Title: Evaluating the effectiveness and cost effectiveness of Dementia Care Mapping (DCM) to enable person-centred Care for people with dementia and their carers: A UK cluster randomised controlled trial in care homes (DCM EPIC trial)
Funder: Department of Health (England)

Abstract: DESIGNCluster randomised controlled trial (RCT) (follow-up over 16-months) cost-effectiveness analysis and process evaluation.SETTINGResidential nursing and dementia care homes in the UK.TARGET POPULATIONCare home residents with dementia their relatives and care home staff.HEALTH TECHNOLOGYDementia Care Mapping (DCM) is an established care home intervention used to support the implementation of person-centred care . DCM is an observational tool within a practice development cycle. A trained observer records the care experience of up to eight people with dementia for up to six consecutive hours. Findings are fed back to staff who develop individual and group action plans. This is repeated every 4-6 months. Whilst DCM has been used in dementia care for nearly 20 years there is limited robust evidence of its efficacy in relation to clinical outcomes such as reduction of behaviours staff find challenging (BSC). Reported practice implementation benefits include improvement of resident well-being and increased staff skills. However there is very limited robust evidence for effectiveness and no examination of its cost-effectiveness as a UK intervention. Therefore a definitive pragmatic RCT of DCM in the UK is urgently needed.MEASUREMENT OF COST AND OUTCOMESThe primary endpoint is the resident-level agitation measured by the Cohen-Mansfield Agitation Inventory (CMAI) at 16 months after randomisation rated by staff members who know the residents well. The CMAI captures the type nature and range of agitated behaviours and has good psychometric properties. The Pittsburgh Agitation Scale (PAS) rated by independent researchers will provide concurrent validity. Secondary outcome measures (Neuropsychiatric Inventory (NPI) use of antipsychotic and/or other psychotropic drugs resident quality of life staff well-being and role efficacy care quality and the quality of staff/ resident interactions) will be assessed at 6 and 16 months following randomisation. For the economic evaluation health status will be captured using the EQ-5D and DEMQOL (and proxy versions) and resource use will be captured using a questionnaire designed especially for the study. Other measures were chosen for their good psychometric properties within this population.SAMPLE SIZE50 (750) care homes (residents) with 30 (450) and 20 (300) in the intervention and control arms respectively providing 90% power at 5% significance level. Assuming a SD of CMAI scores of 7.5 a difference between arms of 3 points at 16 months 25% loss to follow-up and an ICC no greater than 0.1. As provision of care is a further source of clustering an allocation ratio of 3:2 is used.STATISTICAL ANALYSISThe resident-level primary outcome of agitation (CMAI score) at 16 months post-randomisation will be analysed using a linear two-level heteroscedastic regression model adjusting for design factors with a contrast for intervention and control. Secondary outcome measures will be analysed using a similar modelling strategy. The economic evaluation will follow the NICE reference case presenting (where appropriate) incremental cost-effectiveness ratios (ICERs) with the main outcome being cost-per incremental quality-adjusted life year (QALY). Results will be presented on a cost-effectiveness acceptability curve (CEAC). Net benefit regression will also be conducted.TIMETABLEThe study will take place over 49 months with 4 homes recruited per month and each home participating in data collection for 16 months from baseline to final follow-up.EXPERTISEThe team includes expertise on DCM care homes designing and conducting clinical trials in care homes statistical analysis trial management health economic evaluation and service user involvement.


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