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

项目总结 与高加索人相比，非裔美国人(AA)肾移植接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获得移植的机会略有改善，但肾脏移植 今天，与高加索人相比，再生障碍性贫血接受者的作用时间大约是一半。我们的形成性研究 表明在当代肾移植受者中，几个移植后晚期(≥2年)的临床标记物， 包括急性排斥反应、他克莫司低谷变异性以及高血压和糖尿病的次优控制 可以解释氨基酸之间的差异。我们完成了一项60名患者的前瞻性干预性先导研究 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。 这项研究表明，AAS患者在高血压控制方面的临床改善更为显著。我们 还完成了两项随机对照试验，证明实时服药依从性监测 是可行的，并且在肾移植受者中被高度接受。这演示了基于技术的自动化 药物监测系统是识别和预防晚期用药不依从性的一种有前途的干预措施， 从而降低他克莫司的高变异性和晚期排斥反应的风险。基于这项形成性研究，我们 建议进行多方面的干预以改善非裔美国人的移植物结局差异 肾移植(MITIGAAT)研究。MITIGAAT的首要假设是，增加的负担 AA肾移植受者的晚期临床事件和共病负担是主要因素 移植物存活率的差异和多模式干预，以实现更好的识别和 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 对肾移植受者进行大规模、长期、前瞻性、随机、对照的临床试验 目的是证明改善他克莫司谷的可变性和高血压和糖尿病的控制 与对照组相比，随机分配到干预组，同时减少AAs的差异。我们的 第二个目标是进行成本效益分析，以证明干预降低了医疗保健 使用率和相关成本；我们的探索性目标是衡量急性排斥反应和移植物丢失的发生率 在AA肾接受者中，将这一点在干预组和对照组之间进行比较。这一行动的持久目标是 建议是展示一种有效、高效和可行的部署方法，以改善长期结果 在减少健康差距的同时，AA肾移植受者的健康状况也得到了改善。

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.