EMBED-Care (Empowering Better End-of-Life Dementia Care) Framework study

INTERVENTION: STUDY DESIGN: Our study design follows the Medical Research Council Framework for Developing and Evaluating Comple XInterventions. We will also adapt this for methods of evaluation in palliative and end of life care. The study comprises a mixed‐methods (combination of qualitative and quantitative data) feasibility study to explore whether the EMBED‐Care Framework is possible and acceptable to use. Depending on the results of the feasibility study, we will progress to a pilot cluster randomised controlled study. PATIENT AND PUBLIC INVOLVEMENT (PPI): We have an active PPI group involving people living with dementia and carers and former carers of family members who had dementia. They informed the original grant application and have since provided constructive feedback on the WS6 participant information sheets, consent forms and invitation letters to be used with people living with dementia and their carers to ensure that the content and format are appropriate. FEASIBILITY STUDY: Setting: The feasibility study is a single‐arm mixed‐methods study conducted in care homes and Primary Care Teams (PCNs). The feasibility study will be conducted in four settings (clusters), including two residential care home settings and two Primary Care Network (PCN) Teams. Residential care homes are settings that provide 24‐hour residential care but do not employ registered nurses. PCN teams are multi‐disciplinary teams of health and social care professionals providing care to people at home with comple Xor long‐term care needs. As this is a single‐arm study, all settings will receive the EMBED‐Care Framework intervention, and no randomisation will take place. Sampling and sample sizes: We aim to recruit 50 participants, with a minimum of 10‐12 per setting. We assume 15% attrition and there CONDITION: Dementia ; Mental and Behavioural Disorders PRIMARY OUTCOME: Candidate outcome measures for people with dementia:; 1. Quality of life will be measured using the EQ‐5D‐5L and proxy reported EQ‐5D‐5L at baseline, week 4, week 8 and week 12; 2. Symptoms will be measured using the Edmonton Symptom Assessment Scale and the proxy‐reported Edmonton Symptom Assessment Scale at baseline, week 4, week 8 and week 12; 3. Agitation will be measured using the proxy‐reported Neuropsychiatric Inventory ‐ agitation subscale at baseline, week 4, week 8 and week 12; ; Candidate outcome measures for family carers:; 1. Direct impact on caring will be measured using the Scales Measuring the Impact of Dementia on Carers ‐ Direct Impact on Caring at baseline, week 4, week 8 and week 12; 2. Carer support and information needs will be measured using the Scales Measuring the Impact on Carers ‐ Support and Information at baseline, week 4, week 8 and week 12; 3. Carer distress will be measured using the Kessler Psychological Distress Scale at baseline, week 4, week 8 and week 12; 4. Carer decision making will be measured using the Decisional Conflict Scale at baseline, week 4, week 8 and week 12; 5. Carer experience of care will be measured using HowRWe measured at baseline, week 4, week 8 and week 12 SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: Person with dementia: 1. 18 years and older 2. All genders 3. Diagnosis or symptoms suggestive of dementia/cognitive impairment as a result of dementia in medical or care home records (any type/any severity) 4. Permanently resident in participating care home OR 5. New referral to Primary Care Network (PCN) team Carer of person with dementia: 1. 18 years and older 2. All genders 3. Capacity to consent 4. Able to read and write in English 5. Identifies as family/friend carer of PWD 6. Minimum of fortnightly contact with PWD (by phone, in person) Health and social care professionals: 1. All permanent care home staff involved in providing direct resident care 2. Care home managers 3. Bank and temporary staff care home staff 1. Those health/social care professionals with participating people with dementia on their active caseloads, and involved in delivery or using the EMBED‐Care Framework 2. Primary/co