Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

Conditions
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Asthma, Pneumonia, Bronchiolitis

Intervention / Treatment
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* Behavioral: Multi-condition Pathway Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of SARS-CoV-2 Transfer in from another inpatient facility Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participating hospitals will be randomized into either an intervention group (will test simultaneous implementation of 3 clinical pathways) or control (will continue to provide standard care)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-condition Pathway Intervention<br>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, and electronic order sets. | Behavioral: Multi-condition Pathway Intervention<br>* See Experimental/Arm 1 description<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia Evidence Based Practice 1 | Administration of narrow spectrum antibiotic | During a hospitalization, approximately 2 days | 
| Pneumonia Evidence Based Practice 2 | No prescription of macrolide antibiotics | During a hospitalization, approximately 2 days | 
| Asthma Evidence Based Practice 1 | Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old | During a hospitalization, approximately 2 days | 
| Asthma Evidence Based Practice 2 | Use of metered-dose inhalers | During a hospitalization, approximately 2 days | 
| Asthma Evidence Based Practice 3 | Use of an asthma pathway/bronchodilator weaning protocol | During a hospitalization, approximately 2 days | 
| Bronchiolitis Evidence Based Practice 1 | No administration of bronchodilators | During a hospitalization, approximately 2 days | 
| Bronchiolitis Evidence Based Practice 2 | No chest radiographs | During a hospitalization, approximately 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Length Hospital Stay | During a hospitalization, approximately 2 days | 
| Transfer to Intensive Care | The event of patient being transferred to an ICU | During a hospitalization, approximately 2 days | 
| 30-day Hospital Readmission or Emergency Department Revisit | Event of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge | 30 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Clinical pathways, Hospital