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临床试验/NCT05005572
NCT05005572已完成不适用

Treatment Choice and Outcomes for End Stage Renal Disease: Evidence From the First Year of a Nationwide Randomized Evaluation

Amy Finkelstein2 个研究点 分布在 1 个国家目标入组 18,621 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18,621
试验地点
2
主要终点
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days

研究概览

简要总结

The investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice model (ETC). This mandatory-participation program was designed by the Centers for Medicare and Medicaid Services and randomization was conducted at the hospital referral region (HRR) level. 95 HRRs were assigned to the treatment group beginning in January 2021. The investigators will study the impact of this program in the first year on treatment modality choice for ESRD and explore heterogeneity in impact across patients and providers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
66 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Medicare-certified ESRD facilities and Medicare-enrolled managing clinicians located in HRRs in the United States are required to participate.
  • Patient is receiving dialysis or other services for ESRD
  • Patient is new to dialysis, defined as not having received dialysis for at least 12 months prior to their first observed dialysis claim
  • Patient is enrolled in Medicare Part B

排除标准

  • HRRs in US territories
  • HRRs with 20% or more zip codes in Maryland (excluded from randomization)
  • Facilities and clinicians with fewer than 11 attributed beneficiaries
  • Patient is receiving dialysis only for an acute kidney injury
  • Patient is younger than 66 years of age before initiating dialysis
  • Patient received a kidney transplant within 12 months prior to the start of dialysis and does not have a kidney transplant failure code
  • Patient is enrolled in Medicare Advantage, a cost plan, or other Medicare managed care plan
  • Patient resides outside of the US or in one of the US territories
  • Patient has elected hospice
  • Patient has a diagnosis of dementia at any point in the first 90 days or the preceding 12 months before initiating dialysis as identified using Centers for Medicare and Medicaid Services Hierarchical condition categories (CMS-HCC)
  • Patient is residing in or receiving dialysis in a skilled nursing facility (SNF)

结局指标

主要结局

Percentage of Patients Receiving Any Home Dialysis in the First 90 Days

时间窗: The 90-day period beginning on the date of the first dialysis claim.

It is defined as the percentage of patients in our baseline sample who have any home dialysis claims within the first 90 days since the start of dialysis treatment.

次要结局

  • Percentage of Weeks Receiving Any Home Dialysis in First 90 Days(The 90-day period beginning on the date of the first dialysis claim.)
  • Percentage of Dialysis Sessions at Home in First 90 Days(The 90-day period beginning on the date of the first dialysis claim.)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amy Finkelstein

Scientific Director

Abdul Latif Jameel Poverty Action Lab

研究点 (2)

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