Lower Respiratory Tract InfectionROADSNCT06788093
Reducing Overuse of Antibiotics With Decision Support
A study testing ED Clinical Decision Support (CDS-ED) and Transitions Clinical Decision Support (CDS-Tr) in people with Lower Respiratory Tract Infection and Pneumonia, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Lower Respiratory Tract Infection, Pneumonia, Asthma
- What is being tested?
- ED Clinical Decision Support (CDS-ED) and Transitions Clinical Decision Support (CDS-Tr)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2024to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Justine Stassun, MS, 6159367276, justine.stassun@vumc.org
Derek Williams, MD, MPH, derek.williams@vumc.org
- Not yet recruiting
Benioff Children's Hospital - Oakland
Oakland, California, 94609
Suni Kaiser, MD, MSc, 415-476-3392, sunitha.kaiser@ucsf.edu
Suni Kaiser, MD, MSc
- Not yet recruiting
Benioff Children's Hospital - San Francisco
San Francisco, California, 94158
Suni Kaiser, MD, MSc, 415-476-3392, sunitha.kaiser@vumc.org
Suni Kaiser, MD, MSc
About this study
Official title: 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.
Read the 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.
- Being tested
- ED Clinical Decision Support (CDS-ED), Transitions Clinical Decision Support (CDS-Tr)
- Medical subject headings
- Pneumonia, Asthma, Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED Clinical Decision Support (CDS-ED)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care: Emergency Department | No intervention | 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 | The ED clinical decision support tool will be offered to emergency department providers in these enrolled encounters. Receives: Behavioral: ED Clinical Decision Support (CDS-ED) |
| Usual Care: Inpatient | No intervention | 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 | The Transitions clinical decision support tool will be offered to inpatient/ICU providers in these enrolled encounters. Receives: Behavioral: Transitions Clinical Decision Support (CDS-Tr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 10 days
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 10 days
Safety: Need for Intensive Care
Use of intensive care at any point during index encounter
Measured: 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)
Measured: 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
Measured: 14 days
Safety: 3- and 14-day Hospital Reutilization
Any re-hospitalization occurring within 72 and 336 hours of index discharge
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start12 Nov 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In this pragmatic, randomized clinical trial, the investigators will evaluate the effectiveness and implementation of two stewardship-focused CDS interventions, alone and in combination, against usual care.
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of California, San Francisco
- Responsible party
- Principal investigator, Derek Williams, Vanderbilt University Medical Center
- Investigators
- Derek J Williams, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788093
- Sponsor's protocol ID
- 240854
- Other IDs
- R01HS029331
- Acronym
- ROADS
- Status last verified
- Jan 2026
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No