Transforming PCI Informed Consent into an Evidence-based Decision-making Tool

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With the Institute of Medicine’s call for a more evidence‐based, efficient, patient‐centered healthcare system, this study proposes to test the impact of a new mechanism for eliciting informed consent from patients undergoing percutaneous coronary intervention (PCI) on patients’ comprehension of procedural risks/benefits and upon clinicians’ use of effective strategies to minimize the risk of bleeding at the time of PCI. Bleeding is the most common, non‐cardiac complication of PCI and is strongly associated with myocardial infarction (heart attack), stroke, increased length of stay/costs and death. While important adjunctive therapies exist to minimize the risk of bleeding, in current practice, these therapies are most often applied to patients at low risk for bleeding and least often applied to those at the highest risk – a risk‐treatment paradox. Our proposal seeks to clarify patients’ risk of bleeding at the time of PCI so that these adjunctive therapies can be most rationally applied to those at highest risk to support safer, more cost‐effective, patient‐centered care. To accomplish this, the infrastructure of the informed consent process at participating study centers will be transformed by deploying a novel, web‐based system – the Personalized Risk Information Services Manager (PRISM) – that generates individualized consent forms with estimates of risks and outcomes using validated multivariable models from contemporary practice. Using a pre/post study design at 6 institutions, supplemented with a case control matching methodology, the impact of this new mechanism for eliciting informed consent from patients undergoing PCI will be evaluated by explicitly testing whether PRISM: a) improves the quality of the informed consent process, b) supports the more rational use of Bleeding Avoidance Therapies among those at the highest risk for bleeding, c) decreases bleeding events at the time, or within 1 month, of PCI and d) supports a more cost‐effective model of PCI. This project tests a paradigmatic shift in the practice of medicine that is directly aligned with the strategic directions of the NHLBI to translate new knowledge into routine clinical care. Given the unprecedented investment of NHLBI and the ARRA Stimulus Package in supporting comparative effectiveness research, an enormous amount of new knowledge about which patients most benefit from which types of treatment will emerge. By enabling multivariable models to be executed at the point of care, PRISM will enable a transparent, evidence‐based estimate of each individual patient’s risk and benefits from therapy. If successful in this applicaiton, the PRISM tool can be readily translated into numerous clinical decisions for which comparative effectiveness research defines an optimal treatment strategy, ushering in the Institute of Medicine’s vision for higher quality healthcare.