Using principles of health literacy to enhance the informed consent process

Health care today exposes consumers to a significant amount of critical information, ranging from prescription bottle labels to insurance forms and from dietary guides to procedural consents. The complexity of the information prevents a significant number of patients from fully comprehending it. Health literacy, as defined by Healthy People 2010, is

the degree to which individuals have
   the capacity to obtain, process, and
   understand basic health information
   and services needed to make
   appropriate health decisions. (1(p37))

The 2003 National Assessment of Adult Literacy by the National Center for Education Statistics showed that 36% of adults have basic or below-basic health literacy. (2) Basic print literacy may not guarantee comprehension of presented health care-related materials, especially considering the use of health care terminology and that illness, pain, stress, and fear may alter normal abilities.
There is a critical link between health literacy, patient understanding, and patient safety. According to Osborne,

Literacy matters in health care because
   life-threatening or potentially
   harmful mistakes may happen when
   people cannot read or understand
   written information. (3(p8))

This link was further emphasized at a Joint Commission-sponsored conference, where Koransky identified methods of defining and ensuring informed consent. (4) The barriers to informed consent include language-limited interpreters for some languages, cultural issues, and lack of medical knowledge and education, which contribute to patients' inability to fully comprehend information given to them regarding their medical condition and the procedures involved. (4) Koransky suggested solutions including using layperson's language, slowing down to allow time for the patient and family members to understand, and encouraging "repeat back." Repeat back (ie, "teach back") is the practice of asking the patients to state in their own words their understanding of what they have been told by the medical professional.
This article describes how one health system incorporated health literacy into its surgical consent document and process. The goals of the project were to
* educate the staff on health literacy concepts,
* develop an understanding that informed consent is a process,

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* develop a reader-friendly consent form for surgery and procedures,
* increase the number of patients reading the consent document before signing it, and
* incorporate the use of "teach back" to evaluate patient understanding.
IMPETUS
As part of its 2003 Clinical Performance Improvement Strategic Plan, Iowa Health System incorporated health literacy as a systemwide quality initiative. Iowa Health System comprises 10 senior hospital affiliates in seven cities, a rural hospital network, and more than 300 primary care physicians. The hospital affiliate described in this article is a three-campus regional health system in a bi-state location. The Iowa Health System Health Literacy Collaborative was initiated in 2004 with overarching health literacy goals targeted toward improving interpersonal and written communication and creating a patient-centered environment.
Teams chose to improve consent documents and processes as part of their goals to improve patient understanding through the use of plain language, teach back, and reader-friendly print materials. The catalyst for choosing consent documents as one of the first major projects was the team's concern that consent forms are complex. Fry Readability Formula (5) analyses of representative Iowa Health System affiliate consent forms demonstrated that many were written at or above the 17th grade level. Because of this, it was uncertain whether patients understood the consent form before signing it, which made it unclear whether the consent given was informed consent.
Obtaining the patient's informed consent is required by the Joint Commission as stated in Standards RI.2.40, "Informed consent is obtained," (6) and PC.6.30, "The patient receives education and training specific to the patient's abilities as appropriate to the care, treatment, and services provided by the hospital." (7) The Centers for Medicare & Medicaid Services require informed consent for hospitals in several Conditions of Participation. (8-10) Revisions to interpretive guidelines in 2007 demonstrate continued emphasis on the importance of informed consent and patient involvement with informed decisions:

The patient or the patient's representative
   should receive adequate information, provided
   in a manner that the patient or the
   patient's representative can understand, to
   assure that the patient can effectively exercise
   the right to make informed decisions. (11)(p1)

The Office of the General Counsel of the American Medical Association contends that the essence of informed consent is not having a patient sign a written form but is a process involving communication between a patient and physician that includes verification of a patient's understanding and then authorization or agreement to undergo a specific medical intervention. (12) The 2005 White House Conference on Aging proceedings asserted that patients have the right to understand health care information necessary to safely care for themselves and to make choices among health care alternatives. Congruently, health care providers have a duty to provide information in simple, clear, and plain language and to evaluate whether patients have understood the information before ending the conversation. (13)
PROJECT DEVELOPMENT
Each affiliate had a health literacy team that participated in learning sessions and monthly conference calls to confer on a variety of health literacy interventions. The affiliate team cited here was multidisciplinary, including members who served in clinical education, risk management medical education, and adult learners and new readers in a local community college extension program.
Laying a foundation for understanding health literacy at the staff level was an important first step. Each affiliate team developed an education plan for staff, focusing on the Iowa Health Literacy Collaborative goals. At this affiliate, the approach to staff education included
* viewing the Institute of Medicine video Health Literacy: A Prescription to End Confusion; (14)
* completing a computer-based learning module defining health literacy concerns and means of improving communication;
* adding material on health literacy to a learning module on patient rights for new employee orientation and annual all-staff required education; and
* designing a health literacy program and presenting the program to physicians.
Involving new readers on the teams was an important component of the Iowa Health System Collaborative. These were team members who identified themselves as having "poor or underdeveloped reading skills" and were taking steps to improve their literacy levels. A collaborative partnership between the New Readers of Iowa, as well as community adult learning programs, was instrumental in evaluating the readability of patient-education and consent materials.
DEVELOPMENT OF THE CONSENT DOCUMENT
An Institute of Medicine Committee on Health Literacy report found that the readability of informed consent documents exceeds the average reading levels of the majority of adults in the United States. (15) Most adults admit to not reading consent forms for reasons including that
* the form is too long,
* the format is crowded or intimidating,
* the font size is too small, and
* unexplained medical and legal terms are used. (16)
An evaluation of surgical consent forms at Iowa Health System affiliates found documents that mirrored this description (Figure 1).

Figure 1 * Sample section from the original consent
document.

I, --, hereby authorize Dr. -- and/or
such assistants as may be selected by him/her and
-- Hospital, its staff, employees or designees,
to treat the condition or conditions which appear indicated
by the diagnostic studies already performed.