Clinical trial NCT06788093: Reducing Overuse of Antibiotics with Decision Support
Official title: Reducing Overuse of Antibiotics with Decision Support in Lower Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Respiratory Tract Infection
Pneumonia
Asthma
Bronchiolitis, Viral
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of California, San Francisco
First posted: 2025-01-22
Enrollment: 2800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In this pragmatic, randomized clinical trial, the investigators will evaluate the effectiveness and implementation of two stewardship-focused CDS interventions, alone and in combination, against usual care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This is a usual care-controlled superiority clinical trial platform designed to evaluate the effects of hospital-based CDS in the ED (CDS-ED) and after transitioning to the hospital setting (CDS-TR) on antibiotic prescribing and related clinical outcomes for child and adolescent LRTI encounters at 3 U.S. children's hospitals. The investigators hypothesize that both interventions will be superior to usual care and, among patients presenting in the ED and subsequently admitted to the hospital, the combined interventions (CDS-ED + CDS-TR) will be most effective overall. Randomization will occur sequentially in two stages corresponding to the ED CDS and Transitions CDS populations. The first stage of randomization will allocate qualifying ED encounters 1:1 to CDS-ED vs. usual care alone in the ED. The second stage of randomization will allocate participants requiring hospitalization (those discharged from the hospital are not eligible) 1:1 to CDS-TR vs. usual care at the time of admission. To minimize bias, the trial will be embedded within clinical care with minimal exclusions and disruption to usual care activities. Investigators will be blinded to study arm assignment, though blinding of treating clinicians is not possible due to the nature of the study. The trial will also evaluate process and implementation outcomes throughout the study period within the platform population. A formal interim analysis is not planned.

Eligibility criteria: Inclusion Criteria:

1. ED encounter or admission to an inpatient hospital team.
2. 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.

Exclusion Criteria: None

Primary outcomes:
measure: Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index
timeFrame: 10 days
measure: Primary Safety: Proportion of Participants Experiencing Escalation in Treatment
timeFrame: 10 days
Secondary outcomes:
measure: Effectiveness: Proportion of Participants Experiencing Reduction of ASI Score
timeFrame: 10 days
measure: Effectiveness: Total Treatment Duration
timeFrame: 42 days
measure: Effectiveness: ASI per Exposure Day
timeFrame: 10 days
measure: Safety: Need for Intensive Care
timeFrame: 42 days
measure: Safety: Need for Invasive Mechanical Ventilation or Shock Requiring Vasoactive Medications
timeFrame: 42 days
measure: Safety: 3- and 14-day ED Reutilization
timeFrame: 14 days
measure: Safety: 3- and 14-day Hospital Reutilization
timeFrame: 14 days
measure: Death within 14 days of index discharge
timeFrame: 14 days
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Benioff Children's Hospital - Oakland
state: California
city: San Francisco
country: United States
facility: Benioff Children's Hospital - San Francisco
state: California
city: Nashville
country: United States
facility: Monroe Carell Jr Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Derek J Williams, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: