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Registration

Field Before After
Trial Status in_development completed
Trial End Date June 30, 2027 December 31, 2021
Last Published August 09, 2021 05:44 PM October 31, 2022 01:38 PM
Study Withdrawn No
Intervention Completion Date December 31, 2021
Data Collection Complete Yes
Final Sample Size: Number of Clusters (Unit of Randomization) 302 HRRs
Was attrition correlated with treatment status? No
Final Sample Size: Total Number of Observations 18,621 patients
Final Sample Size (or Number of Clusters) by Treatment Arms 91 HRRs - treatment 211 HRRs - control
Is there a restricted access data set available on request? Yes
Program Files Yes
Program Files URL https://www.dropbox.com/s/higurdldzw6unem/ETC%20Replication.zip?dl=0
Data Collection Completion Date December 31, 2021
Is data available for public use? No
Intervention End Date June 30, 2026 December 31, 2021
Building on Existing Work Yes
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Papers

Field Before After
Paper Abstract Importance: 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. Objective: 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). Interventions: The ESKD facilities and managing clinicians received financial incentives for home dialysis use. Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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.
Paper Citation Ji Y, Einav L, Mahoney N, Finkelstein A. Financial Incentives to Facilities and Clinicians Treating Patients With End-stage Kidney Disease and Use of Home Dialysis: A Randomized Clinical Trial. JAMA Health Forum. 2022;3(10):e223503. doi:10.1001/jamahealthforum.2022.3503
Paper URL https://jamanetwork.com/journals/jama-health-forum/fullarticle/2797080
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