Reducing Overuse of Antibiotics with Decision Support in Lower Respiratory Tract Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 3
- 主要终点
- Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index
研究概览
简要总结
Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia.
To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available.
Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.
详细描述
This is a usual care-controlled superiority clinical trial platform designed to evaluate the effects of hospital-based CDS in the ED (CDS-ED) and after transitioning to the hospital setting (CDS-TR) on antibiotic prescribing and related clinical outcomes for child and adolescent LRTI encounters at 3 U.S. children's hospitals. The investigators hypothesize that both interventions will be superior to usual care and, among patients presenting in the ED and subsequently admitted to the hospital, the combined interventions (CDS-ED + CDS-TR) will be most effective overall. Randomization will occur sequentially in two stages corresponding to the ED CDS and Transitions CDS populations. The first stage of randomization will allocate qualifying ED encounters 1:1 to CDS-ED vs. usual care alone in the ED. The second stage of randomization will allocate participants requiring hospitalization (those discharged from the hospital are not eligible) 1:1 to CDS-TR vs. usual care at the time of admission. To minimize bias, the trial will be embedded within clinical care with minimal exclusions and disruption to usual care activities. Investigators will be blinded to study arm assignment, though blinding of treating clinicians is not possible due to the nature of the study. The trial will also evaluate process and implementation outcomes throughout the study period within the platform population. A formal interim analysis is not planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ED encounter or admission to an inpatient hospital team.
- •EHR-based positive screen for suspected LRTI, defined as a qualifying chief complaint (e.g., cough, shortness of breath, etc.), plus triage documentation of abnormal respiratory effort and/or cough.
排除标准
- 未提供
研究组 & 干预措施
Usual Care: Inpatient
No experimental decision support will be provided to the inpatient/ICU providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.
Usual Care: Emergency Department
No experimental decision support will be provided to the emergency medicine providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.
CDS-ED
The ED clinical decision support tool will be offered to emergency department providers in these enrolled encounters.
干预措施: ED Clinical Decision Support (CDS-ED) (Behavioral)
CDS-Tr
The Transitions clinical decision support tool will be offered to inpatient/ICU providers in these enrolled encounters.
干预措施: Transitions Clinical Decision Support (CDS-Tr) (Behavioral)
结局指标
主要结局
Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index
时间窗: 10 days
The Antibiotic Spectrum Index (ASI) is a numerical metric which quantifies the relative breadth of antimicrobial activity of a given antibiotic medication. Tracking the 10-day trajectory of ASI will capture changes in antibiotic use resulting from changes in antibiotic initiation, spectrum of antibiotic activity, and duration of antibiotic use.
Primary Safety: Proportion of Participants Experiencing Escalation in Treatment
时间窗: 10 days
Treatment escalation will capture the escalation to higher level of care and/or antibiotic treatment strategy
次要结局
- Effectiveness: Proportion of Participants Experiencing Reduction of ASI Score(10 days)
- Effectiveness: Total Treatment Duration(42 days)
- Effectiveness: ASI per Exposure Day(10 days)
- Safety: Need for Intensive Care(42 days)
- Safety: Need for Invasive Mechanical Ventilation or Shock Requiring Vasoactive Medications(42 days)
- Safety: 3- and 14-day ED Reutilization(14 days)
- Safety: 3- and 14-day Hospital Reutilization(14 days)
- Death within 14 days of index discharge(14 days)
研究者
Derek Williams
Professor of Pediatrics
Vanderbilt University Medical Center