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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6 Comments
Add CommentI disagree with Deborah Franklin's position as it is presented in this article. I believe that the options discussed to further inform patients would not have the same beneficial effects in practice as it does in theory. It is a theory that would benefit far fewer than she seems to indicate in her article. I believe the effect of more information about procedures and side effects would prevent majority of people away from receiving proper medical attention.
Reply | Report Abuse | Link to thisThe idea of surgery is frightening enough to most patients. For a patient to then be required to undergo a tutorial about the process and be specifically informed of everything that could possibly go wrong would most certainly make the physician’s job more difficult as well as hinder the decision making by the patient.
Contrary to the article, malpractice law suits would more than likely increase. Such a vigorous informed process would make a patient feel completely informed about everything that is going to happen and everything that could happen.
The practice of medicine is a practice of helping others based on odds. What can happen during a procedure is unknown to even the physician himself, and making the patient feel more confident with "what is going to happen" may ultimately be a legal trap for physicians. This may further hinder healthcare because a physician may hesitate to help a patient as best as he can because a necessary procedure (from the physician's point of view) may legally be too much of a risk for the physician to take.
Finally, a patient has the ability to ask the physician or a nurse for more information before they sign an informed consent. One reason why many patients do not actively seek more information about procedures is because they may not want the information. A calm, intelligent person must simply say "what is going to be done, how do side effects come about, and why do I need this procedure?" and a nurse of physician will give the patient the information he or she seeks.
A Physician’s primary goal is to help their patients, not run up hospital bills or perform risky procedures at their patient’s expense for their own personal glory. People see doctors when they cannot handle a health issue on their own. Doctors are consultants, but people need to trust that a doctor is acting in their best interest. Doctors are already extremely busy in their day to day lives, and requiring them to spend significantly more time explaining procedures to patients is just not realistic nor do I see any clear benefit in it.
I'm of the opposite opinion as the previous comment. Nobody want's to be in the hospital unless they are having a baby. The stress level is through the roof because they have no idea of what's going to happen with them. Many hospitals are taking the idea of patient education more seriously because of recent study proving the positive impacts of educating the patients. There is an art to creating effective education designed for patients...they layout, inclusion of art work, reading level.
Reply | Report Abuse | Link to thisPatient consent forms, for many hospitals, are nothing about educating or empowering a patient to make choices regarding their health. They are designed to cover the backside of the hospital...no question. How much detail or time needs to be taken is really something that needs to be looked at, but moving away from the "head in the sand" approach is fantastic.
I would dare say that most consent documents are written at a 10th or 11th grade level...at least. A good consent form with patient education included should be done at a 5th-8th grade reading level. Where the average person can read and understand it.
Hospitals can no longer afford to deal with law suits and high readmission rates (soon to be not covered by Medicare).
Great article and right on the money to where the industry is trending!
I agree that consent forms can be written in a more "patient friendly" format. However, the article is suggesting a more involved process, one that does not seem practical. The more involved process would benefit some Americans, I never denied that. I simply believe that "the majority of people," will not be helped by such a process. Keeping this system simple allows physicians to spend their time diagnosing and treating patients as opposed to thoroughly explaining their decisions to patients. A physician or nurse will gladly answer any questions or explain procedures and alternatives before the consent form is signed, if a patient would simply ask for more information. But if a patient does not ask, why should a physician be required to give more information by law? What the article suggests would simply be a more involved consent process to “cover the backside of the hospital.”
Reply | Report Abuse | Link to thisThe main point of my previous comment was to suggest that the limited studies cited in the article do not provide strong enough evidence to warrant a more involved patient consent process. Again, it is great in theory and a great topic for discussion on ScientificAmerican.com. However, I still fail to see any clear benefit that the "majority of people" would receive by a more informative/involved patient consent process.
I like the idea of being able to review videos of a potential procedure. When was to have an aortic valve replaced in 2001 we (my wife and I) went on the web to find out what this was all about. By the time I gave my consent I had a pretty good idea of what I was in for.
Reply | Report Abuse | Link to thisOn the other hand I recently need to see a urologist. The first one really did not explain much and some form I couldn't decipher was put in front of me. It really did not comprehend what they were going to do and how. After a very painful diagnostic procedure I went elsewhere and was advised I needed some other test. This was even more painful and actually failed (they could get the test to work they way it was supposed to). Although this this second doctor did a much better job of trying to explain what was to be done, I don't think I was really informed.
Part of the problem is you don't want to look stupid when you are in the office and usually you can'
t think of an intelligent question to ask other that "could you repeat that because I don't get it". With an interactive video you get time to think, rethink, and formulaqte questions you can then ask the doctor.
I hope more clinics and hospitals use this tool.
"A physician or nurse will gladly answer any questions or explain procedures and alternatives before the consent form is signed, if a patient would simply ask for more information."
Reply | Report Abuse | Link to thisMy personal experience does not match your vague generalization. I have had some medical professionals that would but many were simply too worn out or too busy to give useful answers. Then there were a couple of them that were offended by my asking questions. In a perfect world your scenario would be correct. In the real world it is not.
If patients choose to give up their right to an informed decision they surely may do so. Having medical professionals take that right away from them arbitrarily is simply wrong.
You have it backwards. The article presents a situation that "in a perfect world" would be correct, but would not "in the real world". By requiring medical professionals who are already "worn out or too busy" to give a patient useful answers would either require more physicians which would increase costs, or require the physicians to spend more time answering the patients questions instead of practicing medicine, thereby lowering the quality of the care they provide. If a patient has a chance, they can do their own research like mfvk63 did when he needed an aortic arch replaced. If you can not, take the physicians advice and sign the form. You can always choose the alternative, refusing medical attention.
Reply | Report Abuse | Link to thisImplied consent (when a patient is unconscious it is assumed that they would accept medical attention) is proof that the law is on the side of the physicians. No one, not even the spouse of a patient, can prevent the care of a person who is unconscious (the only exception is when a patient is under the age of 18 a parent must be asked). The law and healthcare systems are not going to change their opinions on this matter anytime soon, and there is no where near enough proof to show any benefit in a different system.