ISRCTN ISRCTN45174482
DOI https://doi.org/10.1186/ISRCTN45174482
Secondary identifying numbers v8
Submission date
13/01/2012
Registration date
27/03/2012
Last edited
25/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Peter Wilson
Scientific

Microbiology & Virology
University College London Hospitals
60 Whitfield Street
London
W1T 4EU
United Kingdom

Phone +44 (0)20 3447 9516
Email peter.wilson@uclh.nhs.uk

Study information

Study designCohort sequential
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTrial of hand hygiene monitoring system protocol: a cohort sequential study
Study objectivesThe hand hygiene monitoring system records hand hygiene compliance accurately and results in an improvement in compliance
Ethics approval(s)NRES Committee London - Bentham, 18/07/2011, ref: 11/LO/0731
Health condition(s) or problem(s) studiedHospital-acquired infection
InterventionNo 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureA 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 measuresThe 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 study start date29/01/2012
Completion date29/05/2012

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20 staff and 20 patients
Key inclusion criteria1. Able to give written informed consent
2. Over 18 years
3. Patient or member of staff on target ward
Key exclusion criteria1. Unable to give written informed consent
2. Paramedical staff
Date of first enrolment29/01/2012
Date of final enrolment29/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London Hospitals
London
W1T 4EU
United Kingdom

Sponsor information

University College London Hospitals (UK)
Hospital/treatment centre

c/o Philip Diamond
149 Tottenham Court Road
London
W1P 9LL
England
United Kingdom

Phone +44 (0)20 7380 9833
Email philip.diamond@uclh.nhs.uk
ROR logo "ROR" https://ror.org/042fqyp44

Funders

Funder type

Industry

Veraz Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2014 Yes No

Editorial Notes

25/08/2016: Publication reference added.