Title: Introduction of a pharmacy and psychosocial intervention in residential and nursing homes to limit the use of psychotropic medication to treat Behavioural and Psychological Symptoms of Dementia (BPSD) – a feasibility study
Funder: Department of Health and Social Care

Abstract: Background The inappropriate use of anti-psychotics in people with dementia is associated with an estimated 1,800 deaths annually.7,8 Official figures may under-estimate the usage of anti-psychotics and solely focussing on anti-psychotics may transfer prescribing to equally dangerous medicines.9-12 A full clinical medication review, with access to the medical record, by a specialist pharmacist, in collaboration with the GP, may be able to limit the use of psychotropics. However, there is a lack of data on the impact of such reviews and any such intervention needs to be part of a wider initiative to change models of care. Research Question The aim of this trial, set within the MRC framework for developing complex interventions6, is: To develop and test the feasibility of the introduction of a pharmacy-psychosocial intervention to limit the use of psychotropics to treat BPSD in residential and nursing home residents. This project has 3 work packages (WP) each with specific objectives &ndash; To develop a combined pharmacy-psychosocial intervention [WP 1: Development]. To test the feasibility of the proposed methods including recruitment and retention rates to inform a definitive cluster randomised controlled trial (CRCT); [WP2: Feasibility]. To disseminate results from the feasibility study and develop a protocol for a definitive trial of the intervention. [WP3: Dissemination]. Plan of Investigation Development of the pharmacy-psychosocial intervention: a literature review, intervention development. Residential and nursing homes recruited to the study &ndash; 2 residential and 2 nursing. Education and training for staff in the use of behavioural change techniques to support management of challenging behaviours in people with dementia. Recruitment of participants. Consent will be obtained, from the resident or the personal consultee, in keeping with Mental Capacity Act guidance.13,14 Confirmation of inclusion/exclusion criteria using primary care records and cognitive screening. Participants will be screened for dementia using the 6 item Cognitive Impairment Test (6CIT).15,16 A trained Research Assistant (RA) will use search criteria developed as part of EVIDEM2 to search primary care records for dementia. GPs will be asked to review a search summary, 6CIT results and confirm individuals are suitable to be included in the study. Baseline outcome measurement including neuropsychiatric symptoms, quality of life, cognitive tests and prescribed medication. Specialist pharmacist, in collaboration with the GP, person with dementia and carer, undertakes a review of medication (full clinical medication review) used to treat challenging behaviour. Review followed up at one month to see if the recommendations were implemented. Collection of outcome measures at 1, 3 and 6 months (see Gantt chart). A nested qualitative stream will explore (via interviews): pre-intervention assumptions and expectations of carers about the reviews; and post-intervention explore experiences of the intervention. Assessment of the feasibility of the intervention, incorporating qualitative and quantitative methods. Dissemination of the results from the feasibility study and consultation about a definitive trial with stakeholders. Development of a protocol for a definitive trial of the intervention. Potential Benefits This feasibility study will inform the design of a definitive Cluster Randomised Clinical Trial, which will aim to establish whether (in comparison with current practice) the intervention: Improves quality of life and health outcomes by reducing the inappropriate use of psychotropics. Is cost-effective, particularly by ensuring the efficient utilisation of medication. Additionally a definitive study would inform future workforce policy in particular the development of outreach roles for specialists in supporting medication management in the community.

Lay abstract: Older people take many different medicines. Anti-psychotics (powerful tranquilisers) can help to control behaviours &ndash; such as aggression - that occur in people with dementia and which may be difficult for carers to manage. However, because benefits are limited and anti-psychotics can cause significant harm, the Department of Health (DH) would like to reduce their levels of use by two-thirds. From our research we believe that DH data may significantly under-estimate anti-psychotic usage in people with dementia, partly because under-recognition of dementia is common. Additionally the focus on reducing anti-psychotics may simply shift prescribing to equally harmful, mood-altering medicines (psychotropics), such as benzodiazepines (e.g. Lorazepam ). This study will assess the feasibility of a pharmacy-psychosocial intervention in limiting the use of psychotropics in residential and nursing homes and consider if a larger scale trial should be undertaken. The intervention will involve: A medication review to support appropriate prescribing by an experienced specialist pharmacist. A psychosocial element based on education and training of care staff to support them in managing challenging behaviour without medication. We will use GP records to identify potential participants. Patients taking medicines for challenging behaviour and with a formal diagnosis of dementia or whose records, cognitive assessment and clinical review, strongly indicate dementia will be included in the study. Four care homes in the West Midlands will be involved in the study. We will aim to recruit all of the residents who meet the inclusion criteria.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: NEUROLOGICAL