title: Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial.
abstract: Up to 90 % of people living with dementia in care homes experience one or more behaviours that staff may describe as challenging to support (BSC). Of these agitation is the most common and difficult to manage. The presence of agitation is associated with fewer visits from relatives, poorer quality of life and social isolation. It is recommended that agitation is treated through psychosocial interventions. Dementia Care Mapping™ (DCM™) is an established, widely used observational tool and practice development cycle, for ensuring a systematic approach to providing person-centred care. There is a body of practice-based literature and experience to suggests that DCM™ is potentially effective but limited robust evidence for its effectiveness, and no examination of its cost-effectiveness, as a UK health care intervention. Therefore, a definitive randomised controlled trial (RCT) of DCM™ in the UK is urgently needed.
  
  
  
  A pragmatic, multi-centre, cluster-randomised controlled trial of Dementia Care Mapping (DCM™) plus Usual Care (UC) versus UC alone, where UC is the normal care delivered within the care home following a minimum level of dementia awareness training. The trial will take place in residential, nursing and dementia-specialist care homes across West Yorkshire, Oxfordshire and London, with residents with dementia. A random sample of 50 care homes will be selected within which a minimum of 750 residents will be registered. Care homes will be randomised in an allocation ratio of 3:2 to receive either intervention or control. Outcome measures will be obtained at 6 and 16 months following randomisation. The primary outcome is agitation as measured by the Cohen-Mansfield Agitation Inventory, at 16 months post randomisation. Key secondary outcomes are other BSC and quality of life. There will be an integral cost-effectiveness analysis and a process evaluation.
  
  
  
  The protocol was refined following a pilot of trial procedures. Changes include replacement of a questionnaire, whose wording caused some residents distress, to an adapted version specifically designed for use in care homes, a change to the randomisation stratification factors, adaption in how the staff measures are collected to encourage greater compliance, and additional reminders to intervention homes of when mapping cycles are due, via text message.
  
  
  
  Current Controlled Trials ISRCTN82288852 . Registered on 16 January 2014. Full protocol version and date: v7.1: 18 December 2015.
authors.affiliation: Faculty of Health and Social Sciences, Leeds Beckett University, Leeds, LS1 3HE, UK. c.a.surr@leedsbeckett.ac.uk.
authors.forename: Claire A
authors.initials: CA
authors.lastname: Surr
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Rebecca E A
authors.initials: RE
authors.lastname: Walwyn
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Lilley-Kelly
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Cicero
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9LJ, UK.
authors.forename: David
authors.initials: D
authors.lastname: Meads
authors.affiliation: Wolfson Centre for Age Related Diseases, Kings College London, London, UK.
authors.forename: Clive
authors.initials: C
authors.lastname: Ballard
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Kayleigh
authors.initials: K
authors.lastname: Burton
authors.affiliation: University of Technology, Sydney, NSW 2007, Australia.
authors.forename: Lynn
authors.initials: L
authors.lastname: Chenoweth
authors.affiliation: Wolfson Centre for Age Related Diseases, Kings College London, London, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Corbett
authors.affiliation: Wolfson Centre for Age Related Diseases, Kings College London, London, UK.
authors.forename: Byron
authors.initials: B
authors.lastname: Creese
authors.affiliation: School of Dementia Studies, University of Bradford, Bradford, BD7 1DP, UK.
authors.forename: Murna
authors.initials: M
authors.lastname: Downs
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
authors.affiliation: Psychological Services, Oxford Health NHS Foundation Trust, Oxford, OX3 7JX, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Fossey
authors.affiliation: Psychological Services, Oxford Health NHS Foundation Trust, Oxford, OX3 7JX, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Garrod
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Elizabeth H
authors.initials: EH
authors.lastname: Graham
authors.affiliation: Faculty of Health and Social Sciences, Leeds Beckett University, Leeds, LS1 3HE, UK.
authors.forename: Alys
authors.initials: A
authors.lastname: Griffiths
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, LS2 9PH, UK.
authors.forename: Ivana
authors.initials: I
authors.lastname: Holloway
authors.affiliation: School of Dementia Studies, University of Bradford, Bradford, BD7 1DP, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: Jones
authors.affiliation: Faculty of Health and Social Sciences, Leeds Beckett University, Leeds, LS1 3HE, UK.
authors.forename: Baber
authors.initials: B
authors.lastname: Malik
authors.affiliation: Bradford District Care Foundation Trust, Bradford, UK.
authors.forename: Najma
authors.initials: N
authors.lastname: Siddiqi
authors.affiliation: Institute for Aging and Health, University of Newcastle, Newcastle upon Tyne, NE1 7RU, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Robinson
authors.affiliation: Bupa, London, UK.
authors.forename: Graham
authors.initials: G
authors.lastname: Stokes
authors.affiliation: School of Dementia Studies, University of Bradford, Bradford, BD7 1DP, UK.
authors.forename: Daphne
authors.initials: D
authors.lastname: Wallace
mesh_terms: D017028:Caregivers; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000523:psychology / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D018802:Patient-Centered Care; D011788:Quality of Life; D018401:Sample Size
keywords: Agitation; Care homes; Cluster-randomised controlled trial; Dementia; Dementia Care Mapping; Person-centred care