Clinical Pathway Intervention for Pediatric Respiratory Conditions

(SIP Trial)

Overseen by Sunitha Kaiser, MD, MSc

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new way to help doctors treat children with asthma, pneumonia, or bronchiolitis in community hospitals. The method uses simple visual guides to ensure doctors follow the best care practices. The goal is to improve health outcomes and reduce hospital stays and costs.

Research Team

Sunitha Kaiser, MD, MSc

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for children hospitalized with asthma (ages 2-18), pneumonia (ages 2 months to <18 years), or bronchiolitis (<2 years old) in community hospitals. It excludes those with COVID-19, chronic illnesses like lung or heart disease, neurologic disorders, or transfers from other inpatient facilities.

Inclusion Criteria

I have asthma and am between 2 and 18 years old.

I was diagnosed with pneumonia and am between 2 months and 18 years old.

My child was diagnosed with bronchiolitis and is under 2 years old.

Exclusion Criteria

I have been diagnosed with COVID-19.

I have a long-term illness like heart, lung, or nerve problems.

Transfer in from another inpatient facility

Treatment Details

Interventions

• Multi-condition Pathway Intervention (Behavioral Intervention)

Trial Overview The study tests a multi-condition clinical pathway intervention aimed at increasing clinicians' use of evidence-based practices for treating asthma, pneumonia, and bronchiolitis over two years. The trial randomly assigns hospitals to either the new pathway or control group.

Participant Groups

Group I: Multi-condition Pathway Intervention Experimental Treatment 1 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.

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Society of Hospital Medicine

Collaborator

Trials

6

Recruited

24,200+