Diagnostic Stewardship for Ventilator Associated Pneumonia: A Pragmatic Cluster-randomized Crossover Trial of a Hybrid Order-review and Laboratory Reporting Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Proportion of unnecessary antibiotic therapy
研究概览
简要总结
The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for patients who have respiratory cultures obtained, but do not meet clinical criteria for ventilator associated pneumonia (VAP). The main question it aims to answer is: Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit (ICU)? Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results.
详细描述
The specific aims of this project are:
Specific Aim 1: In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers, evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use, VAP diagnoses, and adverse events.
Hypothesis
A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs. control periods across all sites, without a change in adverse events, is expected.
Specific Aim 2: Evaluate overall impact of intervention including clinical and antibiotic outcomes using the "Desirability of Outcome Ranking (DOOR)/ Response Adjusted for Duration of Antibiotic Risk (RADAR)" methodology.
Hypothesis
A change in overall patient outcomes (better DOOR ranking, accounting for duration of antibiotic use) in the intervention vs. control period is expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
Ordering care providers will not be aware if the test results are eligible for modified reporting or not.
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
- •Patient located on ICU unit included in the study
- •Patient is mechanically ventilated
- •Patient had respiratory culture sent >48 hours after admission
- •Patient age ≥ 18 years
排除标准
- •Extra corporeal membrane oxygenation (ECMO) at time of respiratory culture
- •Heart or lung transplant
- •Culture rejected by lab per standard lab protocol
- •Prisoners
- •Severe immunosuppression as defined by:
- •<6 months from solid organ transplant (SOT) OR <6 months from treatment for acute rejection following SOT
- •Active treatment for lymphoreticular malignancies
- •Neutropenic < 1000
- •Receiving lymphodepleting chemotherapy
- •Allogeneic stem cell transplants <6 months
- •Autologous stem cell transplants or chimeric antigen receptor T-cell (CAR-T) therapy <6 months out
- •Allogeneic stem cell transplant with graft vs host disease (GVHD) or receiving 2 or more immunosuppressants
- •Advanced or untreated human immunodeficiency virus (HIV) infection with CD4 < 200
- •Receiving biologics within 6 months
结局指标
主要结局
Proportion of unnecessary antibiotic therapy
时间窗: Respiratory culture collection date through day 28 or patient discharge
The primary efficacy outcome is change in proportion of unnecessary antibiotic therapy for presumed VAP in the intervention (modified reporting) period compared to control (standard reporting) period. Antibiotic use for VAP relative to the index respiratory culture will be classified as follows: 1. Not on empiric antibiotic(s), new antibiotic started based on index respiratory culture result 2. Not on empiric antibiotic(s), no new antibiotics initiated based on culture result 3. On empiric antibiotic(s), changed based on index respiratory culture, completed course for VAP 4. On empiric antibiotic(s), continued without change following index respiratory culture, completed course for VAP 5. On empiric antibiotic(s), antibiotics discontinued based on culture results 6. On empiric antibiotics(s), but this was not directed towards VAP Antibiotic use in categories a, c, and d will together be considered "unnecessary antibiotic therapy for VAP treatment".
次要结局
- Frequency of clinical diagnosis of VAP and tracheobronchitis(Measured within the 7 days after the index respiratory culture)
- Antibiotic use outcome sensitivity analysis(Measured within the 7 days after the index respiratory culture)
- Number of Ventilator-free days(Measured within the 28 days after the index respiratory culture)
- Incidence of Adverse Events(Measured within the 7 days after the index respiratory culture)
- Antibiotic consumption(Measured over the 6 month control period and the 6 month intervention period)
- Frequency of provider requests for complete reports(Measured during the 6 month intervention period)
研究者
Surbhi Leekha
Professor
University of Maryland, Baltimore