A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 42
- 主要终点
- composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
- •enrolled in a facility-based anemia management program
排除标准
- •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)
研究组 & 干预措施
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
干预措施: Early anemia diagnosis and treatment (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.
干预措施: No change from normal routine (Other)
结局指标
主要结局
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
时间窗: one year to accumulate 1500 hospitalizations
次要结局
- 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)