Pulse
Reformed Consent
Staff at HealthEast Care System are simplifying the forms patients sign to indicate their consent for treatment.
Last February, surgery patients at St. Joseph’s Hospital in St. Paul were handed a brand new informed consent form—one written without medical or legal jargon and with short sentences.
The new, simplified one-page document was the result of two years of work by HealthEast Care System employees who, at a 2004 conference sponsored by the Minnesota Alliance for Patient Safety, had come to see poor health literacy as a patient-safety issue.
As the group looked for a piece of the health literacy problem they could tackle at St. Joseph’s, other staff members told them that patients needed a consent form they “could actually understand.” Here was a document whose sole purpose was to indicate that a patient understood medical information—yet patients often couldn’t understand the language on the form. Too often, they said, people either looked at it and their eyes glazed over, or they didn’t bother to read it at all. And that meant that nurses and physicians needed to spend additional time making sure patients understood the form.
“We thought the consent form was actually a barrier to understanding the procedures,” says Robert Moravec, M.D., St. Joseph’s medical director. To the new health literacy advocates, revising the notoriously arcane consent form seemed like an easy first project, a small area where they could make a change before tackling the next, bigger thing.
Simplifying the form, however, quickly turned complicated.
Not Real Simple
The first hurdle was convincing people that the forms could actually be changed, says Bette-Jo Johnson, manager of patient-family education for HealthEast. The perception, she says, was that there would be legal or regulatory barriers.
As Johnson presented the idea to various hospital committees, pointing out that 48 percent of the U.S. population reads at a fifth-grade level and that the health system’s surgical consent forms were written at a 12th-grade level, staff began to see an opportunity for improvement. If the average patient was not able to understand the consent forms, what was the value of their signature on it?
Carol Beehler, HealthEast’s director of risk management and insurance, was consulted about whether the form could be revised. She explained that from a risk-management perspective, all the hospital needed was written evidence that informed consent had been obtained.
Still, it took two years and 30 drafts to revise the surgery form, Johnson says. “Every time it got touched, [it got changed]. Everybody had a different suggestion or a different question.”
Works in Progress
When the surgery form was finally whittled down to a fourth-grade level, according to the Flesch-Kincaid Grade Level scoring instrument built into Microsoft Word, a staff member gave it to her husband, an engineer who had undergone surgery the month before. “This is what I was supposed to understand when I had surgery last month?” he said to his wife. A third-grader who read it said she understood every word but one. “What’s an outcome?” she asked.
In addition to revising the surgical form, the health literacy group has also created new, simpler versions of the consent forms for blood transfusions and for anesthesia. The anesthesia form was at a 16th-grade reading level; the team has brought it down to a sixth-grade level.
Moravec emphasizes that all the revised consent forms are works in progress. “I have a feeling that they’re going to evolve, and evolve considerably,” he says, noting that in November a “flurry” of e-mails related to the consent forms were being sent among staff, as surgeons expressed concern that forms were too “dumbed down” and others noted things that had been deleted. One of the likely changes will be adding back space for a witness’s signature.
Beehler emphasizes that the forms are only a small piece of the informed consent process. She explains that no form protects either the doctor or the hospital from exposure in malpractice cases nor does it indicate how well they have done in obtaining a patient’s informed consent. “How effective physicians are [at obtaining informed consent] has to do with the dialogue with the patient regarding the procedure, the risks, benefits, and alternatives; the risks and benefits of alternative treatment; and the medical assessment of decisional capacity,” she says. “The consent form, no matter how easy you make that to read, is not going to necessarily assure us that the patient’s physician has been effective in obtaining informed consent.”
Beehler says the real value of the form is that it has elevated the issues of health literacy and patient safety among physicians and staff. “It’s another safeguard and opportunity for the patient to speak with someone other than the surgeon about what’s happening,” she says.
Moravec thinks the simplicity of the new forms might actually stimulate such conversations. “It begs the patient to ask more questions,” he says. “It also reminds us that the responsibility for patient consent ultimately rests with the physician.”—Carmen Peota