N/A
N=2,248
Study to Evaluate the Prospective Payment System
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01717989 ↗Enrolled (actual)
2,248
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Percentage of Participants Per Facility With Hemoglobin < 10 g/dL — 11.5; 11.0; 13.1; 12.0 percentage of participants per facility
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Sep 2012
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 | — |
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.
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.