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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 42 Study Locations
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 May 19, 2013