Ensemble Feasibility Cluster Trial: Impact on patient anxiety and quality of life of a training package for evaluation of dementia symptoms in primary care using test bundles.

Background: Dementia presents a pressing challenge globally, with prolonged waiting times for specialist assessment exacerbating concerns, now reaching up to 104 weeks. Accessing secondary care services can be arduous, particularly for marginalized groups, underscoring the urgent need for improved diagnostic pathways in primary care. The James Lind Alliance has highlighted the necessity for more effective routes to dementia diagnosis, with current diagnostic processes often inadequate in addressing cognitive symptoms comprehensively. Aims and Objectives: Aim: to design and test the feasibility of a structured diagnostic approach for suspected dementia in primary care settings. Objectives 1. Develop comprehensive diagnostic modules tailored to patient presentations and GP interviews. 2. Co-design training packages for GPs and Health Care Assistants (HCAs) to enhance diagnostic capabilities. 3. Assess the feasibility of scaling up this approach in a large-scale trial. 4. Explore the impact of training on knowledge, skills, and confidence of primary care providers. 5. Investigate how to maximise inclusion and engagement of underserved individuals in areas of high deprivation, incorporating views of different ethnic groups for the future main trial. Methods: In collaboration with stakeholders, including patients, caregivers, and healthcare professionals, we will iteratively develop diagnostic modules tailored to diverse patient presentations. These modules will incorporate a range of cognitive tests, such as the Montreal Cognitive Assessment (MoCA), the Informant Questionnaire for Cognitive Disorders in the Elderly short form (IQCODE-SF), and GPCOG. Training packages will be co-designed with experts in healthcare education to improve the knowledge and confidence of GPs and HCAs. These packages will include online resources focusing on administering and interpreting cognitive tests. The feasibility of the structured diagnostic approach will be assessed through a trial in primary care. In the feasibility study we will work closely with two practices with a significant Eastern European and Coastal Communities population to test the feasibility of our design and measures. During the feasibility study we will continue to work with other ethnic groups though our separately RCF funded Patient Advisory Group to help inform roll-out of the main trial in other ethnic communities. Measures We will measure clinician engagement, learning, confidence and adherence to the study protocol as part of our education package. We will measure EQ-5D (patients & supporters/carers), Geriatric Anxiety Inventory (GAI; in patients and their supporters/carers), ICECAP-O (in patients) and ASCOT (Adult Social Care Outcomes Toolkit)-carer (supporters/carers) before, immediately after, and six months after assessment in primary care. We will measure diagnosis rates, evaluate for over- and under- diagnosis, the time taken for assessment in primary care by HCAs and GPs, and referral rates. We will also evaluate trial processes qualitatively. Timelines The development and refinement of diagnostic modules and training packages will occur over the initial phase of the project, with iterative feedback from stakeholders. WP3 (intervention arm of future trial) will commence following the completion of training and module development. Impact Findings will be disseminated through peer-reviewed publications, presentations, and engagement with stakeholders as one component of working towards a consistent and equitable approach to the diagnosis of dementia.