Recruiting

Antibiotic Decision Support

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06788093

Conditions

Lower Respiratory Tract Infection

Pneumonia

Asthma

Bronchiolitis, Viral

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

ED Clinical Decision Support (CDS-ED)

Transitions Clinical Decision Support (CDS-Tr)

Study Details

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.

Conditions

Lower Respiratory Tract Infection

Pneumonia

Asthma

Bronchiolitis, Viral

Study ID

NCT06788093

Start date

Nov 12, 2024

Status verified date

Jan, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

2800 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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).

Primary outcome measure

  • Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index [ Time Frame: 10 days ]
  • Primary Safety: Proportion of Participants Experiencing Escalation in Treatment [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Locations

Monroe Carell Jr Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Derek Williams, MD, MPH

derek.williams@vumc.org

Principal Investigator:

Derek Williams, MD, MPH

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-01-22.