Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
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4 Approaches to Informed Consent
4 Approaches to Informed Consent
Pages 53-74
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From page 53... ...
Christopher Trudeau, associate professor at the Thomas M Cooley Law School, spoke about how to redesign consent forms so that they are understandable and meet the requirements of federal and state regulations.
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From page 54... ...
In these instances, as with informed consent under other circumstances, people are often confused by the content of the forms and the many legal terms associated with advanced directive types of forms. Often, patients or their surrogates sign forms with answers to questions regarding resuscitation, machine-assisted breathing, and other life-sustaining treatments that conflict with prior advance directive forms and the patient's true wishes.
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From page 55... ...
59 percent of the time, the answers on this form are not in agreement with what the patients' actual goals when asked in the moment. Other investigators have found similarly confused patient responses to the questions on advance directive forms (Hammes et al., 2010; Heyland et al., 2013; Zhang et al., 2009)
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From page 56... ...
The study she described was nested in a study of the advance directive trial she had already noted. It involved providing test subjects with a consent form written at the sixth-grade reading level and reading it to them verbatim in either English or Spanish.
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From page 57... ...
SOURCE: Sudore et al., 2006. study of surgical intensive care patients found that repeat or teach-back techniques improved informed consent comprehension from 53 percent of the patients to 70 percent, and the improvement was particularly notable with regard to understanding risks and alternatives (Fink et al., 2010)
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From page 58... ...
Though she had previously declined elective surgery on multiple occasions, she now agreed to have surgery, given that the main risk of not having surgery was death. After eight hours of surgery and admittance to the intensive care unit, the patient went into cardiac arrest and was brought back to the operating room to have her bleeding controlled.
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From page 59... ...
The best-case outcome for surgery in this example would be a 6- to 10-hour operation followed by 5 to 7 days of intensive care with a breathing tube and maybe dialysis, 2 to 3 weeks in the hospital, and then transition to a nursing home. After the surgery, it is unlikely that the patient would be able to return to living independently and would likely require living the rest of her life in a nursing home or with palliative care.
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From page 60... ...
In the case of patients with dementia, teach-back may not work, but the possibility exists that it could, because even people with cognitive impairments can make informed medical decisions. When they cannot, caregivers are the alternative for consent, but caregivers do not always have high health literacy.
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From page 61... ...
ESTABLISHING HARMONY BETWEEN THE RULES AND HEALTH LITERACY2 Christopher Trudeau Thomas M Cooley Law School "How can we create a form that complies with the law and promotes a conversation?
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From page 62... ...
Trudeau argued that, from an advocacy perspective, it may be necessary to threaten or pursue lawsuits to trigger changes in the consent form regulations that reflect the health literacy literature that has developed over the past two decades. If health literacy starts becoming the standard, and groups such as the IOM or the American Medical Association (AMA)
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From page 63... ...
Trudeau noted that, although his emphasis is on redesigning the form, there is also the need to redesign most of the educational materials on colonoscopy that patients receive. Step two in the process, he said, is to create clear content that incorporates health literacy principles while also containing the necessary language that describes the technique and outlines the risks, alternatives, and other information germane to a particular treatment that federal and state regulations mandate.
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From page 64... ...
The physician could explain the colonoscope with language such as "I may use this instrument to remove any growths that I find or to remove small pieces of your bowel for testing." Trudeau questioned whether his use of the word "risks" in a subhead was the best approach and wondered if describing the worst-case, best-case, and most likely scenarios might be more understandable by the average patient. If it was not possible to use that type of presentation on the consent form, he suggested that such information be included in education materials to accompany the consent form.
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From page 65... ...
First, he said, lawyers need to know about and understand health literacy and the impact of poorly designed and complicated forms, and, second, they need the skills to draft these forms. Lawyers, he said, have little training in literacy principles, let alone those of health literacy -- if they had, he stated, the Affordable Care Act would not be 2,200 pages long, and credit card agreements would not be written at a 12th-grade level.
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From page 66... ...
Trudeau Page 1 of 2 Continues⇒ FIGURE 4-5 A colonoscopy consent form incorporating teach-back. SOURCE: Trudeau, 2014.
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From page 67... ...
My questions have risks, and its alternatives. I have answered the patient's been answered, and I agree to receive a colonoscopy: questions, and I believe that the patient is informed and consents to the colonoscopy: Sign your name here Medical provider's signature Print your name here Printed name of medical provider Today's date Today's date Disclaimer: This document was created for educational purposes by Chris Trudeau, a Michigan lawyer.
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From page 68... ...
Trudeau, 2014 Page 1 of 2 continues ⇒ FIGURE 4-6 A colonoscopy consent form incorporating teach-back and a more open design with alternatives minimized. SOURCE: Trudeau, 2014.
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From page 69... ...
My questions have risks, and its alternatives. I have answered the patient's been answered, and I agree to receive a colonoscopy: questions, and I believe that the patient is informed and consents to the colonoscopy: Sign your name here Medical provider's signature Print your name here Printed name of medical provider Today's date Today's date Disclaimer: This document was created for educational purposes by Chris Trudeau, a Michigan lawyer.
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From page 70... ...
Regarding Pleasant's comment about outcomes, Sudore responded that the potential for liability when discussing outcomes is higher when the physician does not know the patient who is being asked for consent and does not know what that person's desires and goal are relative to the treatment procedure in question. Michael Villaire noted that his organization and others teach the principles of health literacy to people who create forms and who write patient education materials.
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From page 71... ...
Referring to Sudore's anecdote about the woman whose directives were not in sync with her wishes, roundtable member Winston Wong asked if there was a way to systematically document the health literacy capacity of both the patient and family members. Is there a way, he wondered, to document that patients have spoken to their family members about their wishes and that the family members understand the implications of the patients' decisions.
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From page 72... ...
Sudore said that she discharges patients from hospice care frequently and that there are studies showing that people who get palliative care live longer. "If someone graduates from hospice, it is usually not a problem," said Sudore.
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From page 73... ...
Lori Hall, consultant on health education at the Lilly Corporate Center and a roundtable member, asked Trudeau if he could see informed consents coming into the realm where quality would be judged according to some metrics on plain language. Trudeau responded that judges are the ones who now do the measuring and that is why he believes that convincing one judge of the merits of a lawsuit based on low-health-literacy consent documents would have a major impact.
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From page 74... ...
He noted that any consent form that he would draft would include all of the risks as listed by the expert advisory group because the form has to comply with state regulations. The final question for this panel came from Brach, who asked Sudore to clarify how she presents the best-case and worst-case scenarios to patients and to comment on whether she elicits not only a patient's preference but also their understanding of how likely the different outcomes are for their choices.
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