Decreasing Unnecessary Antibiotics Prescribed for Possible Pneumonia Despite Normal Respiratory Rate and Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 643
- 试验地点
- 2
- 主要终点
- Duration of antibiotics prescribed for pneumonia
研究概览
简要总结
The purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. Patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.
详细描述
Prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. We therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. If the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a EHR-based best practice alert versus pharmacist outreach. The EHR-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. Pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. In all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. We will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. Safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. We will also assess for change in the primary outcome over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- •All patients admitted to Brigham and Women's and BWH Faulkner Hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours.
排除标准
- •Patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)
结局指标
主要结局
Duration of antibiotics prescribed for pneumonia
时间窗: Number of days of antibiotics given during hospitalization plus number of days of antibiotics for pneumonia on discharge prescriptions, up to 30 days
Duration of antibiotics prescribed for pneumonia
次要结局
- Hospital length of stay(Duration of hospitalization, up to 90 days)
- Acute kidney injury (maximum creatinine in the 14-days post-randomization)(14 days post-randomization)
- Readmissions within 30-days of randomization(30-days post-randomization)
- Hospital-free days in the 30-days post-randomization(30-days post-randomization)
- C. difficile infections in the 30-days post-randomization(30-days post-randomization)
- Days from randomization to discharge(Duration of hospitalization, up to 90 days)
- In-hospital mortality(During initial hospitalization with pneumonia, up to 90 days)
- Antibiotic-free days in the 30-days post-randomization(30-days post-randomization)
研究者
Michael Klompas, M.D.
Medical Doctor
Brigham and Women's Hospital