Reducing Overuse of Antibiotics with Decision Support in Lower Respiratory Tract Infections

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Eliminating inappropriate antibiotic use in pediatric lower respiratory tract infections (LRTI) is the central focus of this research. LRTIs (pneumonia, bronchiolitis, and infection-related exacerbations of asthma) account for nearly one-third of all emergency department (ED) visits and 40% of all infection-related hospitalizations in US children. LRTIs also account for more antibiotic use in children's hospitals than any other condition, despite most LRTIs being viral in nature. Inappropriate antibiotics are associated with substantial adverse effects. Accordingly, national guidelines strongly discourage routine antibiotic use for bronchiolitis and acute asthma and argue for significantly reducing antibiotic exposure (initiation, spectrum, and duration) in pneumonia. To address the problem of inappropriate antibiotic use, hospital-based antimicrobial stewardship programs (ASPs) are now common nationwide, and these programs have demonstrated effectiveness in some hospital settings. Unfortunately, traditional ASP approaches do not translate well to the fast-paced and unpredictable ED environment, and hospital-based ASP resources are finite and not always immediately available. Clinical decision support (CDS) embedded within the electronic health record (EHR) is a strategy that could address the ED antibiotic stewardship gap. Informed by a deep understanding of the key facilitators and barriers to using CDS to support appropriate antibiotic use in ED and hospital settings, the investigators have developed two stewardship-focused CDS interventions for pediatric LRTI. The overarching goal of this research is to rigorously evaluate the implementation and effectiveness of these CDS tools, alone and in combination, against usual care only in a pragmatic randomized clinical trial at 3 U.S. children's hospitals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:

• ED encounter or admission to an inpatient hospital team.

• EHR-based positive screen for suspected LRTI, defined as a qualifying chief complaint (e.g., cough, shortness of breath, etc.), plus triage documentation of abnormal respiratory effort and/or cough.

Locations
United States
California
Benioff Children's Hospital - Oakland
NOT_YET_RECRUITING
Oakland
Benioff Children's Hospital - San Francisco
NOT_YET_RECRUITING
San Francisco
Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt
RECRUITING
Nashville
Contact Information
Primary
Justine Stassun, MS
justine.c.stassun@vumc.org
615-936-7276
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-04
Participants
Target number of participants: 2800
Treatments
No_intervention: Usual Care: Emergency Department
No experimental decision support will be provided to the emergency medicine providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.
Experimental: CDS-ED
The ED clinical decision support tool will be offered to emergency department providers in these enrolled encounters.
No_intervention: Usual Care: Inpatient
No experimental decision support will be provided to the inpatient/ICU providers in encounters randomized to the control arm. All patients will receive usual care and treatment will not be restricted or altered in any way by the study.
Experimental: CDS-Tr
The Transitions clinical decision support tool will be offered to inpatient/ICU providers in these enrolled encounters.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: Agency for Healthcare Research and Quality (AHRQ), University of California, San Francisco

This content was sourced from clinicaltrials.gov