Much of what happens to you in the hospital in the name of diagnosing and healing is invasive. Depending on what ails you, a doctor may need to ream out an artery to get more blood to your heart, or flood your body with a poison to kill cancerous cells, or saw through the bones of your leg to replace a crumbling hip or a worn-out knee. If a stranger came at you with a scalpel or syringe in a back alley, you would consider it assault and battery. But in a hospital most of us willingly schedule an appointment and pay big money to be precision-poked and carved because we trust our doctor’s skill and knowledge and assume the alternatives—illness, incapacity or early death—are surely worse.
But how many patients truly understand the alternatives or the risks and benefits of the test or treatment they are undergoing? One of the guiding principles of modern health care is that, except in an emergency, doctors must get the patient’s permission before the start of any invasive medical procedure. That “informed consent” is supposed to be based on an earlier conversation during which physicians make sure patients understand what the procedure will and will not do, along with its benefits and risks relative to other options.
Unfortunately, what typically happens in hospitals and clinics across the U.S. is far from ideal: On the way into surgery or some test or treatment, a nurse or technician slips the patient a clipboard of legalese to sign. In most cases, that piece of paper is either a vague permission slip acknowledging that the patient has been “informed” about the procedure, or it reads like a legal waiver—a laundry list of every single side effect and rare complication that could possibly go wrong. These badly written, hastily signed forms are meaningless or worse, health literacy experts say. Research consistently confirms that the flawed permission slips do not improve the patient’s understanding or safety. Nor do they protect hospitals or doctors from misguided malpractice suits.
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In hopes of filling the gap, a growing number of medical centers are now turning to technology—specifically, interactive computer programs that are designed to get beyond the one-size-fits-no-one consent form. These software solutions vary widely in approach and targeted audience. Some are aimed at doctors, others at patients. Some are meant to be reviewed with a health care provider during an office visit; others can be watched with family members at home. Health researchers still debate each approach’s effectiveness. Rigorous outside testing of them has barely begun. But everyone lauds the goals these new approaches share. First, the programs aim to help make the discussion of the relative pros and cons of every invasive procedure—from angioplasty to tonsillectomy—more meaningful for the patient. Second, they aim to get doctors talking about benefits and risks much earlier in the diagnostic and treatment process so that patients can make truly informed choices about their own health care.
Strong evidence that traditional consent forms fail to inform patients or improve their care has been growing for more than a decade, says Harlan M. Krumholz of Yale University, who studies the ways the system goes wrong. One of the most telling nationwide investigations, he says, was a review published in 2000 of 540 forms collected from 157 randomly selected U.S. hospitals by a public health team led by Melissa M. Bottrell, then at New York University and now with the U.S. Department of Veterans Affairs. Its analysis revealed a haphazard mess: Some forms were short and vague; others were long and confusing. Many contained legalistic language that muddied the decision-making character of the consent process. Only about one in four of the forms went beyond a basic description of the procedure to include common risks, benefits and alternatives.
In nearly 60 percent of the documents studied, protecting “against liability” was the rationale given for using the permission slips, according to the hospitals submitting the forms. Too often, Krumholz says, the informed consent process has deteriorated into “largely a risk management tool for hospitals—a way to try to avoid malpractice suits—instead of a way to promote good decisions. And that seems to me a real shame.”
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.
If more information is required, physicians can call up and print out educational brochures or illustrations from Dialog Medical’s extensive online library. The patient and doctor can study the information together on the screen, or the patient can take it home to review it at his or her own pace with family members. Because the forms become part of the patient’s electronic medical record, anyone on the health team throughout the VA system can easily check to see what sort of consent discussion occurred and answer any further questions.
U.C.S.F.’s Schillinger applauds any attempt to make the informed consent process “more than just a medical Miranda warning.” But he is concerned that there has not been enough independent research to evaluate the effectiveness of various approaches to providing informed consent. Nevertheless, one thing is clear. True face-to-face interactions turn out to be the best medicine.