Reducing Overuse of Antibiotics With Decision Support (ROADS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Asthma; Lower Respiratory Tract Infection; Bronchiolitis, Viral
• Intervention / Treatment: Behavioral: ED Clinical Decision Support (CDS-ED); Behavioral: Transitions Clinical Decision Support (CDS-Tr)

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.

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Stassun, MS; Phone Number: 615-936-7276; Email: justine.c.stassun@vumc.org

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Not yet recruiting
      • Benioff Children's Hospital - Oakland
      • Contact: Suni Kaiser, MD, MSc; Phone Number: 415-476-3392; Email: sunitha.kaiser@ucsf.edu
      • Principal Investigator: Suni Kaiser, MD, MSc
    • San Francisco, California, United States, 94158
      • Not yet recruiting
      • Benioff Children's Hospital - San Francisco
      • Contact: Suni Kaiser, MD, MSc; Phone Number: 415-476-3392; Email: sunitha.kaiser@vumc.org
      • Principal Investigator: Suni Kaiser, MD, MSc
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Monroe Carell Jr Children's Hospital at Vanderbilt
      • Contact: Justine Stassun, MS; Phone Number: 6159367276; Email: justine.stassun@vumc.org
      • Contact: Derek Williams, MD, MPH; Email: derek.williams@vumc.org
      • Principal Investigator: Derek Williams, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: ED Clinical Decision Support (CDS-ED); The ED-CDS intervention is designed as a discrete decision support aid to influence initial antibiotic decision-making in the ED. This intervention will feature a clinician-facing LRTI dashboard for end-users that assimilates relevant clinical data (e.g., vital signs, select diagnostic tests, links to reference information) and offers tailored suggestions for antibiotic initiation, related diagnostic testing, and in those receiving antibiotics, preferred options and alternatives for antibiotic choice, route, dose, and duration.
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.	Behavioral: Transitions Clinical Decision Support (CDS-Tr); The CDS-Tr intervention is designed as a longitudinal decision support aid to influence initial and ongoing (i.e., continuation, discontinuation, escalation, or de-escalation) antibiotic decision-making in the hospital setting. This intervention will also feature the LRTI dashboard along with additional tailored suggestions and recommendations for antibiotic decision-making upon hospital admission, and for those receiving antibiotics, at the time of discharge. Additionally, CDS-Tr will be active at the time of any service transition (i.e., hospital to intensive care or vice versa) and at pre-specified time points (e.g., approximately 48 hours and 120 hours following ED triage for encounters remaining in the hospital).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index	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.	10 days
Primary Safety: Proportion of Participants Experiencing Escalation in Treatment	Treatment escalation will capture the escalation to higher level of care and/or antibiotic treatment strategy	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: Proportion of Participants Experiencing Reduction of ASI Score	De-escalation of antibiotic exposure intensity (1+ level decrease in daily antibiotic exposure intensity) for a duration of at least 72 hours during the first 10 days of treatment	10 days
Effectiveness: Total Treatment Duration	Days until cessation of antibiotic exposure (i.e., daily periods with an ASI score greater than 0) for the index encounter, inclusive of antibiotics received in the ED and hospital, as well as any additional days of antibiotics prescribed at discharge up to 42 days after enrollment.	42 days
Effectiveness: ASI per Exposure Day	The numerator is the cumulative ASI during the first 10 days of treatment (T0-T240) and the denominator is the number of days of antibiotic exposure (i.e., daily periods with an ASI score greater than 0) during this same period.	10 days
Safety: Need for Intensive Care	Use of intensive care at any point during index encounter	42 days
Safety: Need for Invasive Mechanical Ventilation or Shock Requiring Vasoactive Medications	Need for intubation and/or need for vasoactive medications to manage uncompensated shock at any point during the index encounter (excludes intubation or vasoactive medications used for or during planned procedures or surgical intervention)	42 days
Safety: 3- and 14-day ED Reutilization	Any ED revisit occurring within 72 and 336 hours of index discharge that does not result in hospitalization	14 days
Safety: 3- and 14-day Hospital Reutilization	Any re-hospitalization occurring within 72 and 336 hours of index discharge	14 days
Death within 14 days of index discharge	Death by any cause occurring: 1) during the index encounter; 2) within 14 days of the index discharge, or 3) reutilization occurring within 14 days of the index discharge and that results in death at any time during that encounter	14 days

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of California, San Francisco; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Derek J Williams, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Bronchiolitis; Bronchitis; Asthma; Pneumonia; Bronchiolitis, Viral
• Other Study ID Numbers: 240854; R01HS029331 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No