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

随着医学研究所呼吁建立更加循证、高效、以患者为中心的医疗体系，这项研究建议测试一种新的机制，以获得接受经皮冠状动脉介入治疗(PCI)的患者的知情同意，对患者对程序风险/好处的理解，以及对临床医生使用有效策略将经皮冠状动脉介入治疗时的出血风险降至最低的影响。出血是经皮冠状动脉介入治疗最常见的非心脏并发症，与心肌梗死(心脏病发作)、中风、住院时间/费用增加和死亡密切相关。虽然存在着将出血风险降至最低的重要辅助疗法，但在目前的实践中，这些疗法最常应用于出血风险较低的患者，而最少应用于风险最高的患者--这是一个风险-治疗悖论。我们的建议旨在澄清患者在接受介入治疗时的出血风险，以便这些辅助治疗可以最合理地应用于风险最高的患者，以支持更安全、更具成本效益、以患者为中心的护理。为了实现这一目标，参与研究中心的知情同意程序的基础设施将通过部署一种新型的基于网络的系统-个性化风险信息服务管理器(PRISM)-来改变，该系统使用当代实践中经过验证的多变量模型生成个性化同意书，并使用经过验证的多变量模型估计风险和结果。通过对6个机构进行事前/事后研究设计，辅以病例对照方法，将通过明确测试PRISM是否支持在出血风险最高的患者中更合理地使用避免出血疗法，以及(C)减少在介入治疗时或1个月内的出血事件，来评估这一新机制对接受经皮冠状动脉介入治疗患者知情同意的影响：a)提高知情同意程序的质量；b)支持更具成本效益的经皮冠状动脉介入治疗模式。该项目测试了医学实践中的范例转变，这与NHLBI将新知识转化为常规临床护理的战略方向直接一致。鉴于NHLBI和ARRA刺激计划在支持比较有效性研究方面的前所未有的投资，将出现关于哪些患者从哪些类型的治疗中受益最大的大量新知识。通过在护理时执行多变量模型，PRISM将能够对每个患者的风险和治疗收益进行透明的、基于证据的评估。如果在这一应用中取得成功，PRISM工具可以很容易地转化为许多临床决策，比较有效性研究为这些决策定义了最佳治疗策略，从而引入了医学研究所对更高质量医疗保健的愿景。

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.