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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD

Conditions
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Anemia, Mortality

Intervention / Treatment
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* Other: Early anemia diagnosis and treatment
* Other: No change from normal routine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early anemia management<br>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<br>* Patients returning to the unit are immediately assessed and treated for anemia<br>|
| Other: case control<br>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<br>* Normal unit policy for labs and anemia treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Anemia, Hospitalizations, Mortality