Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
- Conditions
- AnemiaMortality
- Interventions
- Other: Early anemia diagnosis and treatmentOther: No change from normal routine
- Registration Number
- NCT01017627
- Lead Sponsor
- Fresenius Medical Care North America
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- age ≥ 18
- resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
- enrolled in a facility-based anemia management program
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Early anemia management Early anemia diagnosis and treatment 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 case control No change from normal routine 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (42)
Yokna River
🇺🇸Oxford, Mississippi, United States
West Nashville
🇺🇸West Nashville, Tennessee, United States
Fresenius Medical Services
🇺🇸Brentwood, Tennessee, United States
North Randall
🇺🇸North Randall, Ohio, United States
Waco
🇺🇸Waco, Texas, United States
Waco West
🇺🇸Waco, Texas, United States
Saganaw Riverside
🇺🇸Saginaw, Michigan, United States
Eupora
🇺🇸Eupora, Mississippi, United States
Saginaw
🇺🇸Saginaw, Michigan, United States
Tarrant County
🇺🇸Fort Worth, Texas, United States
Boardman
🇺🇸Boardman, Ohio, United States
Cortland
🇺🇸Cortland, Ohio, United States
Elyria
🇺🇸Elyria, Ohio, United States
Twin Oaks
🇺🇸Beaverton, Oregon, United States
Smyrna
🇺🇸Smyrna, Tennessee, United States
North Fort Worth
🇺🇸Fort Worth, Texas, United States
Independence Centerpoint
🇺🇸Independence, Missouri, United States
Meridian
🇺🇸Meridian, Mississippi, United States
Westlake
🇺🇸Westlake, Ohio, United States
Desert Inn
🇺🇸Las Vegas, Nevada, United States
Prairie
🇺🇸Chicago, Illinois, United States
South Pecos
🇺🇸Las Vegas, Nevada, United States
Briggs Ave
🇺🇸Durham, North Carolina, United States
Freedom Lake
🇺🇸Durham, North Carolina, United States
Clackamas
🇺🇸Clackamas, Oregon, United States
JAX Beach
🇺🇸Jacksonville, Florida, United States
St. John's
🇺🇸Jacksonville, Florida, United States
Tri Counties
🇺🇸Decatur, Indiana, United States
Denver Central
🇺🇸Denver, Colorado, United States
Floyd County
🇺🇸New Albany, Indiana, United States
Huntington
🇺🇸Huntington, Indiana, United States
Breaux Bridge
🇺🇸Breaux Bridge, Louisiana, United States
Delta
🇺🇸Delta, Louisiana, United States
East Lafayette
🇺🇸Lafayette, Louisiana, United States
Methuen
🇺🇸Methuen, Massachusetts, United States
Roxbury
🇺🇸Roxbury, Massachusetts, United States
Lansing
🇺🇸Lansing, Michigan, United States
Battle Creek
🇺🇸Battle Creek, Michigan, United States
Oshtemo
🇺🇸Kalamazoo, Michigan, United States
East Lansing
🇺🇸East Lansing, Michigan, United States
South Louisville
🇺🇸Louisville, Kentucky, United States
Willoughby
🇺🇸Willoughby, Ohio, United States