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Completed

NCT Number: NCT01717989

Study to Evaluate the Prospective Payment System

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Per Facility With Hemoglobin < 10 g/dL

    Time frame: Data were collected monthly from June 2010 until September 2012

    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.

  2. Percentage of Participants Per Facility With Hemoglobin > 12 g/dL

    Time frame: Data were collected monthly from June 2010 until September 2012

    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.

  3. Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%

    Time frame: Data were collected monthly from June 2010 until September 2012

    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 outcomes

  1. Percentage of Participants Treated by Each Dialysis Modality

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

    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.

  2. Percentage of Participants in Each Vascular Access Type Category

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

    The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.

  3. 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.

    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.

  4. Percentage of Participants Receiving Cinacalcet

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

    The percentage of participants receiving cinacalcet (Sensipar) over time

  5. Percentage of Participants Receiving Phosphate Binding Agents

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

    The percentage of participants receiving phosphate binding agents over time

  6. Percentage of Participants Receiving a Vitamin D Sterol

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

    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.

  7. Mean Hemoglobin Concentration by Quarter

    Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

  8. 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

    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.

  9. 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

    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.

  10. Cumulative Monthly Dose of Epoetin Alfa Administered

    Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

    The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.

  11. Number of Participants Taking Epoetin Alfa by Month

    Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

    The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.

  12. 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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: STEPPS™

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2012
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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