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Completed

NCT Number: NCT05206695

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multi-condition Pathway Intervention

Behavioral

See Experimental/Arm 1 description

Primary outcomes

  1. Pneumonia Evidence Based Practice 1

    Time frame: During a hospitalization, approximately 2 days

    Administration of narrow spectrum antibiotic

  2. Pneumonia Evidence Based Practice 2

    Time frame: During a hospitalization, approximately 2 days

    No prescription of macrolide antibiotics

  3. Asthma Evidence Based Practice 1

    Time frame: During a hospitalization, approximately 2 days

    Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old

  4. Asthma Evidence Based Practice 2

    Time frame: During a hospitalization, approximately 2 days

    Use of metered-dose inhalers

  5. Asthma Evidence Based Practice 3

    Time frame: During a hospitalization, approximately 2 days

    Use of an asthma pathway/bronchodilator weaning protocol

  6. Bronchiolitis Evidence Based Practice 1

    Time frame: During a hospitalization, approximately 2 days

    No administration of albuterol

  7. Bronchiolitis Evidence Based Practice 2

    Time frame: During a hospitalization, approximately 2 days

    No chest radiographs

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: During a hospitalization, approximately 2 days

    Length Hospital Stay

  2. Transfer to Intensive Care

    Time frame: During a hospitalization, approximately 2 days

    The event of patient being transferred to an ICU

  3. 30-day Hospital Readmission or Emergency Department Revisit

    Time frame: 30 days after hospital discharge

    Event of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Society of Hospital Medicine

Registry information

Official study title

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

Acronym: SIP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.