Abstract
Many people with dementia living in care homes have distressing and costly agitation symptoms. Interventions should be efficacious, scalable, and feasible. We did a parallel-group, cluster-randomised controlled trial in 20 care homes across England. Care homes were eligible if they had 17 residents or more with dementia, agreed to mandatory training for all eligible staff and the implementation of plans, and more than 60% of eligible staff agreed to participate. Staff were eligible if they worked during the day providing face-to-face care for residents with dementia. Residents were eligible if they had a known dementia diagnosis or scored positive on screening with the Noticeable Problems Checklist. A statistician independent of the study randomised care homes (1:1) to the Managing Agitation and Raising Quality of Life (MARQUE) intervention or treatment as usual (TAU) using computer-generated randomisation in blocks of two, stratified by type of home (residential or nursing). Care home staff were not masked to the intervention but were asked not to inform assessors. Residents with dementia, family carers, outcome assessors, statisticians, and health economists were masked to allocation until the data were analysed. MARQUE is an evidence-based manualised intervention, delivered by supervised graduate psychologists to staff in six interactive sessions. The primary outcome was agitation score at 8 months, measured using the Cohen-Mansfield Agitation Inventory (CMAI). Analysis of the primary outcome was done in the modified intention-to-treat population, which included all randomly assigned residents for whom CMAI data was available at 8 months. Mortality was assessed in all randomly assigned residents. This study is registered with the ISRCTN registry, number ISRCTN96745365. Between June 14, 2016, and July 4, 2017, we randomised ten care homes (189 residents) to the MARQUE intervention and ten care homes (215 residents) to TAU. At 8 months, primary outcome data were available for 155 residents in the MARQUE group and 163 residents in the TAU group. At 8 months, no significant differences in mean CMAI scores were identified between the MARQUE and TAU groups (adjusted difference -0·40 [95% CI -3·89 to 3·09; p=0·8226]). In the intervention care homes, 84% of all eligible staff completed all sessions. The mean difference in cost between the MARQUE and TAU groups was £204 (-215 to 623; p=0·320) and mean difference in quality-adjusted life-years was 0·015 (95% CI -0·004 to 0·034; p=0·127). At 8 months, 27 (14%) of 189 residents in the MARQUE group and 41 (19%) of 215 residents in the TAU group had died. The prescription of antipsychotic drugs was not significantly different between the MARQUE group and the TAU group (odds ratio 0·66; 95% CI 0·26 to 1·69, p=0·3880). The MARQUE intervention was not efficacious for agitation although feasible and cost-effective in terms of quality of life. Addressing agitation in care homes might require resourcing for delivery by professional staff of a more intensive intervention, implementing social and activity times, and a longer time to implement change. UK Economic and Social Research Council and the National Institute of Health Research.
Highlights
At 8 months, no significant differences in mean Cohen-Mansfield Agitation Inventory (CMAI) scores were identified between the Managing Agitation and Raising Quality of Life (MARQUE) and treatment as usual (TAU) groups
The mean difference in cost between the MARQUE and TAU groups was £204 (–215 to 623; p=0·320) and mean difference in quality-adjusted life-years was 0·015
Agitation or purposeless activity, which includes restlessness, pacing, repetitive vocalisations, and verbally or physically aggressive behaviours,1,2 is one of the most common neuropsychiatric symptoms in dementia.3,4. Such behaviours are unpleasant for the person with dementia,1 can cause family distress and subsequent inability to continue to care at home,5 can precipitate care home admission and, in care homes, are strongly associated with quality of life
Summary
Agitation or purposeless activity, which includes restlessness, pacing, repetitive vocalisations, and verbally or physically aggressive behaviours, is one of the most common neuropsychiatric symptoms in dementia. Such behaviours are unpleasant for the person with dementia, can cause family distress and subsequent inability to continue to care at home, can precipitate care home admission and, in care homes, are strongly associated with quality of life. Agitation accounts for about 12% of dementia health and social care costs, and increases costs for care home residents.7Most care home residents have dementia and complex needs, and around 50% of individuals with moderate or www.thelancet.com/psychiatry Vol 6 April 2019Research in contextEvidence before this study Our 2014 systematic review of randomised controlled trials of non-pharmacological interventions for agitation in people with dementia found activities, structured music therapy, and sensory interventions provided immediate but not lasting benefit. The second intervention included training and support of care home staff by a physician and specialist nurse for two 4 h blocks on behavioural symptoms in dementia using standardised assessments, non-pharmacological and pharmacological interventions, case conferences using standardised case vignettes, and activities delivered twice per week by activity co-coordinators or occupational therapists, for residents not already attending. This intervention was effective at 10 months for agitation. A separate systematic review found that interventions were sustained by interactive training, individual staff support after group training, retention of training materials, incorporating interventions into routine care, and most staff attending
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