The Clinical and Cost Effectiveness of Dementia Care Mapping (DCM™) to Reduce Agitation in Care Home Residents with Dementia: Results of the DCM™ EPIC Cluster Randomised Controlled Trial

Background: This trial investigated the (cost) effectiveness of Dementia Care Mapping (DCM™) for reducing agitation in care home residents with dementia compared to usual care (DCM™ EPIC trial). Methods: Pragmatic, cluster randomised controlled trial, with follow-up at 6- and 16-months. Stratified randomisation of 50 care homes to intervention (n=31) or control (n=19). Care home eligibility included recruitment of =10 residents, not subject to improvement notices or using DCM™ in the previous 18-months. At baseline and 16-months, 726 and 261 residents were recruited, respectively. Resident eligibility included: permanent residence; diagnosis of dementia/score of =4 on the Functional Assessment Staging of Alzheimer's Disease; not at end-of-life/permanently cared for in bed. Clusters were not blinded to allocation. Three DCM™ cycles, delivered by two trained care home staff were scheduled, mirroring standard procedures; supported during cycle one by a DCM™ expert. The primary outcome was agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16-months. Secondary outcomes included neuropsychiatric symptoms and quality of life. Findings: DCMTM was not superior to control on any primary or secondary outcomes (n=675 residents: 287 control, 388 intervention). The adjusted mean difference in CMAI score was -2.11 points in the intervention versus control (95% CI -4.66 to 0.44, p = .104, adjusted ICC control=0, intervention 0.001). Sensitivity analyses supported the primary analysis. Intervention adherence was problematic; only 26% of homes completed >1 DCM™ cycle. Incremental cost per unit improvement in CMAI for baseline recruited residents (n=726, 418 intervention, 308 control) was £289 for intervention versus control. Interpretation: There was no evidence of benefit of DCM™; an important finding given its wide, international use. Further research should urgently consider modifications to existing DCM™implementation models, or other approaches to reducing agitation in care home residents. Trial Registration Number: Registered with the International Standard Randomised Controlled Trial Register (ISRCTN) reference 82288852. Funding Statement: National Institute for Health Research Health Technology Assessment programme (project number 11/15/13). Declaration of Interests: Claire A Surr was previously employed by the University of Bradford, who own the IP to the DCM™ intervention tested in this trial. In this role she held responsibility for DCM training and method development. She was a technical author on the British Standards Institute PAS 800 guide on implementing DCM™ in health and social care provider organizations. She declares personal fees from Hawker publications outside the submitted work. David Meads reports being a member of the NIHR HTA Elective and Emergency Specialist Care Panel (EESC) being a member of the NIHR PGfAR funding panel. Clive Ballard reports grants and personal fees from Acadia pharmaceutical company, grants and personal fees from Lundbeck, personal fees from Roche, personal fees from Otusaka, personal fees from Novartis, personal fees from Eli Lilly, personal fees from Pfizer, outside the submitted work. Murna Downs works at the University of Bradford which holds the Intellectual Property for DCM™ and runs courses for practitioners and professionals who wish to learn how to use the method. Louise Robinson reports grants from NIHR Senior Investigator Award, grants from NIHR Translational Professorship Award, outside the submitted work; and NIHR board membership of the Primary Care Themed Call board. Amanda Farrin reports membership of the NIHR HTA Funding Boards Policy group, the NIHR HTA Clinical Evaluation and Trials board and, previously, the NIHR HTA Themed Call board. All other authors have no conflicts to declare Ethics Approval Statement: The study was granted ethical approval by NRES Committee Yorkshire & The Humber - Bradford Leeds REC ref 13/YH/0016. The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 52nd World Medical Association General Assembly, Edinburgh, Scotland, 1996. Informed written consent will be obtained from the care homes, staff and residents prior to entry into the trial.