Profession

Hospitals look to improve informed consent process

New technology, simpler forms and better dialogue are seen as key to ensuring patient comprehension and preventing harm.

By Kevin B. O’Reilly — Posted Nov. 19, 2007

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

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."

Back to top


ADDITIONAL INFORMATION

Americans' health literacy

The average informed-consent document is written at a college reading level, but half of American adults can only comprehend material written at the 8th-grade level or below. The most recent national assessment found that more than 75 million American adults have limited or low health literacy skills, meaning they can't read and understand complex written material.

Health literacy level Portion of adult population
Below basic 30 million (14%)
Basic 47 million (22%)
Intermediate 114 million (53%)
Proficient 25 million (12%)

Sources: AMA Educating Physicians on Controversies in Health video, "Uninformed Consent: What Can Happen When A Patient Does Not Understand the Information You Have Provided?"; The Health Literacy of America's Adults: Results From the 2003 National Assessment of Adult Literacy, National Center for Education Statistics, U.S. Dept. of Education

Back to top


ADVERTISEMENT

ADVERTISE HERE


Featured
Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story


Read story

Goodbye

American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story


Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story


Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story


Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story


Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story


Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story


Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn