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Informed Consent: It’s Not Just a Form, It’s a Process

Jeffrey Driver, for HealthLeaders Media, June 24, 2008

There has been an increased focus over the past couple of years on patient rights, resulting in a renewed emphasis on informed consent by healthcare regulators, such as The Joint Commission. This raises a number of concerns for hospitals and medical groups: Are your patients truly informed about the benefits and risks of medical procedures? Are they aware of alternatives? Can your hospital or medical group show irrefutable proof of informed consent?

A hospital's inability to prove informed consent in a malpractice case can be very costly indeed. Even a patient-signed informed consent document won't necessarily hold up in court, because informed consent is not simply a form; it's a process.

At Stanford University Medical Center, we found that approximately 75% of our malpractice claims should not have been filed in the first place. Most reflected inadequate patient understanding of a procedure's outcomes, which can fall into two categories: (a) known common or uncommon complications and (b) rare preventable unexpected outcomes or, in lay terms, medical errors. The problem for doctors and hospitals occurs when patients mistakenly assume that a known complication is instead due to medical error. In order to reduce the chances of this occurring, our medical center decided to strengthen the educational component of our informed consent process.

Of course, a face-to-face conversation between doctor and patient about an upcoming procedure is still very much a part of that process. However, the truth is that sometimes patients don't fully understand or retain everything the doctor is trying to explain. We know this can be due to anxiety and fear about a diagnosis, or it might be due to a language barrier, or to the complexity of the doctor's explanation. When I want to confirm effective informed consent, I utilize what I call the "My Dad Test." In other words, can someone like my dad adequately explain to me what the doctor told him? Unfortunately, more often than not, patients cannot pass this test.

The end result is that a patient may sign an informed consent document without full knowledge of the procedure and its potential outcomes. A worst-case scenario is that an informed consent form is passed to the patient for a signature, with little or no discussion about the procedure that the patient is to undergo. According to a February 7, 2007 Joint Commission white paper entitled "'What Did the Doctor Say?': Improving Health Literacy to Protect Patient Safety", 44% of patients who signed an informed consent form did not know the exact nature of the operation to be performed, and 60% to 70% did not read or understand the information in the form.

Therefore, in January 2006 Stanford added a Web-based patient education system to our informed consent process in order to improve patient understanding of treatment and outcomes. More than that, we wanted our patients to be actively engaged in the learning process, to ask questions, to have realistic expectations, and to comply with treatment instructions. We purchased such a program from Emmi Solutions, LLC largely because our surgeons—including our chief of staff, a neurosurgeon—were real believers in this approach. We now have 83% of our clinical departments using this program.

Our staff provides patients with a unique access code, enabling them to log on to a designated Web page for their particular procedure. Then in the comfort of his or her home, the patient views the interactive program, which is a combination of animation and text, with a soothing female voice as a narrator. The material is presented in easy-to-understand language, and the patient watches at his or her own pace and can ask questions online. Family members and caregivers are encouraged to watch, too, so that everyone has a full understanding of the procedure. Throughout this process, each click of the mouse and interaction is tracked, recorded and archived in a secure, HIPAA-compliant database. In the event of a lawsuit, this record is admissible evidence that goes beyond traditional paper consent forms in scope and sophistication.

For example, we recently were able to avert a potential malpractice suit from a patient who had undergone a procedure and experienced a known complication. This particular complication was presumed by the patient to be due to a medical error; however, because the program tracked exactly what this patient viewed, including the specific mention of this potential complication, we had an indisputable evidence trail establishing that the patient was informed of this risk. As a result, we were able to communicate with the patient and avoid an immediate lawsuit. Avoiding this one lawsuit may save us up to a half million dollars or more in claimed damages and expenses arising from the complication, not to mention immeasurable dollars in possible reputation loss.

For us, however, the benefits go far beyond risk management. We have found that the system successfully manages patient expectations and helps them make more informed decisions. Because it answers their questions, it reduces the time our physicians and staff use to spend consulting, while actually increasing the level of medical information that the patient understands and retains. From a goodwill standpoint, it underscores our commitment to patient education, patient satisfaction and quality of care.

Our patients would agree with this assessment, based on the results of a May 2007 to April 2008 survey of 91 Stanford patients who utilized the Web-based program. Nearly everyone said it improved their understanding of their procedure (92%) and provided new information (87%). Likewise, most felt it increased their comfort level (86%) and confidence in the doctor (82%) and alerted them to previously unknown risks (81%). Nearly three in four said it answered their questions and saved them a call to their doctor. Overall, the vast majority came away with better knowledge of what to expect (80%) and wanted to share the program with others (84%). The comments were very positive; one patient said of the program: "I particularly appreciated the ‘risk' section because it covered things that were not addressed in many of the books and literature that I've read."

Our board of directors is extremely supportive of the program, and our main challenge has been ensuring that our administrative staff uses it consistently. For that, we use the IHI's (Institute for Healthcare Improvement) "spread methodology," which helps effectively spread best practices within a healthcare organization.

I'm not sure why more American hospitals aren't using trackable Web-based technology platforms to enhance their informed consent process. Perhaps it is due to cost concerns; in our case, the return on investment is substantial. I also think that many physicians rely too heavily on less consistent and, frankly, less compelling forms of patient education, such as brochures. I would urge risk managers and administrators to remember that it's often the combination of unrealistic expectations and misunderstanding that can lead a patient to file a malpractice claim. A patient with a greater level of understanding is not as angry or surprised when an unfortunate complication occurs. The more you can enhance the informed consent process with tools like Web-based programs to make it more effective, the better off you are.


Jeffrey Driver, JD, MBA, is the chief risk officer of the Stanford University Medical Center and executive vice president of the Stanford University Medical Indemnity and Trust Insurance Company. He can be reached at JDriver@stanfordmed.org.

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