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

Last registered on August 09, 2021
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Pre-Trial

Trial Information

General Information

Title
Treatment Choice and Outcomes for End Stage Renal Disease: Evidence from the First Year of a Nationwide Randomized Evaluation
RCT ID
AEARCTR-0008034
Initial registration date
August 06, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 09, 2021, 5:44 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Name
Amy Finkelstein
Affiliation
MIT
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Other Primary Investigator(s)

PI Name
Yunan Ji
PI Affiliation
Harvard University
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PI Name
Neale Mahoney
PI Affiliation
Stanford University
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PI Name
Liran Einav
PI Affiliation
Stanford University
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Additional Trial Information

Status
In development
Start date
2021-01-01
End date
2027-06-30
Keywords
Health
Additional Keywords
JEL code(s)
Secondary IDs
Abstract
We plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (ESRD) treatment choice. 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. We 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.
External Link(s)

Registration Citation

Citation
Einav, Liran et al. 2021. "Treatment Choice and Outcomes for End Stage Renal Disease: Evidence from the First Year of a Nationwide Randomized Evaluation." AEA RCT Registry. August 09. https://doi.org/10.1257/rct.8034-1.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2021-01-01
Intervention End Date
2026-06-30

Primary Outcomes

Primary Outcomes (end points)
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days
Primary Outcomes (explanation)
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.

Secondary Outcomes

Secondary Outcomes (end points)
- Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
- Percentage of Dialysis Sessions at Home in First 90 Days
- Dialysis Rate per Capita
- Total Number of Dialysis Patients
- Pre-Dialysis Elixhauser Index
- Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020
Secondary Outcomes (explanation)
- 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, we only count the 6 days that fall within the 90 day period and weight it at 6/7 of the other weeks when computing this measure.

- 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.

- 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.

- Total Number of Dialysis Patients: This is the number of Medicare patients who are on dialysis in either modality. We include all dialysis patients when computing this measure, not just new patients.

- Pre-Dialysis Elixhauser Index: This is the average pre-dialysis Elixhauser index among patients in our baseline sample.

- 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 we measure outcomes using data from the year prior to ETC (2020).

Experimental Design

Experimental Design
We propose to study the ESRD Treatment Choice (ETC) program, a nationwide randomized-controlled trial (RCT) of ESRD treatment that was designed by the Centers for Medicare and Medicaid Services (CMS) to encourage greater use of home dialysis. The RCT creates payment adjustments for ESRD facilities and clinicians based on the rates of home dialysis and transplantation. The RCT was first announced in July 2019 for a start date of January 1, 2020 which was later delayed to January 1, 2021. In September 2020, 30% of hospital referral regions (HRRs) were assigned to treatment through a stratified randomization procedure. The RCT is scheduled to last until June 2027.
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.
Experimental Design Details
Randomization Method
HRRs were assigned to treatment through a stratified randomization procedure.
Randomization Unit
Hospital Referral Regions (HRRs)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
302 HRRs
Sample size: planned number of observations
According to 2016 data, the analysis sample includes approximately 19,000 beneficiaries. We expect a similar number of observations in 2021.
Sample size (or number of clusters) by treatment arms
Treatment: 91 HRRs (estimated 6,000 beneficiaries)
Control: 211 HRRs (estimated 13,000 beneficiaries)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Massachusetts Institute of Technology Committee on the Use of Humans as Experimental Subjects
IRB Approval Date
2021-01-15
IRB Approval Number
2101000295
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials