Reducing Overuse of Antibiotics With Decision Support in Lower Respiratory Tract Infections (ROADS)

NCT06788093 NA RECRUITING

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.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	RECRUITING
Enrolment	2800
Start date	2024-11-12
Completion	2027-04

Conditions

• Lower Respiratory Tract Infection
• Pneumonia
• Asthma
• Bronchiolitis, Viral

Interventions

• ED Clinical Decision Support (CDS-ED)
• Transitions Clinical Decision Support (CDS-Tr)

Primary outcomes

• Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index — 10 days
  The Antibiotic Spectrum Index (ASI) is a numerical metric which quantifies the relative breadth of antimicrobial activity of a given antibiotic medication. Tracking the 10-day trajectory of ASI will capture changes in antibiotic use resulting from changes in antibiotic initiation, spectrum of antibiotic activity, and duration of antibiotic use.
• Primary Safety: Proportion of Participants Experiencing Escalation in Treatment — 10 days
  Treatment escalation will capture the escalation to higher level of care and/or antibiotic treatment strategy

Countries

United States