改善非裔美国人肾移植移植结果差异的多方面干预(MITIGAAT 研究):随机对照试验协议》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-10 DOI:10.2196/57784
Morgan Overstreet, Hannah Culpepper, Deanna DeHoff, Mulugeta Gebregziabher, Maria Aurora Posadas Salas, Zemin Su, Jessica Chandler, Felicia Bartlett, Paige Dunton, Taylor Carcella, David Taber
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引用次数: 0

摘要

背景:非裔美国人肾移植受者的结果差异是一个公共卫生问题,自移植领域成立以来一直困扰着该领域。根据国家数据,与白人受者相比,非裔美国人受者在移植后 5 年的移植物损失风险几乎是白人受者的两倍。有证据表明,不坚持用药和他克莫司的高变异性会严重影响移植结果和种族差异,尤其是在移植后晚期(>2 年)。不坚持用药是造成移植物损失的主要原因。前瞻性多中心数据显示,三分之一的移植物损失直接归因于不依从性。我们花了 10 年时间进行重点研究,建立了一个全面的模型来解释导致非裔美国人肾脏受者差异的主要风险因素。然而,患者层面的数据仍然存在缺口,这阻碍了我们对差异的深入理解。缺乏来自患者的数据往往会导致提供者的偏见,而这项干预措施将解决这一问题。在药物治疗管理方面,由药剂师主导的文化胜任型干预措施也将解决治疗惰性问题。药剂师的干预还将减少药物获取障碍(费用和保险拒绝)。因此,这一多维干预措施可解决导致非裔美国肾脏接受者种族差异的患者、提供者和结构性因素:这项前瞻性随机对照试验旨在确定多模式医疗服务干预对非裔美国人肾移植受者健康结果差异的影响。这项研究的目的是通过技术驱动、远程医疗提供的四级干预措施,改善肾移植受者对后期临床问题的依从性和控制,这些问题是造成种族差异的主要因素:MITIGAAT 是一项为期 24 个月的双臂、单中心(南卡罗来纳医科大学)、1:1 随机对照试验,共有 190 名参与者(每臂 95 人)参加,目的是通过技术辅助、远程医疗、4 级干预,衡量对肾脏受者的依从性和后期临床问题控制的影响,这些问题是造成肾脏受者种族差异的主要因素。这项研究的关键临床问题包括他克莫司的变异性、血压和血糖控制(糖尿病患者)。我们还将评估干预措施对医疗服务使用(住院和急诊就诊)的影响,并进行成本效益分析。最后,我们还将评估干预措施对急性排斥反应和移植物存活率的影响,并将其与当代大型国家队列进行比较:本研究于 2023 年 7 月获得资助。2024 年 4 月开始入组,预计 2026 年完成。所有患者将于 2028 年底完成研究:在本协议中,我们描述了正在进行的 MITIGAAT 临床试验中将使用的研究设计、方法、目的和结果测量:试验注册:ClinicalTrials.gov NCT06023615;https://www.clinicaltrials.gov/study/NCT06023615.International 注册报告标识符(irrid):PRR1-10.2196/57784。
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Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT Study): Protocol for a Randomized Controlled Trial.

Background: The outcome disparities for African American recipients of kidney transplant is a public health issue that has plagued the field of transplant since its inception. Based on national data, African American recipients have nearly twice the risk of graft loss at 5 years after transplant, when compared with White recipients. Evidence demonstrates that medication nonadherence and high tacrolimus variability substantially impact graft outcomes and racial disparities, most notably late (>2 years) after the transplant. Nonadherence is a leading cause of graft loss. Prospective multicenter data demonstrate that one-third of all graft loss are directly attributed to nonadherence. We have spent 10 years of focused research to develop a comprehensive model explaining the predominant risk factors leading to disparities in African American kidney recipients. However, there are still gaps in patient-level data that hinder the deeper understanding of the disparities. Lack of data from the patient often lead to provider biases, which will be addressed with this intervention. Culturally competent, pharmacist-led interventions in medication therapy management will also address therapeutic inertia. Pharmacist interventions will mitigate medication access barriers as well (cost and insurance denials). Thus, this multidimensional intervention addresses patient, provider, and structural factors that drive racial disparities in African American kidney recipients.

Objective: This prospective, randomized controlled trial aimed to determine the impact of multimodal health services intervention on health outcomes disparities in African American recipients of kidney transplant. The aims of this study are to improve adherence and control of late clinical issues, which are predominant factors for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered, 4-level intervention.

Methods: The Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT) study is a 24-month, 2-arm, single-center (Medical University of South Carolina), 1:1 randomized controlled trial involving 190 participants (95 in each arm), measuring the impact on adherence and control of late clinical issues for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered, 4-level intervention. The key clinical issues for this study include tacrolimus variability, blood pressure, and glucose control (in those with diabetes mellitus). We will also assess the impact of the intervention on health care use (hospitalizations and emergency department visits) and conduct a cost-benefit analysis. Finally, we will assess the impact of the intervention on acute rejection and graft survival rates as compared with a large contemporary national cohort.

Results: This study was funded in July 2023. Enrolled began in April 2024 and is expected to be complete in 2026. All patients will complete the study by the end of 2028.

Conclusions: In this protocol, we describe the study design, methods, aims, and outcome measures that will be used in the ongoing MITIGAAT clinical trials.

Trial registration: ClinicalTrials.gov NCT06023615; https://www.clinicaltrials.gov/study/NCT06023615.

International registered report identifier (irrid): PRR1-10.2196/57784.

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