Reducing Overuse of Antibiotics With Decision Support

Part of paid clinical trials in Oakland, California.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06788093
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
2,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Primary Effectiveness: 10-day Longitudinal Antimicrobial Spectrum Index [ Time Frame: 10 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Benioff Children's Hospital - OaklandOaklandCalifornia94609
Suni Kaiser, MD, MSc
[email protected]
415-476-3392
Suni Kaiser, MD, MSc (PRINCIPAL_INVESTIGATOR)
Benioff Children's Hospital - San FranciscoSan FranciscoCalifornia94158
Suni Kaiser, MD, MSc
[email protected]
415-476-3392
Suni Kaiser, MD, MSc (PRINCIPAL_INVESTIGATOR)
Monroe Carell Jr Children's Hospital at VanderbiltNashvilleTennessee37232
Justine Stassun, MS
[email protected]
6159367276
Derek Williams, MD, MPH
[email protected]
Derek Williams, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Benioff Children's Hospital - Oakland· Oakland, CABenioff Children's Hospital - San Francisco· San Francisco, CAMonroe Carell Jr Children's Hospital at Vanderbilt· Nashville, TN

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