Easy Hands: A Cluster Randomized Cross-Over Trial Evaluating a Simplified 3-Step Hand Hygiene Technique Versus the WHO 6-Step Technique on the Incidence of Healthcare-Associated Infections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,027
- 试验地点
- 1
- 主要终点
- Time to First Healthcare-Associated Infection
研究概览
简要总结
Healthcare-associated infections (HAIs) remain a major cause of morbidity, mortality, and healthcare costs worldwide. Hand hygiene is the cornerstone of infection prevention; however, adherence to the full WHO 6-step hand hygiene technique may be limited in routine clinical practice due to time constraints and workflow barriers. Simplified hand hygiene approaches may improve compliance while preserving clinical effectiveness.
The Easy Hands study is a pragmatic cluster randomized cross-over trial designed to compare a simplified 3-step hand hygiene technique with the standard WHO 6-step technique in clinical care units. Hospital services were randomized to one of two sequences of intervention and crossed over after the first study period. The primary objective is to evaluate whether the simplified 3-step technique is associated with differences in time to first healthcare-associated infection among hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to a participating cluster during an active intervention period.
- •Adult or pediatric hospitalized patient.
- •Availability of admission and discharge dates.
- •Eligibility for institutional infection surveillance.
排除标准
- •Admission to Emergency Department or Operating Rooms.
- •HAI present at baseline (t0).
- •HAI occurring during the first two hospital days.
研究组 & 干预措施
3-Step Hand Hygiene Technique
Simplified 3-step hand hygiene protocol implemented in assigned clusters during the intervention period
干预措施: 3-Step Hand Hygiene Technique (Behavioral)
WHO 6-Step Hand Hygiene Technique
Standard WHO 6-step hand hygiene protocol implemented in assigned clusters during the comparator period.
干预措施: WHO 6-Step Hand Hygiene Technique (Behavioral)
结局指标
主要结局
Time to First Healthcare-Associated Infection
时间窗: During hospitalization, up to 30 days
Time from hospital admission to first documented healthcare-associated infection according to institutional surveillance criteria.
次要结局
- Incidence Density of Healthcare-Associated Infections(During hospitalization, up to 30 days)
- Cumulative Incidence of Healthcare-Associated Infections(During hospitalization, up to 30 days)
- Hand Hygiene Compliance(During hospitalization, up to 30 days)