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Reducing Overuse of Antibiotics With Decision Support

NCT06788093 · Vanderbilt University Medical Center
In plain English

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Official title
Reducing Overuse of Antibiotics With Decision Support in Lower Respiratory Tract Infections
About this study
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
Study design
Enrollment target: 2800 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2024-11-12
Estimated completion: 2027-04
Last updated: 2026-01-22
Interventions
Behavioral: ED Clinical Decision Support (CDS-ED)Behavioral: Transitions Clinical Decision Support (CDS-Tr)
Primary outcomes
  • Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index (10 days)
  • Primary Safety: Proportion of Participants Experiencing Escalation in Treatment (10 days)
Sponsor
Vanderbilt University Medical Center · other
With: Agency for Healthcare Research and Quality (AHRQ), University of California, San Francisco
Contacts & investigators
ContactJustine Stassun, MS · contact · justine.c.stassun@vumc.org · 615-936-7276
InvestigatorDerek J Williams, MD, MPH · principal_investigator, Vanderbilt University Medical Center
All locations (3)
Benioff Children's Hospital - OaklandNot Yet Recruiting
Oakland, California, United States
Benioff Children's Hospital - San FranciscoNot Yet Recruiting
San Francisco, California, United States
Monroe Carell Jr Children's Hospital at VanderbiltRecruiting
Nashville, Tennessee, United States
Reducing Overuse of Antibiotics With Decision Support · TrialPath