Clinical trial NCT05206695: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Official title: The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Pneumonia
Bronchiolitis
Keywords: Children
Clinical pathways
Hospital
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Society of Hospital Medicine
First posted: 2022-01-25
Enrollment: 3840
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Pneumonia Evidence Based Practice 1
timeFrame: During a hospitalization, approximately 2 days
measure: Pneumonia Evidence Based Practice 2
timeFrame: During a hospitalization, approximately 2 days
measure: Asthma Evidence Based Practice 1
timeFrame: During a hospitalization, approximately 2 days
measure: Asthma Evidence Based Practice 2
timeFrame: During a hospitalization, approximately 2 days
measure: Asthma Evidence Based Practice 3
timeFrame: During a hospitalization, approximately 2 days
measure: Bronchiolitis Evidence Based Practice 1
timeFrame: During a hospitalization, approximately 2 days
measure: Bronchiolitis Evidence Based Practice 2
timeFrame: During a hospitalization, approximately 2 days
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: During a hospitalization, approximately 2 days
measure: Transfer to Intensive Care
timeFrame: During a hospitalization, approximately 2 days
measure: 30-day Hospital Readmission or Emergency Department Revisit
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sunitha V Kaiser, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: