The Seven Pillars: Crossing the Patient Safety-Medical Liability Chasm

描述（由申请人提供）：患者安全和医疗责任改革是美国医疗保健系统面临的关键问题。结合解决方案以最大限度地减少可预防伤害同时遏制医疗责任风险的创新战略很少。其中一个策略是，在透明和充分披露的文化中，当病人受到伤害时，对病人、同事和机构保持开放和诚实。披露和早期提供计划受到了适度的关注;然而，由于缺乏严格的研究来评估患者安全和医疗责任结果的有效性，因此广泛采用受到了阻碍。为了解决这一问题，我们提出了一个示范项目，以评估一个全面的过程中的有效性，为应对病人的伤害事件被称为“七支柱”，已在伊利诺伊大学芝加哥（UIC）自2006年以来。该项目的长期目标是通过改善与患者和家属的沟通，在患者遭受可预防的伤害时进行披露和早期提供，以及从错误中学习以防止未来的伤害-“七支柱”的标志，来改善患者安全并降低医疗责任风险。该项目的短期目标是确定在芝加哥地区的医院实施“七大支柱”程序的可行性，并评估其对病人安全和医疗责任的影响。为了实现这些目标，该项目将追求以下具体目标：1）完善和改进UIC目前实施的“七支柱”流程，并促进芝加哥地区九家医院实施该流程; 2）评估“七支柱”流程对各种患者安全流程和结果措施的影响（例如，不良事件报告数量、报告的重大不良事件数量、患者安全文化、披露数量和质量等）;以及3）评估“七大支柱”流程对各种风险管理和医疗责任流程和结果措施的影响（例如，索赔数量、达成和解协议的时间、医疗事故保险费、患者或家属收到的和解比例等）。本调查的目的是确定基于患者伤害事件“七大支柱”方法的组织变革干预是否可以对一组目标安全性、沟通过程和责任结果产生可衡量的改善。基本设计将是一个中断的时间序列，有一个非等效的、无治疗的对照组，将用于测试以下假设：1）UIC目前实施的“七大支柱”流程可以有效地传播到芝加哥地区的其他医院; 2）实施“七大支柱”流程将改善广泛的患者安全流程和结果措施;及3）“七大支柱”程序的实施将在广泛的财务、医疗责任及风险管理程序及结果措施方面带来重大改善。 公共卫生相关性：该项目旨在严格评估“七大支柱”的影响--对患者伤害的全面应对，将有效和诚实的沟通与改善患者安全和降低医疗责任风险联系起来。与AHRQ的既定目标一致，该模式将患者安全放在首位，通过患者和提供者之间的有效沟通，努力减少可预防的伤害，同时确保对不适当的医疗护理进行公平和及时的赔偿，并减少医疗责任保险费。这个为期三年的示范项目预计将成为在整个伊利诺伊州采用可持续“七支柱”模式的催化剂。

DESCRIPTION (provided by applicant): Patient safety and medical liability reform are key issues being faced by the U.S. health care system. Innovative strategies combining solutions to minimize preventable harms while curbing medical liability risk are rare. One such strategy, embedded in a culture of transparency and full disclosure, is being open and honest with patients, colleagues, and institutions when a patient suffers harm. Disclosure and early offer programs have received modest attention; however, widespread adoption has been impeded by a dearth of rigorous studies evaluating effectiveness in terms of patient safety and medical liability outcomes. To address this issue, we propose a demonstration project to evaluate the effectiveness of a comprehensive process for responding to patient harm events known as the "Seven Pillars" that has been in place at the University of Illinois at Chicago (UIC) since 2006. The long-term objectives of the project are to improve patient safety and mitigate medical liability risk through improved communication with patients and families, disclosure and early offer when patients suffer preventable harm, and by learning from mistakes to prevent future harms - the hallmarks of the "Seven Pillars". The short term objectives of the project are to determine the feasibility of implementing the "Seven Pillars" process at hospitals in the Chicagoland area and to evaluate its impact on patient safety and medical liability. To achieve these objectives, the project will pursue the following specific aims: 1) Refine and improve the "Seven Pillars" process currently in place at the UIC, and facilitate the implementation of the process at nine hospitals within the Chicagoland area; 2) Assess the impact of the "Seven Pillars" process on a variety of patient safety process and outcome measures (e.g., number of adverse event reports, numbers of reported significant adverse events, patient safety culture, number and quality of disclosures, etc.); and 3) Assess the impact of the "Seven Pillars" process on a variety of risk management and medical liability process and outcome measures (e.g., number of claims, time to settlement agreement, malpractice premiums, proportion of settlement received by patient or family, etc.). The purpose of this investigation is to determine whether an organizational change intervention based on the "Seven Pillars" approach to patient harm incidents can produce measurable improvements on a targeted set of safety, communication process, and liability outcomes. The basic design will be an interrupted time series with a non- equivalent, no-treatment control group that will be employed to test the following hypotheses: 1) The "Seven Pillars" process currently in place at UIC can be effectively and efficiently disseminated to other hospitals within the Chicagoland area; 2) Implementation of the "Seven Pillars" process will bring about improvements in a wide range of patient safety process and outcome measures; and 3) Implementation of the "Seven Pillars" process will bring about significant improvements in a wide range of financial, medical liability, and risk management process and outcome measures. PUBLIC HEALTH RELEVANCE: This project aims to rigorously evaluate the impact of the "Seven Pillars" - a comprehensive response to patient harm that links effective and honest communication with improvements in patient safety and reducing medical liability risk. Consistent with AHRQ's stated goals for the grant this model puts patient safety first, works to reduce to preventable injuries through effective communication among patients and providers, while ensuring fair and timely compensation for inappropriate medical care, and reducing medical liability premiums. This three-year demonstration project is expected to be a catalyst for adoption of a sustainable "Seven Pillars" model throughout the State of Illinois.