Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making

Abstract

Background: Standard consent forms result in highly variable communication between patients and physicians. To enhance the consent process and facilitate shared decision making, we developed a World Wide Web-based program, PREDICT (Patient Refined Expectations for Deciding Invasive Cardiac Treatments), to systematically embed patient-specific estimates of death, bleeding, and restenosis into individualized percutaneous coronary intervention informed consent documents. We then compared patients' experiences with informed consent before and after implementation of PREDICT.

Methods and results: Between August 2006 and May 2007, patients undergoing nonemergent cardiac catheterization who received the original consent form (n=142) were interviewed and compared with those who received the PREDICT consent form (n=193). Hierarchical modified Poisson regression models were used to adjust for clustering of patients within physicians. Compared with the original consent group, those in the PREDICT group reported higher rates of reading the consent form (72% versus 44%, relative risk [RR] 1.64, 95% confidence interval [CI] 1.24 to 2.16), increased perception of shared decision making (67% versus 45%, RR 1.48, 95% CI 0.99 to 2.22), and decreased anxiety (35% versus 55%, RR 0.70, 95% CI 0.53 to 0.91). Although there were no differences between groups in patients' ability to name complications of percutaneous coronary intervention, among patients who identified either death or bleeding as a potential complication, more patients in the PREDICT group recalled being informed of their estimated risk of that complication (death: 85% versus 62%, RR 1.37, 95% CI 1.03 to 1.82; bleeding: 92% versus 71%, RR 1.28, 95% CI 1.06 to 1.56).

Conclusions: In this preliminary, single-center experience, individualized consent forms with patient-specific risks were associated with improved participation in the consent process, reduced anxiety, and better risk recall. PREDICT is one potential strategy for improving the current practice of obtaining informed consent for percutaneous coronary intervention.