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: 9309767
• 负责人: Daniela P Ladner
• 金额: $ 66.84万
• 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 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9309767
• 关键词: Address; Adherence; Adverse effects; Adverse event; Affect; Blood Pressure; Care given by nurses; Caring; Chronic Disease; Clinic; Clinical; Complex; Disease Outcome; Effectiveness; Electronic Health Record; Evaluation; Family; Future; Glycosylated hemoglobin A; Health; Health system; Healthcare Systems; Hospitalization; 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; Recruitment Activity; 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; compliance behavior; cost; design; effective therapy; efficacy testing; follow-up; graft failure; health service use; improved; intervention effect; medication compliance; mobile computing; novel; pill; successful intervention; 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策略， 监测方案的使用，并动员适当的移植中心资源，以尽早对肾脏 移植（KT）接受者表现出不充分的依从性。药物不依从是一个主要的 移植失败的根本原因，KT受体的粘附性差报告率最高（约35%）， 所有的器官移植接受者尽管进行了许多尝试，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 随着时间利用我们研究小组以前在其他慢性疾病中广泛研究的证据， 在这种情况下，我们将实施并全面测试一种低成本、“低接触”、因而可高度扩展的干预措施： 通过参与信息技术（TAKE IT）提高肾移植受者的移植方案依从性 战略TAKE IT战略利用移植中心的电子健康记录， 门户网站和移动的技术，以：1）教育患者关于其处方的Rx方案，2）帮助他们组织 以最有效的方式，他们的日常养生计划，3）通过短信提醒他们何时采取他们的 药物，4）常规监测方案的使用，以及5）提供护理警报，以吸引适当的移植中心 当检测到药物问题时，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的支持下开发的，并根据“用户”输入进行了改进 （患者、家庭、诊所工作人员），并在非移植环境中测试其功效。我们的主要目标是：1）测试 与常规护理相比，采取IT策略改善KT接受者治疗的有效性 知识、药物使用、移植特异性和慢性疾病结果。我们的次要目标是： 2)检查在新的和新的两年内， 确定的KT接受者，3）随着时间的推移，评估TAKE IT战略的每个组成部分的保真度，以及 调查任何患者，提供者或移植中心的实施障碍，以及4）确定 从移植中心的角度提供Take IT战略。我们将进行一个双臂，病人- 在两个大型的不同移植中心（西北大学;马约诊所）进行的随机对照试验。300 移植后3个月内的KT接受者（“新生”）和400名18至36岁的“已确定”患者 将招募KT后3个月的受试者，并随访2年。将在基线时进行面对面访谈， 6、12、18和24个月。电子健康和药房记录将被确定，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 从发布到2年随访期间，Take IT战略的组成部分。我们将进一步通知未来 通过估算实施和维持“采取IT”战略的增量成本， 从两个移植中心的角度来看。