A2ALL- Patient Safety System Improvements in Living Donor Liver Transplantation

A2ALL-活体肝移植中患者安全系统的改进

• 批准号: 8188248
• 负责人: Daniela P Ladner
• 金额: $ 80.45万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8188248
• 关键词: Address; Adopted; Adult; Air; Ancillary Study; Area; Attention; Caring; Cessation of life; Clinical; Clinical Trials Data Monitoring Committees; Cohort Studies; Collaborations; Complex; Complication; Critiques; Deep Vein Thrombosis; Development; Effectiveness; Embolism; Event; Face; Failure; Healthcare; Hospital Costs; Industry; Inpatients; Intervention; Knowledge; Lead; Life; Light; Living Donor Liver Transplantation; Living Donors; Lung; Measures; Medical Errors; Medical Records; Methods; Online Systems; Outcome; Patient Care; Phase; Plant Roots; Policies; Positioning Attribute; Postoperative Hemorrhage; Prevention; Procedures; Process; Protocols documentation; Published Comment; Reporting; Risk; Safety; Solutions; System; Transplantation; United States; United States Centers for Medicare and Medicaid Services; cost; design; healthy volunteer; high risk; improved; innovation; liver transplantation; meetings; novel; nuclear power; patient safety; prevent; response

DESCRIPTION (provided by applicant): The Centers for Medicare and Medicaid Services have become increasingly focused on improving healthcare safety and quality while decreasing costs and adopted a policy of no longer reimbursing hospitals for the costs of treating designated preventable inpatient complications. Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. In fact, complication rates for LDLT donors and recipients are 20-30% and 75%, respectively, of which 70% are deemed preventable. Effective elimination of preventable complications in LDLT will require careful attention to the vulnerabilities in the systems and processes of care for LDLT donors and recipients. Prevention of such events is especially important when caring for living donors, given that they are healthy volunteers undergoing a major procedure purely for altruistic reasons without any direct benefit. The importance of donor safety is magnified in light of the two LDLT donor deaths, earlier this year in the United States. Considerable advances in reducing medical errors and preventable complications have already been achieved. In the field of transplantation, new protocols such as those used to confirm ABO compatibility between the donor and recipient have been highly effective. This study proposes to apply the proactive, systematic, and comprehensive approaches successfully used in other high risk industries and adapted for healthcare, to LDLT system and processes of care. The proactive, systematic, and comprehensive identification of potential vulnerabilities will permit the development and implementation of solutions designed to mitigate these vulnerabilities and, thus, reduce medical errors and preventable complications in LDLT. This study will build on the considerable strengths of the Adult-to-Adult Living Liver Transplant Cohort Study (A2ALL) as an ancillary study of the A2ALL consortium. A2ALL has recognized the importance of providing safe and reliable LDLT care, and has made donor safety a secondary aim and fully supports this study. Seven of the nine A2ALL centers will be involved in this study either as an intervention or a control center, thus, representing more than 50% of all LDLTs performed in the US. This study is novel and innovative, because it seeks to shift the paradigm of response to medical errors to a proactive approach of assessing and improving the safety of systems and processes to prevent medical errors in living donor liver transplant (LDLT) before they occur. This study will apply adapted methods successfully applied by other high risk industries to generate new and important information about LDLT safety. LDLT provides an excellent opportunity to fully assess the mechanisms of medical errors and preventable complications as there is little risk of confounding by donor co-morbid conditions. PUBLIC HEALTH RELEVANCE: Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to- Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care. This project will address an important gap in the knowledge needed to achieve high quality and safe LDLT care of patients by developing a process to: 1) proactively, systematically and comprehensively identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of these solutions to improve the safety of LDLT care by measuring clinical and process outcomes before and after solution implementation across four intervention and three control centers. NOTE: The criteria scores and the critiques given below were provided by the reviewers assigned to this application. These do not necessarily reflect the positions of the reviewers at the close of the group discussion or the final majority opinion of the group, although the reviewers were asked to amend their criteria scores and critiques if their positions changed during the discussion. Please note that the criteria scores are not averaged in arriving at the final overall impact scores. If the reviewers have not changed their criteria scores after the discussion, those shown in the critiques may reflect the opinion of the reviewers before the meeting. The Resume and other initial sections of the summary statement are the authoritative representations of the final outcome of the group discussion. If there is any discrepancy between the reviewers' commentaries and the priority/impact score on the face page of this summary statement, the priority/impact score should be considered the most accurate representation of the final outcome of the group discussion.

描述（由申请人提供）：医疗保险和医疗补助服务中心已经越来越专注于改善医疗保健安全和质量，同时降低成本，并采用不再向医院偿还医院的政策，以治疗指定可预防的住院并发症的费用。活供体肝移植（LDLT）涉及复杂的系统和护理过程，这些系统尤其容易受到医疗错误和可预防的并发症的影响。实际上，LDLT供体和受体的并发症发生率分别为20-30％和75％，其中70％被认为可以预防。 有效消除LDLT中可预防的并发症将需要仔细注意LDLT捐赠者和接受者的系统和护理过程中的脆弱性。鉴于他们是健康的志愿者，纯粹是出于无私的原因而没有任何直接利益，因此预防这种事件尤其重要。鉴于今年早些时候在美国，捐助者安全的重要性被放大。在减少医疗错误和可预防并发症方面取得了长足的进步。在移植领域，新方案（用于确认捐赠者和受体之间ABO兼容性的新方案都非常有效。 这项研究建议将成功使用的主动，系统和全面的方法应用于其他高风险行业，并适用于医疗保健，LDLT系统和护理过程。对潜在漏洞的积极，系统和全面的识别将允许开发和实施旨在减轻这些脆弱性的解决方案，从而减少LDLT的医疗错误和可预防的并发症。这项研究将基于成人到成年的生活肝移植队列研究（A2ALL）作为A2All联盟的辅助研究的相当大的优势。 A2ALL认识到提供安全可靠的LDLT护理的重要性，并使捐助者的安全成为次要目标并完全支持这项研究。九个A2ALL中心中的7个将作​​为干预中心或对照中心参与，因此代表了美国执行的所有LDLT的50％以上。 这项研究是新颖而创新的，因为它试图将对医学错误的反应范式转移到评估和改善系统和过程的主动方法，以防止生物供体肝脏移植（LDLT）发生之前的医疗错误。这项研究将采用其他高风险行业成功应用的改编方法来生成有关LDLT安全的新重要信息。 LDLT提供了一个绝佳的机会，可以充分评估医疗错误和可预防的并发症的机制，因为捐助者合并状况几乎没有混淆的风险。 公共卫生相关性：活供体肝移植（LDLT）涉及复杂的系统和护理过程，这些系统和过程特别容易受到医疗错误和可预防的并发症的影响。这项对成人生活肝移植队列研究（A2ALL）的辅助研究将着重于对LDLT护理系统和过程中的脆弱性进行积极，系统和全面的评估，以减少医疗错误并预防并发症，从而改善LDLT护理的安全。该项目将通过开发一个过程来解决患者的高质量和安全LDLT护理所需的知识的重要差距：1）主动，系统和全面地确定LDLT护理中脆弱性的领域，这可能导致医疗错误，2）设计和实施解决方案以减轻这些弱点，3）评估这些解决方案的有效性，通过测量在四个干预中心和三个控制中心实施解决方案之前和之后的临床和过程结果，以提高LDLT护理的安全性。 注意：下面给出的标准分数和评论由分配给本申请的审阅者提供。这些并不一定反映在小组讨论结束时审稿人的立场或小组的最终多数意见，尽管要求审阅者在讨论期间的立场是否改变，以修改其标准分数和批评。请注意，在达到最终的总体影响得分时，标准得分没有平均。如果审稿人在讨论后没有更改其标准分数，那么批评中所示的人可能会在会议前反映审稿人的意见。摘要声明的简历和其他初始部分是小组讨论最终结果的权威代表。如果审阅者的评论与本摘要声明面对面的优先级/影响分数之间存在任何差异，则应将优先/影响分数视为小组讨论最终结果的最准确表示。