Clinical trial NCT02511925: Electronic Hand Hygiene Monitoring and ICU Infection Rates
Official title: A Pragmatic Crossover Cluster Randomised Study of Electronic Compliance Monitoring of Staff Hand Sanitisation in Critical Care (HANDS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cross Infection
Keywords: Critical care
Feedback
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 1065
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU during the study period.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Composite health care infection rate
timeFrame: Until the end of the second calendar day following ICU discharge
Secondary outcomes:
measure: Incidence of central line associated blood stream infections
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of catheter associated urinary tract infections
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of ventilator associated pneumonia
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of surgical site infection
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of clostridium difficult diarrhoea
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of acquisition of new methicilllin resistant staphylococcus aureus
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of secondary blood stream infections
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Incidence of antibiotic resistance infections
timeFrame: Until the end of the second calendar day following ICU discharge
measure: Adverse event rate
timeFrame: 24 weeks
Other outcomes:
measure: Staff attitudes to electronic compliance monitoring
timeFrame: 0 and 24 weeks
measure: Surrogate measures of hand hygiene compliance
timeFrame: 24 weeks
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Patricia Cattini, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng VC, Tai JW, Ho SK, Chan JF, Hung KN, Ho PL, Yuen KY. Introduction of an electronic monitoring system for monitoring compliance with Moments 1 and 4 of the WHO "My 5 Moments for Hand Hygiene" methodology. BMC Infect Dis. 2011 May 26;11:151. doi: 10.1186/1471-2334-11-151.