This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka.
The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.
The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed (a maximum of 14 days).
Admitted within prior 48 hours
New cough or sputum production
Chest pain
Dyspnea or tachypnea (respiratory rate >20 breaths/minute)
Hospitalized recently (within last 28 days)
If they have been enrolled into this clinical trial previously
Surgery in the past 7 days
If they are unable or unwilling to complete the follow-up encounter
Crossover
electronic clinical decision support tool (eCDST) diagnostic plan
Other interventionParticipants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials used. Analyses will compare clinical outcomes and antimicrobial use between the intervention arm and usual care.
Composite of adverse outcomes that could be attributed to withholding antibacterials
A binary clinical endpoint consisting of a composite of adverse outcomes that could be attributed to withholding antibacterials. These outcomes would not be present at enrollment, and could occur anytime until Day 30.
Total duration of antibacterial prescription for the index visit
Total duration of antibacterial prescription for the index visit will include the number of days that antibacterials are prescribed during the index hospitalization, as well as the number of days that antibacterials are prescribed at discharge from the hospital (intended use).
Proportion of participants using non-invasive ventilation
Use of non-invasive ventilation (i.e., continuous positive airway pressure \[CPAP\] or bilevel positive airway pressure \[BiPAP\]) for treatment of the acute illness )
Proportion of participants using mechanical ventilation
Use of mechanical ventilation (via endotracheal tube)
Proportion of participants readmitted to the hospital
Proportion of participants readmitted to the hospital
Proportion of deaths
Proportion of deaths
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Duke University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator