Clinical trial NCT01017627: Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
Official title: A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Mortality
Keywords: ESRD
Anemia
Hospitalizations
Mortality
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
timeFrame: one year to accumulate 1500 hospitalizations
Secondary outcomes:
measure: 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).
timeFrame: one year to accumulate 1500 hospitalizations
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Central
state: Colorado
city: Jacksonville
country: United States
facility: St. John's
state: Florida
city: Jacksonville
country: United States
facility: JAX Beach
state: Florida
city: Chicago
country: United States
facility: Prairie
state: Illinois
city: Decatur
country: United States
facility: Tri Counties
state: Indiana
city: Huntington
country: United States
facility: Huntington
state: Indiana
city: New Albany
country: United States
facility: Floyd County
state: Indiana
city: Louisville
country: United States
facility: South Louisville
state: Kentucky
city: Breaux Bridge
country: United States
facility: Breaux Bridge
state: Louisiana
city: Delta
country: United States
facility: Delta
state: Louisiana
city: Lafayette
country: United States
facility: East Lafayette
state: Louisiana
city: Methuen
country: United States
facility: Methuen
state: Massachusetts
city: Roxbury
country: United States
facility: Roxbury
state: Massachusetts
city: Battle Creek
country: United States
facility: Battle Creek
state: Michigan
city: East Lansing
country: United States
facility: East Lansing
state: Michigan
city: Kalamazoo
country: United States
facility: Oshtemo
state: Michigan
city: Lansing
country: United States
facility: Lansing
state: Michigan
city: Saginaw
country: United States
facility: Saganaw Riverside
state: Michigan
city: Saginaw
country: United States
facility: Saginaw
state: Michigan
city: Eupora
country: United States
facility: Eupora
state: Mississippi
city: Meridian
country: United States
facility: Meridian
state: Mississippi
city: Oxford
country: United States
facility: Yokna River
state: Mississippi
city: Independence
country: United States
facility: Independence Centerpoint
state: Missouri
city: Las Vegas
country: United States
facility: Desert Inn
state: Nevada
city: Las Vegas
country: United States
facility: South Pecos
state: Nevada
city: Durham
country: United States
facility: Briggs Ave
state: North Carolina
city: Durham
country: United States
facility: Freedom Lake
state: North Carolina
city: Boardman
country: United States
facility: Boardman
state: Ohio
city: Cortland
country: United States
facility: Cortland
state: Ohio
city: Elyria
country: United States
facility: Elyria
state: Ohio
city: North Randall
country: United States
facility: North Randall
state: Ohio
city: Westlake
country: United States
facility: Westlake
state: Ohio
city: Willoughby
country: United States
facility: Willoughby
state: Ohio
city: Beaverton
country: United States
facility: Twin Oaks
state: Oregon
city: Clackamas
country: United States
facility: Clackamas
state: Oregon
city: Brentwood
country: United States
facility: Fresenius Medical Services
state: Tennessee
city: Smyrna
country: United States
facility: Smyrna
state: Tennessee
city: West Nashville
country: United States
facility: West Nashville
state: Tennessee
city: Fort Worth
country: United States
facility: North Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County
state: Texas
city: Waco
country: United States
facility: Waco
state: Texas
city: Waco
country: United States
facility: Waco West
state: Texas
Study officials:
affiliation: Fresenius Medical Services
name: Raymond Hakim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2215/CJN.04261206. Epub 2007 Oct 17.