Clinical Trial: Electronic Hand Hygiene Monitoring and ICU Infection Rates

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Current Primary Outcome: Composite health care infection rate [ Time Frame: 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of central line associated blood stream infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition
  • Incidence of catheter associated urinary tract infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition
  • Incidence of ventilator associated pneumonia [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition
  • Incidence of surgical site infection [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    Public Health England definition
  • Incidence of clostridium difficult diarrhoea [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    Public Health England definition
  • Incidence of acquisition of new methicilllin resistant staphylococcus aureus [ Time Frame: Until the end of the second calendar day following ICU discharge ]
  • Incidence of secondary blood stream infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    CDC definition
  • Incidence of antibiotic resistance infections [ Time Frame: Until the end of the second calendar day following ICU discharge ]
    Pre-defined as Acinetobacter baumanii, Pseudomonas aeroginosa (Extended-Spectrum Beta Lacatamase [ESBL] producing), Klebsiella penumoniae (ESBL producing), Escherichia coli (ESBL producing), Stenotrophomonas maltophilia, Serratia marcescens, Clostridium difficile, or MRSA.
  • Adverse event rate [ Time Frame: 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Royal Brompton & Harefield NHS Foundation Trust

Dates:
Date Received: November 26, 2013
Date Started: November 2013
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015