April 10, 2009

Initiative seeks to make consent forms easier to understand

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(photo by Susan Urmy)

Initiative seeks to make consent forms easier to understand

Vanderbilt Medical Center is rewriting and reformatting certain patient consent forms to make them easier for patients to understand.

The rewritten invasive procedure documents are being scrubbed of medical jargon and feature larger print, more white space and more bulleted statements. Originally written at a ninth grade reading level, the documents are being rewritten at a fifth grade reading level.

“If we want a patient-centered environment where patients are engaged in decision-making, we've got to ensure that our patients understand all the key elements of informed consent,” said Terrell Smith, director of Patient/Family Centered Care and leader for the rewriting project. “And clearer written materials are only part of the solution. We also need to help our clinicians adopt proven methods for verbally communicating health information.”

“Low health literacy in the U.S. is a major issue that's generally under appreciated, and one that figures in patient safety, adherence to the care plans and patient satisfaction,” said Sunil Kripalani, M.D., M.Sc., associate director of the Program on Effective Health Communication at Vanderbilt.

In a 2006 study of health literacy in the Journal of General Internal Medicine, the authors concluded that limited literacy is independently associated with a nearly twofold increase in mortality in the elderly.

According to the U.S. Department of Health and Human Services, health literacy is the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions.

The first large-scale assessment of U.S. health literacy was conducted in 2003 by the National Center for Educational Statistics, an arm of the Department of Education.
Dividing subjects into four ability levels, the assessment found that 12 percent of adults were proficient; 53 percent were intermediate; 22 percent had basic health literacy; and 14 percent had below-basic health literacy.

In other words, 75 million adults in the United States have only basic or below-basic health literacy. And according to Kripalani, most common activities in the health care setting, such as understanding a medication label, require at least an intermediate level of health literacy.

Following the NCES assessment, the National Quality Forum, an influential health care quality measurement and reporting group, called for consent forms and other patient documents to be written at a fifth grade reading level.

“We should try to communicate clearly with every patient,” Kripalani said. “When we know health literacy is low, or when the medical issues are complicated, we need to go the extra mile. The informed consent process is one of those situations that calls for added precautions.

“Along with clear verbal communication, clear written materials are a means to ensure that patients understand the purpose of a procedure, its risks and benefits, and the alternatives to the procedure,” Kripalani said.

Smith said the effort to improve health communication at VMC will also involve rewriting patient education materials and sponsoring new education opportunities for Vanderbilt clinicians regarding verbal communication of health information.

For verbal communication by clinicians, Kripalani summarized the guidelines as speaking clearly, eliminating jargon, inviting questions in appropriate ways — for example, asking “What questions can I answer for you?” rather than, “Do you have any questions?” — and the use of a method called ‘teach back’ to get patients to repeat back key information.

Kripalani explained that for teach back to work well, the clinician should present the process as routine, put the burden of patient understanding on his or her own shoulders, and make clear that the purpose is not to test the patient's intelligence but instead to test the clarity of the clinician's explanation.

Kripalani suggests a way to begin could be, “I do this with all my patients. I want to make sure I explained this procedure clearly.” The clinician needs to be specific about what key information the patient is being asked to repeat back, and needs to accept responsibility when the patient is unable to respond, saying, for example, “I didn't explain that well. Let me try again.”

Finally, teach back needs to be repeated whenever it shows patient misunderstanding.
In a related pediatrics project, VMC's Eskind Biomedical Library has convened a team to develop techniques to assess health information needs and perceptions in children.
Supported by a six-month planning grant from the Institute of Museum and Library Services, the team includes librarians, psychologists, child development experts, pediatricians, informaticians, evaluators and educators.

The rewritten consent forms are available through both the E-doc and Star systems. Quality Consultant Tiercy Fortenberry, R.N., rewrote the forms, which were reviewed, edited and approved by the Medical Center Medical Board and other clinical groups across VMC.