McDonough School of Business, Georgetown University, Washington, DC.
Department of Economics, Stanford University, Stanford, California.
JAMA Health Forum. 2022 Oct 7;3(10):e223503. doi: 10.1001/jamahealthforum.2022.3503.
Home dialysis rates for end-stage kidney disease (ESKD) treatment are substantially lower in the US than in other high-income countries, yet there is limited knowledge on how to increase these rates.
To report results from the first year of a nationwide randomized clinical trial that provides financial incentives to ESKD facilities and managing clinicians to increase home dialysis rates.
DESIGN, SETTING, AND PARTICIPANTS: Results were analyzed from the first year of the End-Stage Renal Disease Treatment Choice (ETC) model, a multiyear, mandatory-participation randomized clinical trial designed and implemented by the US Center for Medicare & Medicaid Innovation. Data were reported on Medicare patients with ESKD 66 years or older who initiated treatment with dialysis in 2021, with data collection through December 31, 2021; the study included all eligible ESKD facilities and managing clinicians. Eligible hospital referral regions (HRRs) were randomly assigned to the ETC (91 HRRs) or a control group (211 HRRs).
The ESKD facilities and managing clinicians received financial incentives for home dialysis use.
The primary outcome was the percentage of patients with ESKD who received any home dialysis during the first 90 days of treatment. Secondary outcomes included other measures of home dialysis and patient volume and characteristics.
Among the 302 HRRs eligible for randomization, 18 621 eligible patients initiated dialysis treatment during the study period (mean [SD] age, 74.8 [1.05] years; 7856 women [42.1%]; 10 765 men [57.9%]; 859 Asian [5.2%], 3280 [17.7%] Black, 730 [4.3%] Hispanic, 239 North American Native, and 12 394 managing clinicians. The mean (SD) share of patients with any home dialysis during the first 90 days was 20.6% (7.8%) in the control group and was 0.12 percentage points higher (95% CI, -1.42 to 1.65 percentage points; P = .88) in the ETC group, a statistically nonsignificant difference. None of the secondary outcomes differed significantly between groups.
The trial results found that in the first year of the US Center for Medicare & Medicaid Innovation-designed ETC model, HRRs assigned to the model did not have statistically significantly different rates in home dialysis compared with control HRRs. This raises questions about the efficacy of the financial incentives provided, although further evaluation is needed, as the size of these incentives will increase in subsequent years.
ClinicalTrials.gov Identifier: NCT05005572.
美国终末期肾病（ESKD）治疗的家庭透析率明显低于其他高收入国家，但对于如何提高这些比率知之甚少。
报告全国性随机临床试验第一年的结果，该试验向 ESKD 医疗机构和管理临床医生提供经济激励，以提高家庭透析率。
设计、环境和参与者：分析了美国医疗保险和医疗补助创新中心设计和实施的多年度强制性参与的随机临床试验“终末期肾病治疗选择（ETC）模型”的第一年结果。数据来自于 2021 年开始透析治疗的 66 岁或以上有 ESKD 的 Medicare 患者，数据收集截至 2021 年 12 月 31 日；该研究包括所有符合条件的 ESKD 医疗机构和管理临床医生。符合条件的医院转介区域（HRR）被随机分配到 ETC（91 个 HRR）或对照组（211 个 HRR）。
ESKD 医疗机构和管理临床医生获得家庭透析使用的经济激励。
主要结果是在治疗的前 90 天内接受任何家庭透析的 ESKD 患者比例。次要结果包括家庭透析和患者数量和特征的其他措施。
在符合随机分组条件的 302 个 HRR 中，18621 名符合条件的患者在研究期间开始透析治疗（平均[标准差]年龄，74.8[1.05]岁；7856 名女性[42.1%]；10765 名男性[57.9%]；859 名亚裔[5.2%]，3280 名黑人[17.7%]，730 名西班牙裔[4.3%]，239 名北美原住民，12394 名管理临床医生。在对照组中，有任何家庭透析的患者在前 90 天的比例为 20.6%（7.8%），ETC 组高 0.12 个百分点（95%CI，-1.42 至 1.65 个百分点；P=0.88），差异无统计学意义。组间无其他次要结果存在显著差异。
试验结果发现，在由美国医疗保险和医疗补助创新中心设计的 ETC 模型的第一年中，被分配到模型的 HRR 与对照组 HRR 相比，家庭透析率没有统计学上的显著差异。这对所提供的经济激励的效果提出了质疑，尽管需要进一步评估，因为随后几年这些激励措施的规模将会增加。
ClinicalTrials.gov 标识符：NCT05005572。
