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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: Payment adjustment for home dialysis and transplant

• Study Type: Interventional
• Enrollment (Actual): 18621
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Massachusetts Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Treatment	Other: Payment adjustment for home dialysis and transplant; The ETC model makes two types of payment adjustments for facilities and managing clinicians, an adjustment to the reimbursement rate for home dialysis, and a performance adjustment. The first adjustment, Home Dialysis Payment Adjustment (HDPA), raises the reimbursement rate for home dialysis for the first three years of the program; the amount of increase is 3% in 2021, and reduces to 2% in 2022, and 1% in 2023. The second adjustment, Performance Payment Adjustment (PPA), is an increase or decrease in the reimbursement rate based on the home dialysis rate and the transplant rate attributable to the participating facility or clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days	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.	The 90-day period beginning on the date of the first dialysis claim.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Weeks Receiving Any Home Dialysis in First 90 Days	For each patient, this is the number of weeks the patient received dialysis at home or receiving training for home dialysis within the first 90 days divided by the number of weeks the patient received dialysis in any modality in the first 90 days. For the 13th week since the start of dialysis, only the 6 days that fall within the 90-day period are counted and the week is weighted at 6/7 of the other weeks when computing this measure.	The 90-day period beginning on the date of the first dialysis claim.
Percentage of Dialysis Sessions at Home in First 90 Days	For each patient, this is the number of dialysis sessions at home divided by the total number of dialysis sessions in the first 90 days, weighting peritoneal dialysis sessions as 3/7 of hemodialysis sessions.	The 90-day period beginning on the date of the first dialysis claim.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis Rate per Capita	This is the number of Traditional Medicare patients aged 66 and above who start dialysis in either modality in our baseline sample divided by the number of Traditional Medicare patients aged 66 and above. Patients are counted at the time they start dialysis.	9 months
Total Number of Dialysis Patients	This is the number of Medicare patients who are on dialysis in either modality. All dialysis patients are included when computing this measure, not just new patients.	9 months
Pre-Dialysis Elixhauser Index	This is the average pre-dialysis Elixhauser index among patients in our baseline sample.	1 year before first dialysis session
Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020	This is defined the same way as our primary outcome, except that outcomes are measured using data from the year prior to ETC (2020).	The 90-day period beginning on the date of the first dialysis claim.

Collaborators and Investigators

• Sponsor: Amy Finkelstein
• Collaborators: Massachusetts Institute of Technology
• Investigators: Principal Investigator: Amy Finkelstein, PhD, Massachusetts Institute of Technology; Principal Investigator: Liran Einav, PhD, Stanford University; Principal Investigator: Neale Mahoney, PhD, Stanford University; Principal Investigator: Yunan Ji, BA, Harvard University

Publications and helpful links

General Publications

• 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 Oct 7;3(10):e223503. doi: 10.1001/jamahealthforum.2022.3503.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Hemodialysis; Peritoneal Dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: JPAL-9512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No