Customized Informed Consent Improves Communication

Reed Miller

November 15, 2011

November 14, 2011 (Orlando, Florida) — The PRISM computer clinical risk modeling and informed-consent tool improves PCI patients' understanding of their procedure and allows them to participate in the decision about their own care, according to Dr John Spertus (Mid-American Heart Institute, Kansas City, MO), one of PRISM's developers.

Today at the American Heart Association 2011 Scientific Sessions, Spertus presented results of a nine-center survey of patient experiences with conventional informed-consent forms and forms generated by the PRISM system. Prism uses American College of Cardiology National Cardiovascular Data Registry models to predict the patient's risk of mortality, bleeding, and target vessel revascularization risk and produces a customized informed-consent form to help the patient and doctor decide whether to use a drug-eluting stent (DES) or bare-metal stent.

"There is an important ethical mandate, beyond the legal mandate, of informing patients about their risk and to engage them in choosing therapy aligned with their own personal goals and values," Spertus said. In this decision, the patient must choose between a higher risk of stent thrombosis and a dual antiplatelet therapy requirement with DES or the higher risk of in-stent restenosis that comes with bare-metal stents.

But patients cannot make an informed decision about their own risks or benefits with any given therapy based solely on populationwide data. They need estimates based on their own unique characteristics. "It would be ideal for us to be able to feed back those estimates at the time we're obtaining informed consent so that the patient could really participate in a shared decision-making experience," Spertus said.

In the study Spertus presented, 590 PCI patients reviewed a standard informed-consent form with general information about the procedures and 527 read one created just for them by PRISM. The PRISM-informed patients showed a significantly greater level of "knowledge transfer" than patients who read a standard form. About 70% of the PRISM patients actually read the form vs only about 45% in the control group (p=0.04), and 50% of the PRISM patients said they fully understood the information in the form vs only about 30% of the control group (p=0.04). Also, of the patients who read the forms, nearly 50% of patients in the PRISM group said their form was easy to read compared with about a quarter of the control group (p=0.01). Patients in the PRISM group were also more likely to recall being warned of the specific risks of the PCI procedure.

Importantly, the patients reading the PRISM-generated forms were 2.7 times more likely than patients in the control group to say they discussed the choice of stent with their doctor.

Spertus estimated that patient-specific informed-consent materials will be a big help in about 60% of patients, because about a third of patients will do whatever the doctor advises anyway and another 10% already ask their doctor most of the questions answered in the PRISM-generated informed-consent form.

He hopes future research will show that using these customized informed-consent forms leads to better outcomes and fewer unnecessary procedures, but for now, simply improving patients' engagement with their own care decisions is a big step forward. "We do a terrible job with [informed consent] now in this country, so I was ecstatic that things improved with PRISM. But there's a long way to go still."

Commenting on the study at the meeting, Dr Manesh Patel (Duke University, Durham, NC) agreed that just "showing that patients are more informed with this tool is a significant step forward" over the ad hoc way PCI decisions are often made today in the US, he said. "But . . . showing that shared decision-making leads to some different care that improves the patient outcome would be a home run."

Patel said that further research into customized informed-consent materials should try to sort out which particular features of the PRISM system are most important: is it clear simple language, the patient-specific information, or simply that the patients using the system spent more time discussing it with their doctor? Spertus also said his group would like to study how this enhanced informed consent can improve patient adherence with their prescribed drugs. "One of the real challenges is to get patients to understand why they are taking these medicines," he said.

Spertus is the founder of Health Outcomes Sciences, which disseminates and supports the PRISM tool.