Reducing Overuse of Antibiotics With Decision Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
ED Clinical Decision Support (CDS-ED)
BehavioralThe 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)
BehavioralThe 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).
Treatment groups
2,800 Participants
are divided into 4 treatment groupsGroup A: Usual Care: Emergency DepartmentNo intervention 0 interventions
Group B: CDS-EDExperimental treatment 1 intervention
Group C: Usual Care: InpatientNo intervention 0 interventions
Group D: CDS-TrExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 days2
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
Time frame
10 daysSecondary outcomes
1
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
Time frame
10 days2
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.
Time frame
42 days3
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.
Time frame
10 days4
Safety: Need for Intensive Care
Use of intensive care at any point during index encounter
Time frame
42 daysSponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov