TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): A Stepped-wedge Cluster Randomized Trial of an Electronic Clinical Decision Support Tool (eCDST) for the Diagnosis and Treatment of Lower Respiratory Tract Infection (LRTI) in Selected Hospitals in Southern Sri Lanka
概览
- 阶段
- 不适用
- 干预措施
- electronic clinical decision support tool (eCDST) diagnostic plan
- 疾病 / 适应症
- Lower Resp Tract Infection
- 发起方
- Duke University
- 入组人数
- 765
- 试验地点
- 3
- 主要终点
- Composite of adverse outcomes that could be attributed to withholding antibacterials
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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).
研究者
入排标准
入选标准
- •Admitted within prior 48 hours
- •Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:
- •New cough or sputum production
- •Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
- •Abnormal lung examination
- •Have evidence of acute infection, as indicated by at least one of the following:
- •Self-reported fever or chills
- •Documented fever ≥38 ̊ C (100.4 ̊ F)
- •Documented hypothermia \<35.5 ̊ C (95.9 ̊ F)
- •Leukocytosis (white blood cell count \>10,000/mm3)
排除标准
- •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
- •If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
- •If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:
- •Vasopressor therapy
- •Cystic fibrosis
- •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)
- •Have an accompanying non-respiratory infection
研究组 & 干预措施
Intervention Arm
Clinicians will be asked to use the diagnostic portion of the electronic clinical decision tool (eCDST) on their mobile phones, into which they will enter inputs and receive a diagnostic plan. Point of care (POC) testing as advised by the eCDST will be conducted by either clinical staff or trained research staff. If performed by research staff, results will be delivered on paper within 6 hours of testing to ≥ 2 primary clinicians on the team (including the consultant/ attending-level physician or senior registrar). THK, DGM, and DGH do not have an electronic medical record system. Clinicians will be asked to input the results from diagnostic testing and to follow the treatment recommendations as per the eCDST, but will be advised that the final decision regarding prescription of antimicrobials is entirely at their discretion.
干预措施: electronic clinical decision support tool (eCDST) diagnostic plan
Usual Care Arm
Study staff will inform the treating clinicians to diagnose and treat patients according to usual practice. Clinicians will be able to order routine diagnostic testing as per standard practice. These tests may include complete blood count, chemistries, C-reactive protein (CRP) testing, erythrocyte sedimentation rate (ESR) testing, blood and sputum cultures, and chest x-ray or chest CT imaging.
结局指标
主要结局
Composite of adverse outcomes that could be attributed to withholding antibacterials
时间窗: 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
时间窗: 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).
次要结局
- Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription(Day 30)
- Total antibacterial exposure per patient during hospitalization(Day 30)
- Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative(Day 1, Day 2, Day 3, at discharge, and by Day 30)
- Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization(Index hospitalization, up to approximately 30 days)
- Duration of non-invasive ventilation during index hospitalization(Index hospitalization, up to approximately 30 days)
- Duration of index hospitalization(Index hospitalization, up to approximately 30 days)
- Total oseltamivir exposure per patient during hospitalization(Day 30)
- Physician adherence, as measured by the proportion in whom all treatment recommendations were followed(24 hours and 48 hours)
- Proportion of participants using non-invasive ventilation(Day 30)
- Duration of admission to the intensive care unit (ICU) during index hospitalization(Index hospitalization, up to approximately 30 days)
- Duration of mechanical ventilation during index hospitalization(Index hospitalization, up to approximately 30 days)
- Proportion prescribed oseltamivir- cumulative(Day 1, Day 2, Day 3, at discharge, and by Day 30)
- Proportion of participants readmitted to the hospital(Day 30)
- Proportion of participants using mechanical ventilation(Day 30)
- Proportion of deaths(Day 30)
- Proportion of participants admitted to the intensive care unit (ICU) 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(Index hospitalization, up to approximately 30 days)
- Proportion prescribed antibacterials- cumulative(Day 1, Day 2, Day 3, by discharge, and by Day 30)
- Proportion prescribed antibacterials- at time of assessment(Day 1, Day 2, Day 3, by discharge, and by Day 30)
- Proportion prescribed oseltamivir- at time of assessment(Day 1, Day 2, Day 3, at discharge, and by Day 30)
- Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed(24 hours and 48 hours)
- Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment(Day 1, Day 2, Day 3, at discharge, and by Day 30)
- 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 first recommended diagnostic test (if recommended) was performed(24 hours)
- Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed(48 hours)