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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005572
• Other study ID #: JPAL-9512
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Abdul Latif Jameel Poverty Action Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18621
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts Institute of Technology	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Amy Finkelstein	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

References & 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/jam — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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. Patients are counted at the time they start dialysis.	9 months
Other	Total Number of Dialysis Patients	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.	9 months
Other	Pre-Dialysis Elixhauser Index	This is the average pre-dialysis Elixhauser index among patients in our baseline sample.	1 year before first dialysis session
Other	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 outcomes are measured using data from the year prior to ETC (2020).	The 90-day period beginning on the date of the first dialysis claim.
Primary	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	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.	The 90-day period beginning on the date of the first dialysis claim.
Secondary	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.	The 90-day period beginning on the date of the first dialysis claim.