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

NCT ID: NCT05005572

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Payment adjustment for home dialysis and transplant

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Amy Finkelstein

OTHER

Sponsor Role: lead

Responsible Party

Amy Finkelstein

Scientific Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amy Finkelstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

Liran Einav, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Neale Mahoney, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Yunan Ji, BA

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36206005 (View on PubMed)

Other Identifiers

JPAL-9512

Identifier Type: -

Identifier Source: org_study_id