Massachusetts Institute of Technology
Cambridge, Massachusetts, 02142, United States
NCT Number: NCT05005572
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.
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Notify Me66 year and older
All sexes
Interventional
Not applicable
Cambridge, Massachusetts, 02142, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: The 90-day period beginning on the date of the first dialysis claim.
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.
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.
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: 9 months
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
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: 1 year before first dialysis session
This is the average pre-dialysis Elixhauser index among patients in our baseline sample.
Time frame: The 90-day period beginning on the date of the first dialysis claim.
This is defined the same way as our primary outcome, except that outcomes are measured using data from the year prior to ETC (2020).
Amy Finkelstein
Other
Treatment Choice and Outcomes for End Stage Renal Disease: Evidence From the First Year of a Nationwide Randomized Evaluation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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