Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant: The TEST Trial

项目总结 在过去的两年中，美国的肝硬变和终末期肝病(ESLD)的患病率几乎翻了一番 几十年。肝移植(LT)是ESLD的唯一挽救生命的选择，预计到2040年将增加23%。 它需要相当多的医疗资源，每年花费美国医疗系统267亿美元。它是 在老年人中的表现越来越好；从2006年到2018年，65岁及以上的成年人增长最快 移植等待名单上的年龄组。到2019年，70%的LTR是50岁及以上的成年人。随着技术的进步 随着免疫抑制(IS)和外科技术的发展，肝移植术后5年的平均存活率已超过70%。然而， 维持最佳的、长期的肝移植功能和整体健康取决于适当地遵守 处方药。这可能是困难的，因为肝移植接受者(Ltrs)要与高方案作斗争。 复杂性，平均服用11种有副作用并需要频繁改变剂量的新药。 由于移植前肝性脑病或其他原因，许多肝移植受体有挥之不去的认知障碍。 心理社会、经济或文化因素都会影响坚持治疗的能力。结果，三分之一的人 表明对IS方案的依从性不足。粘附性差是肝移植的主要原因 排斥反应、肝功能衰竭、控制不佳的医疗合并症和随后的死亡率。同样，也不充分 药物知识和无意误用与移植后住院有关。尽管 不充分遵守的负面和代价高昂的后果，几乎没有前瞻性的干预措施 开发和测试以优化LT术后的服药行为和后续结果。然而， 在LT的背景下有一些独特的考虑因素，可以通过干预措施加以利用：1)LTRs仍然存在 无限期地连接到移植中心，利用一系列可用的资源进行跟进；护士协调员， 药剂师，心理和社会服务；2)有资格接受LT的患者必须有照顾者参与 提供肝移植术后支持(迄今还没有涉及照顾者的干预措施)。我们的主要目标是测试 提高治疗依从性和优化治疗的技术支持干预(测试试验)的有效性 3种不同移植方案的360例新移植受者的以患者为中心的临床结果 在宾夕法尼亚州费城、伊利诺伊州芝加哥和佛罗里达州迈阿密。我们的干预利用了现有的移植中心资源， 护理者支持，以及广泛可用的以患者为中心的移动医疗工具，用于远程监控LTRS 依从性行为、“表型”依从性问题，以及移植中心对此的反应 担忧。我们还计划评估干预的保真度，使我们能够评估患者、护理者和提供者 以及卫生系统障碍，以提高可伸缩性的最佳实施。最后，我们将确定成本 以及从移植中心和医疗保健部门的角度进行干预的成本效益。这个测试 审判将能够及时确定LTR遵守障碍的存在和性质，并动员 移植中心和护理人员通过利用现有资源来优化健康，部署量身定制的解决方案。

PROJECT SUMMARY The prevalence of cirrhosis and end-stage liver disease (ESLD) in the U.S. has nearly doubled over the past two decades. Liver transplant (LT) is the only life-saving option for ESLD and is projected to increase 23% by 2040. LT requires considerable healthcare resources, costing the U.S. health system $26.7 billion annually. It is increasingly performed among older adults; from 2006 to 2018, adults 65 and older were the most rapidly growing age group on transplant waitlists. By 2019, 70% of LTRs were adults 50 and older. With advances in immunosuppression (IS) and surgical techniques, average 5-year post-LT survival now exceeds 70%. However, maintaining optimal, long-term liver graft function and overall health are contingent upon proper adherence to prescribed treatment. This can be difficult, as liver transplant recipients (LTRs) contend with high regimen complexity, taking on average 11 new medications that have side effects and require frequent dosage changes. Many LTRs have lingering cognitive impairments due to pre-transplant hepatic encephalopathy, or other psychosocial, financial, or cultural factors that all can affect the ability to adhere to treatment. As a result, a third of LTRs demonstrate inadequate adherence to IS regimens. Poor adherence is a leading cause of liver graft rejection, liver failure, poorly controlled medical comorbidities and subsequent mortality. Similarly, inadequate medication knowledge and unintentional misuse are associated with post-transplant hospitalizations. Despite the negative and costly consequences of inadequate adherence, very few prospective interventions have been developed and tested to optimize medication-taking behaviors and subsequent outcomes post-LT. However, there are unique considerations within the context of LT that can be leveraged by interventions: 1) LTRs remain indefinitely connected to transplant centers for follow-up with a range of available resources; nurse coordinators, pharmacists, psychological and social services; 2) to be eligible for LT, patients must have involved caregivers to provide post-LT support (yet no interventions to date have involved caregivers). Our primary aim is to test the effectiveness of a technology-enabled intervention (TEST trial) to improve treatment adherence and optimize patient-centered and clinical outcomes among a cohort of 360 de novo LTRs at 3 diverse transplant programs in Philadelphia, PA, Chicago, IL, and Miami, FL. Our intervention leverages existing transplant center resources, caregiver support, and widely available patient-centered mobile health tools to remotely monitor LTRs' adherence behaviors, `phenotype' adherence concerns, and tailor transplant center responses to those concerns. We additionally plan to assess intervention fidelity, enabling us to evaluate patient, caregiver, provider and health-system barriers to optimal implementation to enhance scalability. Finally, we will determine the costs and cost-effectiveness of the intervention from a transplant center and healthcare sector perspective. The TEST trial will enable the timely identification of the presence and nature of LTR adherence barriers and mobilize transplant centers and caregivers to deploy tailored solutions by leveraging existing resources to optimize health.