The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198,480
- 试验地点
- 202
- 主要终点
- Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
研究概览
简要总结
The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen.
Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •HCA Healthcare hospitals admitting adults for abdominal infection
- •Facility use of MEDITECH as their electronic health record system
排除标准
- •Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age >=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for abdominal infection.
结局指标
主要结局
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
时间窗: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.
次要结局
- Vancomycin Days of Antibacterial Therapy Per Empiric Day(First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods)
- Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day(First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods)
研究者
Richard Platt
MD, MSc, Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care