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
Study Code / Acronym
DCM EPICAward Number
11/15/13Programme
Health Technology AssessmentStatus / Stage
CompletedDates
2 September 2013 -31 December 2017
Duration (calculated)
04 years 03 monthsFunder(s)
NIHRFunding Amount
£2,331,948.26Funder/Grant study page
NIHRContracted Centre
Leeds Beckett UniversityPrincipal Investigator
Professor Claire SurrPI ORCID
0000-0002-4312-6661WHO Catergories
Economic Impact of DementiaModels across the continuum of care
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 97 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Study Code / Acronym | DCM EPIC |
|---|---|
| Award Number | 11/15/13 |
| Status / Stage | Completed |
| Start Date | 20130902 |
| End Date | 20171231 |
| Duration (calculated) | 04 years 03 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | Leeds Beckett University |
| Funding Amount | £2,331,948.26 |
Abstract
Cluster randomised controlled trial (RCT) (follow-up over 16-months), cost-effectiveness analysis and process evaluation, including cohort collection of data at 6 months, and cross-sectional collection of outcomes at 16 months post randomisation. SETTING Residential, nursing and dementia care homes in the UK.TARGET POPULATION Care home residents with dementia, their relatives and care home staff. HEALTH TECHNOLOGY Dementia 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 OUTCOMES The 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 SIZE 50 (750) care homes (residents) with 31 (465) and 19 (285) 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. Additional residents will be recruited at 16 months post-randomisation from each care home to maintain power and minimise bias (due to higher than anticipated loss to follow-up and ensure the validity of the trial. (Details of the power calculations undertaken will be published as an appendix to the Statistical Analysis Plan) STATISTICAL ANALYSIS The primary analysis will depend on the rate of loss to follow-up at 16 months. If loss to follow-up is = 35% (in line with original expectations the 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. Here, however, data from residents registered at care home randomisation and 16 months post randomisation will be used. The model will be adjusted for the following fixed effects (all care home characteristics using baseline data): type and size, provision of dementia awareness training and recruiting hub, average residents’ dementia severity, and average residents’ baseline CMAI score. Unadjusted and adjusted estimates and corresponding 95% confidence intervals will be presented. Additional supportive analysis, dependent upon the rate of loss to follow-up, will be undertake and presented in the main results paper. 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. TIMETABLE The study will take place over 52 months , with an average of 4 homes recruited per month and each home participating in data collection for 16 months from baseline to final follow-up. EXPERTISE The 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.
Plain English Summary
At least two-thirds of people living in care homes have dementia and many develop behaviours, such as agitation or aggression. This can be upsetting for them, for other residents and difficult for care staff to support. These behaviours are often linked to poor quality care. People with these behaviours are more likely to be admitted to hospital and are often prescribed anti-psychotic drugs which can cause harmful side effects. The UK government has prioritised research into better support for care home staff to help them deliver better care and to reduce the use of drugs. Research shows that care can be improved by tailoring each person’s care to the individual, taking into account their interests, likes and life history. This is known as Person-Centred Care. Training staff in the principles of person-centred care provides them with the skills they need to prevent and support distressing behaviours. However, without extra support for staff to build on their training, these benefits soon disappear. Dementia Care Mapping (DCM) is a technique already widely used in the National Health Service (NHS) and in care homes to help staff to apply their person-centred care training to their caring role. Dementia Care Mapping involves observing the experience of care from the point of view of people with dementia and then feeding this back to staff, who use this information to look at ways they can improve care. This process is carried out every four to six months so changes can be monitored and new improvements identified. To date only one Australian study has been conducted on how effective Dementia Care Mapping is in care homes, and how it provides value for money. This proposed study will build on the Australian study to show whether Dementia Care Mapping is effective and good value for money in care homes in the UK. The study will involve at least 750 people with dementia and care staff in 50 care homes. The whole study will last 52 months. Thirty care homes will be randomly allocated to have staff trained to use Dementia Care Mapping. The success of Dementia Care Mapping will be measured according to changes in behaviours such as agitation in residents, their quality of life, the number of NHS services they need, and the numbers and types of negative events they experience (for example admission to hospital, falls, pain). We will look at these things at the start of the study, after 6 months and after 16 months. The study will also measure how staff feel about their job and the number of staff resignations and sickness. The study will take 52 months in total because we will recruit an average of four care homes per month. This schedule will allow the researchers to collect all the data they need on time. Our research team is comprised of highly experienced experts from Universities, the NHS and care homes. We have also included an international colleague who carried out the only other trial of this type that has been published to date. This means we have the expertise and advisors to ensure the research is carried out to a high standard, and to produce meaningful results. This collaboration between a number of organisations makes this a strong research team. We have a great deal of experience in carrying out projects of this nature and also in sharing what we find with researchers, people who work in care and with people with dementia, their carers and the public. We will work closely with these important stakeholders to make sure the design, delivery and way we share the findings of this research is as effective as possible. The money we have requested to fund this study will be spent on six researchers who will recruit participants at baseline and 16 month follow-up, and collect data on at least 750 residents in the 50 care homes across the period of the work. The funding will also be used to provide staff in 31 care homes with training in DCM and some initial support to make sure DCM is used consistently. It will also be used to fund experts who will manage the study, keep it running to schedule, conduct data analysis and share the findings with different groups of people.