Study to Evaluate the Prospective Payment System
STEPPS™
1 other identifier
observational
2,248
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Typical duration for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedResults Posted
Study results publicly available
January 14, 2014
CompletedJanuary 14, 2014
November 1, 2013
2.3 years
September 12, 2012
November 25, 2013
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (12)
Percentage of Participants Treated by Each Dialysis Modality
Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants in Each Vascular Access Type Category
Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)
Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Receiving Cinacalcet
Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Receiving Phosphate Binding Agents
Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
- +7 more secondary outcomes
Study Arms (1)
Cohort
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (41)
Research Site
Gulf Shores, Alabama, 36542, United States
Research Site
Siloam Springs, Arkansas, 72761, United States
Research Site
Springdale, Arkansas, 72764, United States
Research Site
Azusa, California, 91702, United States
Research Site
Bakersfield, California, 93309, United States
Research Site
Covina, California, 91723, United States
Research Site
Glendale, California, 91205, United States
Research Site
Hacienda Heights, California, 91745, United States
Research Site
Inglewood, California, 90301, United States
Research Site
Lancaster, California, 93534, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Northridge, California, 91324, United States
Research Site
San Dimas, California, 91773, United States
Research Site
West Covina, California, 91790, United States
Research Site
Whittier, California, 90606, United States
Research Site
Pembroke Pines, Florida, 33028, United States
Research Site
Blairsville, Georgia, 30512, United States
Research Site
East Point, Georgia, 30344, United States
Research Site
Honolulu, Hawaii, 96816, United States
Research Site
Honolulu, Hawaii, 96817, United States
Research Site
Quincy, Illinois, 62301, United States
Research Site
Columbia, Mississippi, 39429, United States
Research Site
Pachuta, Mississippi, 39347, United States
Research Site
Lincoln, Nebraska, 68510, United States
Research Site
Lincoln, Nebraska, 68512, United States
Research Site
Lincoln, Nebraska, 68521, United States
Research Site
Livingston, New Jersey, 07039, United States
Research Site
Brooklyn, New York, 11235, United States
Research Site
Maspeth, New York, 11378, United States
Research Site
New York, New York, 10016, United States
Research Site
The Bronx, New York, 10461, United States
Research Site
King, North Carolina, 27021, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Yadkinville, North Carolina, 27055, United States
Research Site
Arlington, Texas, 76015, United States
Research Site
Houston, Texas, 77004, United States
Research Site
Houston, Texas, 77021, United States
Research Site
Houston, Texas, 77074, United States
Research Site
Fairfax, Virginia, 22030, United States
Research Site
South Charleston, West Virginia, 25015, United States
Research Site
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
October 31, 2012
Study Start
June 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
January 14, 2014
Results First Posted
January 14, 2014
Record last verified: 2013-11