Lower Resp Tract Infection
Conditions
Keywords
eCDST
Brief summary
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).
Interventions
OTHERelectronic clinical decision support tool (eCDST) diagnostic plan
Participants 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.
Sponsors
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stepped-wedge, cluster randomized, two-arm, open label This 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. We will use the stepped-wedge design since 1) this design may provide higher statistical power, since clusters act as their own controls, 2) to reduce contamination bias, and 3) to reduce the risk of a cluster dropping out of the study if assigned to the control group.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted within prior 48 hours 2. Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following: 1. New cough or sputum production 2. Chest pain 3. Dyspnea or tachypnea (respiratory rate \>20 breaths/minute) 4. Abnormal lung examination 3. Have evidence of acute infection, as indicated by at least one of the following: 1. Self-reported fever or chills 2. Documented fever ≥38 ̊ C (100.4 ̊ F) 3. Documented hypothermia \<35.5 ̊ C (95.9 ̊ F) 4. Leukocytosis (white blood cell count \>10,000/mm3) 5. Leukopenia (white blood cell count \<3000/mm3) 6. New altered mental status 4. Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent 5. Ability of children 14-17 years of age to provide assent 6. Ability to complete follow-up encounter at 30 days in person or by telephone
Exclusion criteria
1. Hospitalized recently (within last 28 days) 2. If they have been enrolled into this clinical trial previously 3. Surgery in the past 7 days 4. If they are unable or unwilling to complete the follow-up encounter 5. If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital) 6. If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials: 1. Vasopressor therapy 2. Cystic fibrosis 3. Known severe immunosuppression (i. Cancer or another condition with neutropenia (absolute neutrophil count \<1000/ microL; ii. Solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. Active graft-versus-host disease or bronchiolitis obliterans; iv. On chronic steroids equivalent to prednisone 20mg daily for ≥ 2 weeks or other targeted cytotoxic or biologic immunosuppressants within the prior 4 weeks; v. Human immunodeficiency virus infection with a CD4 cell count \<200/mm3) 4. Have an accompanying non-respiratory infection 5. Have evidence of a lung abscess or empyema 6. Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of adverse outcomes that could be attributed to withholding antibacterials | Day 30 | 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 | Index hospitalization, up to approximately 14 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants using non-invasive ventilation | Day 30 | 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 | Day 30 | Use of mechanical ventilation (via endotracheal tube) |
| Proportion of participants readmitted to the hospital | Day 30 | Proportion of participants readmitted to the hospital |
| Proportion of deaths | Day 30 | Proportion of deaths |
| Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription | Day 30 | Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription |
| Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization | Index hospitalization, up to approximately 30 days | Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization |
| Duration of admission to the intensive care unit (ICU) during index hospitalization | Index hospitalization, up to approximately 30 days | Duration of admission to the intensive care unit (ICU) during index hospitalization |
| Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization | Index hospitalization, up to approximately 30 days | Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization |
| Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization | Index hospitalization, up to approximately 30 days | Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization |
| Duration of non-invasive ventilation during index hospitalization | Index hospitalization, up to approximately 30 days | Duration of non-invasive ventilation during index hospitalization |
| Duration of mechanical ventilation during index hospitalization | Index hospitalization, up to approximately 30 days | Duration of mechanical ventilation during index hospitalization |
| Duration of index hospitalization | Index hospitalization, up to approximately 30 days | Duration of index hospitalization |
| Proportion prescribed antibacterials- cumulative | Day 1, Day 2, Day 3, by discharge, and by Day 30 | Any prescription of antibacterials from enrollment to the point of assessment will be considered prescription of antibacterials. |
| Proportion prescribed antibacterials- at time of assessment | Day 1, Day 2, Day 3, by discharge, and by Day 30 | Prescription of antibacterials will only be assessed at the specific time of assessment |
| Total antibacterial exposure per patient during hospitalization | Day 30 | This is defined as the total number of days prescribed an antibacterial |
| Proportion prescribed oseltamivir- cumulative | Day 1, Day 2, Day 3, at discharge, and by Day 30 | Any prescription of oseltamivir from enrollment to the point of assessment will be considered prescription of oseltamivir |
| Proportion prescribed oseltamivir- at time of assessment | Day 1, Day 2, Day 3, at discharge, and by Day 30 | Prescription of oseltamivir will only be assessed at the specific time of assessment |
| Total oseltamivir exposure per patient during hospitalization | Day 30 | This is defined as the total number of days prescribed oseltamivir |
| Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative | Day 1, Day 2, Day 3, at discharge, and by Day 30 | Any prescription of SARS-CoV-2 antivirals from enrollment to the point of assessment will be considered prescription of SARS-CoV-2 antivirals |
| Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment | Day 1, Day 2, Day 3, at discharge, and by Day 30 | Prescription of SARS-CoV-2 antivirals will only be assessed at the specific time of assessment |
| Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed | 24 hours | Physician adherence to the eCDST diagnostic recommendations within 24 hours of receiving recommendations, in the intervention group. |
| Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed | 48 hours | Physician adherence to the eCDST diagnostic recommendations within 48 hours of receiving recommendations, in the intervention group. |
| Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed | 24 hours and 48 hours | Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed |
| Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed | 24 hours and 48 hours | Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed |
| Physician adherence, as measured by the proportion in whom all treatment recommendations were followed | 24 hours and 48 hours | Physician adherence, as measured by the proportion in whom all treatment recommendations were followed |
Countries
Sri Lanka
Contacts
CONTACTGayani Tillekeratne, MD, MSc
CONTACTStefany Olague, MPH
PRINCIPAL_INVESTIGATORGayani Tillekeratne, MD, MSc
Duke University
Outcome results
None listed