Title: The Namaste Care intervention to improve the quality of dying for people with advanced dementia living in care homes: A realist review and feasibility study for a cluster randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Background: Many people with advanced dementia live and die in nursing care homes (NCHs). The quality of life, care and dying experienced is variable. There is a need to identify appropriate, cost effective interventions that facilitate high quality end of life care provision appropriate for this population. Aim: To establish the feasibility of conducting a cluster controlled trial in nursing care homes to understand the impact on quality of dying of the Namaste Care intervention for people with advanced dementia, compared to usual end of life care. Design: a) Realist Evidence review: To determine which Namaste care intervention elements work best for people dying with advanced dementia in the NCH context. b) Intervention Refinement: Consultation workshop with care home staff (n=8-12 from 4 NCHs) and family members of people with advanced dementia, using findings from the Realist Review to refine the Namaste Care intervention. c) Feasibilty study in context of a cluster controlled trial: A feasibility study in 8 sites (6 intervention and 2 control) in the context of a cluster controlled trial (and embedded qualitative process and economic evaluation) to facilitate future design and measurement choices for a full trial. Setting: Nursing care homes (NCH) in England. Target population: Patient: People with advanced dementia (FAST=6-7) prognosis<3months. Informal carer: Main family or informal carer. NCH staff: Care staff paid to provide care in NCHs. Trial Inclusion criteria: NCHs providing palliative care for people with advanced dementia using an established palliative care intervention. Health technology: Namaste Care is a complex intervention delivering proactive structured care focused on enhancements to the physical environment, comfort assessment and management, and sensory engagement incorporating personalised activities to reflect an individual’s life story and preferences. Proposed primary/secondary outcomes and tools: A feasibility aim is to establish the appropriateness, acceptability, timing and administration of instruments for a full trial. We consider two contender primary outcomes for a full trial: (1) quality of dying (dementia) (CAD-EOLD) and (2) quality of life (QUALID). Secondary outcomes include sleep/activity (using actigraphy); neuropsychiatric symptoms (NPI-NH); pain (PAIN-AD). Informal carer outcomes: satisfaction with care at the end of life (EOLD-SWC). Staff outcomes: care giving experiences (ZARIT Burden Scale), satisfaction with care in end of life care (EOLD-SWC). Health Economic outcomes: EQ-5D-5L, ICECAP-O and ICECAP-SCM. Other data: medication/service use (medical records), work activity (staff diary). Sample size: People with advanced dementia (n=64) from 8 clusters; NCHs randomised to Namaste Care (n=6) or control (n=2) Analysis: Primary end point will be determined. Reporting will focus on recruitment, response and completion rates, and missing data. Proxy agreement will be determined. Estimates of standard deviation and intracluster correlation coefficent will be made for definitive trial design. No formal statistical tests of intervention effect will be performed. Process evaluation data will be analysed quantitatively (through descriptive statistics) and qualitatively (using Framework Analysis). Unit cost information will be applied to resource use data to provide initial estimates of cost-effectiveness, identifying drivers of efficiency.

Lay abstract: Aims of the research This project aims to identify if it is feasible to: (1) introduce a new programme (Namaste Care) to improve the quality of dying at the end of life for care home residents with dementia; (2) undertake a trial in care homes to establish if Namaste Care makes a difference to the care of people dying with advanced dementia. Background to the research For many people with dementia, a move into a care home occurs. This is likely to be where they die. People with dementia rarely access specialist palliative care services, although they have palliative care needs. Namaste Care has been developed to provide care for people with advanced dementia at the end of life. It takes place in a prepared group space, where people receive daily individualised comfort assessment and care. A structured approach to care, provided by the usual staff (four hours a day, seven-days a week), engages the individual’s senses, offering meaningful activities that reflect their interests. There is some evidence from small studies that Namaste Care is beneficial for people with dementia. We do not know if this programme achieves better results than usual approaches to end of life care. Design and methods used Phase 1 will involve a review of the literature, to identity the effective features of programmes that provide end of life care in care homes for people with advanced dementia. In Phase 2, Namaste Care resource materials will be reviewed by care home staff and family members. Phase 3, the main study, is a feasibility trial, process and economic evaluation. It will be undertaken in 8 care homes; 8 people with advanced dementia will be recruited in each facility. Six care homes will deliver Namaste care and two will continue to deliver their usual care. The main outcome of this study is to establish the appropriateness, acceptability, timing and use of instruments for a full trial. A number of measures will be assessed: quality of dying, quality of life, sleep and activity (using an actiwatch), behavioural symptoms, pain, infections, use of clinical services. Family and staff outcome measures assess satisfaction and experiences of care. Economic data will be collected using new tools, being tested to see if they are appropriate for assessing this type of care. Data will be collected initially over 4 weeks, as the programme has a quick effect for people with advanced dementia, and then for up to 6 months or until the resident dies. The process evaluation will assess the context for change in each NCH, whether the programme and research have been delivered as planned, and how acceptable they are to family and staff. Data will be collected by the use of activity logs, observations of care, and staff and family interviews. Analysis will look at the acceptability of the programme and which outcome measures are most easily adhered to and provide the most relevant data. Patient and public involvement Consultation has been undertaken with two members of the Alzheimer’s Society Research Network, who have experience as relatives of people with dementia living and dying in a care home. They have agreed to be co-applicants on the study and will facilitate a Public Involvement Panel, involving family carer representatives. The PIP will provide advice on documents, and also introduce the study to relatives in care homes. Dissemination The results of this study will be shared through conference presentations and journal publications.

Research activity codes: 7.2 END OF LIFE CARE
Health categories: NEUROLOGICAL