Title: A cluster randomised controlled trial of a behavioural change package to prevent hand dermatitis in nurses working in the National Health Service
Funder: Department of Health (England)

Abstract: Aims: We will test the hypothesis 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). Secondary aims will be to assess impacts on participants’ beliefs and behaviour regarding hand care and on the colonisation of their hands by pathogenic bacteria. In addition we will assess the cost-effectiveness of the intervention in comparison with normal care. Intervention: The intervention will centre on a bespoke on-line 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 occupational health (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.Methods We will test the intervention in a cluster randomised controlled trial at 26 NHS acute hospital trusts focusing on two groups of staff: (i) student nurses who are about to start their first clinical placements and are at increased risk of hand dermatitis from wet work because of a past history of atopic disease or hand eczema; and (ii) nurses working in intensive care units who are at increased risk of hand dermatitis because of the nature of their work. Nurses at control trusts will be managed according to what would currently be regarded as best practice with provision of an advice leaflet about optimal hand care (also provided to the intervention group and developed by the same team as the BCP) and encouragement to contact their OH department early if hand dermatitis occurs. However they will not receive the BCP or active reinforcement of its messages. Nor will they routinely be offered supplies of moisturising cream over and above what is already standard practice in their trust. The impact of the intervention will be evaluated from information collected by questionnaires and standardised photographs of hands (which will be assessed for the presence of dermatitis blind to other information about the participant). In addition we will assemble relevant economic data for an analysis of costs and benefits and collect information from various sources to evaluate processes. Statistical analysis will be by multi-level regression modelling to allow for clustering by trust and will take account of the paired nature of before and after comparisons in individuals. The principal outcome measure will be the difference between intervention and control trusts in the change in point prevalence of visible hand dermatitis from baseline to 12 months after the intervention. Secondary outcome measures will include: 1)The incidence of new episodes of hand dermatitis presenting to the OH department over the 12-months of follow-up2)The difference between intervention and control trusts in the change in severity of visible hand dermatitis from baseline to the end of follow-up3)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-up4)The change in estimated prevalence of hand colonisation by pathogenic bacteria (with or without associated dermatitis) from baseline to the end of follow-up5)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 the baseline to the end of follow-up in behaviours relevant to skin care.7)The change from baseline to the end of follow-up in quality of life scoreBefore implementing the trial we will undertake a feasibility study in a hospital in Wales (Bangor and Swansea have indicated their willingness to participate in the feasibility study). Procedures will be followed as for the first stages of the main study at an intervention trust after which participants and the lead OH clinician from the trust will be asked to provide qualitative feedback. The main outcome measures will be:1)The numbers of eligible nurses in each group and the numbers (%) agreeing to participate2)The response rates to questionnaires A and B and any problems in their use4)The proportions of recruited nurses participating in the BCP and its ease of use and acceptability.5)The baseline prevalence of hand dermatitis in student and ICU nurses6)The ease of use of the photographic method for assessing the presence and severity of hand dermatitis and the between observer agreement in the assessment of photographs. 7)The response rates to swabbing and any problems in its use.If necessaryamendments will be made to address any problems that come to light from the feasibility exercise. The project will be terminated if in the view of the steering group and funder the feasibility study indicates that the proposed methods are irremediably unsatisfactory or that adequate power could not be achieved.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: SKIN