Uninformed Consent: Tech Solutions for Faulty Permissions in Health Care

Technology can help individuals weigh the risks and benefits of an invasive medical procedure, experts say, but only if doctors and patients keep talking

Often the forms do not achieve even that self-defensive aim, says attorney Jeffrey F. Driver, who advises Stanford University Medical Center on medical malpractice cases. For one thing, research suggests the legalistic tone of such forms irks patients and makes them suspicious of their doctor and the hospital, and that suspicion may increase the likelihood of a later suit. Plus there is good evidence that the long list of potential medical complications does nothing to help people distracted by illness or anxiety understand that even a medical procedure performed perfectly may still produce undesirable results, Driver says. His research showed that patients often sue because they mistakenly assume that a known complication of their procedure is the result of medical error. Lengthy forms only fueled such cases. “We realized what we needed was much better patient education up front,” Driver says, “to make sure the patient’s expectations of what could happen were similar to the doctor’s.”

Communication is essential no matter what the approach. Dean Schillinger, an internist and health literacy specialist at the University of California, San Francisco, and his colleagues recently published a review of 44 small studies of different programs aimed at improving the informed consent process. The key to enhancing patient understanding of risks and trade-offs, they found, was to have a high-quality discussion—whether prompted by a computer program or in response to a simply written printed explanation of pros, cons and alternatives. Anything that got patients to reiterate what they have learned in their own words significantly improved the consent process.

Two new options
One of the first decisions hospitals face when purchasing a technology-based system is whether they want to focus more on the physician’s side of the informed consent process or the patient’s side. In 2006 the Stanford Medical Center chose a patient-oriented product from a Chicago-based company, Emmi Solutions.

Patients log on to one of Emmi’s online computer modules from the doctor’s office or at home. All the programs are interactive and self-paced, typically taking about 30 minutes to complete, although they can be paused or reviewed. Nearly 200 frequently performed procedures—from colonoscopy to hip replacement—are covered. Doctors can enable the viewer to type a question to them or someone else on their staff and send it for a response in an online chat.

One of the audiovisual program’s advantages over strictly paper-based forms is that it automatically checks for comprehension and flags certain items for deeper discussion. For example, the program keeps track of all questions raised by patients as well as every time they request more information. That list alerts the doctor to address the remaining concerns or confusion during the next appointment. Then, before the procedure, patients still sign a very brief written consent, signifying they have watched the interactive program and have had a discussion with their doctor. “Informed consent is the process, not the form,” Driver says. “The piece of paper should just be a tickle to their memory about what’s been discussed.”

The ability to keep track of a patient’s every click and screen view may also keep malpractice costs down. A would-be litigant dropped her malpractice charge against Stanford when she was shown that her pattern of computer clicks confirmed that she had actually looked at a screen shot describing that complication four times and discussed it with her doctor.

Meanwhile the Veterans Health Administration has chosen a different path, relying on software aimed at doctors. A program called iMedConsent, by Dialog Medical in Atlanta, allows the health team to quickly create consent forms and packets of educational materials tailored to each patient’s needs. Doctors type the name of any of 2,200 medical conditions, treatments or procedures into the program, and a consent form specific to that condition or procedure pops up on the screen. Different parts of the online template detail the procedure’s benefits, risks and alternatives in sixth-grade English or Spanish. The template also prompts doctors to discuss with patients their prognosis if they choose to have no treatment or procedure at all.

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