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

Primary Purpose

Asthma, Pneumonia, Bronchiolitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-condition Pathway Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Children, Clinical pathways, Hospital

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multi-condition Pathway Intervention

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pneumonia Evidence Based Practice 1
Administration of narrow spectrum antibiotic
Pneumonia Evidence Based Practice 2
No prescription of macrolide antibiotics
Asthma Evidence Based Practice 1
Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Asthma Evidence Based Practice 2
Use of metered-dose inhalers
Asthma Evidence Based Practice 3
Use of an asthma pathway/bronchodilator weaning protocol
Bronchiolitis Evidence Based Practice 1
No administration of bronchodilators
Bronchiolitis Evidence Based Practice 2
No chest radiographs

Secondary Outcome Measures

Length of Hospital Stay
Length Hospital Stay
Transfer to Intensive Care
The event of patient being transferred to an ICU
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

Full Information

First Posted
January 11, 2022
Last Updated
October 12, 2023
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Society of Hospital Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05206695
Brief Title
Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Acronym
SIP
Official Title
The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Society of Hospital Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Pneumonia, Bronchiolitis
Keywords
Children, Clinical pathways, Hospital

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
16800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multi-condition Pathway Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-condition Pathway Intervention
Intervention Description
See Experimental/Arm 1 description
Primary Outcome Measure Information:
Title
Pneumonia Evidence Based Practice 1
Description
Administration of narrow spectrum antibiotic
Time Frame
During a hospitalization, approximately 2 days
Title
Pneumonia Evidence Based Practice 2
Description
No prescription of macrolide antibiotics
Time Frame
During a hospitalization, approximately 2 days
Title
Asthma Evidence Based Practice 1
Description
Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Time Frame
During a hospitalization, approximately 2 days
Title
Asthma Evidence Based Practice 2
Description
Use of metered-dose inhalers
Time Frame
During a hospitalization, approximately 2 days
Title
Asthma Evidence Based Practice 3
Description
Use of an asthma pathway/bronchodilator weaning protocol
Time Frame
During a hospitalization, approximately 2 days
Title
Bronchiolitis Evidence Based Practice 1
Description
No administration of bronchodilators
Time Frame
During a hospitalization, approximately 2 days
Title
Bronchiolitis Evidence Based Practice 2
Description
No chest radiographs
Time Frame
During a hospitalization, approximately 2 days
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Length Hospital Stay
Time Frame
During a hospitalization, approximately 2 days
Title
Transfer to Intensive Care
Description
The event of patient being transferred to an ICU
Time Frame
During a hospitalization, approximately 2 days
Title
30-day Hospital Readmission or Emergency Department Revisit
Description
Event of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge
Time Frame
30 days after hospital discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunitha V Kaiser, MD, MSc
Phone
415-476-3392
Email
sunitha.kaiser@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunitha V Kaiser, MD, MSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunitha Kaiser, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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