Background: Quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective: To investigate the clinical and cost-effectiveness of Dementia Care MappingTM (DCM™) for reducing agitation, and improving care outcomes for people living with dementia in care homes, versus usual care. Design: A pragmatic, cluster randomised controlled trial with open-cohort design, follow-up at 6- and 16-months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. Primary endpoint was completed by staff-proxy and independent assessors. Setting: Stratified randomisation of 50 care homes to intervention/control on a 3:2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants: Fifty care homes were randomised (31 intervention, 19 control), with 726 residents recruited at baseline and a further 261 at 16-months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM™ in the previous 18-months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia/score of 4+ on the Functional Assessment Staging of Alzheimer’s Disease, were proficient in English, not at end-of-life/permanently cared for in bed. All homes were audited on delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation. Intervention: Two staff from each intervention home were trained to use DCM™ and requested to carry out three DCM™ cycles; the first supported by an external expert. Main outcome measures: The primary outcome was agitation (Cohen-Mansfield Agitation Inventory) at 16-months. Secondary outcomes included resident behaviours and quality of life. Results: There were 675 residents in the final analysis (287 control, 388 intervention). There was no evidence of difference in agitation levels between arms. The adjusted mean difference in CMAI score was -2.11 points, lower in the intervention group than control (95% CI -4.66 to 0.44, p=0.104, adjusted ICC control=0, intervention 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated DCM™ was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM™ cycle. Impacts of and barriers and facilitators to DCM™ implementation were identified. Limitations: Primary completion of resident outcomes was by staff proxy due to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation although supportive analyses suggested any reporting bias was not clinically important. Conclusions: There was no benefit of DCM™ over control on any outcomes. Implementation of DCM™ by care home staff was sub-optimal compared to protocol in the majority of homes. Future work: Alternative models of DCM™ implementation should be considered, which do not rely solely on leadership by care home staff. Trial registration: Current Controlled Trials ISRCTN82288852 Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/15/13)
