PRISM: Custom consent forms helped patients better understand PCI

AHA Scientific Sessions 2011

ORLANDO — Patients who received personalized consent forms before angioplasty or stent implantation better understood the procedure, potential risks of treatment and were more engaged in the decision-making process with their physicians, according to research presented here.

For the study, patients undergoing PCI were given a personalized consent form generated by the Patient Risk Information Services Manager (PRISM; n=527) or standard consent form (n=590) before undergoing the procedure. The PRISM form, generated through a web-based tool, allows physicians to input patients’ specific health information and to execute complex prediction models to generate each patient’s individualized risks and benefits of treatment. The personalized consent form was deemed easy to understand, as it was written on an 8th- or 9th grade reading level and included educational pictures of the procedure, which was different from standard consent forms that are typically written in legal language.

Of the patients who received the PRISM form, 72% reported reading and 52% understanding it. In contrast, 45% of patients who received a standard consent form read it and 31% comprehended the information within. Those who read the consent forms were asked if treatment descriptions and complication information was clear. Forty-nine percent of patients who received the PRISM form said treatment descriptions were clear and 50% thought information about potential complications was clear. For patients who received the standard consent form, one-quarter felt that the descriptions and explanation of complications were clear.

Overall, more patients who received the PRISM consent form were aware of risks associated with PCI:

• 66.6% vs. 36% reported understanding the potential risks for death.
• 61% vs. 31% were aware of risks for bleeding.
• 77% vs. 61% reported feeling less nervous about undergoing the procedure.

Personalized consent forms also opened discussions about stent types between patients and physicians. After using PRISM, almost two-thirds (63%) of patients discussed with their physician whether to use a bare metal or drug-eluting stent, as compared with about one-third (35%) of those who received the standard consent form. Half of the patients exposed to the PRISM consents were also much less likely to feel that the doctor alone made the decision about stent type as compared with traditional consent forms (72%).

John Spertus, MD, MPH, director of Cardiovascular Education and Outcomes Research of the Mid America Heart Institute at the University of Missouri-Kansas City, and the PRISM researchers concluded that it is feasible to implement evidence-based decision aids within the routine flow of patient care. In this study, personalized, evidence-based consents supported an improved informed consent process, better knowledge transfer and more engagement in shared decision making. However, the researchers noted marked variability in benefits observed across sites, and added that the consent form is only one component of the consent process.

In the future, the researchers are looking to define the impact of individualized, personalized consent forms on treatment and outcomes of patients.

“I think this paradigm is extensible to many other conditions,” Spertus said at a press conference. “Within cardiology, we can extend it upstream to think about whether patients with stable coronary disease even would want angioplasty in the first place, as compared with bypass surgery or medical therapy alone. Second, it could extend well beyond cardiology.Orthopedics for back pain and knee surgery or oncology for breast cancer treatments are all ripe areas for the delivery of personalized, evidence-based medicine. Using consents like this is one small step in that direction.” – by Casey Murphy

For more information:

• Spertus JA. LBCT.03. Presented at: the American Heart Association Scientific Sessions 2011; Nov. 12-16, 2011; Orlando.

Disclosure: Dr. Spertus is a founder of the Health Outcomes Sciences, which disseminates and supports the PRISM tool. He reports equity interest in Health Outcomes Sciences, which sells and supports the PRISM technology.

The informed consent process currently is a process of informing our patients on the potential risks and benefits prior to medical therapy or procedure. This is often done on a general population or institutional basis to give them information. In general, the treatment course has also usually been decided. It’s important to remember that during the catheterization process this often occurs in the US and around the world in an ad-hoc fashion, where the patient is undergoing a cardiac catheterization without the anatomy being known.

Manesh R. Patel, MD
Assistant professor of medicine
Duke University School of Medicine

Disclosure: Dr. Patel reports no relevant financial disclosures.

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