Study to Evaluate the Prospective Payment System

Study Overview
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Brief Summary
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To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy [End Stage Renal Disease (ESRD) Prospective Payment System (PPS)] to bundle reimbursement for all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures for dialysis centers over time.

Official Title
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Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Adults ≥ 18 years of age who have given written informed consent Documented physician diagnosis of ESRD requiring dialysis and receiving care at a participating dialysis center Undergoing dialysis on the dialysis schedule assigned to the site Patient Exclusion Criteria: Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility. | Data were collected monthly from June 2010 until September 2012 | 
| Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility. | Data were collected monthly from June 2010 until September 2012 | 
| Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as: Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility. | Data were collected monthly from June 2010 until September 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Treated by Each Dialysis Modality | The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Percentage of Participants in Each Vascular Access Type Category | The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Percentage of Participants Receiving Cinacalcet | The percentage of participants receiving cinacalcet (Sensipar) over time | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Percentage of Participants Receiving Phosphate Binding Agents | The percentage of participants receiving phosphate binding agents over time | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Percentage of Participants Receiving a Vitamin D Sterol | The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Mean Hemoglobin Concentration by Quarter |  | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 
| Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL. | December 2010, March 2011, June 2011, September 2011, December 2011 | 
| Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL | The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight. | December 2010, March 2011, June 2011, September 2011, December 2011 | 
| Cumulative Monthly Dose of Epoetin Alfa Administered | The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis. | December 2010, March 2011, June 2011, September 2011, December 2011 | 
| Number of Participants Taking Epoetin Alfa by Month | The number of participants who took epoetin alfa only, by month, in participants on hemodialysis. | December 2010, March 2011, June 2011, September 2011, December 2011 | 
| Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out |  | June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Prospective Payment System, Center for Medicare and Medicaide Services, End Stage Renal Disease, Concomitant Medications Dosage /Treatment patterns