The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118,562
- 试验地点
- 204
- 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 Skin and Soft Tissue 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 skin and soft tissue 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
- •Facility Inclusion Criteria:
- •HCA Healthcare hospitals admitting adults for skin and soft tissue 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 skin and soft tissue infection.
研究组 & 干预措施
Arm 2: INSPIRE Stewardship Bundle
Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.
干预措施: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection (Other)
Arm 1: Routine Care
Continuation of routine antibiotic stewardship strategies.
干预措施: Arm 1: Routine Care (Other)
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.
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
- 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)
- 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