Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial

项目总结 我们将定期评估旨在促进服药依从性的技术支持战略 监测方案的使用，并调动适当的移植中心资源以及早对肾脏做出反应 移植(KT)受者表现出不充分的依从性。用药不依从性是主要的 移植物失败的根本原因，KT接受者报告的粘附率最高(~35%) 所有器官移植受者。尽管进行了多次尝试，但很少有成功的干预措施得到评估 到目前为止，已经显著改善了KT接受者的方案依从性和随后的健康结果 随着时间的推移。使用我们研究团队先前对其他慢性疾病进行的广泛研究中的证据 在这种情况下，我们将实施并全面测试一种低成本、低接触，从而具有高度可扩展性的干预措施： 利用信息技术对肾移植患者移植方案的依从性(Take IT) 策略。Take IT策略利用移植中心基于网络的患者的电子健康记录 门户和移动技术：1)教育患者了解他们的处方Rx方案；2)帮助他们组织 他们的日常养生计划以最有效的方式进行，3)通过短信提醒他们何时服用 药物，4)常规监测方案的使用，5)提供护理警报，以联系适当的移植中心 临床工作人员(如药剂师、社会工作者、护士护理协调员)在检测到用药问题时。 Take IT战略的所有组成部分都是在NIH先前的支持下开发的，并通过用户输入进行了改进 (患者、家属、诊所工作人员)，并在非移植环境中测试其疗效。我们的主要目标是：1)测试 与常规护理相比，Take IT战略在改善KT接受者治疗方面的有效性 知识、用药情况、特定移植和慢性病结果。我们的次要目标是： 2)检查Take IT战略在两年内对新员工和 确定的KT接受者，3)评估随时间推移Take IT战略的每个组件的保真度，以及 调查任何患者、提供商或移植中心实施的障碍，并4)确定 从移植中心的角度提供Take IT战略。我们将进行双臂手术，病人- 在两个不同的大型移植中心(西北大学和梅奥诊所)进行的随机对照试验。300人 移植后3个月内接受KT的患者(“新”)和400名18至36岁的“已确诊”患者 在KT之后的几个月将被招募，并跟踪两年。面谈将在基线上进行， 6个月、12个月、18个月和24个月。电子健康和药房记录将被确定以获取药物 依从性和临床结果。此外，我们的团队将密切评估所有 从启动到两年跟踪的Take IT战略的组成部分。我们将进一步通知未来 通过估计实施和维持Take IT战略的增量成本来进行传播工作 从两个移植中心的角度来看。

PROJECT SUMMARY We will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant (KT) recipients demonstrating inadequate adherence. Medication non-adherence is a leading root cause of graft failure, and KT recipients have the highest reported rate of poor adherence (~35%) among all organ transplant recipients. Despite many attempts, there have been few successful interventions evaluated to date that have significantly improved KT recipients' regimen adherence and subsequent health outcomes over time. Using evidence from our research team's extensive previous studies in other chronic disease contexts, we will implement and comprehensively test a low cost, `low touch', thus highly scalable intervention: the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy. The TAKE IT strategy leverages a transplant center's electronic health record a web-based patient portal, and mobile technology to: 1) educate patients on their prescribed Rx regimens, 2) help them organize their daily regimen schedule in the most efficient manner, 3) remind them via SMS text when to take their medicine, 4) routinely monitor regimen use, and 5) provide care alerts to engage appropriate transplant center clinical staff (e.g. pharmacist, social worker, nurse care coordinator) when medication concerns are detected. All components of the TAKE IT strategy have been developed with prior NIH support, refined with `user' input (patient, family, clinic staff), and their efficacy tested in non-transplant settings. Our primary aim is to: 1) test the effectiveness of the TAKE IT strategy, compared to usual care, to improve KT recipients' treatment knowledge, medication use, transplant-specific and chronic disease outcomes. Our secondary aims are to: 2) examine the persistence of any effects of the TAKE IT strategy on outcomes over 2 years among new and established KT recipients, 3) evaluate the fidelity of each component of the TAKE IT strategy over time, and investigate any patient, provider, or transplant center barriers to implementation, and 4) determine the costs of delivering the TAKE IT strategy from a transplant center perspective. We will conduct a 2-arm, patient- randomized controlled trial at two large, diverse transplant centers (Northwestern University; Mayo Clinic). 300 KT recipients within 3 months of transplant (`de novo') and 400 `established' patients between 18 and 36 months post-KT will be recruited and followed for 2 years. In-person interviews will be conducted at baseline, 6, 12, 18 and 24 months. Electronic health and pharmacy records will be ascertained to capture medication adherence and clinical outcomes. Additionally, our team will closely evaluate the implementation of all components of the TAKE IT strategy from launch through 2 years follow-up. We will further inform future dissemination efforts by estimating the incremental costs of implementing and sustaining the TAKE IT strategy from the perspective of two transplant centers.