Clinical trial NCT01717989: Study to Evaluate the Prospective Payment System
Official title: Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Dialysis
Prospective Payment System
Center for Medicare and Medicaide Services
End Stage Renal Disease
Concomitant Medications Dosage /Treatment patterns
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-10-31
Enrollment: 2248
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
timeFrame: Data were collected monthly from June 2010 until September 2012
measure: Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
timeFrame: Data were collected monthly from June 2010 until September 2012
measure: Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
timeFrame: Data were collected monthly from June 2010 until September 2012
Secondary outcomes:
measure: Percentage of Participants Treated by Each Dialysis Modality
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Percentage of Participants in Each Vascular Access Type Category
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Percentage of Participants Receiving Cinacalcet
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Percentage of Participants Receiving Phosphate Binding Agents
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Percentage of Participants Receiving a Vitamin D Sterol
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Mean Hemoglobin Concentration by Quarter
timeFrame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
measure: Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
timeFrame: December 2010, March 2011, June 2011, September 2011, December 2011
measure: Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL
timeFrame: December 2010, March 2011, June 2011, September 2011, December 2011
measure: Cumulative Monthly Dose of Epoetin Alfa Administered
timeFrame: December 2010, March 2011, June 2011, September 2011, December 2011
measure: Number of Participants Taking Epoetin Alfa by Month
timeFrame: December 2010, March 2011, June 2011, September 2011, December 2011
measure: Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
timeFrame: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Research Site
state: Alabama
city: Siloam Springs
country: United States
facility: Research Site
state: Arkansas
city: Springdale
country: United States
facility: Research Site
state: Arkansas
city: Azusa
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Covina
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Hacienda Heights
country: United States
facility: Research Site
state: California
city: Inglewood
country: United States
facility: Research Site
state: California
city: Lancaster
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: San Dimas
country: United States
facility: Research Site
state: California
city: West Covina
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Blairsville
country: United States
facility: Research Site
state: Georgia
city: East Point
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Quincy
country: United States
facility: Research Site
state: Illinois
city: Columbia
country: United States
facility: Research Site
state: Mississippi
city: Pachuta
country: United States
facility: Research Site
state: Mississippi
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
city: Livingston
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Maspeth
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: King
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Yadkinville
country: United States
facility: Research Site
state: North Carolina
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: South Charleston
country: United States
facility: Research Site
state: West Virginia
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: