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NCT Number: NCT06788093

Reducing Overuse of Antibiotics With Decision Support

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.

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Key information

Conditions

Lower Respiratory Tract Infection Asthma Bronchial Diseases Bronchiolitis Bronchiolitis, Viral Bronchitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Pneumonia Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benioff Children's Hospital - Oakland, Oakland, California, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ED encounter or admission to an inpatient hospital team.
  • 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

Treatment and study plan

ED Clinical Decision Support (CDS-ED)

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.

Transitions Clinical Decision Support (CDS-Tr)

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).

Primary outcomes

  1. Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index

    Time frame: 10 days

    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.

  2. Primary Safety: Proportion of Participants Experiencing Escalation in Treatment

    Time frame: 10 days

    Treatment escalation will capture the escalation to higher level of care and/or antibiotic treatment strategy

Secondary outcomes

  1. Effectiveness: Proportion of Participants Experiencing Reduction of ASI Score

    Time frame: 10 days

    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

  2. Effectiveness: Total Treatment Duration

    Time frame: 42 days

    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.

  3. Effectiveness: ASI per Exposure Day

    Time frame: 10 days

    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.

  4. Safety: Need for Intensive Care

    Time frame: 42 days

    Use of intensive care at any point during index encounter

  5. Safety: Need for Invasive Mechanical Ventilation or Shock Requiring Vasoactive Medications

    Time frame: 42 days

    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)

  6. Safety: 3- and 14-day ED Reutilization

    Time frame: 14 days

    Any ED revisit occurring within 72 and 336 hours of index discharge that does not result in hospitalization

  7. Safety: 3- and 14-day Hospital Reutilization

    Time frame: 14 days

    Any re-hospitalization occurring within 72 and 336 hours of index discharge

  8. Death within 14 days of index discharge

    Time frame: 14 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Justine Stassun, MS

CONTACT

[email protected]

615-936-7276

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • University of California, San Francisco

Registry information

Official study title

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

Acronym: ROADS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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