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: 8477034
• 负责人: Daniela P Ladner
• 金额: $ 59.49万
• 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/8477034
• 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; Deep Vein Thrombosis; Development; Effectiveness; Embolism; Event; 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; Postoperative Hemorrhage; Prevention; Procedures; Process; Protocols documentation; 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; 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.

描述（由申请人提供）：医疗保险和医疗补助服务中心越来越注重提高医疗保健安全和质量，同时降低成本，并采取了不再向医院报销治疗指定可预防住院并发症的费用的政策。活体肝移植（LDLT）涉及复杂的系统和护理过程，特别容易出现医疗错误和可预防的并发症。事实上，LDLT 捐献者和接受者的并发症发生率分别为 20-30% 和 75%，其中 70% 被认为是可以预防的。有效消除 LDLT 可预防的并发症需要仔细关注 LDLT 捐献者和接受者护理系统和流程中的脆弱性。在照顾活体捐赠者时，预防此类事件尤其重要，因为他们是健康的志愿者，纯粹出于利他原因而接受重大手术，没有任何直接利益。鉴于今年早些时候美国发生的两起 LDLT 捐献者死亡事件，捐献者安全的重要性更加凸显。在减少医疗差错和可预防并发症方面已经取得了相当大的进步。在移植领域，新的方案（例如用于确认供体和受体之间 ABO 兼容性的方案）非常有效。本研究建议将在其他高风险行业成功使用并适用于医疗保健的主动、系统和综合方法应用于 LDLT 系统和护理流程。主动、系统和全面地识别潜在漏洞将有助于开发和实施旨在减轻这些漏洞的解决方案，从而减少 LDLT 中的医疗错误和可预防的并发症。这项研究将建立在成人至成人活体肝移植队列研究 (A2ALL) 的巨大优势之上，作为 A2ALL 联盟的辅助研究。 A2ALL 认识到提供安全可靠的 LDLT 护理的重要性，并将捐赠者安全作为次要目标，并全力支持这项研究。 9 个 A2ALL 中心中的 7 个将作为干预中心或控制中心参与本研究，因此占美国所有 LDLT 的 50% 以上。这项研究具有新颖性和创新性，因为它试图将医疗错误的应对范式转变为主动评估和改进系统和流程的安全性的方法，以防止活体肝移植 (LDLT) 中的医疗错误发生。本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 安全性的新的重要信息。 LDLT 提供了一个绝佳的机会来全面评估医疗错误和可预防并发症的机制，因为捐赠者合并症造成混淆的风险很小。