Abstract 3508: Patient Recall of Complications and their Risk Based on Method of Informed Consent: Original Consent Form versus the PREDICT (Patient Refined Expectations for Deciding Invasive Cardiac Treatments) Tool
Background: While the informed consent process is designed for physicians to describe the risks and benefits of procedures to patients, current systems frequently fail to accomplish this goal. In the setting of PCI, generic consent forms permit highly variable communication between patients and physicians. We developed a web-based program, PREDICT, to systematically embed patient-specific estimates of risk, from validated multivariable models, into PCI consents. We then studied whether PREDICT improved patients’ recall of peri-PCI risks as compared with the Original Consent Form (OCF).
Methods: Between 2/07–5/07, patients receiving the OCF and PREDICT were interviewed within 48 hours of receiving PCI. They were asked what complications were discussed by a physician or a nurse prior to the procedure and the risk of these complications.
Results: The OCF and PREDICT cohorts had similar demographics (age, gender and race). Of patients who recalled the complications, a statistically significant difference in the proportion of patients receiving the OCF (N= 41) versus PREDICT (N=79) recalled “never being told” about the percent risk of death, bleeding or stroke. (Figure 1⇓) Patients receiving the OCF compared to PREDICT responded “never being told” their percent risk of having a heart attack (27% vs. 18%, p= 0.389) or CABG (44% vs. 30%, p=0.202), outcomes for which no PREDICT model was generated.
Conclusion: Individualized consent forms with patient-specific risks for PCI are associated with improved patient recall of the percent risk of complications. These preliminary results suggest that PREDICT is a potential strategy for improving the current informed consent process.