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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Fresenius Medical Care North America
ClinicalTrials.gov Identifier:
NCT01017627
First received: November 18, 2009
Last updated: April 1, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Anemia
Mortality
Other: Early anemia diagnosis and treatment
Other: No change from normal routine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:
  • composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization [ Time Frame: one year to accumulate 1500 hospitalizations ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: one year to accumulate 1500 hospitalizations ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: November 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early anemia management
Upon return to the dialysis unit following hospitalization, patients will be immediately identified and have immediate implementation of the unit anemia protocol rather than waiting for the next regularly scheduled unit labs and regular follow-up. Thus, labs will be obtained within the first 3-7 days following hospitalization and appropriate titration of Epo and iron medications within the 7 days after discharge from hospital and under the direction of the pre-specified algorithm used in the patient's facility; all drug dosing will comply with package insert instructions
Other: Early anemia diagnosis and treatment
Patients returning to the unit are immediately assessed and treated for anemia
case control
Each case will be "data-matched" to an intra-facility (primary control), and then an inter-facility (validation control) control patient. Matching criteria will be by age, gender, diabetic status, attending nephrologist, length of hospitalization stay, and hospital discharge date (to minimize the difference in the date between the case and control). These patients did not have early intervention but followed the usual practice of waiting for the next regularly scheduled dialysis unit labs with anemia management to follow using the regular unit algorithm.
Other: No change from normal routine
Normal unit policy for labs and anemia treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017627

  Hide Study Locations
Locations
United States, Colorado
Denver Central
Denver, Colorado, United States, 80209
United States, Florida
JAX Beach
Jacksonville, Florida, United States, 32250
St. John's
Jacksonville, Florida, United States, 32246
United States, Illinois
Prairie
Chicago, Illinois, United States, 60616
United States, Indiana
Tri Counties
Decatur, Indiana, United States, 46733
Huntington
Huntington, Indiana, United States, 46750
Floyd County
New Albany, Indiana, United States, 47150
United States, Kentucky
South Louisville
Louisville, Kentucky, United States, 40216
United States, Louisiana
Breaux Bridge
Breaux Bridge, Louisiana, United States, 70517
Delta
Delta, Louisiana, United States, 71233
East Lafayette
Lafayette, Louisiana, United States, 70501
United States, Massachusetts
Methuen
Methuen, Massachusetts, United States, 01844
Roxbury
Roxbury, Massachusetts, United States, 02119
United States, Michigan
Battle Creek
Battle Creek, Michigan, United States, 49014
East Lansing
East Lansing, Michigan, United States, 48823
Oshtemo
Kalamazoo, Michigan, United States, 49009
Lansing
Lansing, Michigan, United States, 48911
Saginaw
Saginaw, Michigan, United States, 48602
Saganaw Riverside
Saginaw, Michigan, United States, 48602
United States, Mississippi
Eupora
Eupora, Mississippi, United States, 39744
Meridian
Meridian, Mississippi, United States, 39301
Yokna River
Oxford, Mississippi, United States, 38655
United States, Missouri
Independence Centerpoint
Independence, Missouri, United States, 64057
United States, Nevada
Desert Inn
Las Vegas, Nevada, United States, 89109
South Pecos
Las Vegas, Nevada, United States, 89120
United States, North Carolina
Briggs Ave
Durham, North Carolina, United States, 27703
Freedom Lake
Durham, North Carolina, United States, 27704
United States, Ohio
Boardman
Boardman, Ohio, United States, 44512
Cortland
Cortland, Ohio, United States, 44410
Elyria
Elyria, Ohio, United States, 44035
North Randall
North Randall, Ohio, United States, 44128
Westlake
Westlake, Ohio, United States, 44145
Willoughby
Willoughby, Ohio, United States, 44094
United States, Oregon
Twin Oaks
Beaverton, Oregon, United States, 97006
Clackamas
Clackamas, Oregon, United States, 97015
United States, Tennessee
Fresenius Medical Services
Brentwood, Tennessee, United States, 37027
Smyrna
Smyrna, Tennessee, United States, 37167
West Nashville
West Nashville, Tennessee, United States, 37209
United States, Texas
Tarrant County
Fort Worth, Texas, United States, 76119
North Fort Worth
Fort Worth, Texas, United States, 76119
Waco
Waco, Texas, United States, 76708
Waco West
Waco, Texas, United States, 76712
Sponsors and Collaborators
Fresenius Medical Care North America
Investigators
Principal Investigator: Raymond Hakim, M.D., Ph.D. Fresenius Medical Services
  More Information

Publications:
Responsible Party: Raymond Hakim, M.D., Ph.D., Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT01017627     History of Changes
Other Study ID Numbers: 20090068
Study First Received: November 18, 2009
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Fresenius Medical Care North America:
ESRD
Anemia
Hospitalizations
Mortality

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Hematologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014