Study to Evaluate the Prospective Payment System
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT01717989
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2248
- 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
- Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Per Facility With Hemoglobin < 10 g/dL Data were collected monthly from June 2010 until September 2012 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.
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL Data were collected monthly from June 2010 until September 2012 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.
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% Data were collected monthly from June 2010 until September 2012 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Treated by Each Dialysis Modality Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. 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.
Percentage of Participants in Each Vascular Access Type Category Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.
Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. 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.
Percentage of Participants Receiving Cinacalcet Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. The percentage of participants receiving cinacalcet (Sensipar) over time
Percentage of Participants Receiving Phosphate Binding Agents Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. The percentage of participants receiving phosphate binding agents over time
Percentage of Participants Receiving a Vitamin D Sterol Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. 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.
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 December 2010, March 2011, June 2011, September 2011, December 2011 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.
Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL December 2010, March 2011, June 2011, September 2011, December 2011 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.
Cumulative Monthly Dose of Epoetin Alfa Administered December 2010, March 2011, June 2011, September 2011, December 2011 The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.
Number of Participants Taking Epoetin Alfa by Month December 2010, March 2011, June 2011, September 2011, December 2011 The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Trial Locations
- Locations (1)
Research Site
🇵🇷San Juan, Puerto Rico