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

将 PCI 知情同意转变为基于证据的决策工具

• 批准号: 7695323
• 负责人: JOHN A SPERTUS
• 金额: $ 212.15万
• 依托单位: SAINT LUKE'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7695323
• 关键词: Address; American; Angioplasty; Anticoagulation; Aspirin; Benefits and Risks; Biological Markers; Blood Platelets; Blood Vessels; Cardiac; Cardiology; Cardiovascular system; Caring; Cessation of life; Characteristics; Clinical; Complex; Complication; Comprehension; Consent; Consent Forms; Cost Savings; Data; Databases; Decision Making; Devices; Drug usage; Economic Models; Economics; Educational Materials; Effectiveness; Equilibrium; Evaluation; Event; Future; Genomics; Goals; Health; Health Status; Healthcare; Healthcare Systems; Hemorrhage; Hospitalization; Hospitals; Human; Individual; Informatics; Information Services; Information Technology; Informed Consent; Institute of Medicine (U.S.); Institutes; Institution; Intervention; Investments; Knowledge; Lead; Leadership; Length of Stay; Medical; Medicine; Metals; Methodology; Modeling; Myocardial Infarction; National Heart, Lung, and Blood Institute; Nurses; Online Systems; Outcome; Outcomes Research; Output; Patient Care; Patient Monitoring; Patient-Centered Care; Patients; Pharmaceutical Preparations; Physicians; Population Study; Procedures; Process; Quality of life; Questionnaires; Radial; Registries; Research; Research Design; Research Infrastructure; Research Personnel; Risk; Risk Estimate; Risk Management; Savings; Scientist; Site; Solid; Stents; Stimulus; Stroke; Surveys; Symptoms; System; Techniques; Telephone; Testing; Time; Training; Translating; Translational Research; Translations; United States National Institutes of Health; Vision; Writing; base; bivalirudin; case control; clinical care; clinical practice; college; comparative effectiveness; compliance behavior; coronary angioplasty; cost; cost effectiveness; design; effectiveness research; empowered; evidence base; experience; follow-up; health care delivery; health care quality; high risk; implantation; improved; meetings; novel; patient oriented; percutaneous coronary intervention; prevent; research to practice; restenosis; routine care; thienopyridine; tool; treatment strategy; trend

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.

随着医学研究所呼吁建立一个更加循证、高效、以患者为中心的医疗保健系统，本研究建议测试一种新的机制，即从接受经皮冠状动脉介入治疗（PCI）的患者中获取知情同意，对患者理解手术风险/受益以及临床医生使用有效策略以最大限度地降低PCI时出血风险的影响。出血是PCI最常见的非心脏并发症，与心肌梗死（心脏病发作）、卒中、住院时间/费用增加和死亡密切相关。虽然存在重要的预防性治疗以最大限度地降低出血风险，但在当前实践中，这些治疗最常用于低出血风险患者，最不常用于高风险患者-风险-治疗悖论。我们的建议旨在明确PCI时患者的出血风险，以便这些预防性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，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）-来改造参与研究中心的知情同意过程的基础设施，该系统使用当代实践中经验证的多变量模型生成个性化的知情同意书，并估计风险和结局。使用6家机构的前/后研究设计，辅以病例对照匹配方法，将通过明确测试PRISM是否：a）提高知情同意过程的质量，B）支持在出血风险最高的人群中更合理地使用出血避免治疗，c）减少PCI时或1个月内的出血事件，d）支持更具成本效益的PCI模式。该项目测试医学实践的范式转变，直接与NHLBI的战略方向保持一致，将新知识转化为常规临床护理。鉴于NHLBI和ARRA刺激计划在支持比较有效性研究方面进行了前所未有的投资，将会出现大量关于哪些患者从哪些类型的治疗中最受益的新知识。通过使多变量模型能够在护理点执行，PRISM将能够对每个患者的风险和治疗获益进行透明的、基于证据的估计。如果在这一应用中取得成功，PRISM工具可以很容易地转化为众多的临床决策，比较有效性研究确定了最佳的治疗策略，引领了医学研究所对更高质量医疗保健的愿景。