and measure progress implementing CLAS standards in the future:

Conduct a CLAS-ACT Individual Research Self-Study to assess how well a single clinical trial or study implements CLAS Standards.

Print and follow the Individual Research Self-Study Guidelines found in Appendix A, pages 7 ? 18 of this document.

You can also complete the Individual Research Self-Study online at http://www.bcm.edu/edict/clas-act, where you can automatically calculate and print out a report of how well your research studies address CLAS Standards.

Conduct a CLAS-ACT Institutional Research Self-Study to get an overall picture of how well your agency, institution, or organization implements CLAS Standards across multiple trials or studies.

Print and follow the Institutional Research Self-Study Guideines in Appendix B, pages 19 ? 26 of this document.

You can also review this Handbook as a training exercise with your research staff and administrators. The CLAS-ACT Website http://www.bcm.edu/edict/clas-act has additional resources that can help you reduce disparities in clinical trials. Many of these resources can be found here.

Appendix A. CLAS-ACT Individual Research?Self-Study

Principal Investigator:
Name of Clinical Trial
Institution/Organization:
Address:
Address 2:
City/Town:
State:
Zip/Postal Code:
E-mail Address:
Telephone:
Fax:

Standard 1

Health care organizations should ensure that patients/consumers receive from all staff member's effective, understandable, and respectful care that is provided in a manner compatible with their cultural health beliefs and practices and preferred language.
Do you periodically survey your patients/clinical trial participants about whether they experienced your Project staff as being	Yes	No
1. Have you translated the Informed Consent Form for your study into one or more languages spoken by patients in your area?
2. Effective and efficient?
3. Have you translated the signs where you conduct your study activities into one or more languages spoken by patients in your area?
4. Language #2:
5. Easy to understand, whether in English or other languages spoken by the patients/participants?
6. Respectful to the patients/participants?
7. Sensitive to the cultural and linguistic background of the patients/participants?
Total(Maximum Score: 7 points)

Standard 2

Health care organizations should implement strategies to recruit, retain, and promote at all levels of the organization a diverse staff and leadership that are representative of the demographic characteristics of the service area.
1. Are your staff and leadership diversity proportionate to the demographic characteristics of your service area?
2. Maintain a current demographic, cultural, and epidemiological profile of the community?
Total(Maximum Score: 2 points)

Resources:

If you do not have a community profile or maintain staffing diversity similar to the community you serve, resources under Standard 11, below, can help.

Standard 3

Health care organizations should ensure that staff at all levels and across all disciplines receive ongoing education and training in culturally and linguistically appropriate service delivery.
Do you require your staff to	Yes	No
1. Be familiar with Office of Minority Health (OMH) standards for Culturally and Linguistically Appropriate Services (CLAS)?
2. Complete training in cultural competence?
Total(Maximum Score: 2 points)

Resources:

If you do not require your staff to be familiar with CLAS standards, then you can provide them with written copies of CLAS standards or refer them to the Office of Minority Health CLAS Standards Website: http://www.omhrc.gov/templates/browse.aspx?lvl=2&lvlID=15 If you do not require your staff to complete training to provide culturally and linguistically appropriate services, you can refer them to a number of online resources, for example:

Standard 4

Health care organizations must offer and provide language assistance services, including bilingual staff and interpreter services, at no cost to each patient/consumer with limited English proficiency at all points of contact, in a timely manner during all hours of operation.
For clinical trial participants with limited English proficiency, do you offer and provide language assistance services, including:	Yes	No
1. During Recruitment: Bilingual staff and interpreter services
2. During Recruitment: Written notices about their right to receive language assistance services?
3. During Recruitment: In a timely manner during all hours of operation?
4. During Recruitment: Bilingual staff and interpreter services
5. After Enrollment: Bilingual staff and interpreter services
6. After Enrollment: Written notices about their right to receive language assistance services?
7. After Enrollment: In a timely manner during all hours of operation?
8. After Enrollment: The services above at no cost
Total(Maximum Score: 8 points)

Standard 5

Health care organizations must provide to patients/consumers in their preferred language both verbal offers and written notices informing them of their right to receive language assistance services.
Do you provide the following to patients/clinical trials participants in their preferred language?	Yes	No
1. Verbal information about their right to receive language assistance services?
2. Verbal information about their right to receive language assistance services?
Total(Maximum Score: 2 points)

Standard 6

Health care organizations must assure the competence of language assistance provided to limited English proficient patients/consumers by interpreters and bilingual staff. Family and friends should not be used to provide interpretation services (except on request by the patient/consumer).
When the research staff interact with clinical trial participants, either for recruitment or after enrollment...?	Yes	No
1. Are professional translators available on call?
2. Are volunteer translators available on call?
Total(Maximum Score: 2 points)

Standard 7

Health care organizations must make available easily understood patient-related materials and post signage in the languages of the commonly encountered groups and/or groups represented in the service area.

7.1 Informed Consent	Yes	No
1. Have you translated the Informed Consent Form for your study into one or more languages spoken by patients in your area?
Total(Maximum Score: 1 points)

7.2 Education Materials	Yes	No
2. Have you translated the Educational Materials for your study into one or more languages spoken by patients in your area?
Total(Maximum Score: 1 points)

7.3 Signage	Yes	No
3. Have you translated the signs where you conduct your study activities into one or more languages spoken by patients in your area?
Total(Maximum Score: 1 points)

Standard 8

Health care organizations should develop, implement, and promote a written strategic plan that outlines clear goals, policies, operational plans, and management accountability/oversight mechanisms to provide culturally and linguistically appropriate services.
Do you have a written plan for providing culturally and linguistically appropriate services, including the following?	Yes	No
1. Goals
2. Policies
3. Operational plans
4. Management (persons responsible)
5. Oversight mechanism (how standards will be implemented)
Total(Maximum Score: 5 points)

Standard 9

Health care organizations should conduct initial and ongoing organizational Self-Studys of CLAS-related activities and are encouraged to integrate cultural and linguistic competence-related measures into their internal audits, performance improvement programs, patient satisfaction assessments, and outcomes-based evaluations.
Do you review how well this clinical trial addresses CLAS standards as part of:	Yes	No
1. Initial and ongoing review of participant recruitment and retention?
2. Internal audits?
3. Performance improvement programs?
4. Patient satisfaction assessments?
5. Evaluation of study outcomes?
Total(Maximum Score: 5 points)

Standard 10

Health care organizations should ensure that data on the individual patient's/consumer's race, ethnicity, and spoken and written language are collected in health records, integrated into the organization's management information systems, and periodically updated.
Do you collect and record data on clinical trial participants...?	Yes	No
1. Race, ethnicity?
2. Spoken language?
3. Written language, including education and literacy level?
Total(Maximum Score: 3 points)

Standard 11

Health care organizations should maintain a current demographic, cultural, and epidemiological profile of the community as well as a needs assessment to accurately plan for and implement services that respond to the cultural and linguistic characteristics of the service area.
Do you have a profile of your community with regard to its...?	Yes	No
1. Demographics?
2. Cultural groups?
3. Linguistic characteristics?
4. Epidemiology?
Total(Maximum Score: 4 points)

Resources:

If you do not have a community profile, there are several resources that you can use to quickly develop a profile of the community you serve:

Standard 12

Health care organizations should develop participatory, collaborative partnerships with communities and utilize a variety of formal and informal mechanisms to facilitate community and patient/consumer involvement in designing and implementing CLAS-related activities.
1. Do you have formal or informal partner relationships with community organizations from the racial/ethnic and socioeconomic groups in your area?
2. Do you have an Advisory Group that includes community members from the racial/ethnic and socioeconomic groups in your area?
Total(Maximum Score: 2 points)

Standard 13

Health care organizations should ensure that conflict and grievance resolution processes are culturally and linguistically sensitive and capable of identifying, preventing, and resolving cross-cultural conflicts or complaints by patients/consumers.
1. Do you have a written policy about resolving conflicts or grievances that relate to cross-cultural concerns?
2. Have you shared your policy on resolving cross-cultural conflicts and grievances with your staff?
Total(Maximum Score: 2 points)

Standard 14

Health care organizations are encouraged to regularly make available to the public information about their progress and successful innovations in implementing the CLAS standards and to provide public notice in their communities about the availability of this information.
1. Do you provide educational documents or press releases informing patients and the public about how you implement CLAS standards?
Total(Maximum Score: 1 points)

Resources:

If you do not maintain a current demographic, cultural, and epidemiological profile of your community, you can develop such a profile using the resources under CLAS Standard 11.

How well do you address CLAS standards in clinical trials?

Tally all of your "Yes" answers. There are a total of 71 possible points for "Yes" answers.

CLAS Standard	Number of "Yes" Answers
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Total

Divide your Total by 71.

__________	/	71	=	__________ %
Your Score (total number of "Yes" answers)				implementation of CLAS Standards

The resulting percentage score will gives you an idea of how well you are implementing CLAS Standards.

Appendix B. CLAS-ACT Institutional Research Self-Study

In order to apply CLAS standards effectively, systematically, and consistently, institutions need to identify where the standards can and should be applied, whether they are being applied, and how they can be better applied.

This section offers a guide to conducting such an Institutional Self-Assessment, expanding on the Individual Research Self-Study. Conducting the Self-Study itself is an important first step toward improving the recruitment and retention of minorities and other under-represented groups in clinical trials.

Conducting the CLAS-ACT Institutional Research Self-Study requires going through three steps:

1. Prepare for the Institutional Research Self-Study

2. Calculate your CLAS-ACT Institutional Research Self Study Score; and

3. Improve Implementation of CLAS Standards

1. Self-Study Preparation

The following suggestions will facilitate a thorough and successful Institutional Self-Study:

? Become familiar with the CLAS Standards. The CLAS standards and background are available on the Web at: < http://www.omhrc.gov/templates/browse.aspx?lvl=2&lvlID=15 >.

? Get commitment from the highest level. Adequate implementation of CLAS standards in clinical trials requires your entire institutional organization to foster a culture of concern for eliminating disparities in clinical trials. This requires agreement at the highest level, including necessary budgetary and/or personnel support.

? Establish a CLAS-ACT team. It is important to identify and engage those individuals who are both committed and well placed in your organization to move the self-assessment forward. As with all teams, each person?s responsibilities should be clearly stated, with realistic goals, deliverables, and deadlines. The team leader should have experience in running this type of project, be familiar with the overall organization?s structure and "culture", and understand the role of clinical trials in the organization.

? Clarify the ability of the CLAS-ACT team to address implementation of recommendations after completing the self-assessment. ?Without the ability to implement necessary changes, the self-assessment will become only an exercise. This is another reason to acquire the commitment of the highest level of authority in the organization before beginning.

? Create and maintain a Website for the self-assessment. If you have the organizational resources and commitment, creating a Website for the self-assessment can both improve communication within the team and serve as a reference point for the organization as a whole.

? Collect existing policies. Gather existing organizational policies related to clinical trials recruitment and retention as well as health disparities. The team should review these for its own background, and these documents can be collected in one place on the Self-Assessment Website. Certainly, the team should become familiar with the CLAS standards.

? Go through the CLAS-ACT Self-Assessment Survey standard by standard.

? List, don?t write. For the first pass, don?t worry about how a final report will look. List the findings as bullets and let editing into formal report language be a last step of the Self-Assessment.

? Document what you can. If there are pertinent documents or reports, get copies of them. File them, or post them to the Self-Assessment Website according to the CLAS standards that they address.

2. Calculate your CLAS-ACT Institutional Research Self Study Score

To calculate the CLAS-ACT Institutional Research Self Study score for your agency, institution, or organization, complete

1. In the Institutional Self-Study Chart, list the percentage scores for all the Individual Research Self-Assessments under review.

2. Add all Individual Research Self-Assessment scores.

3. Divide total Individual Self-Assessment scores by the number of research studies under review.

4. The average of the Individual Self-Assessment scores is the overall CLAS Standard Self-Study Score for your institution.

Example

Clinical Trial	Individual Research Self-Assessment Score (Percentage)
1.	42%
2.	63%
3.	72%
4.	83%
5.	21%
Total	281%

281%

56.2%

Total Percentage Score for All Individual Research Studies

Number of Research Studies Reviewed

Percentage of Institutional

Implementation of CLAS Standards

Your CLAS-ACT Institutional Research Self Study Score

Clinical Trial	Individual Research Self-Assessment Score (Percentage)
1.	%
2.	%
3.	%
4.	%
5.	%
Total	%

_____ %

_____

_____ %

Total Percentage Score for All Individual Research Studies

Number of Research Studies Reviewed

Percentage of Institutional

Implementation of CLAS Standards

3. Improve Implementation of CLAS Standards

To complete your Institutional Research Self-Study, answer the following questions based on the results summarized in the chart.

Standard 1. How well does your organization ensure that all staff members provide effective, understandable, and respectful care to all potential clinical trial participants in a manner compatible with their cultural health beliefs and practices and preferred language?