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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Payment adjustment for home dialysis and transplant
Sponsored by
Amy Finkelstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease focused on measuring Hemodialysis, Peritoneal Dialysis

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts Institute of Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 6, 2021
Last Updated
October 31, 2022
Sponsor
Amy Finkelstein
Collaborators
Massachusetts Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05005572
Brief Title
Treatment Choice and Outcomes for ESRD: Evidence From the First Year of a Nationwide Randomized Evaluation
Official Title
Treatment Choice and Outcomes for End Stage Renal Disease: Evidence From the First Year of a Nationwide Randomized Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amy Finkelstein
Collaborators
Massachusetts Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis, Peritoneal Dialysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18621 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Payment adjustment for home dialysis and transplant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Patients Receiving Any Home Dialysis in the First 90 Days
Description
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.
Time Frame
The 90-day period beginning on the date of the first dialysis claim.
Secondary Outcome Measure Information:
Title
Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
Description
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.
Time Frame
The 90-day period beginning on the date of the first dialysis claim.
Title
Percentage of Dialysis Sessions at Home in First 90 Days
Description
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.
Time Frame
The 90-day period beginning on the date of the first dialysis claim.
Other Pre-specified Outcome Measures:
Title
Dialysis Rate per Capita
Description
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.
Time Frame
9 months
Title
Total Number of Dialysis Patients
Description
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.
Time Frame
9 months
Title
Pre-Dialysis Elixhauser Index
Description
This is the average pre-dialysis Elixhauser index among patients in our baseline sample.
Time Frame
1 year before first dialysis session
Title
Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020
Description
This is defined the same way as our primary outcome, except that outcomes are measured using data from the year prior to ETC (2020).
Time Frame
The 90-day period beginning on the date of the first dialysis claim.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Finkelstein, PhD
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liran Einav, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neale Mahoney, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yunan Ji, BA
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Institute of Technology
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36206005
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 Oct 7;3(10):e223503. doi: 10.1001/jamahealthforum.2022.3503.
Results Reference
result

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

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