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

通过利用信息技术提高肾受者的移植方案依从性：TAKE IT 试验

• 批准号: 9906214
• 负责人: Daniela P Ladner
• 金额: $ 62.09万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-04 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906214
• 关键词: Address; Adherence; Adverse event; Affect; Blood Pressure; Care given by nurses; Caring; Chronic Disease; Clinic; Clinical; Complex; Disease; Disease Outcome; Electronic Health Record; Evaluation; Family; Future; Glycosylated hemoglobin A; Health; Health system; Healthcare Systems; Individual; Information Technology; Intervention; Interview; Kidney; Kidney Transplantation; Knowledge; LDL Cholesterol Lipoproteins; Living Donors; Longitudinal Studies; Medical Care Team; Medical Staff; Medicine; Modification; Monitor; Motivation; Nature; Online Systems; Organ Transplantation; Outcome; Patient Monitoring; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Plant Roots; Process; Provider; Public Health; Quality of life; Randomized Controlled Trials; Records; Regimen; Reporting; Research; Resources; Risk; Schedule; Site; Social Workers; Social support; Tacrolimus; Technology; Telephone Interviews; Testing; Text; Time; Touch sensation; Transplant Recipients; Transplantation; United States National Institutes of Health; Universities; arm; clinical center; compliance behavior; cost; design; effective therapy; effectiveness testing; efficacy testing; follow-up; graft failure; health service use; hospital readmission; improved; intervention effect; medication compliance; medication nonadherence; mobile computing; novel; patient portal; pill; post-transplant; recruit; side effect; successful intervention; transplant centers; treatment as usual

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.

项目摘要 我们将评估一项旨在促进药物依从性的技术支持的策略 监视使用方案，并动员适当的移植中心资源以提早回应肾脏 移植（KT）受体表现出依从性不足。药物不遵守是领先的 移植失败的根本原因和KT接受者的依从性率最高（〜35％） 所有器官移植受者。尽管有很多尝试，但很少有成功的干预措施 迄今为止，它们已大大改善了KT接受者的依从性和随后的健康成果 随着时间的推移。利用我们研究团队在其他慢性疾病方面进行的广泛研究 上下文，我们将实施并全面测试低成本，“低触摸”，从而高度可扩展的干预措施： 通过参与信息技术的肾脏接受者的移植方案依从性（接受） 战略。 TAKE IT策略利用了移植中心的电子健康记录 门户和移动技术至：1）对患者的处方RX方案进行教育，2）帮助他们组织 他们以最有效的方式进行的每日方案时间表，3）通过短信提醒他们 医学，4）常规监控方案使用，5）提供护理警报以接合适当的移植中心 临床人员（例如，当发现药物问题时，药剂师，社会工作者，护理护理协调员）。 IT Take IT策略的所有组件都是在事先支持的情况下开发的，并通过“用户”输入进行了完善 （患者，家庭，诊所人员）及其在非移植设置中测试的功效。我们的主要目的是：1）测试 与通常的护理相比，采用IT策略的有效性可以改善KT接受者的治疗 知识，药物使用，移植特异性和慢性疾病结局。我们的次要目标是： 2）检查采用IT策略对新和2年以上结果的持久性 建立的KT接收者，3）评估随着时间的推移，IT策略的每个组成部分的忠诚度，并评估 调查任何患者，提供者或移植中心实施的障碍，4）确定 从移植中心的角度实现采取IT策略。我们将进行2臂，患者 - 在两个大型，多样化的移植中心（西北大学；梅奥诊所）的随机对照试验。 300 KT接受者在移植后3个月内（从头'）和400名``已建立''患者在18至36岁之间 KT后几个月将被招募并遵循2年。面对面访谈将在基线进行 6、12、18和24个月。将确定电子健康和药房记录以捕获药物 依从性和临床结果。此外，我们的团队将密切评估所有人的实施 从发射到2年的随访。我们将进一步告知未来 通过估计实施和维持IT战略的增量成本来传播努力 从两个移植中心的角度来看。

项目成果

A Multifaceted Intervention to Improve Medication Adherence in Kidney Transplant Recipients: An Exploratory Analysis of the Fidelity of the TAKE IT Trial.

• DOI: 10.2196/27277
• 发表时间: 2022-05-05
• 期刊: JMIR FORMATIVE RESEARCH
• 影响因子: 2.2
• 作者: Yoon, Esther S.;Hur, Scott;Curtis, Laura M.;Wynia, Aiden H.;Zheng, Pauline;Nair, Sumi S.;Bailey, Stacy C.;Serper, Marina;Reese, Peter P.;Ladner, Daniela P.;Wolf, Michael S.
• 通讯作者: Wolf, Michael S.