Condition category
Skin and Connective Tissue Diseases
Date applied
13/06/2013
Date assigned
21/06/2013
Last edited
21/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hand dermatitis (eczema) is a common cause of discomfort and loss of productivity in the NHS workforce with treatment costs amounting to £125 million/year. Different preventive measures are used to reduce hand dermatitis in healthcare workers but it is not clear how effective these are. To prevent infections spreading between patients, nurses have to wear gloves and wash their hands a lot of the time. This constant contact with detergents and water often leads nurses to develop hand dermatitis, which in turn may mean that they are more likely to carry harmful bacteria on their hands. The risk of getting hand dermatitis is particularly high in nurses with a past history of allergic disease such as asthma and childhood eczema and among nurses who work in intensive care units (ICUs) where patient contacts and hand washing are more frequent. Hand dermatitis can be reduced by avoiding unnecessary overuse of gloves and washing of hands, drying hands properly after washing, and regular use of hand creams (moisturisers). However, hand care by nurses is often poor. We will study nurses at high risk of hand dermatitis (student nurses with a past history of allergic disease and ICU nurses) and test the effectiveness and value for money of an online training programme (Behavioural Change Package or BCP) which aims to change nurses’ beliefs and behaviours in looking after their hands.

Who can participate?
This study aims to recruit, through the participating trust's Occupational Health (OH) department, at least 40 ICU nurses and 40 first year student nurses at each of 26 NHS trusts in England.

What does the study involve?
NHS trusts will be randomly allocated to one of two groups. 13 trusts will receive BCP and 13 trusts to act as controls. Nurses in the control trusts will be provided with the same written information as the nurses in trusts receiving BCP, and will be encouraged to report hand dermatitis early to their OH department. They will otherwise receive advice in accordance with their local trust's existing policies. Nurses receiving BCP will be encouraged to develop detailed plans to help them change their behaviours, supported by online reminders. The student nurses will be provided with personal tubes of moisturising cream. On ICU wards, facilities for washing and drying hands will be reduced and dispensers of moisturising creams installed. The participants will be asked to complete a questionnaire at the start of the study about past and current hand dermatitis, allergies, beliefs about hand care, use of gloves, soaps, alcohol hand rubs, moisturisers, activities outside work which may lead to dermatitis and current quality of life. BCP will then be implemented in the allocated trusts. We will ask the nurses to complete a shorter questionnaire soon after they have received the BCP and again at the end of 12 months. In addition, any nurses who report hand dermatitis at any stage of the study will be asked to have their hands photographed and checked for harmful germs. Nurses with hand dermatitis will be treated according to normal practice in their trust. Two dermatologists from the study team will review the photographs to grade the severity of dermatitis. We will also randomly check the hands of nurses who do not have dermatitis.

What are the possible benefits and risks of participating?
All nurses participating in the study will benefit from intensive hand care advice. If the programme is effective, those in the BCP-receiving group will benefit from a lower risk of developing hand dermatitis. The results of the study will be circulated to the participants so that all nurses in the study will benefit from increased awareness of the importance of hand care at work. The study has been designed to have few, if any, adverse effects on the study participants. The programme is not painful or intrusive and should have little inconvenience. Once an individual has developed irritant hand dermatitis the outlook is poor. Individuals may develop sleep disturbance and hampered leisure activities.

Where is the study run from?
This study is being led by Guy's and St Thomas' NHS Foundation Trust but involves senior researchers and experts from King's College, London; the University of Southampton; Imperial College, London; University College London; the University of Manchester and Nottingham University Hospitals NHS Trust.

When is the study starting and how long is it expected to run for?
After a feasibility study in a hospital in Wales, the main study will start in September 2014 and will last until May 2017.

Who is funding the study?
The project is funded by the National Institute for Health Research (NIHR), UK

Who is the main contact?
Dr Ira Madan
Ira.madan@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ira Madan

ORCID ID

http://orcid.org/0000-0003-2200-7329

Contact details

Guy's & St Thomas' NHS Trust
Education Centre
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Type

Scientific

Additional contact

Dr Vaughan Parsons

ORCID ID

Contact details

King's College London
c/o Occupational Health Service
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/94/01

Study information

Scientific title

A cluster randomised controlled trial of a behavioural change package to prevent hand dermatitis in nurses working in the National Health Service

Acronym

SCIN

Study hypothesis

It is hypothesised that a behavioural change intervention to improve hand care, based on the theory of planned behaviour and implementation intentions, coupled with provision of hand moisturisers, can produce a clinically useful reduction in the occurrence of hand dermatitis when compared to standard care in at-risk nurses working in the National Health Service (NHS).

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/119401
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/81186/PRO-11-94-01.pdf

Ethics approval

NRES Committee London - City Road & Hampstead, original application approved on 31/10/2013 (ref: 13/LO/09810) and substantial amendment application approved on 05/09/2014. Protocol v14 approved 05/11/2014.

Study design

Four-year cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

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

Hand dermatitis

Intervention

1. Nurses in intervention trusts will receive the bespoke online behavioural change package (BCP). This will be developed by members of the study team with expertise in dermatology, occupational medicine, nursing, and health psychology and care will be taken to ensure compatibility with current guidance on infection control. It will include advice: on when and when not to use gloves; on when to use antibacterial hand rubs; on when and how to wash and dry hands; on when to use moisturising cream; and to contact OH early if hand dermatitis occurs. As part of the package, nurses will be asked to form implementation intentions for performing behaviours in their workplace. These will be recorded, and participants will subsequently be reminded of them and offered the opportunity to revise them. The package will be supported by provisions to encourage adherence, such as moisturising creams. It will be actively reinforced over the course of the study by consistent messages on skin care from local OH and control of infection teams, and from line management.
2. Nurses in control trusts will be provided with an advice leaflet about optimal hand care and encouragement to contact their occupational health department early if hand dermatitis occurs.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome is the change in point prevalence of visible hand dermatitis from baseline to the end of follow up.
Methodology: All study participants will be asked to contact their occupational health department early if they develop hand dermatitis. Their hands, wrists and forearms will be photographed using a standardised method. The images obtained will subsequently be assessed independently by two dermatologists blinded to other information about the participant, to ascertain whether any hand dermatitis is present. A participant will be classed as a case if both observers note visible hand dermatitis. In the event of disagreement, between the two dermatologists a third arbitrator will be consulted.

Secondary outcome measures

Secondary outcomes will be the difference between intervention and control trusts in:
1. The incidence of new episodes of hand dermatitis presenting to the OH department over the 12-months of follow-up
2. Severity of visible hand dermatitis from baseline to the end of follow-up
3. Days lost from sickness absence and days of modified duties because of hand dermatitis per 100 days of nurse time during the 12-months of follow-up
4. The change in estimated prevalence of hand colonisation by pathogenic bacteria (with or without associated dermatitis) from baseline to the end of follow-up
5. The change from baseline to after completion of the BCP, and to the end of the 12-month follow-up in beliefs about dermatitis prevention behaviours.
6. The change from baseline to the end of follow-up in the reported frequency of use of alcohol hand rubs for hand cleansing, hand-washing with water, use of recommended techniques for drying hands after washing, use of moisturising creams and use of gloves for different durations (for student nurses, who will not have started clinical attachments at the beginning of the study, this will reduce to differences between the intervention and control trusts at the end of the follow-up)
7. The change from baseline to the end of follow-up in quality of life score

We will also document the reported participation in the behavioural change package, reasons given for not participating, and comments on its content.

Overall trial start date

01/01/2014

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All NHS trusts in England which train nurses, have an in-house occupational health (OH) service and have at least one intensive care unit (ICU)
2. First year student nurses and ICU nurses

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

2240

Participant exclusion criteria

In order to avoid the risk of student nurses moving placements from an intervention to a control trust (or vice versa), only one trust in each city or town will be invited to participate. London is an exception to this where three trusts were identified in which student nurses did not move to neighbouring trusts during their training.

Recruitment start date

01/09/2014

Recruitment end date

01/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's and St Thomas NHS Foundation Trust
The Education Centre 75-79 York Road Waterloo
London
SE1 7EH
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Centre Robinson Way and Long Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

East Kent University Hospitals NHS Foundation Trust
Kent & Canterbury Hospital Ethelbert Road
Canterbury
CT1 3NG
United Kingdom

Trial participating centre

Frimley Health NHS Foundation Trust
Frimley Park Hospital Portsmouth Road Frimley
Camberley
GU16 7UJ
United Kingdom

Trial participating centre

Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom

Trial participating centre

Hull and East Yorkshire Hospitals NHS Trust
OH Department Castle Hill Hospital Castle Road
Cottingham
HU16 5JQ
United Kingdom

Trial participating centre

Industrial Diagnostics
Atherstone House The Sidings Merry Lees Industrial Est.
Merry Lees
LE9 9FE
United Kingdom

Trial participating centre

Kettering General Hospital NHS Foundation Trust
Rothwell Road
Kettering
NN16 8UZ
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals Foundation NHS Trust
LTH Occupational Health Royal Preston Hospital Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

Trial participating centre

NHS Lothian
NHS Lothian Occupational Health Service Astley Ainslie Hospital Grange Loan
Edinburgh
EH9 2HL
United Kingdom

Trial participating centre

Luton and Dunstable University Hospital NHS Foundation Trust
Luton & Dunstable University Hospital Lewsey Road
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Milton Keynes NHS Foundation Trust
Milton Keynes Hospital Standing Way
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
20 Rouen Road
Norwich
NR1 1QQ
United Kingdom

Trial participating centre

Northampton General Hospital NHS Trust
Occupational Health Department Billing House Cliftonville
Northampton
NN1 5BD
United Kingdom

Trial participating centre

North Tees NHS
University Hospital of North Tees Hardwick
Stockton on Tees
TS19 8PE
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Queens Medical Centre Campus Nottingham Occupational Health Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Oxford University Hospital NHS Trust
John Radcliffe Hospital Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

Pennine Acute Hospital NHS Foundation Trust
North Manchester General Hospital Delaunays Road Crumpsall
Manchester
M8 5RB
United Kingdom

Trial participating centre

Plymouth Hospitals NHS Trust
Kingstor House Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
21 Craven Road
Reading
RG1 5LE
United Kingdom

Trial participating centre

St George's Healthcare NHS Trust
St George's Healthcare NHS Trust Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

The Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

The Leeds Teaching Hospitals NHS Trust
St. James's University Hospital Beckett Street
Leeds
LS9 7TF
United Kingdom

Trial participating centre

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Campus for Aging and Vitality (NGH) Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Woodlands Nurses Home Selly Oak Hospital Raddlebarn
Birmingham
B29 6JF
United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

University Hospital Southampton NHS Trust
Southampton General Hospital Tremona Rd
Southampton
SO16 3YD
United Kingdom

Trial participating centre

Sheffield Hospital NHS Trust
Northern General Hospital Herries Road
Sheffield
S5 7AU
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
Centurion House Centurion Park Tribune Way Clifton Moor
York
YO30 4RY
United Kingdom

Trial participating centre

University of Manchester
The Mill Sackville Street
Manchester
M13 9PL
United Kingdom

Trial participating centre

University of Salford
Allerton Building Frederick Road Campus
Salford
M6 6PU"
United Kingdom

Trial participating centre

Wye Valley NHS Trust
County Hospital Stonebow Rd
Hereford
HR1 3AW
United Kingdom

Trial participating centre

West Suffolk NHS Foundation Trust
West Suffolk Hospital Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Trial participating centre

Old Nurses Home
Glangwilli General Hospital
Carmarthen
SA31 2AF
United Kingdom

Trial participating centre

Ty Hafren Bronglais
General Hospital
Aberystwyth
SY23 1ER
United Kingdom

Trial participating centre

Prince Philip Hospital
Dafen Road
Llanelli
SA14 8QF
United Kingdom

Trial participating centre

Withybush General Hospital
Fishguard Road
Haverfordwest
SA61 2PZ
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust (UK)

Sponsor details

c/o Ms Karen Ingatian
R&D Department
16th Floor
Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26987818

Publication citations

Additional files

Editorial Notes

21/03/2016: Publication reference added.