STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,280
- 试验地点
- 1
- 主要终点
- Antibiotic prescriptions at baseline visit
研究概览
简要总结
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.
The purpose of this study is to assess the impact of the algorithm on antibiotic use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 months-5 years
- •Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough
排除标准
- •Age > 5 years or < 2 months at time of presentation
- •Guardian not present to provide consent
研究组 & 干预措施
Control
Children who present to a village health worker during a control period are evaluated and managed using the current standard of care per Uganda National Guidelines for Integrated Community Case Management (ICCM). Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.
Intervention
Children who present to a village health worker during an intervention period are evaluated and managed using a modified ICCM algorithm that includes point-of-care C-reactive protein testing. Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.
干预措施: STAR Sick Child Job Aid (Other)
结局指标
主要结局
Antibiotic prescriptions at baseline visit
时间窗: Baseline visit
Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.
次要结局
- Unexpected visits(Between baseline visit and Day 7 follow-up assessment)
- Perceived improvement per caregiver(Day 7)
- Clinical Failure (Composite Outcome)(Between baseline visit and Day 7 follow-up assessment)
- Persistent fever(Day 7)
- Development of danger signs(Between Day 1 and Day 7)
- Hospitalization(Between Day 1 and Day 7)
- Death(Between Day 1 and Day 7)
- Antibiotic prescriptions during study follow-up(Between baseline visit and Day 7 follow-up assessment)