Electronic Hand Hygiene Monitoring and ICU Infection Rates (HANDS)

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

1065

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom
        • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the ICU during the study period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU Cluster 1
Adult Intensive Care Unit - Royal Brompton Hospital
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
ICU Cluster 2
Paediatric ICU - Royal Brompton Hospital
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed
ICU Cluster 3
Adult Intensive Care Unit - Harefield Hospital
Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Until the end of the second calendar day following ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of central line associated blood stream infections
Time Frame: Until the end of the second calendar day following ICU discharge
CDC definition
Until the end of the second calendar day following ICU discharge
Incidence of catheter associated urinary tract infections
Time Frame: Until the end of the second calendar day following ICU discharge
CDC definition
Until the end of the second calendar day following ICU discharge
Incidence of ventilator associated pneumonia
Time Frame: Until the end of the second calendar day following ICU discharge
CDC definition
Until the end of the second calendar day following ICU discharge
Incidence of surgical site infection
Time Frame: Until the end of the second calendar day following ICU discharge
Public Health England definition
Until the end of the second calendar day following ICU discharge
Incidence of clostridium difficult diarrhoea
Time Frame: Until the end of the second calendar day following ICU discharge
Public Health England definition
Until the end of the second calendar day following ICU discharge
Incidence of acquisition of new methicilllin resistant staphylococcus aureus
Time Frame: Until the end of the second calendar day following ICU discharge
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
Until the end of the second calendar day following ICU discharge
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.
Until the end of the second calendar day following ICU discharge
Adverse event rate
Time Frame: 24 weeks
24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staff attitudes to electronic compliance monitoring
Time Frame: 0 and 24 weeks
Quantitative and qualitative analysis of questionnaire data
0 and 24 weeks
Surrogate measures of hand hygiene compliance
Time Frame: 24 weeks
Alcohol hand rub usage, Soap usage and visual compliance monitoring
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia Cattini, MSc, Royal Brompton and Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2013IC004B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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