Clinical trial NCT05005572: 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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Peritoneal Dialysis
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
First posted: 2021-08-13
Enrollment: 18621
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Percentage of Patients Receiving Any Home Dialysis in the First 90 Days
timeFrame: The 90-day period beginning on the date of the first dialysis claim.
Secondary outcomes:
measure: Percentage of Weeks Receiving Any Home Dialysis in First 90 Days
timeFrame: The 90-day period beginning on the date of the first dialysis claim.
measure: Percentage of Dialysis Sessions at Home in First 90 Days
timeFrame: The 90-day period beginning on the date of the first dialysis claim.
Other outcomes:
measure: Dialysis Rate per Capita
timeFrame: 9 months
measure: Total Number of Dialysis Patients
timeFrame: 9 months
measure: Pre-Dialysis Elixhauser Index
timeFrame: 1 year before first dialysis session
measure: Percentage of Patients Receiving Any Home Dialysis in First 90 Days in 2020
timeFrame: The 90-day period beginning on the date of the first dialysis claim.
Locations:
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Massachusetts Institute of Technology
name: Amy Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Liran Einav, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Neale Mahoney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Yunan Ji, BA
role: PRINCIPAL_INVESTIGATOR
References:
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.