Hospitals look to improve informed consent process

Toni Cordell's surgery would be "an easy repair," her doctor said. Embarrassed at being a slow reader, she signed the informed-consent papers she was given without understanding them.

She said no one, including her doctor, explained the procedure in detail beforehand or uttered the word "hysterectomy." Cordell didn't discover the nature of her operation until months after surgery when an office nurse inquired about her recovery.

"How are you doing," the nurse asked, "since your hysterectomy?"

In the decades since the surgery, Cordell, a San Francisco native, has become a proficient reader and an outspoken literacy advocate. But back then, she was too ashamed to ask questions that would reveal she had trouble comprehending the forms designed to legally prove she consented to the procedure.

Cordell's story of being bewildered by medical-legal jargon is not unique. According to a 2005 National Quality Forum report, between 60% and 70% of patients do not read or understand informed-consent documents and nearly half cannot recall the exact nature of the operation to be performed.

Now a growing number of hospitals and physicians are moving to redesign informed-consent protocols. They are using new computer technology and education techniques to improve safety and ensure that patients understand a surgery's risks and benefits. Informed consent is a process, they say, not a piece of paper.

The changes come on the heels of guidelines issued in April by the Centers for Medicare & Medicaid Services that detailed what elements hospitals should include in their consent forms. Meanwhile, the Joint Commission and the National Quality Forum have called on hospitals to make forms more reader friendly, engage patients in a dialogue about procedures and use the teach-back method to ensure understanding.

Electronic consent process

One of the organizations leading the way is the Veterans Health Administration, which last month finished rolling out an electronic informed-consent process at its 154 hospitals. The program, iMedConsent, documents each step in the process. Patients sign a digital pad similar to those found in retail outlets.

But iMedConsent is not aimed at merely documenting conversations that already were occurring, said Ellen Fox, MD, director of the VA's National Center for Ethics in Health Care. The program also features a library of anatomical diagrams and explanations -- written at a sixth-grade reading level -- for procedures in more than 30 clinical specialties. It helps physicians explain difficult concepts in ways that patients can understand.

The program prompts physicians to ask patients to explain in their own words the procedure they are undergoing and its risks, a process known as teach back or repeat back. Response from VA physicians and hospitals around the country has been mixed, Dr. Fox said.

"If people were already spending significant time on ensuring that patients are fully informed, then they see [iMedConsent] as helping them do their job more easily," she said. "If they were not spending a lot of time on educating patients previously, they may see this as increasing their burden."

Larry Carey, MD, acting chief of surgery at the James A. Haley Veterans' Hospital in Tampa, Fla., said the program "is a step in the right direction" because it "standardizes the consent process."

Before, he said, "every doctor made up his own approach. Some were quite good at it, and some were quite superficial, I suspect."

Hundreds of hospitals are using a similar, Web-based patient education program called Emmi to help enhance informed consent. After talking with patients about their surgery, physicians ask patients to view the interactive Emmi program at home -- 94 different procedures are available -- and follow up with any questions before the surgery.

A major barrier to informed-consent redesign comes from risk managers and hospital lawyers afraid that simpler forms could fail to satisfy regulatory requirements or lead to greater liability exposure. But when Iowa Health System tested its original and revised forms with adults learning to read, the new readers found the older, jargon-laden document nearly impossible to understand. They also suggested changes aimed at making the new form clearer and more comprehensible.

The testing "helped to put to rest some of the [legal] concerns that we're protected by the complex form," said Mary Ann Abrams, MD, MPH, a health management consultant in clinical performance improvement at Iowa Health.

Pen-and-paper checklist

San Francisco General Hospital just rolled out a new informed-consent document that serves as a guide for conversations with patients, prompting physicians to check off boxes after completing each step of the process.

"We wanted to really deconstruct the major elements of factual information that patients need to know," said Dean Schillinger, MD, director of the University of California, San Francisco Center for Vulnerable Populations at San Francisco General.

Dr. Schillinger, a leading health literacy researcher, said communicating with patients who speak limited English or do not read well is a challenge in all types of care, but "the ethical stakes become higher" with surgery. "That's a shared decision-making moment we need to get right, because we're going to cut off your leg," he said.

The leading hospitals in informed-consent redesign are incorporating teach back in one way or another. The method "is by far better studied than anything else in terms of ensuring the information has been accurately conveyed," said Matthew K. Wynia, MD, MPH, director of the American Medical Association's Institute for Ethics and co-author of a forthcoming study on how innovative hospitals are rethinking their informed-consent processes.

Teach back "is the one way you actually know the person understands," Dr. Wynia said.

The AMA Foundation has worked to raise awareness about health literacy issues through toolkits, monographs, tip cards and organizational partnerships. The AMA's Code of Medical Ethics says physicians are obliged to help patients make informed decisions, based on the principle that "the patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice."