Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 3
- 主要终点
- Hospital antibiotic days of therapy
研究概览
简要总结
The goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.
详细描述
Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. In this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. Patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. This guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. The final decision on whether to continue antibiotic therapy will be up to the primary team. The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Adult patients admitted to the University of Maryland Medical Center or University of Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected community-acquired respiratory infection.
- •Protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value.
排除标准
- •Hospitalization for >72 hours prior to protocol-based diagnostic testing.
- •Previous molecular testing for viral infection during the same hospital encounter.
- •Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression
研究组 & 干预措施
Electronic alert plus structured communication of test results
An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.
干预措施: Electronic alert (Behavioral)
Electronic alert plus structured communication of test results
An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.
干预措施: Structured communication of test results (Behavioral)
Electronic alert without structured communication of test results
An electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance.
干预措施: Electronic alert (Behavioral)
结局指标
主要结局
Hospital antibiotic days of therapy
时间窗: Up to 90 days after randomization
The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter, from arrival in the emergency department or on the hospital ward until discharge.
次要结局
- Antibiotic de-escalations within 72 hours after initiation(3 days after randomization.)
- Acute kidney injury(Within 14 days of randomization)
- Ventilator-free days in the 30-days post-randomization(30 days after randomization.)
- Hospital-free days in the 30-days post-randomization(30 days after randomization.)
- In-hospital mortality(Up to 90 days after randomization)
- Readmissions within 30-days of randomization(Within 30 days after randomization)
- Hospital length of stay(Up to 90 days after randomization)
- C. difficile infections in the 30-days post-randomization(Within 30 days after randomization)
研究者
Jonathan Baghdadi
Assistant Professor
University of Maryland, Baltimore