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临床试验/NCT02511925
NCT02511925已完成不适用

A Pragmatic Crossover Cluster Randomised Study of Electronic Compliance Monitoring of Staff Hand Sanitisation in Critical Care (HANDS Study)

Royal Brompton & Harefield NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 1,065 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,065
试验地点
1
主要终点
Composite health care infection rate

研究概览

简要总结

If patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. Indeed, there is much public concern about infections such as MRSA. Patients who require intensive care are probably at the greatest risk.

Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance include lack of time, skin irritation, lack of facilities, intensity of workload and forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff may not associate their (lack of) actions with having caused harm.

Measuring compliance levels enables staff to understand whether they could improve. Direct observation of staff is labour intensive and is not continuous or universal. We will monitor hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise that comprehensive personalised feedback will reduce healthcare associated infections. We will undertake the study in three intensive care units.

详细描述

All patients admitted to three intensive care units will be monitored for healthcare associated infections. In parallel the units will be cluster randomised to implement the electronic compliance monitoring in three different ways:

  • Unit level feed back every week of current compliance for each of three staff groupings (doctors, nurses, allied health professionals)
  • Personalised feedback in the form of an email at the end of a shift stating an individuals performance relative to the average for their professional grouping.
  • Real time feedback in the form of a badge worn by the healthcare worker that vibrates when the system thinks they have missed or are about to miss an opportunity for hand hygiene.

All healthcare workers will receive the level of feedback defined in the randomisation for the duration of the three intervention periods. The units will cross-over with an interventing two week wash out period.

All personal feedback will be confidential and private to the individual.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients admitted to the intensive care units
  • All healthcare workers caring for the patients on the intensive care units.

排除标准

  • Healthcare workers with skin sensitivity to both alcohol hand rub and soap

结局指标

主要结局

Composite health care infection rate

时间窗: Until the end of the second calendar day following ICU discharge

One of the following three: Bacteriological proven infection at a normally sterile site. The sterile sites vein considered are a prior defined as blood, broncho-alveolar lavage, urine sampled from a catheter, chest drain fluid, and surgical wounds. Blood cultures that grow normal skin commensals will be included Endotracheal secretions that culture organisms other than normal upper respiratory tract flora Clostridium difficult related diarrhoea

次要结局

  • Adverse event rate(24 weeks)
  • Incidence of catheter associated urinary tract infections(Until the end of the second calendar day following ICU discharge)
  • Incidence of ventilator associated pneumonia(Until the end of the second calendar day following ICU discharge)
  • Incidence of surgical site infection(Until the end of the second calendar day following ICU discharge)
  • Incidence of central line associated blood stream infections(Until the end of the second calendar day following ICU discharge)
  • Incidence of clostridium difficult diarrhoea(Until the end of the second calendar day following ICU discharge)
  • Incidence of acquisition of new methicilllin resistant staphylococcus aureus(Until the end of the second calendar day following ICU discharge)
  • Incidence of secondary blood stream infections(Until the end of the second calendar day following ICU discharge)
  • Incidence of antibiotic resistance infections(Until the end of the second calendar day following ICU discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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