Treatment Choice and Outcomes for ESRD: Evidence From the First Year of a Nationwide Randomized Evaluation

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT05005572

Run by

Amy Finkelstein

People needed

18621

Starts

2021-01-01

Expected to finish

2021-12-31

Last updated by the study team

2022-11-02

Who can join

Age: 66 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Massachusetts Institute of Technology — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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