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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Active, not recruiting

Conditions

Asthma
Bronchiolitis
Pneumonia

Treatments

Behavioral: Multi-condition Pathway Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05206695
R61HL157804 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,840 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No 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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3,840 participants in 2 patient groups

Multi-condition Pathway Intervention
Experimental group
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.
Treatment:
Behavioral: Multi-condition Pathway Intervention
Standard of Care
No Intervention group
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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Sunitha V Kaiser, MD, MSc

Data sourced from clinicaltrials.gov

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