Text Size

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: May 30, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of patients within each facility meeting each of the Centers for Medicare and Medicaid policy for End Stage Renal Disease Prospective Payment System quality metrics over time [ Time Frame: Up to 54 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Practice of Site Treatment Patterns [ Time Frame: Up to 54 months ] [ Designated as safety issue: No ]
    Prescription, Route, Dose, and changes of Erythropoiesis-stimulating agents(ESA) use over time; Patterns for anemia treatments; Patterns for Secondary hyperparathyroidism treatment protocol; Frequency of Hemoglobin measurements per month; Presciption, Dose, and changes of Iron use over time; Patterns for Dialysis Data with each session; Frequency of Laboratory monitoring/testing; Frequency of Transfusions and observation of corresponding Hospitalizations


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)
  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 subjects treated) and setting (i.e., rural and urban settings) and potentially, dialysis modalities offered as well as payor mix.

Criteria

Subject 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

Subject Exclusion Criteria:

  • Subjects will be ineligible for the study if they do not consent to have their data collected for research purposes.
  Contacts and Locations
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:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01717989     History of Changes
Other Study ID Numbers: 20080234
Study First Received: September 12, 2012
Last Updated: May 30, 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
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013