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
1 other identifier
interventional
1,500
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 2, 2010
April 1, 2010
1 year
November 18, 2009
April 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
one year to accumulate 1500 hospitalizations
Secondary Outcomes (1)
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
Study Arms (2)
Early anemia management
OTHERUpon 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
case control
OTHEREach 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.
Interventions
Patients returning to the unit are immediately assessed and treated for anemia
Eligibility Criteria
You may qualify if:
- age ≥ 18
- resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
- enrolled in a facility-based anemia management program
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Denver Central
Denver, Colorado, 80209, United States
St. John's
Jacksonville, Florida, 32246, United States
JAX Beach
Jacksonville, Florida, 32250, United States
Prairie
Chicago, Illinois, 60616, United States
Tri Counties
Decatur, Indiana, 46733, United States
Huntington
Huntington, Indiana, 46750, United States
Floyd County
New Albany, Indiana, 47150, United States
South Louisville
Louisville, Kentucky, 40216, United States
Breaux Bridge
Breaux Bridge, Louisiana, 70517, United States
Delta
Delta, Louisiana, 71233, United States
East Lafayette
Lafayette, Louisiana, 70501, United States
Methuen
Methuen, Massachusetts, 01844, United States
Roxbury
Roxbury, Massachusetts, 02119, United States
Battle Creek
Battle Creek, Michigan, 49014, United States
East Lansing
East Lansing, Michigan, 48823, United States
Oshtemo
Kalamazoo, Michigan, 49009, United States
Lansing
Lansing, Michigan, 48911, United States
Saganaw Riverside
Saginaw, Michigan, 48602, United States
Saginaw
Saginaw, Michigan, 48602, United States
Eupora
Eupora, Mississippi, 39744, United States
Meridian
Meridian, Mississippi, 39301, United States
Yokna River
Oxford, Mississippi, 38655, United States
Independence Centerpoint
Independence, Missouri, 64057, United States
Desert Inn
Las Vegas, Nevada, 89109, United States
South Pecos
Las Vegas, Nevada, 89120, United States
Briggs Ave
Durham, North Carolina, 27703, United States
Freedom Lake
Durham, North Carolina, 27704, United States
Boardman
Boardman, Ohio, 44512, United States
Cortland
Cortland, Ohio, 44410, United States
Elyria
Elyria, Ohio, 44035, United States
North Randall
North Randall, Ohio, 44128, United States
Westlake
Westlake, Ohio, 44145, United States
Willoughby
Willoughby, Ohio, 44094, United States
Twin Oaks
Beaverton, Oregon, 97006, United States
Clackamas
Clackamas, Oregon, 97015, United States
Fresenius Medical Services
Brentwood, Tennessee, 37027, United States
Smyrna
Smyrna, Tennessee, 37167, United States
West Nashville
West Nashville, Tennessee, 37209, United States
North Fort Worth
Fort Worth, Texas, 76119, United States
Tarrant County
Fort Worth, Texas, 76119, United States
Waco
Waco, Texas, 76708, United States
Waco West
Waco, Texas, 76712, United States
Related Publications (1)
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.
PMID: 17942761BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Hakim, M.D., Ph.D.
Fresenius Medical Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 20, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
April 2, 2010
Record last verified: 2010-04