Condition category
Infections and Infestations
Date applied
13/01/2012
Date assigned
27/03/2012
Last edited
25/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hand hygiene is essential in preventing the spread of infection between patients in hospital wards. However, measuring the compliance of staff with hand hygiene can be difficult in single rooms or when bed curtains are used. Observers can only monitor for periods of 20 minutes and not at night. This study aims to establish if automatic monitoring of hand hygiene and patient contact improves compliance with feedback of results and is acceptable to patients and staff. Patients in wards where the equipment is installed will be asked to participate. Written informed consent is required.
A monitoring system (VeraMedico) has been devised by Veraz Ltd that can detect the use of alcohol gel through monitoring alcohol vapour and the use of soap and water through a device implanted in the waste outlet. Further devices are attached to furniture and equipment in the patient’s immediate environment (the patient zone) including the bed, locker and chair. Staff members wear a badge attached to the uniform on the upper chest. The devices detect contact between the staff member and the patient or any item of tagged furniture or equipment in the patient zone and can display a traffic light according to whether hand hygiene is needed before patient contact. The hand hygiene ‘opportunities’ (points where hand hygiene is required) and compliance are automatically recorded.

Who can participate?
Nurses and junior doctors on three wards

What does the study involve?
Independent visual observation would be conducted by research staff in two 20-minute sessions at set times during each day. The following phases will be included.
1. Two weeks visual observation only.
2. Two weeks observation with badges set at green and no feedback. The equipment would monitor the rate of hand hygiene.
3. Two weeks no intervention.
4. Two weeks observation plus badges working with colour change and feedback to professional. groups or on request the individual.
5. Eight weeks no intervention.
6. Two weeks monitoring with no badge colour change.
Spot checks of contamination of the high contact sites within the monitored zone would be made at random each day to determine the rate of hand transmission of pathogens.

What are the possible benefits and risks of participating?
Potential benefits are that staff hand hygiene will improve, reducing the risk of hospital-acquired infection. However, patients will be able to see if the staff member has or has not washed hands and may be concerned as a result. Patient group representatives have been involved in the study and will be available on the ward to deal with any concerns.

Where is the study run from?
University College London Hospitals (UK)

When is the study starting and how long is it expected to run for?
February 2012 to May 2012

Who is funding the study?
Veraz Ltd (UK)

Who is the main contact?
Dr Peter Wilson
peter.wilson@uclh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Wilson

ORCID ID

Contact details

Microbiology & Virology
University College London Hospitals
60 Whitfield Street
London
W1T 4EU
United Kingdom
+44 (0)20 3447 9516
peter.wilson@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v8

Study information

Scientific title

Trial of hand hygiene monitoring system protocol: a cohort sequential study

Acronym

Study hypothesis

The hand hygiene monitoring system records hand hygiene compliance accurately and results in an improvement in compliance

Ethics approval

NRES Committee London - Bentham, 18/07/2011, ref: 11/LO/0731

Study design

Cohort sequential

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hospital-acquired infection

Intervention

No patients will be fitted with equipment in this study. The equipment will be placed on beds, tables, chairs and sinks. The staff will wear badges that sense alcohol vapour and receive wifi information on whether hand hygiene has been performed before contact. The study will follow phases with no intervention, with the badges working but no feedback of information to staff or patients, badges working with feedback to staff and patients and then repeat observations to determine if there is any long lasting effect on hand hygiene.

Intervention type

Device

Phase

Drug names

Primary outcome measures

A daily report of hand hygiene compliance would be provided and displayed in the nurses’ station in each ward. Patients would be able to see the colour of badges worn by staff caring for them. Patients and staff would be approached with a simple questionnaire at the end of the monitoring (or when they were about to leave the ward if sooner) to determine acceptability of the system.

Secondary outcome measures

The effect of the system on hand hygiene and carriage of pathogens would be determined. Subset analysis would be attempted to examine the effect on each type of ward.

Overall trial start date

29/01/2012

Overall trial end date

29/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able to give written informed consent
2. Over 18 years
3. Patient or member of staff on target ward

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

20 staff and 20 patients

Participant exclusion criteria

1. Unable to give written informed consent
2. Paramedical staff

Recruitment start date

29/01/2012

Recruitment end date

29/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals
London
W1T 4EU
United Kingdom

Sponsor information

Organisation

University College London Hospitals (UK)

Sponsor details

c/o Philip Diamond
149 Tottenham Court Road
London
W1P 9LL
United Kingdom
+44 (0)20 7380 9833
philip.diamond@uclh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Veraz Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25115494

Publication citations

Additional files

Editorial Notes

25/08/2016: Publication reference added.