Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)

Not Applicable

• Conditions: Anemia; Mortality

• Registration Number: NCT01017627
• Lead Sponsor: Fresenius Medical Care North America

Brief Summary

The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.

Detailed Description

The post-hospitalization quality improvement project will be piloted across 30 Fresenius clinics. Targeted enrollment of 1500 episodes of hospitalization in which the patient returns after discharge to resume outpatient dialysis.

Patient outcomes will be followed for up to 30 days from the time of discharge from hospital.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-01
• Last Update Posted: 2010-04-02
• Primary Completion: 2010-11
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• age ≥ 18
• resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
• enrolled in a facility-based anemia management program

Exclusion Criteria

• enrolled in hospice
• previous hospitalization within the past 30 days (ie. patients discharged from a repeat hospitalization)
• anticipated discharge from the outpatient dialysis facility within 30 days (ie anticipated transfer to another facility or hospice)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization	one year to accumulate 1500 hospitalizations

Secondary Outcome Measures

Name	Time	Method
hemoglobin, transferrin saturation, albumin, white blood cell count, and C-reactive protein* levels measured in the period following hospitalization and change relative to values measured prior to hospitalization (where available).	one year to accumulate 1500 hospitalizations

Trial Locations

Locations (42)

Denver Central; 🇺🇸 Denver, Colorado, United States

St. John's; 🇺🇸 Jacksonville, Florida, United States

JAX Beach; 🇺🇸 Jacksonville, Florida, United States

Prairie; 🇺🇸 Chicago, Illinois, United States

Tri Counties; 🇺🇸 Decatur, Indiana, United States

Huntington; 🇺🇸 Huntington, Indiana, United States

Floyd County; 🇺🇸 New Albany, Indiana, United States

South Louisville; 🇺🇸 Louisville, Kentucky, United States

Breaux Bridge; 🇺🇸 Breaux Bridge, Louisiana, United States

Delta; 🇺🇸 Delta, Louisiana, United States

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