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

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

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.

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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

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05206695


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

Locations
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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
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Principal Investigator: Sunitha V Kaiser, MD, MSc University of California, San Francisco
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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    Key Record Dates
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.

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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:
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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