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

Primary Purpose

Anemia, Mortality

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early anemia diagnosis and treatment
No change from normal routine
Sponsored by
Fresenius Medical Care North America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia focused on measuring ESRD, Anemia, Hospitalizations, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Denver Central
  • St. John's
  • JAX Beach
  • Prairie
  • Tri Counties
  • Huntington
  • Floyd County
  • South Louisville
  • Breaux Bridge
  • Delta
  • East Lafayette
  • Methuen
  • Roxbury
  • Battle Creek
  • East Lansing
  • Oshtemo
  • Lansing
  • Saganaw Riverside
  • Saginaw
  • Eupora
  • Meridian
  • Yokna River
  • Independence Centerpoint
  • Desert Inn
  • South Pecos
  • Briggs Ave
  • Freedom Lake
  • Boardman
  • Cortland
  • Elyria
  • North Randall
  • Westlake
  • Willoughby
  • Twin Oaks
  • Clackamas
  • Fresenius Medical Services
  • Smyrna
  • West Nashville
  • North Fort Worth
  • Tarrant County
  • Waco
  • Waco West

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early anemia management

case control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization

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).

Full Information

First Posted
November 18, 2009
Last Updated
April 1, 2010
Sponsor
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT01017627
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Mortality
Keywords
ESRD, Anemia, Hospitalizations, Mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early anemia management
Arm Type
Other
Arm Description
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
Arm Title
case control
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Early anemia diagnosis and treatment
Intervention Description
Patients returning to the unit are immediately assessed and treated for anemia
Intervention Type
Other
Intervention Name(s)
No change from normal routine
Intervention Description
Normal unit policy for labs and anemia treatment
Primary Outcome Measure Information:
Title
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
Time Frame
one year to accumulate 1500 hospitalizations
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Hakim, M.D., Ph.D.
Organizational Affiliation
Fresenius Medical Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Central
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
St. John's
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32246
Country
United States
Facility Name
JAX Beach
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Prairie
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Tri Counties
City
Decatur
State/Province
Indiana
ZIP/Postal Code
46733
Country
United States
Facility Name
Huntington
City
Huntington
State/Province
Indiana
ZIP/Postal Code
46750
Country
United States
Facility Name
Floyd County
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
South Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40216
Country
United States
Facility Name
Breaux Bridge
City
Breaux Bridge
State/Province
Louisiana
ZIP/Postal Code
70517
Country
United States
Facility Name
Delta
City
Delta
State/Province
Louisiana
ZIP/Postal Code
71233
Country
United States
Facility Name
East Lafayette
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70501
Country
United States
Facility Name
Methuen
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Roxbury
City
Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02119
Country
United States
Facility Name
Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49014
Country
United States
Facility Name
East Lansing
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Oshtemo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Facility Name
Saganaw Riverside
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Eupora
City
Eupora
State/Province
Mississippi
ZIP/Postal Code
39744
Country
United States
Facility Name
Meridian
City
Meridian
State/Province
Mississippi
ZIP/Postal Code
39301
Country
United States
Facility Name
Yokna River
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Facility Name
Independence Centerpoint
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Desert Inn
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
South Pecos
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89120
Country
United States
Facility Name
Briggs Ave
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Freedom Lake
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Boardman
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Cortland
City
Cortland
State/Province
Ohio
ZIP/Postal Code
44410
Country
United States
Facility Name
Elyria
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
North Randall
City
North Randall
State/Province
Ohio
ZIP/Postal Code
44128
Country
United States
Facility Name
Westlake
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Willoughby
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Twin Oaks
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States
Facility Name
Clackamas
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Fresenius Medical Services
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Smyrna
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
West Nashville
City
West Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
North Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76119
Country
United States
Facility Name
Tarrant County
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76119
Country
United States
Facility Name
Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Waco West
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17942761
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.
Results Reference
background

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

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