Supporting good quality, community-based end-of-life care for people living with dementia: the SEED research programme including feasibility RCT

Our ageing societies and prevalence of dementia

The number of people living with dementia is predicted to double by 2040. 1,2 Dementia has the greatest disease burden of all long-term illnesses. 1,3 Nationally, the cost of dementia care is estimated to be £26B, with community care costs accounting for almost half of this. 2,4 More older people are experiencing a slower, more unpredictable, dying pathway5,6 as a result of multimorbidity,7 age-related illnesses such as dementia8,9 and frailty, leading to an increased need for better-integrated community care, especially if the preferred final outcome is death in the usual place of care. 5,10–12

Dying with dementia

In the UK, the National Institute for Health and Care Excellence (NICE) considers end-of-life care (EOLC) to include all health and social care provided in all settings to the following groups of people: those who are likely to die within 12 months, those with advanced, progressive, incurable conditions, and those with life-threatening acute conditions. 13–15 EOLC also covers support for families and carers. More recently, NICE has provided separate evidence-based care recommendations for patients whom professionals consider to be in the last few days of their life, when more intensive support is needed. 13,14 Because of the unpredictable dying trajectory in dementia, professionals often find it difficult to predict when a person is dying. 16,17 EOLC can, therefore, be considered more than the last few days of life: the term ‘supportive care’ was coined to reflect the need for sustained care throughout the illness trajectory. 18 In terms of the quality of care, evidence consistently shows that people with advanced dementia experience poorer EOLC than those with cancer, with increased hospitalisation, inadequate pain control and fewer palliative care interventions. 19–21 In addition, family carers of people with advanced dementia require more emotional support prior to the person’s death than afterwards;22 many do not consider dementia as a terminal illness and know little about the symptoms and prognosis of the advanced illness. 23 With respect to place of death for people with dementia in the UK, few people die at home. Nearly half die in care homes and around one-third die in hospital;24–26 very few people with a primary diagnosis of dementia use hospice care. 27

Palliative care in dementia

Palliative care is defined as:

An approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.

World Health Organization. 28 © Copyright World Health Organization (WHO), 2020. All Rights Reserved. URL: www.who.int/cancer/palliative/definition/en/

People with advanced dementia experience symptoms that are comparable to the symptoms of those dying with cancer. 12 Professionals experience a number of difficulties in meeting the palliative care needs of people with advanced dementia; for example, pain and symptom management is particularly difficult, as people with dementia may not be able to verbalise their symptoms. Despite this, however, the use of evidence-based pain assessment tools in community settings is low. 29 In addition, some professionals do not consider dementia a terminal illness30 and find prognostication difficult. 20,21,31 Both medical and nursing home staff consistently overestimate prognosis in advanced dementia. In one US study,31 only 1% of care home residents at admission were thought to have a life expectancy of < 6 months, yet 71% died in that period. A palliative care approach as dementia progresses is recommended both nationally29,32 and internationally;33 however, the evidence base to inform translation of these recommendations into practice is still limited.

End-of-life care in dementia in the UK: current service provision and commissioning

In the UK, access to specialist palliative care by families caring for people with advanced dementia is limited. 34 The quality of EOLC, in general, has been strongly influenced by the introduction of a national End of Life Care Strategy and programme,35 with associated quality markers to measure care outcomes. 36 These include the use of advance care planning (ACP), to promote patient choice, and EOLC pathways, for example the Liverpool Care Pathway for the Dying Patient (LCP)37 and the Gold Standards Framework (GSF). 38 However, the national End of Life Care Strategy35 was developed from cancer care, and directly transferring interventions may not be appropriate in dementia, for which the dying trajectory is longer and more unpredictable. 39,40 In a UK population, median survival time in dementia is 4.1 years from diagnosis,41 but this can be up to 7–10 years in younger age groups (60–69 years),42 or as low as 1.3 years in an older care home population. 43 Evidence has been slow to emerge of the effectiveness of ACP in dementia care44–46 in terms of reducing potentially harmful interventions such as hospitalisation, but few families living with dementia seem to want to complete formal ACP documents. 47–49

In England, guidance on commissioning dementia services is available from several sources,50 and NICE reiterated the need to follow other relevant existing guidance. 32,51 Currently, health and well-being boards in England do not prioritise EOLC in their strategies. 52 The Department of Health has developed dementia commissioning resources on early diagnosis and intervention, better care in acute hospitals and support for people in the community,53 but none of these documents covers EOLC in detail.

End-of-life care in dementia in the UK: research to date

Despite increasing international research, there has been little UK research in this area,20,54–56 even though EOLC was highlighted as a national research priority. 57 The Marie Curie, Alzheimer’s Society James Lind Alliance Priority Setting partnerships, which worked with the public, have also prioritised research in this area. 58,59

One UK-based study explored what constituted good EOLC in dementia with bereaved carers and professionals. 47 Family carers felt that people with dementia should die free from pain and surrounded by their relatives, whereas professional carers identified physical needs, emotional and spiritual issues, and care planning. However, general practitioners (GPs), who provide most of the EOLC in dementia,60 were not included.

England still has a high rate of hospital death in dementia (40%),61 and few people with dementia die at home. 35,62 Avoiding care transitions is important, but policy has focused mainly on promoting death in the usual place of care, rather than on the quality of dying. 35 Carers and people with dementia report comfort and QoL as the main goals of care. 43 Updated NICE dementia guidance states that people with dementia should receive flexible, needs-based palliative care that addresses the unpredictable progression,29 but models of how to achieve this in practice are lacking. Recent (2013–18) UK research has found high levels of persistent pain in care home residents with severe dementia,63 increasing anguish for carers,64,65 and rising numbers of people with dementia attending emergency departments in the last year of life. 66 Realist methods have increased understanding of integration67 and the barriers to and facilitators of good dementia palliative care,68,69 but significant research gaps remain. These include the following:

• development/testing of new interventions for primary care, as opposed to specialist care70

• research focused on people dying at home rather than in care homes43,63,71

• management of more complex dementia patients, namely those with multimorbidity

• health economic evaluations.

Workstream 3

The original proposal aimed to develop and evaluate an integrated care pathway (ICP) for professionals to use with people dying from, or with, dementia in community settings. This was grounded in the palliative care intervention, the LCP,37 which provided professionals with advice on how to provide better care in the last days of life. The LCP had been widely implemented on a national level. However, following the recommendation of a national review in 2013, the LCP was withdrawn from practice. 75 The SEED programme team, advised by the ESC, thus avoided any future use of the phrase ‘care pathway for the dying’, or ICP, and developed the intervention from the empirical data.

Workstream 6

In 2015, NICE announced that its dementia care guidelines were to be updated. As this national guidance was anticipated to include evidence-based recommendations on care towards, and at, the EOL in dementia, the ESC recommended postponing the development of any guidance for commissioners based on the SEED intervention findings until the updated guidance was published (in June 2018). 29

Methods

We built on a previous systematic review of dementia practice guidelines. 77 The original review retrieved 27 sets of dementia practice guidelines, 12 of which were eligible for inclusion [i.e. scored at least four on the Appraisal of Guidelines for REsearch and Evaluation II (AGREE II) instrument78]. Of these, five guidelines specifically addressed palliative care and EOLC:

1. Clinical Practice Guidelines and Care Pathways for People with Dementia Living in the Community79 (Queensland University of Technology, 2008)

2. guideline on supporting people with dementia and their carers in health and social care80 [NICE–Social Care Institute for Excellence (SCIE), 2007]

3. Guideline for Alzheimer’s Disease Management81 (California Workgroup on Guidelines for Alzheimer’s Disease Management, 2008)

4. Ministry of Health’s Dementia: MOH Clinical Practice Guidelines82 (Singapore, 2013)

5. Ministry of Health’s Clinical Practice Guidelines, Management of Dementia, 2nd edition83 (Malaysia, 2009).

In collaboration with WS5, we further examined the content in each guideline, looking specifically at setting, content, timing, care model(s), staff and resource implications, and clinical audit parameters. This exercise helped inform WS5 in terms of cost estimation and subsequent modelling.

Key findings

Existing guidelines recommended that people with dementia be managed as far as possible in the community. Recommendations varied as to when palliative care for people with dementia should be introduced, ranging from as early as diagnosis through to < 6 months to live. Only UK guidelines did not make any clear recommendations on the timing of the introduction of palliative care. Guidelines covered a range of aspects of palliative dementia care, including assessment, access to services, ACP and symptom management. Guidelines varied in the level of primary care involvement and support, and included shared care and case management models. Finally, no guideline incorporated any quality indicators/outcomes specific to the palliative care phase of the dementia care trajectory.

Methods

To map national initiatives, including examples of good and sustainable practice in EOLC in dementia, we updated and repeated the National Council for Palliative Care 2008 local practice online survey from October 2014 to the end of February 2015. We enquired about (1) general information regarding the service (i.e. title, contact information and location), (2) service activities and referral criteria, (3) team size and composition, (4) situation, funding mechanisms and sectors of operation and (5) dissemination and evaluation activities. 84 More than 60 services, set up specifically to provide EOLC to people with dementia, were purposively sampled via targeted e-mail invitation, in addition to open-call invitations.

Key findings

Fifteen respondents representing discrete service initiatives responded. Two-thirds of returns were received in response to targeted e-mail invitations, and one-third in response to open calls. Initiatives engaged in a wide range of activities, predominantly providing direct care and workforce development/advisory or educational activities. Findings suggested that sustainability of services was reliant on (1) enthusiastic clinicians with a leadership role, (2) wider system support through reliable funding mechanisms and (3) a minimum level of integration with normal service provision. More recent initiatives were largely built on the expertise of the nursing professions, and driven mainly by charity and hospice sector funding.

Methods

We had previously identified a number of existing systematic reviews of outcome measures for EOLC in dementia and, therefore, did not repeat this work. 87–89 To identify quality indicators to measure good-quality EOLC in dementia, we built on a previous systematic review of quality indicators for palliative care by de Roo et al. 90 The original review identified 17 sets of quality indicators for palliative care, containing 326 unique indicators. After screening, we excluded over half of the indicators because they were not applicable to long-term care settings, lacked procedural relevance or were specific to a particular scale. In addition, other indicators excluded at this stage were not applicable to UK care settings or lacked conceptual clarity. The remaining indicators (n = 156) were mapped against the European Association for Palliative Care (EAPC) framework for optimal palliative care in older people with dementia, which was developed through a rigorous international consensus process. 33 The framework comprises 11 domains:

1. applicability of palliative care

2. person-centred care, communication and shared decision-making

3. setting care goals and ACP

4. continuity of care

5. prognostication and timely recognition of dying

6. avoid aggressive treatment

7. comfort and optimal symptom treatment

8. psychosocial and spiritual support

9. family carer involvement

10. education of the health-care team

11. societal and ethical issues.

Key findings

Overall, quality indicators available to assess optimal palliative care in older people with dementia covered some of the EAPC domains, including ACP (domain 3), continuity of care (domain 4), prognostication and timely recognition of dying phase (domain 5) and family carer involvement (domain 9). However, existing indicators would need to be further developed in order for each to comprise the necessary elements (i.e. numerator, denominator and performance standard) and have its fundamental properties assessed (i.e. feasibility, acceptability, reliability, sensitivity to change and predictive validity).

There were major gaps in existing quality indicators in the following areas: (1) person-centred care, especially in specific aspects of dementia care (behaviour that challenges), (2) non-pharmacological interventions, (3) the appropriateness of pharmacological and other interventions at EOL (i.e. use of restraints, tube nutrition and the use of antibiotics), (4) the need for appropriate skill mix in health-care teams, including specialist nursing care and dementia care to support optimal symptom management, and (5) the quality of the dying environment.

Methods

Q-methodology is a mixed-methods approach combining qualitative and quantitative techniques to study subjectivity. 92 In this study, it was used to identify the views of people with mild dementia, family carers and bereaved carers on what is important (or unimportant) to them about the care provided to people with dementia approaching the EOL. In the first stage, participants ranked in order, from the most important to the least important, a set of 24 cards printed with statements about the type of care patients could receive (the statements are available in Report Supplementary Material 1). By-person factor analysis was used to identify clusters of respondents who completed the Q-sort in a similar way,92 and these clusters helped define the different factors. Short interviews were conducted following the card sort to provide additional information to aid interpretation of the factors.

Key findings

Four distinct viewpoints were identified:

1. Family involvement – decisions should be made by, and with, the family, and the wishes of people with dementia should be documented in advance to help families with this process. Family carers do not see caring for their relative as a burden: it is more important to keep the person with dementia in their own home and have the family with them at the EOL.

2. Living in the present – people with dementia live life day by day, and carers are more concerned with ensuring the comfort and safety of the person with dementia at that moment in time rather than planning ahead.

3. Pragmatic expectations – carers acknowledge their limits as carers for their relative with dementia and give high priority to having processes in place to provide the best possible care. This may include moving the person with dementia to a care home.

4. Autonomy and individuality – people with dementia want a significant level of autonomy and individuality, with their opinions and choices respected and integrated into their EOLC plans.

These findings reveal several different views on what is important about EOLC for people with dementia; therefore, a one-size-fits-all approach to care is unlikely to be the most appropriate. However, areas of consensus across all views did emerge, including the provision of compassionate care and ensuring that relevant information was available to people with dementia and their families when making decisions.

Phase 1: generating and prioritising ideas

A series of five workshops with the full SEED programme team was undertaken (November 2014 – December 2015). The initial five workshops involved early and ongoing discussions of the existing evidence base (WS1 reviews) and qualitative findings (WS2). The focus was to identify possible frameworks for the intervention, and appropriate methods and processes to inform its development. A brief summary of each workshop is provided in Appendix 3, Developing an evidence-based intervention. Following this series of workshops, the co-design process then continued in a smaller group to develop the intervention in more detail and facilitate translation into practice.

Phase 2: prototype development

The smaller group met every few weeks over a 12-month period, with a 5-month gap between months 4 and 9 (when Sandra Neves was on maternity leave). Members included the design team, PPI members, key researchers, clinical experts and service providers. The main focus of the smaller group was to consider how the ideas identified in the workshops linked to existing theoretical frameworks and could be operationalised in terms of what the intervention would comprise, who it would be targeted at, where it would be based, who would deliver it and how intervention delivery could best be supported. A summary of each of these areas is provided in the following sections.

Using the theory of change to translate theory into practice

The next stage of intervention development involved translating the conceptual model into practical activities. For each of the seven components, we began by identifying objectives for working (1) with individual people with dementia and their families and (2) at a strategic level (Box 1). The activities were also presented as checklists that could be used by the DNSs to document activities and plan their work. These documents were included in an appendix to the SEED manual [see examples in Appendix 3, Example of SEED activities and outcomes for one key component (timely planning discussions), and Example of SEED activity checklists for one key component (timely planning discussions)].

We then summarised the intervention using the theory of change. 106,121 This was used because it focuses on desired outcomes, adopts a collaborative approach and explicitly explores the rationale underlying interventions. Developing a theory of change for the SEED intervention involved an iterative and collaborative process between the research team and key local stakeholders, including a palliative care clinical lead, who would support the DNSs, and a specialist dementia nurse (who was subsequently seconded to the role of DNS for the pilot trial).

The stages involved in developing the theory of change included:

• identifying a realistic and definite goal for the SEED intervention (Figure 3 presents the ultimate goal)

• working backwards from the goal to identify outcomes that would contribute to achieving the goal

• summarising activities needed to achieve these outcomes and the intended changes through which the outcomes would be achieved

• identifying resources required for the intervention.

FIGURE 3.

Theory of change for the SEED intervention.

In addition, we explored the assumptions underlying the links between activities and the overall goal. The theory of change aimed to provide an overview of the intervention. Individual activities included in Figure 3 are, therefore, not specifically linked to individual components of the SEED intervention (e.g. planning for changing needs at the EOL is clearly linked to timely planning discussions, but is also likely to affect other components, such as providing supportive care, working effectively with primary care and managing hospitalisation). Similarly, the intended changes may result from one or more of the activities (e.g. increased acceptance of, and ability to manage, the uncertainty of EOL in dementia may result from developing and supporting the workforce and/or from planning for changing needs at the EOL). The outcomes and ultimate goal are, therefore, achieved through a combination of activities, rather than being directly linked to a specific activity.

Co-development of the care resource kit

A key role of the DNSs was to provide appropriate information to the right people at the right time. Therefore, we developed a care resource kit containing examples of existing resources to facilitate intervention delivery, and identified potential new resources to address any gaps.

Existing resources

Existing resources were identified through online searches, targeting key websites (e.g. Alzheimer’s Society, Alzheimer’s Association and the National Council for Palliative Care) and using the keywords ‘end-of-life care’ and ‘dementia’. A small group of SEED programme team members with personal and professional experience of EOLC in dementia reviewed the suitability of resources for (1) people with dementia and their families and (2) professional carers. Selected resources were grouped according to:

• relevance to one or more of the seven key components

• whether the resource focused on EOLC in general or was specific to dementia

• target audience (people with dementia, family carers and professionals)

• country of origin.

The accessibility of the resources was also considered in terms of format and availability (e.g. downloadable, free or paid for). The quality of the identified resources was then reviewed by considering whether and how research evidence had informed their development. In view of the large number of resources identified, many of which covered similar areas, we then selected the most appropriate existing resources for inclusion in the care resource kit, based on the following criteria: dementia-specific, freely available, UK based and evidence based. International resources for professionals were selected if they were of high quality with a strong evidence base. International resources for people with dementia and their families were included if they were accurate, of high quality and judged acceptable by the PPI member of the SEED team.

This process resulted in a detailed table of resources, which was included in the appendices to the SEED manual [see Appendix 3, Example of resources for one key component (timely planning discussions), for an example]. Different ways of enabling the DNSs to quickly identify and access the resources were considered. One suggestion was to develop a web portal to facilitate searching and retrieval of documents, which could be used by people with dementia and their families, as well as professionals. A preliminary structure for the web portal was agreed, in which resources would be organised by their intended audience, the seven components and format (e.g. booklet or video). Although a blueprint for the portal was developed, there were insufficient resources to develop it further.

New resources

The review of existing resources highlighted gaps in three key areas:

1. a simple introductory guide to planning for the future

2. clinical scenarios illustrating common issues in EOLC in dementia and strategies to address these

3. online training for both family carers and professional carers focused on advanced dementia and EOLC.

The rationale for selecting these areas and description of the progress made in developing new resources are described in detail in Appendix 3, Development of new SEED resources. Only one of these new resources, a MOOC on advanced dementia, was successfully completed and marketed.

Recruitment

Allowing for 10% attrition, we aimed to recruit a total of 66 people with dementia, to meet the recommended minimum sample size of 30 participants per trial arm. 128 To test the feasibility of recruitment, we aimed to recruit at least 11 people with dementia from each practice. People with dementia were initially identified from the practice dementia register and were screened by a GP to ascertain whether or not:

• they had been diagnosed within 2 years (hereafter termed ‘recently diagnosed’)

• they were on the palliative care register

• they were thought to be approaching EOL, as judged by the question ‘Would you be surprised if this patient were to die in the next 12 months?’129 (hereafter termed ‘potentially approaching EOL’).

Those on the palliative care register were assumed to be approaching EOL and were, therefore, combined with the third group. We anticipated that the intervention would focus on future care preferences with the recently diagnosed group and on the co-ordination of care and supporting non-specialists caring for those potentially approaching EOL. Full eligibility criteria are provided in Appendix 4, Pilot trial methods.

Following screening, selected eligible participants were sent a participant information sheet (PIS) giving them the opportunity to opt out of further contact. The remainder were contacted by a member of the practice team to seek verbal consent to pass their contact details to the research team. The researchers then telephoned potential participants to discuss the study further, and, if appropriate, arranged a home visit to take formal consent and complete the baseline outcome measures. We followed the provisions of the Mental Capacity Act 2005130 for those people with dementia thought to be unable to give informed consent; in such cases, we approached either a personal or a nominated consultee.

Although not essential to participation, for each person with dementia we sought to recruit a family carer and, for those living in care homes, a key informant. They were identified by the person with dementia, the general practice or the care home managers. Family carers and key informants were provided with a PIS, then followed up by the research team, as described previously. We analysed the numbers of eligible participants seen over the recruitment period, and the resulting rates of recruitment, and retention, both by intervention arm and by practice.

Process evaluation

Although the primary focus of the process evaluation was on the implementation, feasibility and acceptability of the intervention, it also provided insights into recruitment and outcome measures. The consent form for people with dementia, family carers and key informants asked if they were also willing to participate in the process evaluation. Additional health and social care professionals for the process evaluation were identified through the DNSs, lead GP and/or practice manager and non-participant observation. The principles of purposive sampling100 were used to obtain a maximum variation sample of people with dementia and family carers in terms of demographic factors, social arrangements, stage of dementia and types of engagement with the DNS. Health and social care professionals (e.g. social workers, members of community palliative care and mental health teams, home care and care home staff) were sampled in terms of level and type of involvement with the DNS. We also interviewed both DNSs at different time points during the study and members of the supervisory team.

All potential process evaluation participants were sent a PIS and followed up by the researcher, and consent was sought prior to data collection. People with dementia who lacked mental capacity to consent, as judged by the researcher and in line with guidance,130 were eligible to participate in observation.

Interviews with professionals were informed by NPT,114 for example by asking about whether or not and how the SEED intervention was distinct from existing services, whether or not and how host general practices supported the DNSs, skills displayed and required by the DNSs, and ways in which the intervention evolved over time. All interviews and informal discussions covered selected areas from the following list, tailored for different types of participant:

• recruitment processes

• views on outcome measures and perceived impacts

• feasibility and acceptability of the SEED intervention

• fit with existing services

• factors influencing implementation.

For the process evaluation, we continued data collection until data saturation was reached; we estimated that this would be achieved with up to 10 people with dementia, 15 family carers and 30 professionals.

We also captured intervention delivery through intervention supervision and activity logs (see Appendix 4, Delivery of the SEED intervention). Initially, the DNSs kept weekly activity logs using a predefined list of categories. As the role evolved, additional activity logs were introduced to capture, in more detail, interactions with people with dementia and family carers, care home staff and other professionals.

Details of data management for the process evaluation are provided in Appendix 4, Pilot trial methods. Data were analysed thematically. 101 The team discussed emerging issues and themes in data workshops and drafted a coding frame; this was then applied to new transcripts and modified until a final version was agreed. All qualitative data were coded in NVivo version 10 (QSR International, Warrington, UK). Team members wrote narrative summaries for each code for discussion in further data workshops. Data relating to implementation of the SEED intervention were subsequently mapped to the key constructs of NPT. This framework has been used extensively in exploring the implementation of complex health-care interventions,115 and focuses on the individual and collective work of implementation. 114

We iteratively developed and piloted a coding frame with each type of activity log (weekly, individual, care home, professional), until a final coding frame was agreed. All logs were then coded in a bespoke Microsoft Access® database (Microsoft Corporation, Redmond, WA, USA). Data from different logs were cross-referenced to ensure that data were as complete as possible and to avoid double counting. Data were transferred to IBM SPSS Statistics version 22 (IBM Corporation, Armonk, NY, USA) for simple descriptive analysis.

We also developed a series of vignettes to provide insight into the SEED intervention and the ways in which the seven components were enacted in practice. We purposefully sampled four people with dementia (and their family carers and/or key informants) to showcase the range of activities, settings and ways in which the intervention was tailored to the needs of individuals and services. The individuals varied in terms of their eligibility criteria (recently diagnosed or potentially approaching EOL), informal support and living arrangements. Data from interviews, observation and activity logs were cross-referenced to develop a comprehensive account of the content and delivery of the SEED intervention for each selected participant. To capture the more strategic components of the intervention, we used similar methods to develop a vignette from a care home perspective. A care home was selected where the DNS had worked with individual study participants and at a more strategic level to improve EOLC.

Collection of outcome data

A detailed description of all outcome measures and their interpretation is provided in Appendix 4, Table 12. In brief, measures relating to the person with dementia explored neuropsychiatric symptoms, physical health, pain and QoL. Family carer measures included anxiety and depression, views on care provided and QoL. Key informants completed measures relating to the care provided. Data on resource use by people with dementia and carers were collected using a bespoke questionnaire. Family carers and/or key informants completed a proxy version of the EuroQol-5 Dimensions, five level version (EQ-5D-5L),131 for all people with dementia at all time points to ensure that full data were available in case the person with dementia was unable or unwilling to complete this measure. When data were provided by both a family carer and a key informant, the latter was given precedence because key informants usually had more consistent daily contact with the person with dementia.

Most outcome measures were completed at baseline and at 4, 8 and 12 months (Table 2). Demographic data were collected during baseline study visits. A post-death study visit was completed at either 2 months (family carers) or 2 weeks (key informants) after the death of the person with dementia. These time periods were selected to avoid the interview request clashing with the NHS survey typically sent out 3 months after death (for family carers) and to maximise recall (for key informants). Data on comorbidities, ACP and, when appropriate, cause of death were collected from general practice and/or care home records at baseline and either at 12 months or post death (see Table 2).

The feasibility and acceptability of outcome measures were assessed by examining:

• the proportion of outcome measures completed within data collection windows

• the proportion of people with dementia for whom outcome data were collected

• data completion rates for each outcome measure

• the views of people with dementia, family carers, key informants and the researchers administering the outcome measures.

Statistical analyses of outcome measures focused on data completeness of outcome measures and any potential bias in the completion of follow-up data (see Appendix 4, Pilot trial methods). When statistical analysis indicated larger numbers of missing data, or when findings were inconsistent with data from other studies [e.g. Pain Assessment in Advanced Dementia (PAINAD)], we drew on data from reflective field notes by the researchers and interviews with people with dementia, family carers and key informants to explore reasons for missing data.

Recruitment

We achieved the minimum target of 11 people with dementia per practice, but fell marginally short of the overall target (62/66). Recruitment and retention of people with dementia are summarised in a Consolidated Standards of Reporting Trials (CONSORT) flow diagram (Figure 4). CONSORT diagrams for family carers and key informants are provided in Appendix 4, Figures 5 and 6. Overall, 82% of patients who were screened met the eligibility criteria. Either a family carer or a key informant was recruited for at least part of the study for all but three people with dementia.

FIGURE 4.

The CONSORT flow diagram for people with dementia. P, practice.

There was some variation in screening and recruitment processes between practices (see Figure 4). The proportion of people on the dementia register who were screened ranged from 89.3% to 91.1%, and the proportion of those screened who were eligible ranged from 73.1% to 91.2%. Lack of resources in control practices meant that almost three-quarters (74%) of people with dementia who were eligible and potentially contactable (i.e. had not been excluded by the GP and, if appropriate, had a contactable consultee) were not approached, compared with only 11% in intervention practices. This explains the better recruitment rates observed in intervention practices (where 36.7% and 38.8% of eligible patients were recruited, compared with 10.7% and 14.3% of those eligible in control practices).

Three-quarters (75%) of the 56 family carers identified were recruited; only one person with dementia requested that we did not approach a family carer. Key informants were identified, and agreed to take part, for 26 of the 33 (79%) people with dementia who lived in a care home at some point during the study. Although key informants were not recruited for the remaining seven people with dementia, this was at the request of either the person with dementia or their family carer, with the latter providing information instead.

Retention

Retention was better than expected: 12-month data were successfully collected for 41 (66%) people with dementia, exceeding the target of 33 people. Mortality was lower than expected: 12 people with dementia died during the study, five in the intervention and seven in the control arm. All of those who died had been identified as potentially approaching the EOL by a GP during screening. Post-death interviews were completed for 11 out of the 12 people with dementia who died; one family carer declined. Four people with dementia withdrew from the study: three moved to a care home and changed general practice, and one was withdrawn because of the ill health of his spouse.

No family carers died during the study. Four family carers withdrew: two when the person with dementia moved care home and changed general practice, one because of ill health and one did not give a reason. Post-death information was provided by five of the six family carers who were the main informants for people with dementia who died.

Three key informants were withdrawn when the person with dementia moved care home. There was considerable continuity of key informant, with 18 key informants providing information at all time points; two key informants were involved for seven people with dementia, and information on one person with dementia was provided by three different key informants. An additional 10 key informants were recruited during the study: eight replaced key informants who were unavailable at follow-up and another two provided data for people with dementia who moved into a care home or moved between care homes. Post-death interviews were completed with key informants for six of the eight people with dementia who died while in a care home (the family carer provided post-death information for the remaining two people).

We collected data at the end of the study to examine the accuracy of the ‘surprise’ question by reviewing the status of all patients who had been on the dementia register at the time of screening. Patients for whom the surprise question was not answered (n = 28) and those whose status was not known at the end of the study (e.g. because they had moved practice; n = 35) were excluded (Table 4).

Only 9% of patients not thought to be potentially approaching the EOL had died by the end of the study, compared with 37% of those thought by the GP to be potentially approaching the EOL. These figures nevertheless confirm the difficulties of identifying people with dementia approaching the EOL, as > 60% of those thought to be potentially approaching the EOL were still alive at the end of the study.

Participant characteristics

Participant characteristics were reasonably well balanced between intervention and control arms, given the relatively small study. Full details are provided in Appendix 4, Tables 19–22.

As previously described, we aimed to recruit two distinct groups of patients: those recently diagnosed and those potentially approaching the EOL. Patients who met both criteria have been classed as potentially approaching EOL in Table 5. This shows that the majority of patients screened (85%) were considered to be potentially approaching the EOL. Those not considered to be potentially approaching EOL were almost four times as likely to be recruited as those potentially approaching EOL (42% vs. 11%). Despite the unequal recruitment of patients from the two eligible groups, the majority of those recruited (69.4%) were nevertheless thought to be potentially approaching the EOL. We are, therefore, confident that the intervention was provided to both groups of eligible patients.

Data from the qualitative interviews suggest that reservations over approaching patients and their families thought to be approaching the EOL and concerns over what the intervention would involve or could offer this patient group contributed to the under-recruitment of people with dementia potentially approaching the EOL. Similar issues with access to patients approaching the EOL and their carers were experienced in the process evaluation, whereby the DNSs could be protective towards potential participants thought to be at the EOL.

Recruitment to the process evaluation

We completed a total of 55 interviews with 59 interviewees in the process evaluation. Interviewees included people with dementia; family carers; DNSs; the intervention supervisory team; general practice staff (intervention and control sites), including GPs, practice managers, administrative staff and pharmacists; and a range of health-care and social care professionals who worked in care homes, community mental health teams, palliative care teams, primary care, sheltered housing and hospices. On average, interviews lasted 33 minutes.

Non-participant observation was conducted on 23 occasions (total time: 1243 minutes, mean 54 minutes, range 15–120 minutes). Observations were predominantly of intervention delivery, including training, working with other practitioners and working with people with dementia and their families. Observation settings included care homes, hospitals, GP surgeries and participants’ homes. DNS training and intervention supervision sessions provided by the research team were also observed and audio-recorded with the consent of all participants.

Views on screening and recruitment

Key findings from the qualitative data are summarised in this section; full details with illustrative quotations are provided in Appendix 4, Feasibility and acceptability of recruitment and retention. Feedback from practice staff and the DNSs indicated that the process of screening patients and recruitment was more challenging than anticipated. This was partly because of difficulties in answering the screening questions, with some GPs questioning the validity of the ‘surprise’ question. Recruitment of family carers was hindered by poor documentation of next of kin in GP records. Relatively few potential participants opted out of further contact from the research team, suggesting that this approach was acceptable to this group of patients and carers. Few comments were made by people with dementia and carers about recruitment processes. Some people with dementia and their carers who had been recently diagnosed did not see the SEED intervention as relevant to their situation. However, some of those who initially thought that the intervention had little to offer were subsequently surprised by how much they gained from the intervention. Key issues relating to recruitment and potential strategies to maximise recruitment to a future trial are summarised in Appendix 4, Table 23.

Stakeholder views on the SEED intervention

Key issues relating to the feasibility and acceptability of the SEED intervention concerned the location of the SEED intervention in primary care, relevance of the seven components to real-world practice, appropriateness of working with individuals and at a more strategic level, qualifications and training needed to fulfil the DNS role, and the fit of the SEED intervention with existing services. These issues are summarised in this section, with further elaboration and illustrative quotations provided in Appendix 4, Feasibility and acceptability of the SEED intervention.

Basing the intervention in primary care was valued because this facilitated access for people with dementia and family carers, face-to-face contact with GPs, access to patient records and links with other services.

Each of the seven components was thought to be relevant, and no additional components were identified. Although the DNSs were initially more comfortable working with individuals, through intervention supervision and the growing familiarity with their role, they became enthusiastic about working at a systems level (see examples in Table 6). The DNS role in co-ordinating care (across primary and secondary care) was valued by family carers and enhanced continuity of care. From a GP perspective, a proactive approach was thought to avoid crises, and reduce hospitalisation and demands on their time. The emphasis on timely planning discussions was valued by health-care professionals, as no existing professionals had a clear responsibility for these. Some of the barriers to planning ahead that were identified in our earlier work,96 for example reluctance to talk about the future and a preference to focus on the present, were encountered by the DNSs. The opportunity to invest time in relationship-building and to embed such discussions in a broader context of talking about changes in circumstances were key to facilitating ACP.

The nursing background of the DNSs was valued by both family carers and care home staff. Others considered professional background less important, but emphasised personal attributes, such as inspiring confidence and being reliable and approachable. Most stakeholders viewed the SEED intervention as complementary to existing services and tensions over role boundaries were rare.

We drew on the framework of NPT114 to identify factors influencing the implementation of the SEED intervention (see Appendix 4, Feasibility and acceptability of the SEED intervention). The NPT analysis suggested that the individual and collective work required for successful implementation of a new intervention was largely achieved. In terms of coherence (whether or not the intervention was easy to grasp and made sense), the DNSs and practice staff contested the focus on EOLC and were keen to extend the intervention to all people with dementia. Although the perceived lack of clarity over the focus and content of the SEED intervention was initially a barrier to implementation, as the DNSs became more confident with the components underpinning the intervention they valued the opportunity to develop the intervention autonomously.

Cognitive participation or investment in the SEED intervention was high for the DNSs, but varied between the two host general practices; this affected the extent to which the DNSs were successfully embedded and limited the scope for improving systems in one practice. The temporary nature of the intervention influenced buy-in of all stakeholders and required a strong focus on relationship-building by the DNSs to successfully engage people with dementia, family carers and care homes.

The work involved in delivering the SEED intervention (collective action) required experienced staff who were used to working autonomously. Supervision arrangements ensured access to specialist knowledge and support relating to different aspects of their role. Intervention supervision was particularly important because of the initial uncertainties of the DNSs over the scope of the intervention, and to encourage working at a more strategic level.

Although the SEED intervention was piloted for only 12 months, there was evidence of reflexive monitoring: the process of reflecting on, and adapting, the intervention. Access to different perspectives through supervision facilitated reflection on the intervention. A number of pieces of work were undertaken iteratively with care home managers, GPs and other local professionals to maximise likelihood of integration into practice. System-level changes likely to be sustained after the study included the annual dementia review template in one general practice, comfort care planning and revised EOL documentation in some care homes.

Completion of outcome measures

All data were collected within the target window with one exception, confirming that the time parameters set for data collection were achievable. Aggregating data across all time points for current study participants (i.e. excluding those who had died or withdrawn), data were collected from 86% of people with dementia, 97% of family carers and 100% of key informants. The main reason for missing data was that some people with dementia were not approached for data collection at the request of their family carer or key informant, because the family carer or key informant either thought that the person would not be able to provide data and/or thought that data collection would have a negative impact (e.g. creating anxiety). Data were occasionally missing because of ill health or holidays. Data for family carers were missing because of unavailability, typically because of holidays, their own ill health or difficult circumstances.

The proportion of fully completed measures (i.e. those with no missing items) at each time point by type of respondent ranged from 9.1% to 100%. All but three measures were fully completed on > 80% of occasions. The three measures with poor completion rates were as follows:

• the PAINAD during movement, with a full completion rate of 53.5% across all time points and respondents (range 43.8–68.4%; see Appendix 4, Tables 30–33)

• the EQ-5D-5L completed by people with dementia, with a full completion rate of 65.1% across all time points (range 54.2–86.7%; see Appendix 4, Table 36)

• the Satisfaction with Care at the End of Life in Dementia (SWC-EOLD), with full completion rates of 40.7% for family carers (range 11.8–100%) and 35.4% for key informants (range 9.1–66.7%; see Appendix 4, Tables 30–33 and Table 35).

Qualitative data and further analyses suggested that the reasons for missing data were specific to individual measures. Missing data on the PAINAD were because of the inability of researchers to rate pain during movement when people with dementia remained seated (or asleep). Difficulties on the EQ-5D-5L appeared to reflect the difficulties experienced by some people with dementia in understanding and grasping the task. Given the large number of missing data on the SWC-EOLD, completion rates for individual items were reviewed. This suggested particular difficulties with two items (questions 4 and 10; see Appendix 4, Table 34, for details). The finding that completion of this measure improved at the post-death interview (see Appendix 4, Table 35) may suggest that the items are more relevant at the EOL, although interpretation is difficult because numbers are small. The validity of the SWC-EOLD was disputed by key informants who commented that they were unlikely to criticise their own care; this may contribute to the large numbers of missing data.

Detailed scores for numeric outcome measures are tabulated by time point and intervention arm in Appendix 4, Tables 40–61.

Capturing data on advance care planning

Although the intention had been to collect data from both general practice and care home records at baseline, 12 months and post death to ascertain whether or not plans were filed in both places, only one set of records was routinely checked. Data were available for all people with dementia at baseline and for all but four individuals at follow-up, most commonly because they had withdrawn (see Appendix 4, Table 38). Further analyses indicated wide variation between practices in the proportion of people with dementia for whom plans were available in either general practice or care home records (see Appendix 4, Table 39).

Stakeholder view on outcome measures

A detailed analysis of the qualitative data relating to outcome measures, including quotations from participants, is provided in Appendix 4, Feasibility and acceptability of outcome measures. In summary, all participants thought that the set of measures was acceptable. The relevance of some measures was questioned, for example whether or not the End of Life in Dementia (EOLD) measures were appropriate for recently diagnosed people with dementia, and whether or not rating satisfaction with care was appropriate for care home staff. Concerns were raised over the reliability of some measures; in particular, some family carers and key informants queried the responses of the person with dementia to the EQ-5D-5L. Some measures [e.g. Neuropsychiatric Inventory (NPI), Comfort Assessment in Dying with Dementia (CAD-EOLD)] were potentially distressing for family carers, either because they raised awareness of the range of symptoms that might occur in the future or because they highlighted discrepancies between desired and actual care. A number of potential modifications to the resource use questionnaire were identified to reduce respondent burden.

Recruitment to a future trial

Given the high proportion (82%) of patients on the dementia register who were eligible, the rationale for excluding the remainder was questioned. Broadening the eligibility criteria would ensure equitable provision to all people with dementia. It would also streamline recruitment processes. A range of practical barriers to recruitment were identified. One successful strategy used in the pilot trial was to pay for a locum to free up GP time for screening; although the screening process may be less onerous in a future trial (if the eligibility criteria change), this strategy should still be considered. The acceptability of an opt-out approach was demonstrated for this patient group. Training other practice staff to make the follow-up telephone calls could also reduce the burden on GPs. The lack of information routinely recorded on next of kin created additional work and caused delays in recruitment. Working with practices prior to recruitment to improve recording of next of kin is recommended in a future trial. The pilot trial demonstrated the importance of close, formal monitoring of recruitment processes, and this should be planned from the outset. Detailed recommendations for maximising recruitment to a future trial are provided in Appendix 4, Table 23.

Changing the eligibility criteria would, however, have implications for the intervention that was developed rigorously using extensive data from WS2 and the previous experience of the MCDP to improve EOLC. Additional components are likely to be relevant at other stages of the illness trajectory and further work would be needed to identify these and to consider how best to address them if the intervention were to be extended to cover the entire dementia trajectory.

Implementation of the SEED intervention in a future trial

Basing the intervention in general practices was successful, but more explicit negotiation about the required level of engagement from GPs and practice staff is needed. Intervention supervision facilitated an ongoing dialogue about the boundaries of the intervention, how to operationalise the seven key components and opportunities for making strategic changes. It is, therefore, recommended that similar arrangements are made in a future trial. Although we did not succeed in establishing a MDT to support the DNSs, the clinical supervision from old-age psychiatry and palliative care met their needs.

Data from the pilot trial could be used to further refine the intervention manual and resources (e.g. by providing examples of the range of activities). This should enable DNSs in a future trial to feel clearer and more confident about their new role. Assessing the fidelity of a complex, tailored intervention was inevitably challenging. Involving the DNSs in the development of activity analysis tools and iteratively monitoring and refining their use is recommended in a future trial. Despite clear areas of overlap with existing services, particularly Admiral nurses, most stakeholders saw this as a benefit, rather than a problem. Each intervention practice was allocated a full-time DNS in the pilot trial; alternative, less costly, ways of providing the intervention should be explored.

Outcomes for a future trial

Many of the outcome measures appeared to work well in the pilot trial in terms of acceptability to participants and completion rates. However, we did not clearly identify an appropriate primary outcome measure for a future trial, particularly if the intervention was extended to include the full illness trajectory. Despite the previous validation and successful use of the SWC-EOLD in the USA138 and the UK,64,119,143 it was poorly completed and criticised by respondents and researchers in this study. Identifying measures that focus on well-being, not just deficits, is also recommended because the intervention may foster a positive sense of well-being.

We demonstrated the feasibility of collecting data on resource use and health-related QoL. Given the relatively large numbers of missing data on the EQ-5D-5L for people with dementia, collecting proxy data at all times is recommended in a future trial. People with dementia may also find the EuroQol-5 Dimensions, three-level version (EQ-5D-3L), easier to complete. Further investigation of how to prioritise or combine data from proxy respondents is needed. A number of recommendations for modifying the resource use questionnaire were made to reduce respondent burden. Data on ACP were successfully captured and suggest that the percentage change in documentation in practices may be a more appropriate way of analysing data in a future study. Although we focused on whether a range of plans was present or absent from the notes, content analysis of such plans may provide a more nuanced approach. Given the emphasis on staff training, the inclusion of measures of staff knowledge, skill and confidence could be considered in a future trial.

Methods

Five scenarios were developed that described different combinations of the seven key components to support good EOLC identified from WS2. These five scenarios mirrored the comparators used in the economic model. The contingent valuation survey took a community perspective, with respondents asked to give their WTP for the SEED intervention to be available in the NHS, even though they would not (necessarily) benefit from it themselves. Given this perspective, respondents were asked their WTP in the form of an additional tax per month that they would pay for the next 10 years. The survey comprised three sections: background information on current provision of dementia care towards the EOL and on the SEED intervention, the WTP questions and the participant demographics (see Report Supplementary Material 1). The survey was pre-piloted with Newcastle University staff using the ‘think-aloud’ technique. 149 Piloting of the full web survey was conducted in a subsample of the target general population. For the pilot and final surveys, the sample of the general population was recruited from the online panel managed by a marketing company (ResearchNow, London, UK). For the main survey, a sample of 1000 respondents was targeted, with quotas on age, gender and employment status to be representative of the UK general population.

Key findings

Data were collected from 1002 members of the general public (see Appendix 5, Valuing the consequences of the SEED intervention for details of the sample). Table 7 reports the mean and median WTP values across the scenarios for both the untrimmed and the trimmed data sets. The trimmed data set excluded the top 1% of responses. The mean WTP computed from the untrimmed data set for the alternative scenarios was much higher than the mean WTP value for the main scenario, and the very wide 95% confidence intervals (CIs) indicate the presence of very high outlier values. When the top 1% of WTP values were trimmed,150 the mean WTP for the main scenario was higher than for the alternatives and the CIs were narrower. The medians for both the trimmed and the untrimmed data sets generally remained the same. The number of zero responses per scenario ranged from 19% to 35% of the total sample, of which 10–13% could be classified as protest zeros, that is respondents indicated that they were not willing to pay because they believe that should not have to pay for health care. The protest zero responses were removed from the analysis of mean/median WTP.

Compared with individuals with no experience of dementia, individuals who have seen their close family members, friends or relatives with dementia placed a higher value on the tailored support provided by the DNS and the provision of high-quality EOLC to people with dementia (see Appendix 5, Table 65). Respondent characteristics, such as age, gender, household size or health utility score, did not influence the WTP value (see Appendix 5, Table 66). However, some higher-income groups had WTP values that were significantly higher than the WTP values of those on the lowest income level, which is consistent with economic theory. These findings suggest that members of the general public do value the care provided by the SEED intervention. Moreover, a higher WTP value for the main scenario indicated that it was valued more than packages with selected features only.

Methods

A decision-analytic model was developed to estimate the impact of the SEED intervention activities on relevant service outputs and related outcomes for people with dementia (see Appendix 5, Economic evaluation of the SEED intervention), as well as health and societal costs. We modelled the main elements of a patient’s journey through care, as well as how dementia may progress over time. The literature was reviewed for economic evaluations to inform the model structure (see Appendix 5, Economic evaluation of the SEED intervention). In the model, care and health events occur based on probabilities derived from different sources. Following the diagnosis, dementia progresses in three severity domains (see Appendix 5, Event probabilities, and Appendix 6, Dementia progression). The setting of care for an individual may change between home, care home and hospital (see Appendix 5, Event probabilities, and Appendix 6, Transition probabilities between care settings). An individual eventually requires palliative care, and there is a risk of death at any stage of the model (see Appendix 6, Mortality and palliative care). The likelihood of care and health events were influenced by patient characteristics (see Appendix 6, Baseline population) and by the prevalence of specific dementia care services (see Appendix 6, Care services and their effects). Finally, costs were assigned to the SEED intervention, the care settings and the care services (see Appendix 6, People with dementia: care-setting costs).

The cost–consequence analysis compared the presence of the SEED intervention with usual care. The effect of the SEED intervention on service outputs and related outcomes for people with dementia is unknown. Therefore, a set of scenarios was designed to estimate the relative impact of all activities combined and each activity individually:

• the maximum and minimum expected provision of all activities are set in a favourable and conservative SEED scenario, respectively

• the minimum and maximum expected provision of each activity was set, while the remaining four activities were set at the average level of provision.

In the cost–benefit analysis, the net monetary benefit of providing a SEED intervention over an illustrative 5-year period was estimated for each of the scenarios described in Appendix 5, Valuing the consequences of the SEED intervention, compared with a scenario in which these services are absent. The net monetary benefit is the difference between the WTP for the services and the additional costs associated with the services.

Key findings

Methods

A mixed-methods approach was used, combining a narrative review and qualitative interviews with commissioners of EOLC for people with dementia. The former examined current guidance and policy (national and international) and academic literature with initial web-based searches in January 2014, repeated in January 2016. Academic papers were included if they focused on commissioners’ experiences of the commissioning process, service providers’ experiences of the commissioning process or factors that enable or inhibit the commissioning process, or if they compared commissioning arrangements. Using review findings, a semistructured topic guide was developed (see Report Supplementary Material 1). Interviews with professionals responsible for commissioning EOLC for people living with dementia (n = 20) took place between October 2014 and January 2016. All interviews were audio-recorded and transcribed verbatim, then checked and anonymised prior to analysis.

Policy and guidance documents included in the narrative review were categorised as follows:

• guidance (a guide to commissioning or clinical practice)

• policy (documents concerned with aspirations and aims issued by the Department of Health and Social Care, NHS England and other government agencies)

• strategy (e.g. national EOLC strategy)

• non-governmental organisation position papers (e.g. Alzheimer’s Society, Nuffield Trust and The King’s Fund).

Findings from the academic literature were summarised and grouped thematically. Interview transcripts were analysed using a thematic approach. 101

Key findings

The review found major gaps in commissioning guidance for EOLC, specifically for people with dementia. Findings from the academic literature mainly focused on commissioning at a general level, with little on condition-specific commissioning for EOLC. Three key themes emerged from the triangulated findings of the narrative review and first round of commissioner interviews:157

1. the importance of joint commissioning

2. a lack of clarity in commissioning processes

3. facilitators of and barriers to commissioning.

Commissioners faced several challenges, not least a constantly changing policy landscape. Broader policy change, for example the introduction of sustainability and transformation plans and constantly changing commissioning structures, led to commissioners working in a context of persistent uncertainty. In exploring health professionals’ perceptions of the commissioning process, uncertainty emerged as an overarching theme. In terms of expertise, commissioners need succinct evidence summaries, knowledge of local resources and an understanding of how health-care organisations function at a national level. New guidance could focus on assisting commissioners to address day-to-day practical problems and contain concise evidence to inform activities such as contract specification (a structured description of what the commissioning organisation requires from a provider).

The narrative review was updated with new searches conducted between February and June 2017 using the same search strategy and search terms as the original review. Only studies published since 2015 were considered for inclusion. Fifteen potentially relevant articles were retrieved, of which eight met the inclusion criteria. Three studies explored dementia and EOLC,159–161 with the other five focused on general commissioning of health services. 30,162–165 A summary of the studies included in the updated narrative review is provided in Appendix 7, Table 95. Key findings revealed increasing complexity and persistent lack of clarity in processes, particularly in three areas: the role of the GP, contracting models and the commissioning of palliative care and EOLC in general.

Follow-up interviews

Further commissioner interviews (n = 7) were conducted between January and August 2017, to explore any subsequent changes to commissioning processes and information needs. There were a number of parallels with the thematic analysis conducted for the first round of interviews. A theme of continuous organisational change with persistent lack of clarity in processes prevailed.

Organisation of commissioning

Participants commented on the continued re-organisation of commissioning services alongside complex top-heavy commissioning structures and new initiatives (such as sustainability and transformation plans), which created additional upheaval. There was also a lack of clarity around commissioning processes and where responsibility lay for commissioning. Notwithstanding a new proposed local organisational structure, an Accountable Care Organisation was considered an opportunity for more efficient, integrated working.

End-of-life care and dementia: lack of integrated guidance

Some progress has occurred regarding integrated EOLC in dementia, but, generally, systems remained separate. For example, it was highlighted that the EOL guidelines do not include dementia, and dementia commissioning guidelines do not include the EOL.

Specification as an emerging art form

Participants still considered specification, a structured description of what the commissioning organisation requires from the service provider, a useful tool. However, this too was a constantly changing process to adapt to a shifting political and organisational landscape. It did, however, provide an opportunity to clearly define the detail of service provision, and its evidence base, and to incorporate performance measurement.

Methods

Following a decision to suspend the development of SEED specific guidance in view of the updated NICE guidance in dementia care, the new 2018 guidance, once published, was scrutinised to identify new recommendations and/or changes in guidance specific to EOLC in dementia, for example care planning, review and co-ordination, and involving people with dementia in decisions about their care. Sections of the original32 and updated29 clinical guideline were extracted and entered into a structured data table. The content along with the strength and quality of the evidence underpinning the recommendations was compared.

Key findings

Although very similar in terms of the recommendations for practice, the evidence base underpinning the 2018 NICE recommendations had strengthened considerably, owing to an increase in both the quantity and the quality of available research. The one exception to this was for palliative care and EOLC, for which there was still limited empirical research. Three key components were relevant to improving EOLC in dementia; these are outlined below.

Comparison with the SEED intervention findings

Table 10 shows how the seven SEED components, identified as essential to the delivery of good EOLC for people with dementia, closely align with several elements of the NICE recommendations29 (e.g. providing ongoing opportunities throughout the illness trajectory, use of a person-centred approach, co-ordination of care). To ‘[p]rovide people living with dementia with a single named health or social care professional who is responsible for co-ordinating their care’ [reproduced with permission from NICE. 158 © NICE 2018 Resource Impact Report: Dementia: Assessment, Management and Support for People Living with Dementia and their Carers (NG97). Available from www.nice.org.uk/guidance/ng97/resources/resource-impact-report-pdf-4897901485. All rights reserved. Subject to Notice of rights] was one of three original (clinical guideline 4232) NICE recommendations that was identified as not having been fully implemented, and for which there was evidence of wide variation in practice. 158 The SEED intervention, developed with the seven factors at its core, provides a potential solution to the uptake of this recommendation.

Dissemination and refinement of guidance on end-of-life care in dementia

A series of local and national dissemination activities for commissioners and service providers was undertaken to publicise both the NICE 2018 dementia guidance specific to EOLC and the SEED intervention.

Workstream 1

Amador S, Goodman C, Robinson L, Sampson EL. UK end-of-life care services in dementia, initiatives and sustainability: results of a national online survey. BMJ Support Palliat Care 2016;8:424–7.

Hill SR, Mason H, Poole M, Vale L, Robinson L. What is important at the end of life for people with dementia? The views of people with dementia and their carers. Int J Geriatr Psychiatry 2017;32:1037–45.

Amador S, Sampson EL, Goodman C, Robinson L. A systematic review and critical appraisal of quality indicators to assess optimal palliative care for older people with dementia. Palliat Med 2019;33:415–29.

Workstream 2

Lee RP, Bamford C, Exley C, Robinson L. Expert views on the factors enabling good end of life care for people with dementia a qualitative study. BMC Palliat Care 2015;14:1–10.

Lee RP, Bamford C, Poole M, McLellan E, Exley C, Robinson L. End of life care for people with dementia: the views of service managers and frontline staff on key requirements for good practice. PLOS ONE 2017;12:1–19.

Bamford C, Lee RP, McLellan E, Poole M, Harrison-Dening K, Robinson L, et al. What enables good end of life care for people with dementia? A multi-method qualitative study with key stakeholders. BMC Geriatr 2018;18:302.

Poole M, Bamford C, McLellan E, Lee RP, Exley C, Hughes J, et al. End-of-life care: a qualitative study comparing the views of people with dementia and family carers. Palliat Med 2018;32:631–42.

Workstream 3

Macdonald A, Neves S, McLellan E, Poole M, Harrison-Dening K, Tucker S, et al. End of life care: resources to strengthen support. J Dement Care 2018;26:28–31.

Workstream 5

Bhattarai N, Mason H, Kernohan A, Poole M, Bamford C, Robinson L, Vale L. The value of dementia care towards the end of life – a contingent valuation study. Int J Geriatr Psychiatry 2020;35:489–97.

Workstream 6

Gotts ZM, Baur N, McLellan E, Goodman C, Robinson L, Lee RP. Commissioning care for people with dementia at the end of life: a mixed methods study. BMJ Open 2016;6:e013554.

Massive open online course

Poole M, Yemm H, Young J, Davis M, Robinson L. Living well as dementia progresses: a MOOC for all. J Dement Care 2019;27:20–3.

Poole M, Davis N, Robinson L. Massive Open Online Courses: enhancing caregiver education and support about dementia care towards and at end of life. Age Ageing 2020;49:171–4.

Other outputs

Setting

Overall, guidelines recommend that people with dementia be managed, as far as possible, in the community. UK guidelines80 do, however, recognise that admission to acute or general inpatient services/psychiatric admission may sometimes be required. Only Malaysian guidelines83 recommend assessment and treatment in outpatient and inpatient, as well as community, settings.

Timing

Recommendations vary as to when palliative care for people with dementia should be introduced (Table 11). Only one set of guidelines (UK) does not make a clear recommendation as to the timing of palliative care. Both Australian79 and Singaporean82 guidelines tie the introduction of palliative care to the severity of dementia as assessed by the Functional Assessment Staging Tool (FAST),195 in addition to specified dementia-related comorbidities. Californian81 guidelines also recommend the introduction of palliative care when the person with dementia becomes eligible for hospice care (mortality predicted within 6 months). Finally, Malaysian83 guidelines suggest that palliative care begins from the time of diagnosis to death.

Content

Guidelines are a mix of evidence- and consensus-based recommendations (note that Asian guideline recommendations are graded according to the strength of the evidence underpinning them, which may include workgroup consensus only). Guidelines outline anywhere between 5 and 11 recommendations, covering the following issues (see Table 11):

• assessment (including staging) and review

• palliative care approaches in dementia

• access to palliative care services and communication within and across services

• hydration and nutrition (including tube-feeding)

• management of fever and infection

• pain management

• ACP (including decisions to resuscitate)

• assessment of carers needs (including support system, grief and loss).

Two topics are not included in Table 11, as each appears in only a single guideline. Australian guidelines79 include two recommendations on admission to residential care (when care outside the home is needed, staff should be aware of the wishes of the person with dementia; a carer may benefit from the help of health professionals in planning for residential care). Malaysian guidelines83 cover the use of restraints (physical restraint should be used sparingly and should be individualised).

In addition, Australian79 and Singaporean82 guidelines provide context-specific contact information for local programmes, helplines and services termed ‘practice tips’ and ‘community resources’, respectively. Californian,81 Malaysian83 and Singaporean82 guidelines provide copies of some of the assessment tools (e.g. functional and nutrition assessment), which are cited in the text. Finally, Australian79 guidelines include three advanced phase pathways for care workers, allied health professionals and GPs.

Care lead/model

The model of care outlined by each set of recommendations has been identified and categorised using Luckett et al.’s199 definitions of models of palliative care.

Both Singaporean82 and Malaysian83 guidelines appear to recommend a ‘consultation model’ approach to care, in as much as neither outlines mechanisms for collaboration between the health-care professionals involved. Luckett et al. 199 define a consultation model as:

An approach to care by which specialist advice is provided on assessment and treatment of symptoms, communication about goals of care and support for complex medical decision-making, provision of practical and psychosocial support, care coordination and continuity, and bereavement services when appropriate. Advice is provided without necessarily assuming primary responsibility for care, although there is negotiation of the level of palliative care involvement.

Luckett et al. 199 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

UK80 and Californian81 guidelines recommend a ‘case management model’, led by care managers/co-ordinators and primary care practitioners. Luckett et al. 199 define a case management model as:

. . . a collaborative process of assessment, planning, facilitation and advocacy for options and services to meet an individual’s holistic needs through communication and available resources to promote quality cost effective outcomes. The definition of case management notes the focus upon the meeting of a client’s health needs. Case management can be placed within a social model of health, within which improvement in health and well-being are achieved by directing efforts towards addressing the social and environmental determinants of health, in tandem with biological and medical factors.

Luckett et al. 199 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Finally, Australian79 guidelines recommend a ‘shared-care model’ approach to palliative care involving GPs, allied health professionals/care managers and care workers. Luckett et al. 199 provide one definition of shared care as:

. . . an approach to care which uses the skills and knowledge of a range of health professionals who share joint responsibility in relation to an individual’s care. This also implies monitoring and exchanging patient data and sharing skills and knowledge between disciplines.

Luckett et al. 199 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (https://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Staffing/resourcing

Overall, guidelines outline the type of resourcing required, rather than the quantity of the resource use that is needed, for example how much of a care worker’s time is required.

Clinical audit parameters/indicators for quality improvement

Only Singaporean82 and Malaysian83 guidelines have a set of indicators for quality improvement, although neither provides a set of indicators that is specific to the palliative care phase. Remaining guidelines either do not address clinical audit and/or quality improvement, or recommend that inspection standards be developed separately within a more broadly based implementation strategy (i.e. UK80 guidance).

Overview of phase 1 workshops to generate and prioritise ideas

• Workshop 1 comprised small group activities to discuss the purpose of the intervention and potential uses and users, and to clarify the boundaries of the intervention.

• In workshops 2 and 3, care trajectories from the MCDP cohort data and clinical scenarios from WS2 data were used to prompt discussion of the possible content of, and resources needed to support, the intervention.

• Workshop 4 considered how existing national guidance could inform the intervention and reviewed available educational/training resources.

• In workshop 5, key findings from WSs 1 and 2 were presented, followed by team activities to identify gaps in existing care and identify possible ideas for the intervention.

Person specification for dementia nurse specialist

Job title: dementia nurse/care facilitator.

Department: palliative care.

Location: North Tyneside Community.

Timely planning discussions

Introductory guide to planning for the future

Although a wide range of resources addressed planning for the EOL, there was no simple, introductory overview of the different options available or that provided key information on completed plans (e.g. where such plans were stored and whether or not they had been discussed with the GP). WS2 highlighted the lack of knowledge of ACP and misconceptions over the validity and status of completed documents. For example, even when preferences for invasive treatment had been discussed, these had not necessarily been shared with the GP or documented in a way that would ensure that these preferences were followed in the event of an emergency. A simple document, outlining the range of plans to consider, prompting discussion of key plans with the GP and indicating where the plans were stored, was, therefore considered a potentially useful resource.

A co-design approach was seen as integral to the development of a meaningful and useful care planning guide (CPG) to meet the needs outlined above. 103,104 A key tenet of co-design is that users, as experts of their own experience, become central to, and embedded within, the design process. 105,201 The process was led by researchers from the Glasgow School of Art who were experienced in using co-design and stakeholder engagement for co-developing health-care interventions. A combination of approaches was used, beginning with full project team workshops and then moving onto small task group work202 with potential users of the CPG (i.e. people with dementia, families and professionals). The development of the prototype involved two stages:

1. initial ideas and prototypes were developed during internal project workshops with the multidisciplinary SEED team, which included PPI, and the PPAB convened to support the SEED programme

2. refinement of the prototype CPG through three external workshops involving 20 newly recruited participants from key stakeholder groups (people with dementia, family carers, paid carers, doctors, nurses, support workers and occupational therapists).

These external workshops resulted in a mock-up of the CPG in paper format and diagrams to illustrate a potential digital/app format. The latter was subsequently developed into a demonstration prototype app. However, it became apparent that different stakeholder groups had different needs and wishes. Meanwhile, the NHS created a new EOLC website,203 which was widely recommended for national use. Consequently, further development of the SEED CPG was considered unnecessary as this new resource covered much of the same ground.

Clinical scenarios to illustrate common issues in end-of-life care in dementia

Workstream 2 findings highlighted a number of areas in which user-friendly resources were needed to support good EOLC. The comparative case studies suggested that developing clinical scenarios to illustrate common issues and facilitate discussion would be valued. Such resources could either be used for staff training or be used with people with dementia and carers as a way of opening up discussions. Using electronic learning (e-learning) resources was identified as a key way of reaching a large number of participants, with limited input required post development. Examples that illustrated common clinical situations and areas of difficult decision-making that are likely to be encountered towards, and at, the EOL in dementia were identified. One example, relating to continuing care after death, was developed (see Appendix 3, Clinical scenario: continuing care after death). The WS2 team developed the initial content using WS2 data. This was then refined and further developed by the WS3 team. The presentation was informed by the review of existing resources, including The Sound Doctor (films focused on a wide variety of long-term illnesses, including dementia)204 and Breech Birth (an animated film exploring decision-making). 205 The Sound Doctor resource for dementia comprises a series of films for people with dementia and their families, which cover the trajectory from diagnosis to the later stages of the illness. The films are designed for people with dementia and carers, but are also relevant to health-care and social care staff. Owing to resource constraints, it was not feasible to develop the clinical scenarios further; however, the work was subsequently used in the development of the MOOC (see below).

Massive open online course

Newcastle University had already developed a MOOC that focused on the earlier stages of dementia: Dementia Care: Living Well and Staying Connected. This MOOC was hosted by FutureLearn (part of the Open University) and had attracted > 7000 active learners across 168 countries since its launch in 2016. Having presented the findings of the resource review and a demonstration of the dementia MOOC to the PPAB, it recommended that a second dementia MOOC should be developed focusing on the more advanced stages of dementia and based on the key findings from the SEED programme. Additional funding from Newcastle University was secured for the development of the MOOC. Further details of the MOOC are provided in Workstream 3: development of the SEED intervention.

Inclusion criteria

People with dementia on the dementia register who:

• received a diagnosis of dementia in the previous 2 years

• were on the palliative care register

• were considered to be within 12 months of EOL as judged by a member of the clinical care team (e.g. GP, district nurse, care home nurse) who knows them well using the ‘surprise’ question ‘Would you be surprised if this patient were to die in the next 12 months?’.

Family carers:

• main family carer of the participating person with dementia

• aged ≥ 18 years.

Key informants:

• health or social care professionals who know the person well, who are in direct service provision to the person with dementia and are able to report on QoL, behavioural and psychological symptoms of dementia, symptom management and so on.

Exclusion criteria for all participants

• Potential participants who refuse consent.

• Individuals aged < 18 years.

• Potential participants who are judged as inappropriate for the study by a member of the primary care team (e.g. because of concurrent life events such as bereavement).

• Participants who are not fluent English speakers, because they would be unable to complete the standardised outcome measures (people with dementia, family carers and key informants) and are likely to have difficulties in participating in a qualitative interview (people with dementia, family carers and professionals).

Process evaluation

The process evaluation aimed to understand the implementation, feasibility and acceptability of the intervention. The aim was also to explore stakeholder views on recruitment processes and outcome measures (in terms of burden, ease of completion and perceived relevance). Inclusion criteria for the process evaluation were as follows:

• people with dementia who have consented to participate in the pilot trial and agreed to contact from the qualitative research team

• family carers of people with dementia recruited to the study who have consented to participate in the pilot trial and agreed to contact from the qualitative research team

• health and social care professionals linked to intervention sites who provide EOLC to people with dementia and their families

• members of the intervention supervision team

• members of the primary care team most closely involved in screening and study recruitment.

People with dementia and/or family carers who did not consent to contact from the qualitative team during the initial trial consent process were not eligible for the process evaluation. Potential participants who refused consent were excluded, as were any individuals aged < 18 years.

Interviews, training and supervision were audio-recorded, transcribed verbatim, anonymised and checked prior to analysis. Field notes were written during or soon after events were observed, and were anonymised and checked.

Outcome data

As this is a pilot trial, the main outcomes were feasibility outcomes. We ascertained data completeness of the instruments and any potential bias in the completion of follow-up data to inform the choice of instruments in a future trial. Complete responses were defined as participants completing all items on the questionnaire, and partial responses were defined as participants completing at least 80% of the items but not fully completing the questionnaire. Missing was defined as answering < 80% of the questionnaire items. Details of scoring procedures are provided in Table 12. Data were analysed using Stata® version 14 (StataCorp LP, College Station, TX, USA).

The majority of the outcome data are presented in simple descriptive tables with percentages, means and standard deviations and/or a five number summary (as appropriate), for each arm of the study. This information will inform the design, choice of primary outcome, necessary sample size and approach to the analysis of a future definitive trial.

Research ethics and governance

The study received ethics approval from the Newcastle and North Tyneside 1 Research Ethics Committee (REC) on 16 January 2017 (reference number 16/NE/0356). Health Research Authority approval was granted on 18 January 2017. Scheduled reports were submitted to the REC as planned: an annual progress report was submitted on 15 January 2018 and the end-of-study notification was submitted on 8 January 2018. No concerns or queries were received from the REC after report submissions. The SEED WS4 study was sponsored by Northumbria Healthcare NHS Foundation Trust [reference number Integrated Research Application System (IRAS) 211291]. Study management, including database management, was delegated to the Newcastle Clinical Trials Unit; full details, including amendments and protocol deviations, are provided below.

Key site dates

Site initiation visits were conducted at each site by the study senior research associate and trial manager. Key site dates are shown in Table 13. The date of the ‘last patient, last visit’ was 6 August 2018.

Clinical Research Network

Discussions with primary care sites have indicated that they often struggle to find the capacity to support some research administration tasks, for example maintenance of essential documentation in the investigator site file. With this in mind, assistance was requested from the local Clinical Research Network. Facilitators from Clinical Research Network North East and North Cumbria provided support to sites by ensuring that the investigator site file was complete, particularly when new documentation was implemented as a result of substantial amendments.

Protocol amendments

Protocol amendments are listed in Table 14.

Trial management group

The trial management group was scheduled to meet monthly from the study set-up period until the first draft of the study final report. In total, over 32 months, 24 trial management group meetings were held.

Trial Oversight Committee

An independent Trial Oversight Committee provided external oversight of the WS4 clinical trial. Members comprised four independent members of the SEED ESC (dementia care physicians and a statistician), and an independent patient representative. The Trial Oversight Committee met three times during the trial, and no concerns relating to the safety of the participants or scientific integrity of the trial were raised.

Safety

Adverse events were not recorded in this study. Practice managers were contacted on a quarterly basis and asked to review the practice patient complaints log. There were no complaints from participants, and no concerns were raised by the DNSs or by the SEED research team regarding participant safety and well-being as a result of their participation in the study.

Deviations

Three protocol deviations took place; all were reviewed by the Newcastle Clinical Trials Unit quality assurance team and the sponsor. Full details of the deviations and sites affected are provided in Table 15.

Trial monitoring

Monitoring was conducted according to the trial monitoring plan. As well as the site initiation visits, the trial manager carried out planned on-site monitoring at each site at the end of the recruitment window. The SEED WS4 research team also received two on-site monitoring visits, primarily to monitor original consent and case report forms. In total, 100% of the eligibility criteria for 100% of the participants with dementia were monitored. No ineligible participants were identified. A total of 100% of the informed consent and consultee declaration forms for the participants with dementia were monitored. No deviations from the informed consent process were identified. After the research team confirmed that data collection was complete, a close-out monitoring visit was conducted by the trial manager at each site.

Participant characteristics

The characteristics of all participants were reasonably well balanced between the intervention and the control arms, given the relatively small study (see Tables 16–22). Participating people with dementia were predominantly female, and more than one-third owned and lived in their own home (Table 16). More people with dementia in the intervention arm than in the control arm lived in a dementia-specific care home (10 intervention, compared with one control). The average age was around 85 years (Table 17). In terms of the eligibility criteria, 32 people with dementia were recently diagnosed and 43 were potentially approaching EOL (13 met both eligibility criteria). Place of residence was fairly stable during the study: three people with dementia moved house, five moved into a care home and one changed care home. Most people with dementia had at least two comorbidities according to the Charlson Comorbidity Index questionnaire at baseline (Table 18).

Most family carers were female and more than half lived in the same household as the person with dementia (Table 19). Most family carers had frequent contact with the person with dementia (60% had contact for 6 days of the week). Although average contact time per week appeared to be more extensive in the control arm, and the control arm had slightly more males and family carers living in the same home as the people with dementia (see Table 19), these slight imbalances were to be expected given the relatively small number of family carers and the non-randomised nature of the study. On average, family carers had known the person with dementia for > 56 years and the average contact time with them in the previous week was substantial (mean of 15 hours per week; Table 20).

Family carers of people with dementia in care homes were more likely to decline to participate in the trial (n = 11) than family carers of people living at home (n = 1). Typically, carers were happy for the person with dementia to take part and for care home staff to act as key informants, but did not wish to be involved themselves.

Because the number of key informants fluctuated during the study, data are presented for the 23 key informants recruited at baseline. Key informants were predominantly female and had mixed working roles, but most were managers (Table 21). Key informants had at least 3 days’ contact with the person with dementia per week (average contact time per week was 7.3 hours; Table 22). The average length of time key informants had known the person with dementia was 30.2 months, but there was an apparent difference between arms, with key informants in the intervention arm having known the person with dementia for longer, although numbers are sparse.

Qualitative data on recruitment processes

The process of completing the screening forms was generally considered too onerous, particularly by one control practice. In this practice, the situation was resolved by paying for a locum to enable a senior GP to spend half a day screening the forms. A researcher checked the screening forms as they were completed, and this proved an efficient approach as it minimised missing data and subsequent queries. The approach taken by GPs to the ‘surprise’ question varied. The question was sometimes left blank, for example when the GP had not seen the person with dementia for some time, or when the person with dementia was new to the practice. Some GPs found it difficult to make a judgement and questioned the validity of the ‘surprise’ question:

It was almost impossible to answer that [surprise] question . . . we’ve got lots of our patients that are old and frail that go on for a longer period of time than we might expect. It’s just a very difficult – if you ask 10 GPs about the same patient ‘would you be surprised?’, you might not get the same 10 answers.

Interview, GP 3.2, site 3

To try to manage the recruitment process, practices staggered recruitment, approaching a few people at a time, rather than approaching all of those who were eligible. This may have led to some ‘cherry-picking’ of potential participants. Although the intention was for the researchers to assist with the selection of people with dementia to be approached, this was feasible in only one practice, with other practices preferring to make the decisions themselves of who to approach.

The invitation letters gave potential participants the opportunity to opt out of further contact by telephoning the general practice. Only nine potential participants opted out and no complaints were received about this approach, suggesting that it is acceptable to this group of patients and carers. One control practice would have preferred to have used an opt-in approach, whereby potential participants contacted the research team directly. This would have reduced the workload for GPs and DNSs (who made the follow-up telephone calls), but would also probably have reduced recruitment.

Those who did not opt out were followed up by telephone by either the DNS (intervention practices) or a GP (control practices). The DNSs found these calls challenging, partly because they saw them as a research activity (and of which they had no previous experience), but also because the telephone calls were made at the outset of the study when they were uncertain about what the intervention would entail:

The actual recruiting bit wasn’t particularly comfortable . . . you didn’t know who you were ringing . . . And also because I didn’t really know what the role was, we were trying to persuade people to become involved in something that I didn’t actually know what it was going to be.

Interview, DNS1

Although concerns were expressed that the follow-up telephone calls might turn into ‘mini consultations’, they proved less time-consuming than anticipated. Relatively few people with dementia or carers raised additional issues during the telephone calls, and one GP viewed the opportunity to deal with urgent problems as a benefit:

We would never have known she had problems because she was just trying to carry on on her own. But it meant we got her sorted and it was great. That was a really nice thing to do. There were only a couple of those or ‘I can get the nurse to come out to you. That’s not a problem while I’m on the phone to you’. There has been a benefit for the practice from that point of view.

Interview, GP 4.1, site 4

One GP in a control practice commented that recruitment might have been easier if it had taken place prior to allocation to trial arm:

I think it might have made it easier to, I think ‘sell’ is a strong word, but to promote to patients if we thought that there may have been a possible gain in terms of a nurse specialist being involved with them. . . . obviously it’s a control practice, we were going in and saying ‘we are not going to do anything to help your relative, we are really just going to sort of ask questions and things for a trial’, you know. I think it’s harder to market or promote to patients than if you are saying ‘I don’t know which arm you are going to. It’s possible that you might get extra support from a nurse specialist.’

Interview, GP 2.1, site 2

Few comments specifically about recruitment processes were made by people with dementia and carers. Consistent with previous studies, the primary motivation for participating was altruism, with people with dementia and carers hoping that their involvement would help others in the future:

I’m happy to get involved in any sort of research that’s going to help people. I mean, I might be one of these people in the future, who knows. So I think it’s a really good thing.

Interview, family carer 3018

Some people with dementia who had been recently diagnosed, and their family carers, did not see the SEED intervention as appropriate to their situation. Although they felt that the immediate post-diagnostic period was too early for the intervention, they found it difficult to identify the most appropriate time:

(What is the best point at which to offer some kind of nurse specialist role?) When you need help. I’m sorry, but that is ‘How long is a piece of string?’.

Interview, family carer 1070

The key issues relating to recruitment and potential strategies to maximise recruitment to a future trial are summarised in Table 23.

Training and supervision of the dementia nurse specialists

Table 24 provides an overview of training and supervision arrangements. The initial 3-day training and induction programme was provided by the research team and clinical leads (Table 25 contains the agenda) and included an educational needs assessment (see Appendix 3, Educational needs assessment for dementia nurse specialist). Additional training needs were met through supervision, tailored training sessions and self-directed learning using the care resource kit and e-learning. One general practice provided a 1-week induction programme to help the DNSs integrate with the primary care teams.

To address the issues of anxiety and deskilling, which were inevitably associated with taking on a new role, bespoke supervision arrangements provided support with recruitment processes, the content and delivery of the intervention, palliative care and dementia. Establishing a MDT to provide supervision was not feasible. Instead, support for the first two areas was provided through monthly intervention supervision sessions led by the research team and a palliative care clinical lead. The palliative care clinical lead and an old-age psychiatrist provided clinical support and case supervision. In addition, both DNSs continued to receive supervision from their previous work teams. The DNSs also met regularly for peer support. Their different backgrounds (in palliative care and mental health) proved useful in joint working and mutual support.

Both DNSs found the monthly supervisions with the research team a helpful way of working through ideas, identifying problems and sharing solutions. From the lead researcher’s perspective, these meetings were useful in clarifying boundaries, promoting systems work and obtaining feedback on the intervention. More administrative and IT support from the host general practices would have been useful. Only one DNS received supervision from the dementia lead GP; without this, the role was potentially isolating and scope for improving systems within the practice was limited. In addition to formal supervision arrangements, both DNSs valued informal contact with the researchers.

Delivery of the SEED intervention

In this section, we illustrate how the SEED intervention was translated into practice using data from activity logs, the vignettes and the resources developed by the DNSs.

Activity analysis

The activity logs enabled us to examine the proportion of days on which prespecified activities were recorded, the focus of direct work with patient–carer dyads, and collaborative working. The initial analysis focused on the number of days on which specific activities were recorded (Figure 7 and Table 26). Details of activities were recorded for 206 days for DNS1 and 180 days for DNS2, reflecting their different working hours and patterns. In terms of the proportion of days on which specific activities were recorded, major components of the intervention were addressing the current needs of people with dementia, current needs of family carers, and networking and service mapping (with all of these activities being recorded on > 50% of working days). The proportion of days on which different activities were recorded was similar for both DNSs, with the exception of developing and implementing systems and research activities. DNS1 had more scope for developing systems because she worked with a larger number of care homes and in a practice that was more open to change. The difference in research activities reflects the different approach to recruitment in the two practices. DNS1 attended daily MDT meetings in the practice and discussed a few potential participants each day, whereas DNS2 distributed screening forms to the most appropriate GP and then collated the completed forms, which was less time-consuming.

FIGURE 7.

Proportion of days on which activities were recorded by DNSs.

TABLE 26 - Number and proportion of days on which selected activities were recorded

Activity	Days, n (%)		Total days, n (%)
	DNS1	DNS2
Training	95 (46.1)	95 (52.8)	190 (49.2)
Study activities	74 (35.9)	43 (23.9)	117 (30.3)
Networking, service mapping	119 (57.8)	103 (57.2)	222 (57.5)
Addressing current needs of person with dementia/carer	115 (55.8)	104 (57.8)	219 (56.7)
Planning for future with person with dementia/carer	54 (26.2)	42 (23.3)	96 (24.9)
Developing and implementing systems to improve EOLC	86 (41.7)	52 (28.9)	138 (35.8)
Workforce development	76 (36.9)	64 (35.6)	140 (36.3)
Total days	206 (100)	180 (100)	386 (100)

We also examined the number and type of direct contacts (i.e. face-to-face meetings and telephone calls) with individual patient–carer dyads. The number of such contacts ranged from 0 to 18 (median 7) for people with dementia and from 0 to 31 for carers (median 4). Nearly all contacts were in their place of residence, with only seven contacts elsewhere. The most common activities with participating dyads related to the well-being of the person with dementia (97%), family carer well-being (35%) and future planning (33%). With the exception of future planning, people with dementia living in care homes and their family carers tended to receive fewer contacts relating to all other activities than those living in their own homes (Figure 8 and Table 27).

FIGURE 8.

Focus of direct work with participating dyads by place of residence.

TABLE 27 - Activities during direct contacts with participating dyads by place of residence

Activity	Number of direct contacts, n (%)
	Community dwelling (n = 178)	Care home residents (n = 183)	All (n = 361)
Patient well-being	168 (94.4)	181 (98.9)	96.7 (361)
Carer well-being	87 (48.9)	39 (21.3)	126 (34.9)
Future plans	53 (29.8)	65 (35.5)	118 (32.7)
Managing medication	53 (29.8)	47 (25.7)	100 (27.7)
Patient informal networks and social support	58 (32.6)	18 (9.8)	76 (21.1)
Carer informal networks and social support	25 (14.0)	1 (0.5)	26 (7.2)
Patient understanding of dementia	31 (17.4)	7 (3.8)	38 (10.5)
Carer understanding of dementia	44 (24.7)	19 (10.4)	63 (17.5)
Environment and assistive technology	29 (16.3)	13 (7.1)	42 (11.6)
Post-bereavement support	1 (0.6)	1 (0.5)	2 (0.6)

Further analysis of aggregated data for individual patient–carer dyads showed high levels of collaborative working or informal discussions (83.8% of dyads) and indicated that just over half (51.4%) were referred to another service, most frequently the third sector (Figure 9 and Table 28). Collaborative working was most common with colleagues in primary care, care home staff and MDTs. The high proportion of dyads (70%) discussed with primary care colleagues is likely to have been facilitated by physical proximity, which enabled brief informal discussions with GPs. Further analyses showed that people with dementia living in care homes and their family carers were referred less frequently (33.3%) than those living in their own homes (75%), but no differences were found in the frequency of informal discussions according to place of residence.

FIGURE 9.

Referrals and collaborative working with participating dyads.

TABLE 28 - Referrals and collaborative working with participating dyads

Sector/professional	n (%)
	Referrals (N = 37)	Collaborative working (N = 37)
Primary care	5 (13.5)	26 (70.3)
Mental health	4 (10.8)	6 (16.2)
Profession allied to medicine	9 (24.3)	5 (13.5)
Social services	4 (10.8)	4 (10.8)
Third sector	10 (27)	5 (13.5)
Care home staff	0 (0)	15 (40.5)
MDT	0 (0)	12 (32.4)
Hospital staff	0 (0)	3 (8.1)

Despite the challenges of recording and analysing activity data, the analyses were generally consistent with the findings of observation and interviews, suggesting that the data were reasonably robust. For example, the DNS who was more embedded in the general practice discussed a higher proportion (89%) of dyads with primary care colleagues than the DNS based in the less engaged practice (53%).

Stakeholder views on feasibility and acceptability of the SEED intervention

Factors influencing implementation of the SEED intervention

The framework of NPT114 was used to identify factors influencing the implementation of the SEED intervention.

1. Coherence

   This considers whether or not the SEED intervention made sense to all stakeholders, was easy to understand and was distinct from existing services. The intervention was not perceived as relevant to some people with dementia and family carers because of the focus on EOLC; this aspect of the intervention was also contested by the DNSs and other stakeholders who were keen to expand the intervention to all people with dementia. The location of the intervention in primary care was valued by nearly all stakeholders. The fact that the SEED intervention was seen as overlapping with existing interventions was nearly always viewed positively, although tensions occasionally arose over role boundaries.

   A recurring theme in early intervention supervision and initial interviews with the DNSs was uncertainty over their new role, suggesting a lack of coherence:Interview, DNS1

   From the outside looking in, people probably think it’s quite a straightforward role. Often, I feel like a duck that looks quite calm on the outside, but paddling like mad underneath, thinking ‘What on earth am I supposed to be doing?’. I think there’s a lot of self-motivation and discipline required around mapping out what the role is.

   Many of these anxieties were resolved over time as they began working with individual people with dementia and carers, established their role in the practice and gained confidence around the seven components.

2. Cognitive participation

   Cognitive participation focuses on whether or not stakeholders engaged with, and invested in, the SEED intervention. The temporary nature of the intervention influenced the buy-in of all stakeholders. Relationship-building was key to engaging people with dementia, family carers and care homes. Investing time in getting to know study participants often led to the identification of unmet needs, opportunities to intervene and the potential avoidance of crises. Differing levels of engagement and commitment were observed in the two general practices:Interview, DNS2Interview, DNS1

   Well, I think I’ve been unlucky in the fact that there hasn’t been a dementia lead GP with a vested interest in dementia. I think that’s been an obstacle, really, from the start, because none of the GPs have shone out with a great enthusiasm for dementia, and even end of life. I think they are so under pressure just doing their job. But, I think it does need to start with a GP who wants to invest in care of people with dementia.

   I had a 2-week induction at the surgery, which was really well planned, so [name], who is the sort of head administrator come everything really, she had organised for me to go out with different people, and that was great.

3. Collective action

   Intervention implementation depends on whether or not work is allocated to the right individuals and whether or not they are adequately trained and resourced. The different professional backgrounds of the DNSs were complementary, enabling them to share specialist knowledge and work together effectively:Interview, GP 1.1, site 1

   I think the key thing, really, about [DNS1] being in role is the fact that she is a mental health nurse. It’s the fact that she’s got that knowledge and those links that have made it work . . . Because a lot of the focus hasn’t been on the last few days of somebody’s life, it’s not been on that palliative, necessarily, care, it’s been on their future care and planning, and an understanding around dementia diagnosis and things.

   Supervision arrangements proved successful in ensuring access to specialist knowledge and support relating to different aspects of their role. Intervention supervision was particularly important because of the initial uncertainties of the DNSs over the scope of the intervention. The relationships that people with dementia and family carers developed with the DNSs were valued and were key to engaging them in ACP:Field notes, site 3

   She gave a very emotional account of having discussed it [do not attempt cardiopulmonary resuscitation (DNACPR)] with DNS2, but didn’t feel ready. However, soon after she read an article in the Sunday newspaper (which she found quite harrowing) about the ambulance service ‘forcing’ people to do CPR [cardiopulmonary resuscitation] on their relatives who were clearly already dead (she became tearful when talking about this), and drew on her knowledge as a prior first aider, knowing that performing the procedure could often break bones, and decided that DNACPR was probably right for her mother . . . At a later visit, the wish to complete DNACPR was discussed with DNS2 who signposted to the GP and this was arranged with the GP over the telephone. So it seemed that DNS2 had ‘planted the seed’, and then given the carer space to make her decisions in the time frame appropriate to her.

   The extent to which the host general practices supported the intervention varied. This was evident through the level of involvement of the lead dementia GP, but was also demonstrated through the lack of support provided with practice IT systems.

4. Reflexive monitoring

   A key aspect of successful implementation is the extent to which stakeholders are aware of the difference made by a new intervention, whether this is through formal or informal means. The ability to reflect on, and adapt, the intervention in the light of this appraisal is also crucial. Although no formal mechanisms for evaluating impacts were in place, informal feedback from study participants, including care home staff and some GPs, was positive:Interview, family carer 1053Interview, GP 1.1, site 1Interview, clinical lead, care home 2, site 1

   I mentioned it to [DNS1], I said ‘I’m having a real struggle for them to realise that dad can’t physically get to the surgery any more’. Then within a day, 2 days, the district nurses were there, taking his samples and giving him the blood.

   She’s been proactive in picking up medical problems. So she would be speaking to them, and relatives would maybe mention something, and before I know it, she’s coming back to me, saying ‘I wonder whether this person might actually have an underlying physical health problem. We need to do a blood test.’. So that proactive work, I’m sure, has decreased the burden on secondary care.

   She’s also helped to implement emergency health-care plans and DNRs [do not resuscitate], which we previously didn’t do, which has been a big help, because the GPs have been understaffed and struggling, and we haven’t been able to get them, basically, since the community matron left post.

   Although such comments were not necessarily directly fed back to the DNSs, the benefits identified often led to ongoing work with individual patient–carer dyads and requests from care homes for further input confirming the value of the DNS input. Access to different perspectives through supervision also facilitated reflection on the intervention.

   Overall, the individual and collective work required for successful implementation of a new intervention was largely achieved. Although investment in the intervention was relatively poor in one GP practice, and other stakeholders were, understandably, reluctant to engage with a short-term intervention, the interpersonal skills of the DNSs and having time to develop relationships enabled them to build engagement throughout the trial.

Data completion of outcome measures

Analysis of outcome measures focused initially on missing data. Imputed scores for partially completed responses made little difference to overall attrition rates, with the exception of the SWC-EOLD questionnaire, for which there were predominantly partial responses. As there was little evidence that completion rates varied between intervention arms, summary figures provide an overview of baseline data, and tables present the full data for intervention and control arms at each time point.

Outcome measures relating to symptoms and well-being of people with dementia and family carers

Completion rates for these outcome measures were generally good (Figure 10, Tables 30–33). Several family carers were unable to complete the Quality of Life in Late-stage Dementia (QUALID) because they had not spent the required time with the person with dementia in the previous week. Data on the PAINAD during movement were missing for the significant number of people with dementia who remained seated throughout the assessment.

FIGURE 10.

Data completion of outcome measures relating to symptoms and well-being of people with dementia and family carers at baseline. a, Unavailable includes those who were not approached or were unwell. BANS-S, Bedford Alzheimer Nursing Severity Scale; HADS, Hospital Anxiety and Depression Scale; KI, key informant; NPI-NH, Neuropsychiatric Inventory-Nursing Home; QUALID, Quality of Life in Late-stage Dementia.

TABLE 30 - Summary of questionnaire completeness at baseline and at 4 months in the intervention arm

BANS-S, Bedford Alzheimer Nursing Severity Scale; HADS, Hospital Anxiety and Depression Scale; NPI-NH, Neuropsychiatric Inventory-Nursing Home.

Missing is defined as answering < 80% of questions on the questionnaire.

Partial responses are defined as at least 80% of the questions on the questionnaire being completed, but not all questions.

Complete responses are defined all questions on the questionnaire being completed.

Excludes withdrawn participants and people with dementia who died between baseline and the 4-month assessment.

Questionnaires completed by both the key informant and the family carer, but completion by either is deemed a response.

Questionnaire	Baseline, n (%)			4 months, n (%)
	Missinga	Partialb	Completec	Missinga	Partialb	Completec
Questionnaires completed by family carers (n = 25)				(n = 23)d
HADS
Anxiety	0 (0)	0 (0)	25 (100)	1 (4)	0 (0)	22 (96)
Depression	0 (0)	0 (0)	25 (100)	1 (4)	0 (0)	22 (96)
Overall score	0 (0)	0 (0)	25 (100)	1 (4)	0 (0)	22 (96)
NPI	0 (0)	4 (16)	21 (84)	1 (4)	3 (13)	19 (83)
QUALID	3 (12)	0 (0)	22 (88)	3 (13)	0 (0)	20 (87)
SM-EOLD	1 (4)	1 (4)	23 (92)	2 (9)	2 (9)	19 (83)
SWC-EOLD	3 (12)	10 (40)	12 (48)	1 (4)	14 (61)	8 (35)
Questionnaires completed by key informants (n = 15)				(n = 11)d
NPI-NH	0 (0)	1 (7)	14 (93)	2 (18)	1 (9)	8 (72)
BANS-S	0 (0)	0 (0)	15 (100)	0 (0)	0 (0)	11 (100)
QUALID	0 (0)	0 (0)	15 (100)	1 (9)	1 (9)	9 (81)
SM-EOLD	0 (0)	0 (0)	15 (100)	0 ()	0 (0)	11 (100)
SWC-EOLD	1 (7)	7 (47)	7 (47)	1 (9)	9 (81)	1 (9)
Questionnaires completed by both key informant and family carere (n = 37)				(n = 30)d
QUALID	3 (8)	0 (0)	34 (92)	2 (7)	1 (3)	27 (90)
SM-EOLD	2 (5)	1 (3)	34 (92)	2 (7)	0 (0)	28 (93)
SWC-EOLD	5 (14)	17 (46)	15 (41)	2 (7)	19 (63)	9 (32)
Questionnaire completed by research team (n = 37)				(n = 32)d
PAINAD
At rest	6 (16)	0 (0)	31 (84)	7 (22)	0 (0)	25 (78)
During movement	18 (49)	0 (0)	19 (51)	18 (56)	0 (0)	14 (44)

TABLE 31 - Summary of questionnaire completeness at baseline and at 4 months in the control arm

BANS-S, Bedford Alzheimer Nursing-Severity Scale; HADS, Hospital Anxiety and Depression Scale; NPI-NH, Neuropsychiatric Inventory-Nursing Home.

Missing is defined as answering < 80% of questions on the questionnaire.

Partial responses are defined as at least 80% of the questions on the questionnaire being completed, but not all questions.

Complete responses are defined all questions on the questionnaire being completed.

Excludes withdrawn participants and people with dementia who died between baseline and the 4-month assessment.

Questionnaires completed by both the key informant and the family carer, but completion by either is deemed a response.

Questionnaire	Baseline, n (%)			4 months, n (%)
	Missinga	Partialb	Completec	Missinga	Partialb	Completec
Questionnaires completed by family carers (n = 17)				(n = 17)
HADS
Anxiety	0 (0)	0 (0)	17 (100)	1 (6)	0 (0)	16 (94)
Depression	0 (0)	1 (6)	16 (94)	1 (6)	0 (0)	16 (94)
Overall score	0 (0)	1 (6)	16 (94)	1 (6)	0 (0)	16 (94)
NPI	1 (6)	0 (0)	16 (94)	1 (6)	1 (6)	15 (88)
QUALID	2 (12)	0 (0)	15 (88)	3 (18)	0 (0)	14 (82)
SM-EOLD	0 (0)	2 (12)	15 (88)	1 (6)	0 (0)	16 (94)
SWC-EOLD	5 (29)	10 (59)	2 (12)	3 (18)	8 (47)	6 (35)
Questionnaires completed by key informants (n = 8)				(n = 7)d
NPI-NH	0 (0)	0 (0)	8 (100)	0 (0)	0 (0)	7 (100)
BANS-S	0 (0)	0 (0)	8 (100)	0 (0)	0 (0)	7 (100)
QUALID – key informant	0 (0)	0 (0)	8 (100)	2 (29)	0 (0)	5 (71)
SM-EOLD – key informant	0 (0)	0 (0)	8 (100)	0 (0)	0 (0)	7 (100)
SWC-EOLD – key informant	1 (12)	5 (63)	2 (25)	1 (14)	4 (57)	2 (29)
Questionnaires completed by both key informant and family carere (n = 25)				(n = 23)d
QUALID	2 (8)	0 (0)	23 (92)	4 (17)	0 (0)	19 (83)
SM-EOLD	1 (4)	2 (8)	22 (88)	1 (4)	0 (0)	22 (96)
SWC-EOLD	7 (28)	14 (56)	4 (16)	4 (17)	11 (48)	8 (35)
Questionnaire completed by research team (n = 25)				(n = 24)d
PAINAD
At rest	2 (8)	0 (0)	23 (92)	3 (12)	0 (0)	21 (88)
During movement	9 (36)	0 (0)	16 (64)	12 (50)	0 (0)	12 (50)

TABLE 32 - Summary of questionnaire completeness at 8 and 12 months in the intervention arm

BANS-S, Bedford Alzheimer Nursing Severity Scale; HADS, Hospital Anxiety and Depression Scale; NPI-NH, Neuropsychiatric Inventory-Nursing Home.

Missing is defined as answering < 80% of questions on the questionnaire.

Partial responses are defined as at least 80% of the questions on the questionnaire being completed, but not all questions.

Complete responses are defined all questions on the questionnaire being completed.

Excludes withdrawn participants and people with dementia who died between the 4- and 8-month assessments.

Excludes withdrawn participants and people with dementia who died between the 8- and 12-month assessments.

Questionnaires completed by both the key informant and the family carer, but completion by either is deemed a response.

Questionnaire	8 months, n (%)			12 months, n (%)
	Missinga	Partialb	Completec	Missinga	Partialb	Completec
Questionnaires completed by family carers (n = 22)d				(n = 20)e
HADS
Anxiety	0 (0)	0 (0)	22 (88)	0 (0)	0 (0)	20 (100)
Depression	0 (0)	0 (0)	22 (88)	0 (0)	0 (0)	20 (100)
Overall score	0 (0)	0 (0)	22 (88)	0 (0)	0 (0)	20 (100)
NPI	0 (0)	5 (23)	17 (77)	0 (0)	5 (25)	15 (75)
QUALID	3 (14)	0 (0)	19 (86)	5 (25)	0 (0)	15 (75)
SM-EOLD	1 (5)	0 (0)	21 (95)	1 (5)	0 (0)	19 (95)
SWC-EOLD	1 (5)	13 (59)	8 (36)	0 (0)	10 (50)	10 (50)
Questionnaires completed by key informants (n = 13)d				(n = 12)e
NPI-NH	0 (0)	1 (8)	12 (92)	0 (0)	1 (8)	11 (92)
BANS-S	0 (0)	1 (8)	12 (92)	0 (0)	1 (8)	11 (92)
QUALID	1 (8)	0 (0)	12 (92)	1 (8)	0 (0)	11 (92)
SM-EOLD	0 (0)	0 (0)	13 (100)	0 (0)	0 (0)	12 (100)
SWC-EOLD	0 (0)	8 (62)	5 (38)	2 (17)	5 (42)	5 (42)
Questionnaires completed by both key informant and family carerf (n = 30)d				(n = 29)e
QUALID	2 (7)	0 (0)	28 (93)	5 (17)	0 (0)	24 (83)
SM-EOLD	0 (0)	0 (0)	30 (100)	1 (3)	0 (0)	28 (97)
SWC-EOLD	1 (3)	19 (63)	10 (33)	2 (7)	12 (41)	15 (52)
Questionnaire completed by research team (n = 30)d				(n = 29)e
PAINAD
At rest	5 (17)	0 (0)	25 (83)	3 (10)	0 (0)	26 (90)
During movement	14 (47)	0 (0)	16 (53)	15 (52)	0 (0)	14 (48)

TABLE 33 - Summary of questionnaire completeness at 8 and 12 months in the control arm

BANS-S, Bedford Alzheimer Nursing Severity Scale; HADS, Hospital Anxiety and Depression Scale; NPI-NH, Neuropsychiatric Inventory-Nursing Home.

Missing is defined as answering < 80% of questions on the questionnaire.

Partial responses are defined as at least 80% of the questions on the questionnaire being completed, but not all questions.

Complete responses are defined all questions on the questionnaire being completed.

Excludes withdrawn participants and people with dementia who died between the 4- and 8-month assessments.

Excludes withdrawn participants and people with dementia who died between the 8- and 12-month assessments.

Questionnaires completed by both the key informant and the family carer, but completion by either is deemed a response.

Questionnaire	8 months, n (%)			12 months, n (%)
	Missinga	Partialb	Completec	Missinga	Partialb	Completec
Questionnaires completed by family carers (n = 14)d				(n = 12)e
HADS
Anxiety	1 (7)	0 (0)	13 (93)	0 (0)	0 (0)	12 (100)
Depression	1 (7)	0 (0)	13 (93)	0 (0)	0 (0)	12 (100)
Overall score	1 (7)	0 (0)	13 (93)	0 (0)	0 (0)	12 (100)
NPI	1 (7)	2 (14)	11 (79)	0 (0)	1 (8)	11 (92)
QUALID	3 (21)	0 (0)	11 (79)	2 (17)	0 (0)	10 (83)
SM-EOLD	1 (7)	0 (0)	13 (93)	0 (0)	0 (0)	12 (100)
SWC-EOLD	5 (36)	4 (29)	5 (36)	3 (25)	4 (33)	5 (42)
Questionnaires completed by key informants (n = 5)d				(n = 5)e
NPI-NH	0 (0)	0 (0)	5 (100)	0 (0)	1 (20)	4 (80)
BANS-S	0 (0)	0 (0)	5 (100)	0 (0)	0 (0)	5 (100)
QUALID	1 (20)	0 (0)	4 (80)	1 (20)	0 (0)	4 (80)
SM-EOLD	0 (0)	0 (0)	5 (100)	0 (0)	0 (0)	5 (100)
SWC-EOLD	1 (20)	2 (40)	2 (40)	0 (0)	3 (60)	2 (40)
Questionnaires completed by both key informant and family carerf (n = 17)d				(n = 16)e
QUALID	2 (12)	0 (0)	15 (88)	2 (13)	0 (0)	14 (88)
SM-EOLD	0 (0)	0 (0)	17 (100)	0 (0)	0 (0)	16 (100)
SWC-EOLD	5 (29)	6 (35)	6 (35)	3 (19)	6 (38)	7 (44)
Questionnaire completed by research team (n = 19)d				(n = 17)e
PAINAD
At rest	3 (16)	0 (0)	16 (84)	1 (6)	0 (0)	16 (94)
During movement	6 (32)	0 (0)	13 (68)	7 (41)	0 (0)	10 (59)