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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Asthma; Bronchiolitis
• Intervention / Treatment: Behavioral: Multi-condition Pathway Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 16800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunitha V Kaiser, MD, MSc; Phone Number: 415-476-3392; Email: sunitha.kaiser@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94153
      • Recruiting
      • University of California, San Francisco
      • Contact: Sunitha Kaiser, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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, and electronic order sets.	Behavioral: Multi-condition Pathway Intervention; See Experimental/Arm 1 description
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Society of Hospital Medicine
• Investigators: Principal Investigator: Sunitha V Kaiser, MD, MSc, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Children; Hospital; Clinical pathways
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Bronchitis; Pneumonia; Asthma; Bronchiolitis
• Other Study ID Numbers: R61HL157804 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: The data will become available after peer-reviewed publication, and it will be available for 3 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No