N/A
Completed N=2,248
Study to Evaluate the Prospective Payment System
Source: ClinicalTrials.gov NCT01717989 ↗Enrolled (actual)
2,248
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Percentage of Participants Per Facility With Hemoglobin < 10 g/dL — 11.5; 11.0; 13.1; 12.0 percentage of participants per facility
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Per Facility With Hemoglobin < 10 g/dL |
11.5; 11.0; 13.1; 12.0; 12.7; 13.2 | — |
| PRIMARY Percentage of Participants Per Facility With Hemoglobin > 12 g/dL |
30.2; 28.3; 28.2; 30.6; 28.7; 27.8 | — |
| PRIMARY Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% |
84.8; 85.0; 85.0; 86.9; 87.9; 87.8 | — |
| SECONDARY Percentage of Participants Treated by Each Dialysis Modality |
2.0; 2.2; 3.6; 2.8; 2.9; 94.4 | — |
| SECONDARY Percentage of Participants in Each Vascular Access Type Category |
62.8; 63.2; 63.5; 63.8; 63.7; 17.2 | — |
| SECONDARY Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) |
91.2; 92.0; 90.9; 91.2; 89.4 | — |
| SECONDARY Percentage of Participants Receiving Cinacalcet |
22.3; 26.2; 29.3; 30.0; 31.0 | — |
| SECONDARY Percentage of Participants Receiving Phosphate Binding Agents |
60.9; 66.0; 70.4; 74.2; 73.3 | — |
| SECONDARY Percentage of Participants Receiving a Vitamin D Sterol |
80.6; 76.2; 77.5; 77.7; 79.4; 76.0 | — |
| SECONDARY Mean Hemoglobin Concentration by Quarter |
11.28; 11.17; 11.06; 11.00; 10.78 | — |
| SECONDARY Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time |
11.8; 10.0; 10.0; 4.0; 6.3; 21.6 | — |
| SECONDARY Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL |
2.4; 0.6; 1.4; 1.0; 0.7 | — |
| SECONDARY Cumulative Monthly Dose of Epoetin Alfa Administered |
39000.0; 35000.0; 33800.0; 28000.0; 32900.0 | — |
| SECONDARY Number of Participants Taking Epoetin Alfa by Month |
1269; 1299; 1244; 1212; 1140 | — |
| SECONDARY Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out |
54; 56; 50; 39; 36; 71 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01717989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.