Study to Evaluate the Prospective Payment System

Chronic Kidney Disease Clinical Trial

— STEPPS™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717989
• Other study ID #: 20080234
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: November 25, 2013
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2248
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Puerto Rico	Research Site	San Juan
United States	Research Site	Arlington	Texas
United States	Research Site	Azusa	California
United States	Research Site	Bakersfield	California
United States	Research Site	Blairsville	Georgia
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Columbia	Mississippi
United States	Research Site	Covina	California
United States	Research Site	East Point	Georgia
United States	Research Site	Fairfax	Virginia
United States	Research Site	Glendale	California
United States	Research Site	Gulf Shores	Alabama
United States	Research Site	Hacienda Heights	California
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Inglewood	California
United States	Research Site	King	North Carolina
United States	Research Site	Lancaster	California
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Livingston	New Jersey
United States	Research Site	Los Angeles	California
United States	Research Site	Maspeth	New York
United States	Research Site	New York	New York
United States	Research Site	Northridge	California
United States	Research Site	Pachuta	Mississippi
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Quincy	Illinois
United States	Research Site	San Dimas	California
United States	Research Site	Siloam Springs	Arkansas
United States	Research Site	South Charleston	West Virginia
United States	Research Site	Springdale	Arkansas
United States	Research Site	West Covina	California
United States	Research Site	Whittier	California
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Yadkinville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Mean Hemoglobin Concentration by Quarter		Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out		June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.	No

External Links

•   AmgenTrials clinical trials website