Study to Evaluate the Prospective Payment System (STEPPS™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01717989
First received: September 12, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants Per Facility With Hemoglobin < 10 g/dL [ Time Frame: Data were collected monthly from June 2010 until September 2012 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Per Facility With Hemoglobin > 12 g/dL [ Time Frame: Data were collected monthly from June 2010 until September 2012 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% [ Time Frame: Data were collected monthly from June 2010 until September 2012 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Percentage of Participants Treated by Each Dialysis Modality [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants in Each Vascular Access Type Category [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.

  • Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Receiving Cinacalcet [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    The percentage of participants receiving cinacalcet (Sensipar) over time

  • Percentage of Participants Receiving Phosphate Binding Agents [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    The percentage of participants receiving phosphate binding agents over time

  • Percentage of Participants Receiving a Vitamin D Sterol [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
    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.

  • Mean Hemoglobin Concentration by Quarter [ Time Frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]
  • Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time [ Time Frame: December 2010, March 2011, June 2011, September 2011, December 2011 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL [ Time Frame: December 2010, March 2011, June 2011, September 2011, December 2011 ] [ Designated as safety issue: No ]
    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.

  • Cumulative Monthly Dose of Epoetin Alfa Administered [ Time Frame: December 2010, March 2011, June 2011, September 2011, December 2011 ] [ Designated as safety issue: No ]
    The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.

  • Number of Participants Taking Epoetin Alfa by Month [ Time Frame: December 2010, March 2011, June 2011, September 2011, December 2011 ] [ Designated as safety issue: No ]
    The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.

  • Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out [ Time Frame: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. ] [ Designated as safety issue: No ]

Enrollment: 2248
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717989

  Show 41 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01717989     History of Changes
Other Study ID Numbers: 20080234
Study First Received: September 12, 2012
Results First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Dialysis
Prospective Payment System
Center for Medicare and Medicaide Services
End Stage Renal Disease
Concomitant Medications Dosage /Treatment patterns

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on October 01, 2014