About this trial
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).
Eligibility criteria
Qualifiers
Admitted within prior 48 hours
New cough or sputum production
Chest pain
Dyspnea or tachypnea (respiratory rate >20 breaths/minute)
Disqualifiers
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
Trial design
Treatments tested in this trial
- electronic clinical decision support tool (eCDST) diagnostic plan
Treatment groups
Sponsors and collaborators
Duke University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator