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.

项目概要 我们将定期评估旨在促进药物依从性的技术支持策略 监测治疗方案的使用，并调动适当的移植中心资源，对肾脏病尽早做出反应 移植（KT）接受者表现出依从性不足。不依从用药是一个主要原因 移植失败的根本原因，KT 受者的依从性差的比例最高 (~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被评估 迄今为止，已显着改善 KT 接受者的治疗依从性和随后的健康结果 随着时间的推移。利用我们研究团队之前对其他慢性疾病进行的广泛研究的证据 在这种情况下，我们将实施并全面测试低成本、“低接触”、因此高度可扩展的干预措施： 通过使用信息技术（TAKE IT）提高肾受者的移植方案依从性 战略。 TAKE IT 策略利用移植中心的电子健康记录和基于网络的患者 门户网站和移动技术：1) 教育患者了解处方治疗方案，2) 帮助他们组织 以最有效的方式安排他们的日常养生计划，3）通过短信提醒他们何时服用 药物，4) 定期监测治疗方案的使用，以及 5) 提供护理警报以联系适当的移植中心 当发现药物问题时通知临床工作人员（例如药剂师、社会工作者、护士护理协调员）。 TAKE IT 策略的所有组成部分都是在 NIH 的先前支持下开发的，并根据“用户”输入进行了完善 （患者、家属、诊所工作人员）及其在非移植环境中测试的功效。我们的主要目标是：1）测试 与常规护理相比，TAKE IT 策略在改善 KT 接受者治疗方面的有效性 知识、药物使用、移植特异性和慢性病结果。我们的次要目标是： 2) 检查 TAKE IT 策略对新员工和新员工 2 年内结果的持续影响 已建立的 KT 接收者，3) 评估 TAKE IT 策略每个组成部分随着时间的推移的忠诚度，以及 调查任何患者、提供者或移植中心实施的障碍，以及 4) 确定成本 从移植中心的角度实施 TAKE IT 策略。我们将进行 2 臂、病人- 在两个大型、不同的移植中心（西北大学；梅奥诊所）进行的随机对照试验。 300 移植后 3 个月内的 KT 接受者（“从头”）和 400 名 18 岁至 36 岁之间的“既定”患者 KT 后几个月将被招募并跟踪 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的实施情况 TAKE IT 战略从启动到两年后续的各个组成部分。未来我们将进一步告知 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。

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.