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

NCT05005572 | Completed

• 1 other identifier: JPAL-9512
• Study Type: interventional
• Target: 18,621
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Weeks Receiving Any Home Dialysis in First 90 Days

  The 90-day period beginning on the date of the first dialysis claim.

• Percentage of Dialysis Sessions at Home in First 90 Days

  The 90-day period beginning on the date of the first dialysis claim.

Other Outcomes (4)

• Dialysis Rate per Capita

  9 months

• Total Number of Dialysis Patients

  9 months

• Pre-Dialysis Elixhauser Index

  1 year before first dialysis session

Study Arms (2)

Treatment

EXPERIMENTAL

Other: Payment adjustment for home dialysis and transplant

Control

NO INTERVENTION

Interventions

Payment adjustment for home dialysis and transplant OTHER

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.

Treatment

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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)

Sponsors & Collaborators

• Amy Finkelstein: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02142, United States

Location

Related Publications (1)

• 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.

  PMID: 36206005 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

US (1)