Study to Evaluate the Prospective Payment System

NCT ID: NCT01717989

Last Updated: 2014-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2248 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort

Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

* Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Gulf Shores, Alabama, United States

Site Status

Research Site

Siloam Springs, Arkansas, United States

Site Status

Research Site

Springdale, Arkansas, United States

Site Status

Research Site

Azusa, California, United States

Site Status

Research Site

Bakersfield, California, United States

Site Status

Research Site

Covina, California, United States

Site Status

Research Site

Glendale, California, United States

Site Status

Research Site

Hacienda Heights, California, United States

Site Status

Research Site

Inglewood, California, United States

Site Status

Research Site

Lancaster, California, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

Northridge, California, United States

Site Status

Research Site

San Dimas, California, United States

Site Status

Research Site

West Covina, California, United States

Site Status

Research Site

Whittier, California, United States

Site Status

Research Site

Pembroke Pines, Florida, United States

Site Status

Research Site

Blairsville, Georgia, United States

Site Status

Research Site

East Point, Georgia, United States

Site Status

Research Site

Honolulu, Hawaii, United States

Site Status

Research Site

Honolulu, Hawaii, United States

Site Status

Research Site

Quincy, Illinois, United States

Site Status

Research Site

Columbia, Mississippi, United States

Site Status

Research Site

Pachuta, Mississippi, United States

Site Status

Research Site

Lincoln, Nebraska, United States

Site Status

Research Site

Lincoln, Nebraska, United States

Site Status

Research Site

Lincoln, Nebraska, United States

Site Status

Research Site

Livingston, New Jersey, United States

Site Status

Research Site

Brooklyn, New York, United States

Site Status

Research Site

Maspeth, New York, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

The Bronx, New York, United States

Site Status

Research Site

King, North Carolina, United States

Site Status

Research Site

Winston-Salem, North Carolina, United States

Site Status

Research Site

Yadkinville, North Carolina, United States

Site Status

Research Site

Arlington, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Fairfax, Virginia, United States

Site Status

Research Site

South Charleston, West Virginia, United States

Site Status

Research Site

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Related Links

Access external resources that provide additional context or updates about the study.

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20080234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preventing Early Dialysis Starts
NCT02183987 COMPLETED NA
Symptom Management in Patients on Dialysis
NCT05515991 ACTIVE_NOT_RECRUITING NA