This study was grounded in the recommendations of the Medical Research Council’s guidance on complex interventions which asserts: ‘Best practice is to develop interventions systematically, using the best available evidence and appropriate theory, then to test them using a carefully phased approach, starting with a series of pilot studies targeted at each of the key uncertainties in the design, and moving on to an exploratory and then a definitive evaluation.’.
Given the uncertainties surrounding case management for dementia, we approached the adaptation of the PREVENT intervention as a design process for an innovative way of working. The adoption of new ways of working may depend on the characteristics of the new approaches themselves, and those of the professionals and patients/carers who use them . The characteristics of innovations that favour their uptake and diffusion through clinical practice [18–20] are: their compatibility with the values, norms and perceived needs of intended adopters; their simplicity; the clear, unambiguous advantage they offer; their openness to experimentation by intended users; the ability to adapt, refine or otherwise modify the innovation; their ability to add to the user's social standing; and the voluntary nature of their use. We were conscious that attempts to introduce new methods of working and new technologies into primary care are often unsuccessful. There is a risk of ‘shoe-horning’ – forcing the innovation into practice – that provokes resistance to change amongst practitioners .
We assumed that a complex process of case management for a complex disease, namely dementia, would work against standardisation of clinical methods and in favour of professional creativity and person-centredness. “Standardising care without identifying desirable variation or unique adaptations that take advantage of local opportunities or strengths misses an opportunity to identify and investigate unanticipated circumstances or locally adapted practice configurations associated with better health care outcomes”.
Full ethical approval was granted from the North West London Research and Ethics Committee (10/H0722/50) and all work was carried out within the guidelines set by the declaration of Helsinki.
The design process
The aims of work package one (WP1) of the CARE-DEM study were to review, adapt and customise the PREVENT intervention for NHS general practice. WP1 corresponds to the first stage (development) of Mohler et al.’s criteria for describing complex interventions .
We used a co-design method to gain insight from a diverse range of experienced practitioners and carers . Following meetings of the co-design development group, the materials produced were then reviewed and critiqued by a separate group of practitioners, carers and older people with experience of using health and social care services. This was a cyclic process in which a series of prototypes was refined until the development group felt confident that it had produced a version worth field-testing in work package two (WP2).
Prior to each meeting, the materials for discussion and any amendments that had been made from the previous meeting were circulated via email to members. Those unable to make a meeting were invited to email their comments in advance. This process was repeated with each of the outputs until the group declared itself happy with the materials in a final review meeting.
We anticipated that contextual issues underpinning the development process would be:
The staff likely to become case managers would be experienced NHS or social work professionals, so principles of adult learning would core to the intervention;
Case managers would need to be flexible in working with geographical variations in service and professional availability, and the differing boundaries of organisations;
They would need to navigate through changes underway in health and social care services.
Setting and process
The research team undertook development work in one area of England to facilitate group meetings. The site chosen covered a diverse population and different organisational boundaries. Research staff in Kent and Medway NHS and Social Care Partnership Trust were asked to identify potential members for an expert group of stakeholders, and to recruit a range of people and professionals, including family carers as well as health and social care practitioners. It was not possible to identify a person with dementia to join the group and only one family carer was recruited. Individuals were invited to a preparatory meeting to explain the study and to outline what commitment was being requested (such as attendance at six meetings). Refreshments and travel costs were met by the research grant and ‘back-fill’ money was available to meet the cost of attendance of NHS professionals. Venue costs were met by the research grant. Ethical permission for this part of the study was required and successfully sought (NW London Rec1 10/H0722/50) and local research governance permissions were obtained.
Twelve people volunteered to join the core multidisciplinary group which consisted of an occupational therapist, social workers, an Admiral nurse (community nurse specialising in dementia support), a family carer, a consultant psychiatrist, a GP, a community psychiatric nurse, and an outreach worker from the local branch of the Alzheimer’s Society. Practical arrangements, including meeting room arrangements, refreshments, invitations, circulation of documents, and so on, were undertaken by local research support staff.
The group met six times from April 2010 to June 2011, using a nominal group technique to carry out the following tasks:
To adapt the PREVENT intervention to meet service and cultural expectations in England;
To devise a job description and a list of desirable and essential attributes for a case manager;
To agree the contents of an educational needs assessment that would inform training and mentoring;
To produce written information designed to be used by the case manager with carers and people with dementia.
Nominal groups are a potentially powerful learning and development tool  which have a particularly useful role in analysing health care problems , and can help bridge the gap between researchers and practitioners . A nominal group technique was used, rather than a focus group, to encourage participants to solve specific problems (e.g. how to revise the PREVENT approach to fit with English care systems and nomenclature) rather than to explore the subject generally.
A nominal group technique designed for complex problems enabled this small group to debate the subject specifics and to contribute from their own experiences. This required the group to generate ideas, confirm that they were addressing the same problem, analyse the content of the ideas, categorise ideas and clarify the items in each category . The nominal group meetings were led by a member of the research team who facilitated discussion to cover the key questions, and focused attention on achieving a common understanding of these questions and their answers, whilst two other researchers, acting as participant observers, took notes.
A wider group of professionals and carers furthered the co-design principles by offering their comments on the work of the development group. The research team recruited ten professionals from different parts of England to provide comment in writing by email and arranged a meeting of 11 older people with substantial experiences of using health and social care services, including current and former carers of people with dementia. This was a diverse group, including people from different ethnic backgrounds, different sexual orientations, different socio-demographic characteristics, and holding a range of family or caregiving relationships (such as spouse/partner carers and adult child carers). Some were members of voluntary sector groups, such as the Alzheimer’s Society, others had connections with older people’s or community based organisations. The group membership was drawn from different locations than the nominal group in order to reflect a broader range of current service arrangements. A presentation was given on the objectives and outputs of WP1, specific questions were asked of the group and they were asked for their views. This group provided feedback through intense and detailed group discussion, they were also encouraged to contact the team via email if they had anything further to add after the meeting. This group served as a helpful validation step, in their constructive comments which helped to provide some assurance that the products of the development group were transferable to other parts of England.