Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
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Appendix C: Best Practices and New Models of Health Literacy for Informed Consent: Review of the Impact of Informed Consent Regulations on Health-Literate Communications
Appendix C: Best Practices and New Models of Health Literacy for Informed Consent: Review of the Impact of Informed Consent Regulations on Health-Literate Communications
Pages 119-174
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Horowitz Center for Health Literacy University of Maryland, College Park Ayma Martha Rouhani, Graduate Student Department of Behavioral and Community Health University of Maryland, College Park July 2014 119
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120 INFORMED CONSENT AND HEALTH LITERACY Contents Acknowledgments 121 Introduction and Executive Summary, 121 Methods for Data Collection, 124 A Summary of Federal Guidelines, 127 Findings from the Literature Review, 128 Informed Consent Defined, 129 Health Literacy Defined, 130 Overall Trend Across the Literature, 130 Before: Preparation for Informed Consent, 131 During: Communication and Informed Consent Documents, 134 After: Assessing Comprehension, 139 Findings from Expert Interviews, 141 Perspectives on Federal Regulations, 141 Perceived Challenges, 142 Lessons Learned, 143 Summary of Top 30 Best Practices, 145 Preparing, 145 Communicating, 147 Evaluating, 147 Discussion and Conclusion, 148 Future Research Agenda, 149 Visual Models for Health-Literate Informed Consent, 151 Conclusion, 154 References, 155 Appendixes C-A: Roadmap to Health-Literate Informed Consent, 159 A C-B: Situation Risk Model for Communicating Informed Consent, 160 C-C: Bibliography of Useful Resources, 161 C-D: Interview Guide, 167 C-E: ode of Federal Regulations, Part 46, Protection of Human Subjects, C Basic HHS Policy for Protection of Human Research Subjects, Sections on Informed Consent, 168 C-F: AHRQ Sample Informed Consent Form from Toolkit, 172
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Individuals with limited health literacy are less likely to understand terminology, risks, and benefits as described in traditional informed consent documents (Donovan-Kicken et al., 2012)
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. Studies have examined how to improve the format and content of informed consent documents to address low health literacy and improve patient understanding while abiding by requirements for information mandated by the U.S.
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Fourth, little research has focused on low-healthliterate populations and health literacy disparities in informed consent outcomes. Finally, there is a dearth of research on communicating informed consent in community-based research.
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Phase 1: Literature Review Phase 1 was a systematic collection and review of research, government reports, and Web-based information focused on informed consent and health literacy. The following search engines were used: Medline, HealthSource, and PubMed databases, plus Communication and Mass Media Complete, ERIC, PsycInfo, and Academic Search Premiere from EPSCO.
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In particular, the Institute of Medicine's workshops and presentations on informed consent and health literacy in clinical trials can be found online at http://www. youtube.com/watch?
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An interview guide was developed with open-ended questions that asked about health literacy and informed consent. Questions addressed perceptions about informed consent, applicability of federal guidelines, challenges experienced with the process and forms, and examples and resources that would be helpful in increasing the health literacy of the informed consent process.
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The informed consent process must convey voluntariness of the participant and include an explanation about having the right to refuse or discontinue participation at any time (FDA, 2014)
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Appendix C-F has a copy of AHRQ's Sample Informed Consent Form. FINDINGS FROM THE LITERATURE REVIEW The body of literature on informed consent and health literacy mainly fell within two domains or major areas for informed consent.
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This is likely due to similar attempts at adhering to the same federal guidelines for protection of human subjects. The summary below is thus organized by best practices for health literacy before, during, and after enacting informed consent procedures.
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across domains for informed consent, increased use of technology to streamline the informed consent process and improve patient understanding. As authors have shown, traditional consent forms have been intended primarily for the providers' legal protection, so the forms are swathed in complex medical and legal terminology and often written above the eighth-grade reading level (Brink, 2012; Lidz, 2006; Lorenzen et al., 2008; Matiasek and Wynia, 2008; Paasche-Orlow et al., 2003)
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(2010) posited that "comprehension was maximized when the informed consent discussion was undertaken for 15 to 30 minutes." Know the Risks Studies on the informed consent process illustrated the primary need for practitioners and investigators to know the study's protocol and the weight of its risks and benefits in order to convey the risk level to participants (NQF, 2005a)
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Authors outlined four steps for staff: • Completing a computer-based learning module defining health lit eracy concerns and means of improving communication, • Adding material on health literacy to a learning module on patient rights for new employee orientation, • Updating staff education annually, and • Designing a health literacy program for physicians. Other authors have suggested that the person who conducts the consent procedures be different from the researcher responsible for the study outcomes (Sugarman and Paasche-Orlow, 2006)
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. Disparities in Health Literacy Some of the literature addressed disparities in health literacy that certain vulnerable populations have that leads to more problems with informed consent.
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. An article that focused on Spanish speakers with low health literacy in clinical trials demonstrated the importance of additional training for researchers to increase their ability to effectively interact with this group to ensure that particular information needs are met (Cortes et al., 2010)
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. Written Communication The literature is consistent in citing problems with the written format and messaging used in consent forms and other documents related to the informed consent process.
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Verbal Communication Most of the literature focuses on written communication because informed consent documents are the primary means by which individuals are reaching their decisions to participate in trials, medical treatments, and screenings. Also, according to some authors, the research in health literacy has focused on print, with limited work conducted on oral literacy (McCarthy et al., 2012)
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, "The low comprehension scores for participants with inadequate health literacy indicate that much work remains to make the computer agent effective for this population" (p.
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Hall and colleagues (2012) found that iMedConsent, an online informed consent process, increased patient comprehension of procedure-specific risks and benefits.
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This literature also suggested how best to assess participant comprehension during the informed consent process (AHRQ, 2009; Cortes et al. 2010; Fernandez, 2010; Tamariz et al., 2013)
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tested the effects of self-efficacy on the relationship between health literacy and patient confusion and comprehension of informed consent forms. They found that lower health literacy predicted lower self-efficacy, which predicted feeling less well informed and less prepared, being more confused about treatment procedures and risks, and wanting more information about the risks.
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These individuals were asked to share their perspectives on different aspects of informed consent procedures, documents, and work with institutions and the federal government. The discussions mainly centered on three aspects: federal regulations, challenges to improving informed consent processes in the context of these regulations, and lessons learned about communicating informed consent.
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A poor organizational culture surrounding the informed consent process creates a lack of value placed on the process and increases challenges
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One interviewee recommended the Clinical Trials Transformation Initiative as an example of organizational commitment and value placed on the informed consent process. One interviewee described the paradigm shift needed as one from "persuasion" to "pedagogy." Commit to Supervision and Accountability Researchers and practitioners should supervise and monitor staff throughout the informed consent process and address possible improvements that need to be made afterward to improve future informed consent procedures.
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One interviewee shared a third-party evaluation system, where the participants phone a reviewer who asks comprehension questions after the informed consent process. Another interviewee video records each process for proper documentation and evaluation.
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Create a culture that places a high value on the informed consent process. Creating a culture that values truly, informed consent leads to better patient-centered practices and communication.
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13. Think creatively for non-English speakers and people with low health literacy.
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27. Assess comprehension before beginning informed consent proce dures.
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Interviewees and authors of various editorials and studies have argued for a move away from "persuasion" to get participants to consent and toward "pedagogy" and individualized empowerment for informed consent. However, what we found surprising was that, even with the accumulation of evidence and examples of best practices for communication, there continue to be barriers with regard to health literacy during informed consent used in clinical trials, medical treatments, and diagnostic screenings.
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It was also evident that the level of risk, setting characteristics, and participant factors might be used to construct clear and comprehensible informed consent procedures. On the other hand, there were gaps in the current literature about health literacy and its effects on informed consent, which led us to suggest a research agenda for the future.
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4. Little research has focused on low-health-literate populations and health literacy disparities in informed consent outcomes.
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. In the area of informed consent, a universal precautions approach suggests that information be geared to the lowest health literacy levels, and a universal procedure of clear, meaningful, and simple messages would be implemented.
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Although individual levels of health literacy are not always possible to measure, there are several factors to understanding your population: what might be average health literacy levels and formal education, and how cultural norms and beliefs about medicine and health might influ ence the participants' reaction to informed consent procedures.
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The purpose of this step is to evaluate not the comprehension of a participant, but the success of the overall system put in place for health-literate informed consent. Having the staff document successes and discuss failures allows for transpar ency of the values and goals in place for what is really the intent of the informed consent process.
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The interviewees who participated offered insightful and creative expertise on informed consent and health literacy, but the paper might have been richer if more voices had been included with those that were summarized here. Even with the limitations, we found the relationship between health literacy and participant understanding of informed consent to be a strong one, with research supporting the links between plain language, clear communication, and informed consent.
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2009. Using computer agents to explain medical documents to patients with low health literacy.
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2010. Health literacy universal precautions toolkit.
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2008. Using principles of health literacy to enhance the informed consent process.
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2013. Improving the informed consent process for research subjects with low literacy: A systematic review.
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APPENDIX C 159 APPENDIX C-A A Roadmap to Health-Literate Informed Consent
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160 INFORMED CONSENT AND HEALTH LITERACY APPENDIX C-B Situation Risk Model for Communicating Informed Consent
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2009. Using computer agents to explain medical documents to patients with low health literacy.
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2010, April. Health literacy universal precautions toolkit.
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Earles. 2008 Using principles of health literacy to enhance the informed consent process.
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2011. Improving patient-provider communication for patients having surgery: Patient perceptions of a revised health literacy-based consent process.
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2005. Recommendations for informed consent forms for critical care clinical trials.
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2005. Improving patient safety through informed consent for patients with limited health literacy.
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2A. How do you think government regulations affect how people understand the informed consent process?
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or (d) of this section, in seeking informed consent the following information shall be provided to each subject: (1)
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For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8)
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(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1)
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of this section, the consent form may be either of the following: (1) A written consent document that embodies the elements of informed consent required by § 46.116.
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172 INFORMED CONSENT AND HEALTH LITERACY APPENDIX C-F AHRQ Sample Informed Consent Form from Toolkit (first two pages of sample)
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* This form is designed for minimal risk, noninterventional
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Your survey answers, health information, and a copy of this document will be locked in our files. We will not put your answers into your medical record.
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