Cindy Brach started this session by recounting what she heard regarding the tools that are available to create a new culture in health care organizations. Her list started with medical and continuing education, IRB education in the case of research, and legislation and regulations, including those that state which standard applies and that mandate access to language-appropriate documents or translators. Malpractice suits and the threat they hold are also a potential tool, and she asked Christopher Trudeau if he would provide a list of the most salient cases in that area after the workshop’s conclusion. She thinks that efforts to empower patients to demand change and to support leadership that drives change should also become part of the toolkit for culture change. Brach asked if there are other things that leadership cares about that can be a driver for change, such as patient-centered care or shared decision making. She also commented on the need to “hardwire” these change agents through sustained attention and the role that better consent forms, communication tools, supervision, and documental and other structural processes can play as levers in that regard.
Kim Parson commented that what she heard was that the current system for informed consent is not effective for any person, no matter the health-literacy level. She noted that there have been many attempts at making processes and documents more patient friendly, that these efforts should be applauded, and that the lessons learned from those efforts should be applied going forward. The unintended complexity that results from the intended protections put in place by state departments of insurance and through multiple regulations from federal agencies has a disproportionate impact on patients, caregivers, and providers, she said. Parson thought that
the day’s discussions were a good starting point for further exploration of the impact of rules and regulations on organizations’ abilities to act in a health-literate manner. Parson also heard that the opportunity exists to compile best practices for informed consent that are built on the concepts of simplicity, human-centered design principles, and, above all, partnerships with patients and participants. “By co-creating with patients who have experienced the informed consent process and with people who are potential participants in the process, we will discover their needs and how they want those needs to be met. The results will be a more knowledgeable, willing, and engaged end user while we are achieving the goals of those seeking consent,” said Parson. George Isham added the comment that the next step may be for the roundtable to convene a conversation around determining needs and wants and design principles.
Lori Hall commented that she is often inspired by sources outside of health care and noted a book called A Whole New Mind by Daniel Pink. In this book, Pink talks about how in this age of information overload, although it is possible to create efficiencies and streamline processes, the power of empathy should not be overlooked. With that in mind, she noted that nothing replaces the power of human engagement to induce change. Patient engagement, she said, is required to build the trust needed to educate and empower patients so that true shared decision making can take place.
After thanking Paasche-Orlow for his list of recommendations and several of the speakers for emphasizing the need to add cultural and linguistic pieces to the informed consent process, Wilma Alvarado-Little noted the importance of tone of voice when interpreting for visually impaired patients. She also noted that it is important to remember that the deaf and hard-of-hearing community is full of people who do not speak English as their native language or who are not literate. Simply handing them a consent document will not be sufficient to obtain meaningful informed consent, she said.
Another thing to keep in mind, said Alvarado-Little, is that a patient’s caretaker, regardless of education, may not have the foresight to ask certain questions, particularly when the caretaker has an emotional connection to the patient. She stressed the need to educate health care providers on the proper use of an interpreter in the consent process. Alvarado-Little said that if she, in her role as an interpreter, misspeaks with the consent form in front of her, she can be subpoenaed just like anybody else. She also said that from a community research perspective, IRBs in academia need to have some insight about what resonates with the community.
Alvarado-Little also provided comments from Lindsay Robinson, who had to leave the workshop prior to this discussion. Robinson noted that dentistry was not represented in these discussions, in part because dentists
are not asked to engage in informed consent even though they should be for many procedures. The perception exists that the level of risk associated with dental procedures is low and that there is less litigation in dentistry compared to medicine. There is also an inherent conflict of interest, she said, because most of the services are provided by dentists who are in a private business, and they are the ones making the decisions.
Robert Logan mentioned that some law schools have programs in mediation that train attorneys to think of a standard or goal that is higher than meeting the needs of one particular client or adversary. He wondered if there is a vital role for mediation in establishing better cooperation and collegiality among the stakeholders involved in the informed consent process. He added that he does not think of the legal profession as part of the problem but a potential part of the solution. “I think we are not talking to the right lawyers today,” said Logan, suggesting that those who are concerned about informed consent should speak with experts in mediation who can look at informed consent not as a means of protecting a hospital from litigation but as a tool that can serve a broader social purpose. Isham said that he supported this idea because working through judges, while effective, will take too long to achieve the necessary change.
Logan also thought it would be useful to outline in a paper all of the individual, cultural, clinical, ethical, social, public health, and community harm that stems from dense language or excessive complexity in consent in other clinical forms, an idea that Isham said that he supports. Logan noted that there is currently no good way of outlining those issues to people so that anybody who is interested in those things will see immediately how they are involved in a process that causes enormous harm. “Can’t we find people who can better outline the range of that harm and, from a very ethical perspective across the range, demonstrate what that is?” Logan asked.
Catina O’Leary commented that the discussions at the workshop were rather narrow in their focus on what is informed consent and why it matters, whereas the paper that the roundtable commissioned also highlighted the fact that not much is known about health literacy and informed consent in community-based research. While acknowledging that it is important to talk about risks involved in participating in clinical trials in a hospital setting, she said that the risks of doing informed consent poorly in the community setting is that it can destroy the trust of researchers and health care providers throughout a community. She stressed the importance of having conversations on who gets to decide who gets to have the conversation, what shared decision making is, and who gets to lead that conversation in shared decision making.
Bernard Rosof supported O’Leary’s emphasis on community research and said that there is a notable lack of guidelines and toolkits for health-literate informed consent in community-based research, particularly given
the increasing emphasis that is being put on community-based research as a means of improving population health and defining healthy living. “If we talk about shared decision making, particularly between the family and the participant or the patient, I think the community is the area where that needs emphasis more than anything else in the hospital environment,” said Rosof.
Benard Dreyer focused his initial comments on the role of language in informed consent and said that the field is nowhere near where it should be in terms of providing appropriate interpretation of any kind to the large and growing population of people in this country who have limited English proficiency. He said that raising awareness of the challenges in achieving health literacy in this group of less-than-proficient English speakers is an important task, given how little progress has been made in this area despite its obviousness. He then commented on the important role that partnerships with patients and families can play in creating a better informed consent process. Building these partnerships will require empowering patients and families and educating them on the importance of asking questions during the informed consent process.
Regarding complexity, Dreyer said he was impressed with the tension between the obvious need to create simpler and more understandable forms and the need to convey specific information to patients or study participants. “When you start adding all of those things up, it ends up, even if it is in clear language, being pretty complex,” said Dreyer. He encouraged the roundtable to think further about how to address this tension.
Winston Wong said that for him, informed consent comes down to two conflicting dynamics—protection and empowerment. Taken from an institutional point of view, there is protection of the organization, the individual, and the provider, and empowerment to be able to do the right kind of thing ostensibly for the benefit of the patient, explained Wong. That same dynamic is also apparent with regard to patient and family, that is, protecting patients from insult and injury, but also empowering them to make the right kinds of decisions for themselves and their families. “It seems that there is a very thin line between what constitutes protections and empowerment,” said Wong. “To that extent, I think that having the patient voice be the definitive voice with regard to looking at how the balance between protection and empowerment is achieved is a really important point.”
Dreyer also noted that the field needs to consider the role that numeracy plays in conveying risk and to integrate what has been learned about numeracy into the informed consent process. The field also needs to develop a better understanding about the role of culture in influencing health beliefs and how to accommodate that in the informed consent process.
Isham remarked that the field needs to use data systematically to understand the needs of patients, both in the aggregate and individually, a point
with which Rosof agreed. Rosof then noted that improving informed consent is not really about patient education but rather is about a culture change for researchers, IRBs, clinicians, and other members of the health care team. Wong suggested that the argument for change could be made from the perspective of health equity and health disparities. Another possibility, said Wong, would be to capture the kind of suffering that is occurring because of poor informed consent processes.
In his comments, Gem Daus, public health analyst for the Health Resources and Services Administration, underscored the importance of language in informed consent and the fact that translation does not equal comprehension. “Translating is not the end of the intervention,” said Daus. “It is really just the beginning.” He encouraged the roundtable to continue discussing the role of language in informed consent and, more broadly, health literacy. He also noted that his agency is quite interested in primary care, primary care physicians, and the system of primary care. From this perspective he commented that it is not just the primary care physician’s responsibility to educate patients and ensure comprehension, but it is also that of other members of the care team who interact with the patient along the care continuum. He pointed out that community health centers, which are by law consumer focused and required to have consumers on their boards, could be an important venue for accomplishing many of the tasks that were raised at the workshop in terms of building partnerships and changing expectations among members of the community. He also noted that by increasing health care plan enrollment, the Affordable Care Act has created opportunities to reach a larger proportion of the American public as well as created the challenge of obtaining consent from more of them. His final comment was that he supported the use of infographics and pictures to enhance comprehension throughout the consent process.
Steven Rush, director of the Health Literacy Innovations Program at UnitedHealth Group, said that he heard several concepts repeated several times during the workshop. The first was that informed consent needs to move from an ethos of persuasion to one of pedagogy and that the focus has to shift to that of consumers and their values. He commended Trudeau and others for stressing the importance of plain language and its potential role as an agent of change. The third concept was that one size does not fit all for informed consent and for shared decision making.
Michael Villaire’s takeaway from the workshop was that informed consent needs to get back to its original intended function, which was to protect the patient. From that perspective, it is essential to ask patients what they want and use that as a baseline for how much information and complexity to build into the consent process. He liked the emphasis that the workshop speakers placed on putting the patient at the center of the informed consent process. To him, “patient centered” means using all of
the arsenal, all of the terminology, and all of the facets of how health care providers look at patients in terms of language and culture and how much they are activated by and are interested in the informed consent process. A patient-centered process also means that patients will be given the time that they need to understand all of the important concepts and terms in a consent document. Villaire asked the question, “Who does the informed consent process serve?” and his answer was that it should be serving the patient. “We need to communicate on their turf, not on ours,” said Villaire.
Andrew Pleasant pointed out that it is easy to criticize the informed consent form and process from a perspective that is different from what the process and form were initially designed to do. It would be lovely, he said, if informed consent were designed to protect patients, but as Jeremy Sugarman noted, it was designed to protect institutions and professionals from lawsuits. “To change the culture, I believe we need to be direct and up front that we are not asking for tweaks to the process, we are asking for a very different process with a very different desired outcome,” said Pleasant. “Anything else, and people who have the power to make those changes will sort of nod their head and say how nice for you and walk away as they have done for some time because their priorities are not our priorities.”
He supported the need for more work in the area of informed consent in community-based research and noted that he would not be surprised that when that research is conducted, it will identify best practices that can guide all aspects of the informed consent process. Pleasant also reiterated the importance of language interpretation and pointed out that there are existing laws regarding interpretation that are not being enforced. Having made that point, he said that he is convinced that enough is known to push regulations forward beyond where they are now to change the process. “Whether that happens in the guidance aspect, the regulations, or in the actual writing of a law or the issuing of an executive order is something that a group should explore and figure out,” said Pleasant. He also said that there is enough evidence on health literacy, shared decision making, and how to create informed decisions among patients in health care contexts to move that bar forward now. “More research is always nice, but not at the expense of actual action,” he said.
One thing that he did not hear over the course of the day, he said, was including a group process in the informed consent process, something that can save time and money in that one person’s question becomes the group’s question. Although the whole consent process cannot be performed solely in a group format, it can be an important contributor to the process. He also commented that the field does a good job at getting information to people but not so much at getting people to a place where they comprehend that information in the context of their lives and getting them to act on that information. “That is something that most informed consent processes
absolutely don’t do, helping patients communicate their understanding to their friends and families around them to create a platform for behavior change,” said Pleasant. “As a result, we really don’t achieve a true informed consent because we haven’t included those processes of health literacy in the overall effort. I think we can and should.”
Laurie Francis said that the field is getting better at nesting health literacy in the context of human-to-human interactions, and so she applauded the panelists for making that connection repeatedly throughout the day. She also noted that the field has much to learn from the way that the palliative care and mental health communities involve patients in shared decision making. She made the point that “until we understand what the person with whom we are engaging wants and needs in their lives and how our conversation fits with that, I think we have missed the boat.”
Francis also said that testing should extend not only to patient comprehension but also to health care provider comprehension. “Test us on if we understand the priorities of the people we are sitting across from and how this informed consent fits within their priorities,” said Francis. “I really think we would move the world with that test.” She finished her comments by stating that “we are a lot of smart people in the room, but we are not as smart as we think. I think that to really change our mental model, we actually need different thinkers at the table. Bringing ourselves together over and over to try and tweak a system we are pretty comfortable in probably won’t create the disruptive innovation we need in this world to try to engage people in the way that they can make behavior changes.”
Parson seconded that idea and suggested that the nation needs to have a shared conversation about informed consent. Parson also said that there is a need for a primer on informed consent that would answer basic questions about informed consent: What is it? How do I administer it? Why is it important for me? Why is it important for my family and my community? Such a primer could serve as the basis for having a shared national conversation. She noted that one of the beauties of working on this topic and striving to improve informed consent is that it encourages everyone participating to care. “I applaud those who are engaged in caring and the opportunity to be part of a conversation with others working to roll the Sisyphean ball,” said Parson.
Christopher Trudeau said that he liked the idea of taking a systems approach to informed consent and getting the right stakeholders to sit down and hash out a system that could create informed consent for those rare occasions when there will not be any type of preprinted form. He said he believes that it is possible to create a system for categorizing informed consent according to the setting or risk levels, for example. Isham seconded this idea and wondered if something like the Institute for Healthcare
Improvement’s Improvement Map1 would enable a group of stakeholders to figure out what informed consent is really about, who it is serving, what the desired outcomes are, and what each stakeholder needs to get from the process.
The last comments came from Alicia Fernandez, who reminded attendees that even simple changes can be slow in coming. As an example, she pointed out that the science of hand washing is more than 100 years old. Yet when she was a medical student in the Bronx at the height of the HIV epidemic, hand washing was not yet common in the wards. Today, everyone washes their hands, but it took a great many actions, including education and leadership, to change the culture to one in which nobody now thinks twice about washing their hands when they come into the wards. In her mind, we are facing a much more difficult task than making hand washing standard procedure because there are entrenched interests that are happy with the system as it now exists. She encouraged continuing efforts to shine a light on informed consent and health literacy, stating that doing so will bring others to the table. “If you say informed consent matters and we need to look at literacy and language and all of the issues that were raised here today, perhaps the [American Association of Medical Colleges] will consider it a core competence in communication that medical students should learn to do informed consent and that that should be a measurable core competence for every medical student,” said Fernandez.
Isham thanked the roundtable and planning committee members, speakers, and participants for an interesting and informative day and adjourned the workshop.
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1 According to the Institute for Healthcare Improvement’s website, “The Improvement Map is a free, interactive, Web-based tool designed to bring together the best knowledge available on the key process improvements that lead to exceptional patient care.” See http://www.ihi.org/Engage/Initiatives/Improvemaphospitals/Pages/default.aspx (accessed December 10, 2014).
