Title: Dementia - Person Aligned Care Team (D-PACT)
Funder: Department of Health and Social Care

Abstract: Background: The burden of dementia for individuals with dementia (IwD) and their carers and family is substantial. The cost to society of care is great &ndash; but despite these costs post diagnostic care is recognised as inadequate with an imbalance between proactive care promoting quality of life and reactive care (including avoidable, iatrogenic and/or prolonged admissions). While some benefit has been derived from development of biomedical treatments, relatively little research has examined how best to provide post diagnostic support. Aim: To develop and evaluate a theoretically sound and practically feasible multidisciplinary complex intervention based in primary care for improving wellbeing and health-related quality of life for people with dementia and their carers/families. Overall design: Four linked work packages (WPs) to develop a theoretically sound and practically deliverable intervention (WP1), to develop the methodology for a definitive cluster randomised controlled trial (cRCT) (WP2), and to assess the effectiveness and cost-effectiveness of the intervention (WP3). PPI work carried out through a peer research group and an implementation work package (WP4) will be integrated throughout the five years. Public and patient involvement: A peer researcher group will be developed and supported. It will particularly contribute to WP1 and 2, and to dissemination. Intervention concept: Supervised dementia support workers (DSWs) will be located within general practices and integrated within the primary care team to support people with dementia and their carers with critical aspects of care: emotional and practical support; relationships and activities; physical health promotion and care; anticipatory care to prevent and reduce length of time away from the home. An intervention delivery platform will include a manual, training and supervision. Intervention development (WP1): Theory development using a critical realist framework incorporating 10-14 international expert interviews, interviews with individuals with lived experience, focused literature assessment (WP1a). Iterative testing and refining of intervention in practice though a feasibility study with embedded formative process evaluation, using clinical records, observation, 36 interviews and 20 recordings of interactions (WP1b). Development of trial procedures (WP2): Selection of outcomes: selection of outcome domains through iterative mapping against need and capacity of intervention to have impact; selection of measures based on review of psychometrics and stakeholder involvement (WP2a). Development of recruitment strategy through iterative testing in four practices aiming for 30% of eligible patients; decisions about inclusion criteria (e.g. severity, presence of carer/family, whether living in care home) (WP2b). Piloting trial procedures within the feasibility study, including recruitment of six practices, cluster randomisation, recruitment of 40 patients, outcome measure collection, follow up data collection (WP2c). Cluster randomised controlled trial (WP3): Final procedures and parameters will be based on WPs 1 and 2. Current proposal: Supervised DSWs based in general practice as developed in WP1 36 practices recruited from two areas and cluster randomised after baseline measures collected 586 IwD, with moderate cognitive or functional problems Sample size based on Bristol Activities of Daily Living Scale (BADLS) Flexible procedures used to approach, take consent and collect baseline measures from IwD (based on WP2b) Outcome measures to include functioning, quality of life, mental wellbeing, carer wellbeing as agreed in WP2a Follow up 10-12 months after baseline Parallel process evaluation (WP3b) Embedded cost effectiveness study (WP3c) Implementation (WP4): Consideration of implementation of the intervention during and after trial will be integrated into WPs 1 and 3. In years 3-5, in parallel with the cRCT, case studies of interventions to support people with dementia will examine real world implementation issues at that time (2020-2021). We will examine both DSWs operating outside of the trial, and more generic workers (e.g. care navigators for people with multi-morbidity including dementia) likely to be operating as part of the emerging new models of care. Results from WP3 and these case studies will be used to revise the programme theory developed in WP1 to produce a Theory of Change Logic Model specifying how the intervention produces change and detail the resources and planned activities required to produce the desired outcomes, over time.

Lay abstract: There are a variety of dementia support roles (Dementia Support Workers (DSWs); Dementia Navigators; Dementia Advisors) in different settings around the country. These roles can be clinical or non-clinical and designed to help people diagnosed with dementia and their carers, deal with the problems they might face. While they are valued highly there is lack of evidence as to what the best bits of support are, where it would be best delivered and whether or not it is cost effective. Commissioners and providers are therefore reluctant to invest fully in these services. The Dementia-PACT programme aims to identify the most effective parts of good dementia support and test its delivery in GP practices. We will develop a DSW intervention, which provides ongoing support to tackle a range of needs of people with dementia and their carers: mental well-being; physical health; support to achieve social goals and improved quality of life. Supervised by experienced mental health care workers the DSWs will work alongside GPs and practice nurses and link to community resources. We will train the DSWs to use a coaching approach to agree goals linked to personal priorities including future care decisions. We think this approach has the best chance to ensure physical health care is prioritised alongside other social and emotional needs. In years one and two, we will develop the theory of how such an intervention will work by reviewing the literature and talking to experts. We will then test this in a small trial in GP practices and get feedback so we can make improvements. Previous trials have only recruited small proportions of people from GP settings. We will develop procedures for recruitment to ensure those who need the intervention most are not excluded. We will also test whether it is possible to recruit people with dementia who do not have a carer (who are often excluded from trials). Stakeholders will decide together the outcome measures used to evaluate the intervention. In years three to five we will run a larger trial with around 36 GP practices in 2-3 UK settings. We will split the practices equally between those that get the intervention and those that do not. We will measure differences in outcomes such as functioning, quality of life, carer well-being and cost. Throughout the programme, we will look at how the intervention will work within the health and social care environment &ndash; in the trial and afterwards. This will help us understand how policy, organisations, training and commissioning can ensure the results of the research are used. We have brought together a team of people with the right skills and experience, including people with dementia and their carers to deliver the programme.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL