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

November 18, 2009
April 1, 2010
November 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01017627 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Anemia
  • Mortality
  • Other: Early anemia diagnosis and treatment
    Patients returning to the unit are immediately assessed and treated for anemia
  • Other: No change from normal routine
    Normal unit policy for labs and anemia treatment
  • 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
    Intervention: Other: Early anemia diagnosis and treatment
  • 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.
    Intervention: Other: No change from normal routine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1500
December 2010
November 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017627
20090068
No
Raymond Hakim, M.D., Ph.D., Fresenius Medical Care North America
Fresenius Medical Care North America
Not Provided
Principal Investigator: Raymond Hakim, M.D., Ph.D. Fresenius Medical Services
Fresenius Medical Care North America
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP