Reducing Overuse of Antibiotics with Decision Support (ROADS)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Asthma; Lower Respiratory Tract Infection; Bronchiolitis, Viral; Pneumonia

Treatments: Behavioral: ED Clinical Decision Support (CDS-ED); Behavioral: Transitions Clinical Decision Support (CDS-Tr)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06788093

R01HS029331 (U.S. AHRQ Grant/Contract)

240854

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,800 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,800 participants in 4 patient groups

Usual Care: Emergency Department

No Intervention group

Description:

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.

CDS-ED

Experimental group

Description:

The ED clinical decision support tool will be offered to emergency department providers in these enrolled encounters.

Treatment:

Behavioral: ED Clinical Decision Support (CDS-ED)

Usual Care: Inpatient

No Intervention group

Description:

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.

CDS-Tr

Experimental group

Description:

The Transitions clinical decision support tool will be offered to inpatient/ICU providers in these enrolled encounters.

Treatment:

Behavioral: Transitions Clinical Decision Support (CDS-Tr)