Reducing Overuse of Antibiotics With Decision Support

NCT ID: NCT06788093

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2027-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CDS-ED

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

Group Type: EXPERIMENTAL

ED Clinical Decision Support (CDS-ED)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CDS-Tr

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

Group Type: EXPERIMENTAL

Transitions Clinical Decision Support (CDS-Tr)

Intervention Type: BEHAVIORAL

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).

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Derek Williams

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek J Williams, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Benioff Children's Hospital - Oakland

Oakland, California, United States

Site Status: NOT_YET_RECRUITING

Benioff Children's Hospital - San Francisco

San Francisco, California, United States

Site Status: NOT_YET_RECRUITING

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Justine Stassun, MS

Role: CONTACT

justine.c.stassun@vumc.org

615-936-7276

Facility Contacts

Suni Kaiser, MD, MSc

Role: primary

sunitha.kaiser@ucsf.edu

415-476-3392

Suni Kaiser, MD, MSc

Role: primary

sunitha.kaiser@vumc.org

415-476-3392

Justine Stassun, MS

Role: primary

justine.stassun@vumc.org

6159367276

Derek Williams, MD, MPH

Role: backup

derek.williams@vumc.org

Other Identifiers

R01HS029331

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

240854

Identifier Type: -

Identifier Source: org_study_id