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

Anemia Clinical Trial

Official title:

A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01017627
• Other study ID #: 20090068
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 18, 2009
• Last updated: April 1, 2010
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Mortality

Intervention

Other:
• Early anemia diagnosis and treatment
Patients returning to the unit are immediately assessed and treated for anemia
• No change from normal routine
Normal unit policy for labs and anemia treatment

Locations

Country	Name	City	State
United States	Battle Creek	Battle Creek	Michigan
United States	Twin Oaks	Beaverton	Oregon
United States	Boardman	Boardman	Ohio
United States	Breaux Bridge	Breaux Bridge	Louisiana
United States	Fresenius Medical Services	Brentwood	Tennessee
United States	Prairie	Chicago	Illinois
United States	Clackamas	Clackamas	Oregon
United States	Cortland	Cortland	Ohio
United States	Tri Counties	Decatur	Indiana
United States	Delta	Delta	Louisiana
United States	Denver Central	Denver	Colorado
United States	Briggs Ave	Durham	North Carolina
United States	Freedom Lake	Durham	North Carolina
United States	East Lansing	East Lansing	Michigan
United States	Elyria	Elyria	Ohio
United States	Eupora	Eupora	Mississippi
United States	North Fort Worth	Fort Worth	Texas
United States	Tarrant County	Fort Worth	Texas
United States	Huntington	Huntington	Indiana
United States	Independence Centerpoint	Independence	Missouri
United States	JAX Beach	Jacksonville	Florida
United States	St. John's	Jacksonville	Florida
United States	Oshtemo	Kalamazoo	Michigan
United States	East Lafayette	Lafayette	Louisiana
United States	Lansing	Lansing	Michigan
United States	Desert Inn	Las Vegas	Nevada
United States	South Pecos	Las Vegas	Nevada
United States	South Louisville	Louisville	Kentucky
United States	Meridian	Meridian	Mississippi
United States	Methuen	Methuen	Massachusetts
United States	Floyd County	New Albany	Indiana
United States	North Randall	North Randall	Ohio
United States	Yokna River	Oxford	Mississippi
United States	Roxbury	Roxbury	Massachusetts
United States	Saganaw Riverside	Saginaw	Michigan
United States	Saginaw	Saginaw	Michigan
United States	Smyrna	Smyrna	Tennessee
United States	Waco	Waco	Texas
United States	Waco West	Waco	Texas
United States	West Nashville	West Nashville	Tennessee
United States	Westlake	Westlake	Ohio
United States	Willoughby	Willoughby	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wingard RL, Pupim LB, Krishnan M, Shintani A, Ikizler TA, Hakim RM. Early intervention improves mortality and hospitalization rates in incident hemodialysis patients: RightStart program. Clin J Am Soc Nephrol. 2007 Nov;2(6):1170-5. Epub 2007 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization		one year to accumulate 1500 hospitalizations	No
Secondary	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	No