Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)

多方面干预以改善非裔美国人肾脏移植的移植结果差异 (MITIGAAT)

• 批准号: 10729237
• 负责人: David J. Taber
• 金额: $ 61.91万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10729237
• 关键词: Acute; Address; Adherence; African American; Blood Glucose; Blood Pressure; Caring; Caucasians; Cessation of life; Clinical; Clinical Markers; Clinical Trials; Competence; Cost Savings; Cost-Benefit Analysis; Coupled; Data; Diabetes Mellitus; Disparity; Dropout; Emergency department visit; Event; Goals; Graft Survival; Health Services; Health Services Accessibility; Hospitalization; Hypertension; Immunologics; Immunosuppression; Improve Access; Incidence; Intervention; Investments; Kidney; Kidney Transplantation; Measures; Medication Management; Methods; Mobile Health Application; Modeling; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Outcome; Participant; Patients; Pharmaceutical Preparations; Pharmacists; Pilot Projects; Policies; Population; Public Health; Public Health Informatics; Randomized; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Reduce health disparities; Research; Risk; Self Determination; System; Tacrolimus; Technology; Testing; Therapeutic; Time; Transplant Recipients; Transplantation; United States Agency for Healthcare Research and Quality; Veterans; arm; biomedical informatics; blood glucose regulation; blood pressure control; cohort; comorbidity; comparison control; cost; design; diabetes control; disparity reduction; economic evaluation; health care service utilization; health disparity; health outcome disparity; high risk population; hospital readmission; hypertension control; improved; mHealth; medication compliance; medication nonadherence; motivational enhancement therapy; multi-component intervention; multidisciplinary; organ allocation; outcome disparities; post-transplant; prevent; prospective; racial bias; racial disparity; racial health disparity; randomized, clinical trials; remote patient monitoring; service intervention; stem; telehealth; televisit; theories; treatment arm

PROJECT SUMMARY Compared to Caucasians, African American (AA) kidney transplant recipients have twice the risk of graft loss. Despite recent studies demonstrating marginal improvements in access to transplant, a kidney transplanted today functions about half as long in AA recipients as compared to Caucasians. Our formative research demonstrates that in contemporary kidney recipients, several late (≥2 years) post-transplant clinical markers, including acute rejection, high tacrolimus trough variability and sub-optimal control of hypertension and diabetes can explain disparities in AAs. We completed a 60 patient prospective interventional pilot study demonstrating significant improvements in the control of hypertension and diabetes through a technology-enabled intervention. This study demonstrated that clinical improvements in hypertension control were more substantial in AAs. We also completed two randomized controlled trials demonstrating that real-time medication adherence monitoring is feasible and highly accepted within kidney recipients. This demonstrates a technology-based automated medication monitoring system is a promising intervention to identify and prevent late medication non-adherence, thus reducing high tacrolimus variability and the risk of late rejection. Based on this formative research, we propose to conduct the Multifaceted Intervention to Improve Graft outcome disparities in African American Kidney Transplants (MITIGAAT) study. The overarching hypothesis for MITIGAAT is that the increased burden of late clinical events and comorbidity burden within AA kidney transplant recipients are the primary contributor to disparities in graft survival and a multimodal intervention that achieves improved identification and management of these issues will address this disparity. We will test this hypothesis through a rigorously conducted large-scale, long-term, prospective, randomized, controlled clinical trial in kidney transplant recipients aiming to demonstrate improved tacrolimus trough variability and control of hypertension and diabetes in those randomized to the intervention arm, as compared to the control arm while reducing disparities in AAs. Our secondary aim is to conduct a cost benefit analysis to demonstrate that the intervention reduces healthcare utilization and associated costs; our exploratory aim is to measure the incidence of acute rejection and graft loss in AA kidney recipients, comparing this between the intervention and a control cohort. The enduring goal of this proposal is to demonstrate an effective, efficient, and feasibly deployable method to improve long-term outcomes in AA kidney recipients while reducing health disparities.

项目摘要 与白人相比，非裔美国人（AA）肾移植受者的移植物丢失风险是白人的两倍。 尽管最近的研究表明，在获得移植，肾脏移植边际改善， 今天，AA接受者的功能时间约为白人的一半。我们的形成性研究 表明在当代肾脏接受者中，几种晚期（≥2年）移植后临床标志物， 包括急性排斥反应、他克莫司谷值变异性高以及高血压和糖尿病控制欠佳 可以解释AA的差异。我们完成了一项60例患者的前瞻性干预性初步研究， 通过技术支持的干预措施，显著改善高血压和糖尿病的控制。 本研究表明，AA组高血压控制的临床改善更为显著。我们 还完成了两项随机对照试验，证明实时药物依从性监测 是可行的，并且在肾接受者中被高度接受。这表明了一种基于技术的自动化 药物监测系统是识别和防止晚期药物不依从性的有希望的干预， 从而降低他克莫司的高变异性和晚期排斥的风险。基于这种研究，我们 建议进行多方面干预，以改善非裔美国人的移植结果差异 肾移植（MITIGAAT）研究。MITIGAAT的首要假设是， AA肾移植受者的晚期临床事件和合并症负担是主要原因 移植物存活率的差异和多模式干预， 对这些问题的管理将解决这一差距。我们将通过一个严格的 在肾移植受者中进行了大规模、长期、前瞻性、随机、对照临床试验 目的是证明他克莫司谷值变异性的改善和高血压和糖尿病的控制， 与对照组相比，随机分配至干预组，同时减少AA的差异。我们 第二个目的是进行成本效益分析，以证明干预措施减少了医疗保健 利用率和相关成本;我们的探索性目的是测量急性排斥反应和移植物丢失的发生率 在AA肾接受者中，比较干预组和对照组之间的差异。这个持久的目标 该提案旨在展示一种有效、高效和可行的方法，以改善长期结果 同时减少健康差距。