The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,760
- 试验地点
- 1
- 主要终点
- Pneumonia Evidence Based Practice 1
研究概览
简要总结
This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The hypothesis is that the multi-condition pathway intervention will be associated with significantly greater increases in clinicians' adoption of evidence-based practices compared to control. The study is a pragmatic, cluster-randomized trial in US community hospitals. The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.
详细描述
Asthma, pneumonia, and bronchiolitis are the top causes of childhood hospitalization in the US, leading to approximately 350,000 hospitalizations and $2 billion in costs annually. Poor guideline adoption by clinicians contributes to poor health outcomes for children hospitalized with these respiratory illnesses, including longer recovery time/hospital stay, higher rates of transfer to intensive care units, and increased risk of hospital readmission.
Pathways can improve clinicians' adoption of evidence-based practices/guidelines in both children's and community hospital settings. Pathways are simple, visual diagrams that guide clinicians step-by-step through the evidence-based care of a specific medical condition (accessed via paper or electronically). Most hospitals implement pathways for a single medical condition at a time (e.g., asthma). But Seattle Children's Hospital developed an intervention for simultaneously implementing pathways for multiple conditions. This intervention led to sustained guideline adoption, decreased length of stay, and decreased costs; and, these effects were comparable to those shown with single-condition pathway implementation. This multi-condition pathway intervention has not yet been studied in community hospitals, which face unique implementation barriers.
The study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The study is a pragmatic, cluster-randomized trial in US community hospitals. The pathway intervention will be implemented using the key implementation strategies defined for this intervention (audit and feedback, electronic health record integration, plan-do-study-act cycles). The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, clinicians, and investigators cannot be masked due to the nature of the intervention. However, outcomes assessors will be masked.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of asthma AND age >2 to <18 years-old at time of admission to the hospital OR
- •Primary diagnosis of pneumonia AND age >2 months and <18 years at time of admission to the hospital OR
- •Primary diagnosis of bronchiolitis AND age <2 years at time of admission to the hospital
排除标准
- •Diagnosis of SARS-CoV-2
- •Transfer in from another inpatient facility
- •Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)
研究组 & 干预措施
Multi-condition Pathway Intervention
The multi-condition pathway intervention consists of pathways clinicians select from to guide the care of children with asthma, pneumonia, or bronchiolitis. Key implementation strategies include audit and feedback, plan-do-study-act cycles, electronic order sets, and mentoring/facilitation.
干预措施: Multi-condition Pathway Intervention (Behavioral)
Standard of Care
Hospitals randomized to the control arm will not receive the multi-condition pathway intervention or any external supports for implementation. They will continue to provide current standards of care.
结局指标
主要结局
Pneumonia Evidence Based Practice 1
时间窗: During a hospitalization, approximately 2 days
Administration of narrow spectrum antibiotic
Pneumonia Evidence Based Practice 2
时间窗: During a hospitalization, approximately 2 days
No prescription of macrolide antibiotics
Asthma Evidence Based Practice 3
时间窗: During a hospitalization, approximately 2 days
Use of an asthma pathway/bronchodilator weaning protocol
Bronchiolitis Evidence Based Practice 2
时间窗: During a hospitalization, approximately 2 days
No chest radiographs
Asthma Evidence Based Practice 1
时间窗: During a hospitalization, approximately 2 days
Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Asthma Evidence Based Practice 2
时间窗: During a hospitalization, approximately 2 days
Use of metered-dose inhalers
Bronchiolitis Evidence Based Practice 1
时间窗: During a hospitalization, approximately 2 days
No administration of albuterol
次要结局
- Length of Hospital Stay(During a hospitalization, approximately 2 days)
- 30-day Hospital Readmission or Emergency Department Revisit(30 days after hospital discharge)
- Transfer to Intensive Care(During a hospitalization, approximately 2 days)