Electronic Hand Hygiene Monitoring and ICU Infection Rates

Cross Infection Clinical Trial

— HANDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511925
• Other study ID #: 2013IC004B
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: July 27, 2015
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1065
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cross Infection

Intervention

Other:
• Weekly poster of unit performance
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
• Daily email of personal feedback
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
• Active reminder from badge
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff attitudes to electronic compliance monitoring	Quantitative and qualitative analysis of questionnaire data	0 and 24 weeks	No
Other	Surrogate measures of hand hygiene compliance	Alcohol hand rub usage, Soap usage and visual compliance monitoring	24 weeks	No
Primary	Composite health care infection rate	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	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of central line associated blood stream infections	CDC definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of catheter associated urinary tract infections	CDC definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of ventilator associated pneumonia	CDC definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of surgical site infection	Public Health England definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of clostridium difficult diarrhoea	Public Health England definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of acquisition of new methicilllin resistant staphylococcus aureus		Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of secondary blood stream infections	CDC definition	Until the end of the second calendar day following ICU discharge	No
Secondary	Incidence of antibiotic resistance infections	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.	Until the end of the second calendar day following ICU discharge	No
Secondary	Adverse event rate		24 weeks	Yes