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.

Study Overview

• Status: Unknown
• Conditions: Mortality; Anemia
• Intervention / Treatment: Other: Early anemia diagnosis and treatment; Other: No change from normal routine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization	one year to accumulate 1500 hospitalizations

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresenius Medical Care North America
• Investigators: Principal Investigator: Raymond Hakim, M.D., Ph.D., Fresenius Medical Services

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): April 2, 2010
• Last Update Submitted That Met QC Criteria: April 1, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Anemia; ESRD; Mortality; Hospitalizations
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 20090068