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

Asthma Clinical Trial

— SIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206695
• Other study ID #: R61HL157804
• Secondary ID: R61HL157804
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Sunitha V Kaiser, MD, MSc
• Phone: 415-476-3392
• Email: sunitha.kaiser[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16800
• Est. completion date: June 30, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Bronchiolitis
• Pneumonia

Intervention

Behavioral:
• Multi-condition Pathway Intervention
See Experimental/Arm 1 description

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI), Society of Hospital Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia Evidence Based Practice 1	Administration of narrow spectrum antibiotic	During a hospitalization, approximately 2 days
Primary	Pneumonia Evidence Based Practice 2	No prescription of macrolide antibiotics	During a hospitalization, approximately 2 days
Primary	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
Primary	Asthma Evidence Based Practice 2	Use of metered-dose inhalers	During a hospitalization, approximately 2 days
Primary	Asthma Evidence Based Practice 3	Use of an asthma pathway/bronchodilator weaning protocol	During a hospitalization, approximately 2 days
Primary	Bronchiolitis Evidence Based Practice 1	No administration of bronchodilators	During a hospitalization, approximately 2 days
Primary	Bronchiolitis Evidence Based Practice 2	No chest radiographs	During a hospitalization, approximately 2 days
Secondary	Length of Hospital Stay	Length Hospital Stay	During a hospitalization, approximately 2 days
Secondary	Transfer to Intensive Care	The event of patient being transferred to an ICU	During a hospitalization, approximately 2 days
Secondary	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