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减少肾移植可及性差异区域研究:美国东南部的一项随机试验

Reducing Disparities in Access to Kidney Transplantation Regional Study: A Randomized Trial in the Southeastern United States.

作者信息

Patzer Rachel E, Buford Jade, Urbanski Megan, McPherson Laura, Paul Sudeshna, Di Mengyu, Harding Jessica L, Katz-Greenberg Goni, Rossi Ana, Anand Prince Mohan, Reeves-Daniel Amber, Jones Heather, Mulloy Laura, Pastan Stephen O

机构信息

Department of Surgery, Indiana University School of Medicine, Indianapolis, Indiana.

Regenstrief Institute, Indianapolis, Indiana.

出版信息

Clin J Am Soc Nephrol. 2024 Dec 13;20(2):256-66. doi: 10.2215/CJN.0000000586.

Abstract

KEY POINTS

Declines in referral mirror national trends; however, declines were less for some groups receiving the intervention, warranting long-term follow-up. The findings provide important context for future modification and scale-up of multilevel, multicomponent interventions in dialysis settings.

BACKGROUND

The Southeastern United States has among the lowest rates of kidney transplantation nationally and has documented racial and socioeconomic disparities in transplant access. We assessed the effectiveness and implementation of a multicomponent intervention aimed at increasing access and reducing disparities in access to early transplant steps in Georgia, North Carolina, and South Carolina.

METHODS

The Reducing Disparities in Access to Kidney Transplantation Regional Study randomized 440 dialysis facilities in Georgia, North Carolina, and South Carolina to receive the Reducing Disparities in Access to Kidney Transplantation Regional educational and quality intervention or standard of care in 2018. The primary outcome was a change in dialysis facility–level transplant referral within 1 year of dialysis start after intervention, with secondary outcomes examining changes in evaluation start within 6 months of referral and waitlisting within 1 year of evaluation start. A process evaluation included a postimplementation survey (=220) and semistructured interviews of staff (=4). Generalized linear mixed-effects models assessed intervention effectiveness overall and in race subgroups.

RESULTS

Among the 25,586 patients with ESKD treated in 440 dialysis facilities, referral rates decreased across both intervention arms 1 year after intervention; however, a greater decrease in referrals was observed among control (11.2% to 9.2%) versus intervention (11.2% to 10.5%) facilities. We observed no significant difference in the likelihood of referral among Black patients in intervention versus control facilities after intervention (adjusted odds ratio, 1.12; 95% confidence interval, 0.94 to 1.33); however, a significant increase in referral was observed among White patients in intervention facilities after intervention (odds ratio, 1.24; 95% confidence interval, 1.02 to 1.51). Interviews highlighted the importance of tailored interventions, federal mandates, and implementation challenges for large pragmatic trials.

CONCLUSIONS

Postintervention declines in referral mirror national trends; however, these declines were less for some groups receiving the intervention, warranting long-term follow-up. These findings provide important context for future modification and scale-up of multilevel, multicomponent interventions in dialysis settings.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

: The study protocol is available on ClinicalTrials.gov (identifier: NCT02389387).

摘要

关键点

转诊率的下降反映了全国趋势;然而,对于一些接受干预的群体,下降幅度较小,需要进行长期随访。这些发现为未来在透析环境中调整和扩大多层次、多成分干预措施提供了重要背景。

背景

美国东南部的肾脏移植率在全国处于最低水平,并且在移植机会方面存在种族和社会经济差异。我们评估了一项多成分干预措施在佐治亚州、北卡罗来纳州和南卡罗来纳州增加早期移植步骤的获取机会并减少获取差异方面的有效性和实施情况。

方法

“减少肾脏移植获取差异区域研究”于2018年将佐治亚州、北卡罗来纳州和南卡罗来纳州的440个透析设施随机分为接受“减少肾脏移植获取差异区域教育与质量干预”或标准治疗组。主要结局是干预后透析开始1年内透析设施层面移植转诊的变化,次要结局是检查转诊后6个月内评估开始的变化以及评估开始后1年内列入等待名单的变化。过程评估包括实施后调查(n = 220)和对工作人员的半结构化访谈(n = 4)。广义线性混合效应模型评估了总体及种族亚组中的干预效果。

结果

在440个透析设施中接受治疗的松25586例终末期肾病患者中,干预1年后两个干预组的转诊率均下降;然而,与干预组(从11.2%降至10.5%)相比,对照组(从11.2%降至9.2%)的转诊下降幅度更大。干预后,我们观察到干预设施与对照设施中黑人患者的转诊可能性无显著差异(调整优势比,1.12;95%置信区间,0.94至1.33);然而,干预设施中白人患者干预后的转诊显著增加(优势比,1.24;95%置信区间,1.02至1.51)。访谈强调了量身定制的干预措施、联邦指令以及大型实用试验实施挑战的重要性。

结论

干预后转诊率的下降反映了全国趋势;然而,对于一些接受干预的群体,这些下降幅度较小,需要进行长期随访。这些发现为未来在透析环境中调整和扩大多层次、多成分干预措施提供了重要背景。

临床试验注册名称和注册号

该研究方案可在ClinicalTrials.gov上获取(标识符:NCT02389387)。

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