Development, feasibility, and acceptability of an intervention to improve care for agitation in people living in nursing homes with dementia nearing the end-of-life.

OBJECTIVES: To develop a staff training intervention for agitation in people with severe dementia, reaching end-of-life, residing in nursing homes (NHs), test feasibility, acceptability, and whether a trial is warranted. DESIGN: Feasibility study with pre- and post-intervention data collection, qualitative interviews, and focus groups. SETTING: Three NHs in South East England with dementia units, diverse in terms of size, ownership status, and location. PARTICIPANTS: Residents with a dementia diagnosis or scoring ≥2 on the Noticeable Problems Checklist, rated as "severe" on Clinical Dementia Rating Scale, family carers, and staff (healthcare assistants and nurses). INTERVENTION: Manualized training, delivered by nonclinical psychology graduates focusing on agitation in severe dementia, underpinned by a palliative care framework. MEASUREMENTS: Main outcomes were feasibility of recruitment, data collection, follow-up, and intervention acceptability. We collected resident, family carer, and staff demographics. Staff provided data on resident's agitation, pain, quality of life, and service receipt. Staff reported their sense of competence in dementia care. Family carers reported on satisfaction with end-of-life care. In qualitative interviews, we explored staff and family carers' views on the intervention. RESULTS: The target three NHs participated: 28 (49%) residents, 53 (74%) staff, and 11 (85%) family carers who were eligible to participate consented. Eight-four percent of staff attended ≥3 sessions, and we achieved 93% follow-up. We were able to complete quantitative interviews. Staff and family carers reported the intervention and delivery were acceptable and helpful. CONCLUSIONS: The intervention was feasible and acceptable indicating a larger trial for effectiveness may be warranted.

Clinical and cost-effectiveness of the Managing Agitation and Raising Quality of Life (MARQUE) intervention for agitation in people with dementia in care homes: a single-blind, cluster-randomised controlled trial.

BACKGROUND: Many people with dementia living in care homes have distressing and costly agitation symptoms. Interventions should be efficacious, scalable, and feasible. METHODS: 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. FINDINGS: 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). INTERPRETATION: 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. FUNDING: UK Economic and Social Research Council and the National Institute of Health Research.