ORLANDO, FL—A personalized consent form that enables patient engagement and individualized risk modeling allows for a greater understanding of the procedure and a more interactive process for subjects prior to percutaneous coronary intervention (PCI), according to results of a late breaking clinical trial session presented November 14, 2011, at the American Heart Association Scientific Sessions.

In order to give informed consent, patients choosing between BMS and DES need to weigh the higher risk of stent thrombosis and need for dual antiplatelet therapy associated with DES against the higher risk of in-stent restenosis linked with BMS. Using PRISM (Personalized Risk Information Services Manager), a computer clinical risk modeling and informed-consent tool, patients will have improved informed consent processes and better knowledge transfer, said study author John Spertus, MD, MPH, of Saint Luke’s Mid America Heart Institute (Kansas City, MO).

PRISM allows doctors to input patients’ specific health information and to execute complex prediction models that generate each patient’s individualized risks and benefits of treatment. These results were imbedded into a consent form that included educational pictures of the procedure. The multicenter study compared patients receiving standard informed consent forms (n = 590) with those receiving customized forms generated by the PRISM system (n = 527). Using surveys, researchers investigated patient engagement and understanding, risk and benefit knowledge, and shared decision-making.

PRISM Performs Better

Ultimately, surveys showed more patients in the PRISM consent form arm able to give better informed consent than patients with the standard form (table 1).

Table 1. Survey Results of Both Consent Form Groups

Also, more patients in the PRISM group had discussions about stent type with their physicians than those in the original consent form group (~58% vs. ~30%; OR 2.7; P = 0.02). Lastly, more patients in the original consent form arm said their doctor alone made their stent type decision (~72% vs. ~52%) while less said the decision was equally split between their doctor and themselves (~12% vs. ~21%) or made mostly by their doctor (~15% vs. ~25%, P = 0.05 for all).

Moving the Field Forward

Because it was nonrandomized, Dr. Spertus said the study could not determine which components of the PRISM consent led to the improved outcomes. He also noted that “marked variability in benefits observed across the sites suggests that the consent form is only 1 component of the consent process.”

“This study by Spertus et al moves the field forward,” stated AHA discussant Manesh R. Patel, MD, of the Duke University Medical Center (Durham, NC). Dr. Patel commented that the usual process of informing patients of their potential risks and benefits prior to medical therapy or a procedure often provides only general population or institutional information. In addition, the treatment course, from the physician’s viewpoint, has usually already been decided.

Shared medical decision-making, however, involves a real transfer of knowledge from the medical team to the patient with information on the patient’s specific condition and on the risks and benefits of various care pathways, he said. Likewise, the medical team needs to understand the patient’s values and treatment preferences.

The benefits of a successful shared decision-making process, Dr. Patel said, citing a recent study (Antman EM et al. Circulation. 2009:119;1180-1185), would include:

• Increased use of effective therapies
• Decreased use of inappropriate, unnecessary, and potentially harmful therapies
• Improved patient outcomes with reduced cost of health care delivery

Dr. Patel acknowledged that PRISM offers a real innovation, combining patient specific data on risks and potential outcomes with the informed consent process. Also, he said, the study outcomes clearly demonstrated an increase in patient knowledge and an overall improved experience for patients undergoing PCI.

Study Details

While the reading grade levels of the PRISM forms ranged between 8.0 and 9.5, the original consent forms had a much wider variance among the different study sites (9.5-15.7). Of the 9 total sites, 5 of them have since replaced their original forms with the PRISM forms.

Baseline characteristics were comparable for both groups, except PRISM patients were more likely to have a history of smoking (42% vs. 33%, P = 0.006), depression (10% vs. 5%, P = 0.001), or stable CAD (51% vs. 34%, P < 0.001).

Disclosures

• Dr. Spertus is the founder of Health Outcomes Sciences, the company which disseminates and supports the PRISM tool.
• Dr. Patel reports receiving research funds from Astra Zeneca, Johnson and Johnson, and NHBLI and serving as a consultant and/or advisor to Bayer HealthCare, Genzyme, Modest, and Ortho McNeil Jansen.

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