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

• ClinicalTrials.gov Identifier: NCT05206695
• Recruitment Status: Recruiting
• First Posted: January 25, 2022
• Last Update Posted: May 27, 2022
• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Society of Hospital Medicine
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma; Pneumonia; Bronchiolitis	Behavioral: Multi-condition Pathway Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Outcomes Assessor)
• Masking Description: Participants, care providers, and investigators cannot be masked due to the nature of the intervention. However, outcomes assessors will be masked.
• Primary Purpose: Health Services Research
• Official Title: The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
• Actual Study Start Date: April 1, 2022
• Estimated Primary Completion Date: October 31, 2024
• Estimated Study Completion Date: November 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 bronchodilators
7. Bronchiolitis Evidence Based Practice 2 [ Time Frame: During a hospitalization, approximately 2 days ]
   No chest radiographs

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: Sunitha V Kaiser, MD, MSc; 415-476-3392; sunitha.kaiser@ucsf.edu

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94153

Contact: Sunitha Kaiser, MD, MSc

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Society of Hospital Medicine

Investigators

• Principal Investigator: Sunitha V Kaiser, MD, MSc; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05206695
• Other Study ID Numbers: R61HL157804 ( U.S. NIH Grant/Contract ); R61HL157804 ( U.S. NIH Grant/Contract )
• First Posted: January 25, 2022
• Last Update Posted: May 27, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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).
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: The data will become available after peer-reviewed publication, and it will be available for 3 years.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Children; Clinical pathways; Hospital

Additional relevant MeSH terms:

Pneumonia; Bronchiolitis; Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Bronchitis