protocolSection identificationModule nctId: NCT06331364, orgStudyIdInfo id: Pro00114347, secondaryIdInfos id: R01AI168420, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AI168420, briefTitle: TREATment of Lower Respiratory Tract Infection in Sri Lanka (TREAT-SL), acronym: TREAT-SL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: 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., conditionsModule conditions: Lower Resp Tract Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: stepped-wedge, cluster randomized, two-arm, open labelThis design combines elements of a cluster randomized trial (intervention is applied in clusters) and a before-after design (each cluster switches to intervention). All 9 pairs of wards (clusters) will start with an initial period of usual care. At intervals of 3-6 months (steps), a set of 3 pairs of wards (clusters) will switch in a randomized order to use the intervention, until all pairs of wards have crossed over., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 765, type: ESTIMATED, armsInterventionsModule interventions name: electronic clinical decision support tool (eCDST) diagnostic plan, outcomesModule primaryOutcomes measure: Total duration of antibacterial prescription for the index visit, primaryOutcomes measure: Composite of adverse outcomes that could be attributed to withholding antibacterials, secondaryOutcomes measure: Proportion of participants using non-invasive ventilation, secondaryOutcomes measure: Proportion of participants using mechanical ventilation, secondaryOutcomes measure: Proportion of participants readmitted to the hospital, secondaryOutcomes measure: Proportion of deaths, secondaryOutcomes measure: Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription, secondaryOutcomes measure: Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization, secondaryOutcomes measure: Duration of admission to the intensive care unit (ICU) during index hospitalization, secondaryOutcomes measure: Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization, secondaryOutcomes measure: Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization, secondaryOutcomes measure: Duration of non-invasive ventilation during index hospitalization, secondaryOutcomes measure: Duration of mechanical ventilation during index hospitalization, secondaryOutcomes measure: Duration of index hospitalization, secondaryOutcomes measure: Proportion prescribed antibacterials- cumulative, secondaryOutcomes measure: Proportion prescribed antibacterials- at time of assessment, secondaryOutcomes measure: Total antibacterial exposure per patient during hospitalization, secondaryOutcomes measure: Proportion prescribed oseltamivir- cumulative, secondaryOutcomes measure: Proportion prescribed oseltamivir- at time of assessment, secondaryOutcomes measure: Total oseltamivir exposure per patient during hospitalization, secondaryOutcomes measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative, secondaryOutcomes measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment, secondaryOutcomes measure: Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed, secondaryOutcomes measure: Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom all treatment recommendations were followed, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False