Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
SIP
The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
1 other identifier
interventional
11,760
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started May 2022
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedStudy Start
First participant enrolled
May 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2025
CompletedApril 20, 2026
April 1, 2026
3.4 years
January 11, 2022
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 albuterol
During a hospitalization, approximately 2 days
Bronchiolitis Evidence Based Practice 2
No chest radiographs
During a hospitalization, approximately 2 days
Secondary Outcomes (3)
Length of Hospital Stay
During a hospitalization, approximately 2 days
Transfer to Intensive Care
During a hospitalization, approximately 2 days
30-day Hospital Readmission or Emergency Department Revisit
30 days after hospital discharge
Study Arms (2)
Multi-condition Pathway Intervention
EXPERIMENTALThe 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.
Standard of Care
NO INTERVENTIONHospitals 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.
Interventions
See Experimental/Arm 1 description
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of SARS-CoV-2
- Transfer in from another inpatient facility
- Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94153, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunitha V Kaiser, MD, MSc
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants, clinicians, and investigators cannot be masked due to the nature of the intervention. However, outcomes assessors will be masked.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2022
First Posted
January 25, 2022
Study Start
May 13, 2022
Primary Completion
October 21, 2025
Study Completion
October 21, 2025
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will become available after peer-reviewed publication, and it will be available for 3 years.
Data generated under this project will be administered in accordance with the policies of the University of California San Francisco (UCSF) and NIH/NHLBI. The Final Research Data (the dataset necessary to document and support research findings) will be made available for sharing after the main research findings from the final data set have been accepted for publication in a peer-reviewed journal. Prior to sharing, data will be redacted to strip all direct identifiers of hospitals (no identifiers of patients/individuals will be collected).