Study to Evaluate the Prospective Payment System (STEPPS™)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 2248

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • Research Site
• United States
  • Alabama
    • Gulf Shores, Alabama, United States, 36542
      • Research Site
  • Arkansas
    • Siloam Springs, Arkansas, United States, 72761
      • Research Site
    • Springdale, Arkansas, United States, 72764
      • Research Site
  • California
    • Azusa, California, United States, 91702
      • Research Site
    • Bakersfield, California, United States, 93309
      • Research Site
    • Covina, California, United States, 91723
      • Research Site
    • Glendale, California, United States, 91205
      • Research Site
    • Hacienda Heights, California, United States, 91745
      • Research Site
    • Inglewood, California, United States, 90301
      • Research Site
    • Lancaster, California, United States, 93534
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • San Dimas, California, United States, 91773
      • Research Site
    • West Covina, California, United States, 91790
      • Research Site
    • Whittier, California, United States, 90606
      • Research Site
  • Florida
    • Pembroke Pines, Florida, United States, 33028
      • Research Site
  • Georgia
    • Blairsville, Georgia, United States, 30512
      • Research Site
    • East Point, Georgia, United States, 30344
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Research Site
    • Honolulu, Hawaii, United States, 96816
      • Research Site
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Research Site
  • Mississippi
    • Columbia, Mississippi, United States, 39429
      • Research Site
    • Pachuta, Mississippi, United States, 39347
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Research Site
    • Lincoln, Nebraska, United States, 68521
      • Research Site
    • Lincoln, Nebraska, United States, 68512
      • Research Site
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Brooklyn, New York, United States, 11235
      • Research Site
    • Maspeth, New York, United States, 11378
      • Research Site
    • New York, New York, United States, 10016
      • Research Site
  • North Carolina
    • King, North Carolina, United States, 27021
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
    • Yadkinville, North Carolina, United States, 27055
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76015
      • Research Site
    • Houston, Texas, United States, 77074
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Houston, Texas, United States, 77021
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22030
      • Research Site
  • West Virginia
    • South Charleston, West Virginia, United States, 25015
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of approximately 50 SDOs selected to participate in the registry. All efforts will be made to select a diversified group of facilities by evaluating geography, facility size (i.e., number of patients treated) and setting (i.e., rural and urban settings) and potentially, dialysis modalities offered as well as payor mix.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort; Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Dialysis; Prospective Payment System; Center for Medicare and Medicaide Services; Concomitant Medications Dosage /Treatment patterns
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 20080234