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Completed

NCT Number: NCT02511925

Electronic Hand Hygiene Monitoring and ICU Infection Rates

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.

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Key information

Conditions

Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weekly poster of unit performance

Other

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

Other

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

Other

The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of central line associated blood stream infections

    Time frame: Until the end of the second calendar day following ICU discharge

    CDC definition

  2. Incidence of catheter associated urinary tract infections

    Time frame: Until the end of the second calendar day following ICU discharge

    CDC definition

  3. Incidence of ventilator associated pneumonia

    Time frame: Until the end of the second calendar day following ICU discharge

    CDC definition

  4. Incidence of surgical site infection

    Time frame: Until the end of the second calendar day following ICU discharge

    Public Health England definition

  5. Incidence of clostridium difficult diarrhoea

    Time frame: Until the end of the second calendar day following ICU discharge

    Public Health England definition

  6. Incidence of acquisition of new methicilllin resistant staphylococcus aureus

    Time frame: Until the end of the second calendar day following ICU discharge

  7. Incidence of secondary blood stream infections

    Time frame: Until the end of the second calendar day following ICU discharge

    CDC definition

  8. 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.

  9. Adverse event rate

    Time frame: 24 weeks

Other outcomes

  1. Staff attitudes to electronic compliance monitoring

    Time frame: 0 and 24 weeks

    Quantitative and qualitative analysis of questionnaire data

  2. Surrogate measures of hand hygiene compliance

    Time frame: 24 weeks

    Alcohol hand rub usage, Soap usage and visual compliance monitoring

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: HANDS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2015
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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