A decision aid to support family carers of people living with dementia towards the end‐of‐life: Coproduction process, outcome and reflections

Abstract Background Family carers of people living with dementia often need support with making decisions about care. Many find end‐of‐life care decisions particularly difficult. The aim of this article is to present an evidence‐ and theoretical‐based process for developing a decision aid to support family carers of people with dementia towards the end‐of‐life. Methods Following a systematic process, we developed a decision aid using coproduction methods and matrices to synthesize data from a systematic review and qualitative interviews with people living with dementia and family carers. Data were presented to coproduction workshops of people living with dementia, family carers, practitioners and professionals. Development was guided by the Ottawa Decision Support Framework and a modified Interprofessional Shared Decision‐Making model. Results The decision aid covers four decision areas: (1) changes in care; (2) eating and drinking difficulties; (3) everyday well‐being; and (4) healthcare, tests and medication. We present an interactive decision aid, using a variety of approaches including written text, Frequently Asked Questions, top tips and illustrative quotes from people living with dementia and family carers. Conclusion This is the first decision aid that focusses on multiple decisions towards the end‐of‐life in dementia care. The process offers a template for others to develop decision aids or similar interventions, and how to include people living with dementia in coproduction. Patient or Public Contribution Family carers provided feedback on data collection, data analysis and the decision aid, and one is a coauthor. People living with dementia and family carers were integral to the coproduction workshops.


| BACKGROUND
Most people living with dementia live in the community, in their own homes or with family. 1,2 Approximately 700,000 family members and friends are primary carers providing the majority of care for people living with dementia in the United Kingdom. 3 For the purpose of this study, we used the term family carer to describe family and friends providing unpaid care for someone living with dementia, acknowledging that they may not identify themselves as a carer. 4,5 Shared decision-making is an important part of healthcare and person-centred dementia care. 6 However, as an individual's dementia progresses, he or she becomes less likely to be able to make decisions about his or her care, well-being and general welfare. Advance care planning (ACP) is a process of planning for care in the future. Studies have demonstrated the effectiveness of ACP on several outcomes including family satisfaction with care and burdensome transitions in care. 7,8 However, many individuals reach the point when they no longer have capacity to make their own decisions. In England and Wales, under the Mental Capacity Act (MCA) 2005, decisions for those who lack capacity should be made in their best interests if there is no prior legal authority. 9 Decision-makers will vary and are usually made through a family carer or a health or care professional depending on the significance of the decision to be made and national legislation; however, a shared decision-making approach should be encouraged.
Family carers find decisions or discussions about severe dementia and end-of-life difficult, such as stopping treatment, [10][11][12] and they may benefit from support in making decisions. [13][14][15] Help may be welcomed by carers making significant decisions, especially about support when their family member is in the severe stages of dementia and towards the end-of-life. 16,17 A recent ACP intervention in nursing homes has been shown to be effective in reducing family carer uncertainty with decision-making, and improving perceptions of quality of care. 18 However, this approach includes a facilitator and is based in nursing homes, where there may be more support to complete ACP than for carers at home with the person living with dementia. It has been recognized that alternative approaches to decision-making are required across different settings. 7 Another approach to support family carers is decision aids, which guide the decision-maker through different stages of a decision. These can take various forms including booklets, pamphlets, videos or web-based tools. Decision aids provide information about the decision and summarize options along with associated benefits and harms to enable people to make and document decisions. 19 There is substantial evidence from the health sector demonstrating the effectiveness and feasibility of decision aids to support decisionmaking. 19,20 The clarity about the options that decision aids offer may be particularly useful for family carers of people living with severe dementia or those approaching the end-of-life. Such times often involve a variety of symptoms and comorbidities, potentially creating confusion and a multitude of difficult decisions for the family carer. 21 Decision aids suitable for use by family carers in dementia care have been shown to improve knowledge and communication, and reduce decisional conflict among family carers. 16,22 However, these decision aids only focus on a single decision, including eating and feeding options, 23 place of care 24,25 and goals of care. 26,27 When caring for someone living with dementia towards the end-of-life, family carers are often faced with multiple decisions, and these are often inter-related. There is currently no decision aid for dementia care that covers multiple decisions. There is a need for holistic decision aids to reflect this complexity. 16 In particular, studies have identified a need for decision aids that focus on those with dementia towards the end-of-life. 16,17 It is important that end users (family carers), together with those who the decision aid affects (people living with dementia) and those who will interact with carers using the decision aid (practitioners and carer organizations/advocates), are involved in development. However, reviews of patient decision aids have highlighted a lack of clear reporting about the development process of decision aids. 16,28 This article reports the systematic development and components of a decision aid for family carers of a person living with dementia towards the end-of-life. This builds on a programme of work that included a systematic review of evidence for effectiveness of existing decision aids, 16 and a qualitative study with family carers of people with dementia towards the end-of-life and people living with dementia themselves. 29 The aim of this article is to present an evidence-and theoreticalbased process for developing a decision aid to support family carers of people with dementia towards the end-of-life.

| Design
A coproduction approach was adopted to develop a decision aid, as part of a systematic development process for decision aids. 28,30 Coproduction is increasingly being used in healthcare research and for the development of resources used in clinical practice, including in dementia research. [31][32][33] Partnership with stakeholders and end users has been identified as a fundamental approach of intervention development and this is the core premise of coproduction. 34 The use of coproduction is particularly recommended for use in the development of patient decision aids. 35 We were informed by a review of developing complex interventions, 34 which provides a comprehensive range of approaches and actions to develop complex interventions. Actions are described across the domains of conception, planning, designing, creating, refining, documenting and planning for future evaluation.

| Theoretical frameworks underpinning development
The development of content for the decision aid was guided by two theories: (1) the Ottawa Decision Support Framework (ODSF) 36

| ODSF
The ODSF was developed to help facilitate shared decision-making between patients and healthcare professionals. 24,36 Decision aids developed using the ODSF have been shown to be effective in reducing decisional conflict and improving decisional quality. 20 We chose this framework as it supports health decisions that lack clear choice, are value laden, require much deliberation and are subject to changing circumstances. 36 This resonates with the decisions that carers of people with dementia encounter. The aim of the ODSF is to improve the quality of decision-making by addressing modifiable and suboptimal determinants of decisions, including unrealistic expectations, unclear views, unclear norms, unwanted pressure, inadequate support and inadequate personal and external resources to make the decision. ODSF is organized into (1) decisional needs, (2) decision support and (3) decision quality (see Table 5). It states that the decisional needs will affect the quality of the decision, and this can be mediated by decision support such as a decision aid.

| The IP-SDM model
The IP-SDM model has been widely used to inform development of decision aids; 38 it conceptualizes the decision-making process and the factors that influence this. 37 We used a modified model based on the dementia population, who lack capacity, and the specific decisions facing family carers. 29 The model consists of two sections: the context in which decisions are made and the decision-making process. The context considers personal preferences, ACP and legal aspects of decisionmaking, health and well-being of the individual (including capacity), support from others and clarity of decision-maker roles. The process consists of (1) identifying the decision-maker or team, (2) sharing and exchanging information, (3) clarifying values and preferences, (4) managing and considering emotions, (5) considering the feasibility of options, (6) balancing the preferred choice and the actual choice, and (7) implementation and reflecting on outcomes.

| International patient decision aid standards
We report the content and development of the decision aid against the International Patient Decision Aid collaboration set of Standards and criteria (IPDASi v 4.0) for decision aids 39 (see appendix).

| Practitioners
Eleven practitioners who provided care for people with dementia towards the end-of-life and from carer support organizations were recruited through contacts of the research team and supplemented with snowballing methods. Participants were purposively sampled for a variety of occupations.

| Inclusion and exclusion criteria
All participants had to be able to read and speak English and provide informed written consent.

Inclusion criteria
• Family member or friend who provided unpaid care for a person living with dementia in the later stages of dementia or towards the end-of-life.
• Current or former carer.
• Proxy decision-maker for the person living with dementia, either informally or through lasting power of attorney for health and welfare.
• Over the age of 18 years.

Exclusion criteria
• Carers bereaved in the past 3 months.

Inclusion criteria
• Clinical diagnosis of any type of dementia.
• Mental capacity to provide informed consent.
• Over the age of 65 years.

Inclusion criteria
One or more of the following: • Practitioners in a caring role (health or social care), for someone with dementia.
• Experienced in providing end-of-life care and contributing to decision-making dementia or family carers.
• Experienced in working directly with people living with dementia or family carers.

| Procedure
An experts by experience group consisting of four family carers oversaw the whole project, commenting on study documents, procedures and findings. An overview of the process and procedure is provided in Figure 1.

| Earlier phases of the overall project
The systematic review 16 and qualitative data collection 29  Previous work -systematic review and qualitative interviews Step 3: Refining the decision aid through our think tank Step 2: Designing and creating Step 1: Planning and synthesis of data Step 4: Refining the decision aid through user testing F I G U R E 1 Overview of the development process • understand the problems or issues (decisions) to be addressed; • understand the experiences of family carers and people living with dementia about decision-making; • understand the perspectives and the psycho-social context of family carers making decisions; • understand the wider context of decision-making in dementia care; • consider where the decision aid will be implemented; and • identify evidence of the effectiveness of similar interventions.
The qualitative data highlighted the key decisions to be made and professional input and support. Finally, these data were used to revise the IP-SDM model and provide the seven steps of the decision-making process detailed in the IP-SDM section above. 29 The systematic review helped to identify existing decision aids to share with the coproduction groups, understand what components were included in previous decision aids and which decision aids were effective. 16 The review concluded that decision aids developed thus far have focussed on single decisions. Further decision aids are required that reflect the complexity of dementia care with multiple decisions to be made by family carers, which are often inter-related.
Coproduction was divided into four main steps: Step 1: Planning and synthesis of data.
To synthesize the findings from the qualitative data and systematic review, we constructed a series of matrices to allow a transparent and thorough mapping of the different sources of data.
This process was iterative and on-going, before and during the coproduction workshops, and when refining the decision aid. After each workshop, key points were summarized in Table 1. This provided a clear overview of the potential topics and decisions to be included in the decision aid.
Step 2: Designing and creating.
We constructed a series of coproduction groups to meet in workshops.

| Aim of workshops
Based on O'Cathain et al.'s taxonomy, 34 the aims of the workshops were to understand wider stakeholders' perspectives of the decisions and issues, decide upon the specific decisions that the decision aid should address, and the aims or goals for the decision aid; consider real-world delivery of the decision aid; decide on the content, format and delivery; and make prototypes of the decision aid.

| Composition of the workshops
We created four homogeneous coproduction groups: people living with mild dementia, family carers and two groups of professionals from health and social care services (see Tables 2-4).

| Including people living with dementia in coproduction workshops
We worked closely with our experts by experience group and practitioners working in dementia care to carefully consider how to optimally run a workshop with people living with dementia. We ensured that this workshop consisted of a small number of participants (e.g., [3][4][5], to minimize distractions and confusion. We wanted to ensure a feeling of being in a safe environment and of feeling comfortable throughout, developing trust and a rapport with researchers. 40 To establish this trust and safe environment, we offered the option of bringing a person with them such as a family carer. However, to ensure that the contributions of people living with dementia were heard, we asked, if possible, that the other person might sit in an adjacent room. As most participants had taken part in the qualitative phase of the study, at least one of the researchers was familiar to them. We also held a preworkshop telephone discussion to provide information about the study and build on the rapport and T A B L E 1 Matrix completed iteratively before and during the Coproduction process We provided accessible (large print and plain English) printed worksheets and information to support participants living with dementia. We ensured that a third researcher was available to sit with the carers who attended. Participants were also given the option to use a printed coloured card that read 'I wish to speak' to hold up if they were not able to speak out or felt that they could not be heard.  Step 3: Refining the decision aid through our think tank.
In parallel to Step 2, Step 3 focussed on refining and finalizing the decision aid. A fifth group acting as a 'think tank' to support coproduction was created. This group consisted of two family carers, a General Practitioner (GP), an Admiral Nurse (specialist dementia nurse that support families), two gerontologists and a social work expert. The research team also joined this group, consisting of two psychologists, a GP and an Old Age Psychiatrist. The detailed notes were summarized and presented to the group. In particular, the group: • provided clarity about ideas and discussions from coproduction workshops; • ensured that the research team considered the views from all three coproduction groups; and • ensured that the decision aid was grounded in evidence.
The fifth group met three times for 1-2 h, in between the workshops.
Step 4: Refining and user testing.
Once the decision aid was finalized by the 'think tank,' it was tested with the experts by the experience group and two carers from the coproduction workshop. They read through the decision aid with one individual researcher, and using the principles of the think aloud method, 44 provided their initial impressions of the format and content of the decision aid.
The results from the user testing were discussed among the core research team (N.D., G.R., E.L.S.), and comments were incorporated. Subsequently, carers record their social network, including who they see on a daily basis, and record this on a social network diagram (see Figure 2).
Participants at all workshops considered that it was important to highlight who was responsible for making decisions, and to emphasize that decisions were not necessarily the family carers' to make, in Box 1. Stages of workshops

| Decisions
The workshops were presented with seven decisions from the qualitative data. After the initial discussion, workshops ranked the decisions based on importance and relevance to include in the decision aid. This helped to consider decisions in turn to inform subsequent discussions. Carers in the workshops were not surprised by any of the decisions that we presented.

| Format and engagement
Directed by the seven stages of the adapted IP-SDM model, we broke down the decision-making process for each of the four decisions. Throughout these seven stages, we carefully followed the ODSF to inform the content. Tables 5 and 6  Based on family carer suggestions, we included individual stories or broad scenarios from people who have experienced similar situations, with information about how they came to their decision and the outcomes. Participants felt that carers would relate more to a story than just facts. This approach was used for discussing continence, an often embarrassing topic.
Following suggestions from the professionals workshop, we included the benefits and disadvantages of options using an activity asking carers to list all the reasons why they would choose the option (i.e., benefits) and reasons why not to choose this option (i.e., disadvantages) on a set of blank paper cards provided with the decision aid. These cards can then be stacked into two piles to help visualize which options/preferences have the most benefits and disadvantages.
Finally, carers are asked if they have enough information and, if yes, which preference or option they prefer, recording their decision.
If they do not have enough information to make a decision, the final section for each decision provides both (1) signposting to specific groups and organizations and (2) a space to write questions to discuss with a health or care provider. Throughout the decision aid, carers are encouraged to discuss options and decisions with other members of their support network, including health and social care professionals, ensuring a shared decision-making approach.

| DISCUSSION
This article presents a novel decision aid to support family carers of people living with dementia towards the end-of-life. This is the first decision aid to cover multiple decisions that family carers may face when a person living with dementia is approaching the end-of-life, filling an important gap identified in the decision-making literature. 7,16,22 This is one of the first papers to provide a detailed description of a systematic approach to coproducing a decision aid, grounded in theory, evidence and lived experience. There is increasing recognition of the importance of high-quality reporting of coproduction methods and the development process of decision aids. [45][46][47] Few decision aids developed in dementia care report their development clearly. 16 We have provided clarity on how data from multiple sources including theory can be synthesized and presented to end users and meaningfully contribute to coproduction. This transparent method will be helpful to researchers developing complex interventions through coproduction. Importantly, this study is one of the first to include people living with dementia in coproduction, and we provide key learning points.
Family carers have reported feeling ill-prepared for decisions about end-of-life care and a lack of professional support. 48 The course of dementia is unpredictable, and goals of care and preferences may change over time 49 ; therefore, it is important to acknowledge the complexities of decision-making and the need for carers to be adequately supported. Decisions will need to be revisited and may change over time 50 ; our decision aid encourages carers to revisit decisions and to discuss with professionals and other family members, which can enhance decision-making. 51  The decision aid is an interactive booklet using multiple approaches to engage participants and encourage reflection, moving beyond simple provision of information. The decision aid focusses on support across changes in care, eating and drinking difficulties, everyday well-being in dementia and healthcare tests and medication.
It was important that we provided information and options across these decisions in a balanced and neutral manner, 53 providing evidence-based information.
One of the unique features of the development of this decision aid was the inclusion of people living with dementia in the design of the intervention. In the methods, we have highlighted our approach to ensuring that they were adequately supported to participate.
Previous work has developed alternative methods to increase the inclusivity and engagement of people in coproduction, 46 but considering this in the context of living with dementia is important.
There are increasing numbers of articles reporting on the inclusion of people with dementia in research; however, they lack detail on coproduction methods. 54 Importantly, we consider that some of the key lessons from our experience include ensuring people living with dementia feel comfortable, acknowledged in the research procedures and have the time to contribute meaningfully. These can be achieved through minor modifications to research procedures including holding smaller groups, reducing the number of tasks in workshops, increasing the number of researchers to provide support (this may need to be one to one), considering the cognitive load of tasks and using accessible documents including consent and information sheets.
We prepared tasks for participants to rank the priority of decisions to be included. This was well received by family carers, although many felt that some were equally important. Professionals felt that many of the topics were not isolated decisions and they were difficult to rank. This reflects the clinical reality of having to consider multiple challenges rather than a clear ranked list of priorities. People living with dementia found this task demanding. We provided one-on-one support for this task, but they continued to struggle, and on reflection, this was a cognitively demanding task that we would not recommend for future workshops with people living with dementia. Tasks that involved visual representations proved much easier, including providing participants with an example of our prototype decision aid.

| Implications for research
Research needs to further explore optimal methods and approaches for including people living with dementia in decision-making research and end-of-life research.
Our article provides an example of how a matrix approach can be used to synthesize findings and for intervention development.
This is a vital step that is missing in guidance on developing complex interventions. 28,55 It is an iterative approach that provides transparency and clarity.
The decision aid developed will be tested in a feasibility study exploring optimal methods of evaluation and considering acceptability. We will continue to work with end users and stakeholders in the evaluation, which is vital to support implementation in routine care and practice. 56 Finally, it is also important to consider in future research the inclusion of those who do not speak English; this will allow us to tailor the decision aid to these populations.

| Implications for policy and clinical practice
This decision aid has many potential benefits for family carers, people living with dementia and health and social care practitioners.

| Strengths and limitations
We used a systematic approach following the principles of an evidence-based process for developing decision aids. 28 To supplement the gaps in guidance about specific approaches to design of complex interventions, we used a taxonomy of evidence-based approaches from O'Cathain and colleagues. 34 Our decision aid is strengthened by the theoretical foundations, using the IP-SDM model modified for dementia care decisions and the ODSF. 24,36 These enabled us to break down complex decisions and provide a clear pathway for carers using the decision aid. Furthermore, this was supplemented by experts from across clinical and academic fields, but most importantly, included people living with dementia and family carers in the design process.
The matrix-based approach for synthesis offered a transparent and systematic approach to synthesis, ensuring that the development was rigorous and evidence based.
Due to the size of coproduction workshops, we were unable to include all professional roles that may have been relevant. For example, the inclusion of pharmacists, speech and language therapists and dieticians would have been beneficial and should be targeted in future research. Furthermore, we were not able to include people who did not speak English; therefore, we may have missed some important cultural variations and factors that need to be considered when making decisions with those who do not speak English.

| CONCLUSION
This article presents the first decision aid that focusses on multiple decisions towards the end-of-life for people living with dementia. We provide a detailed overview of the systematic development process of a decision aid for family carers of people living with dementia. The process offers a template for others to develop decision aids or similar decision-making interventions, and how to include people living with dementia in coproduction.

ACKNOWLEDGMENTS
The authors would like to thank all the participants who took part in the workshops, all members of the think tank and our experts by experience group. Nathan Davies was supported by a Fellowship fromAlzheimer's Society, UK (grant number: AS-JF-16b-012).

CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.

AUTHOR CONTRIBUTIONS
Nathan Davies conceived the idea and design of the study and acquired funding, acquired data, led analysis and interpretation of the results and drafted and finalized the manuscript. Elizabeth L.
Sampson and Greta Rait conceived the idea and design of the study and acquired funding, and assisted in data analysis and interpretation. Emily West, Jill Manthorpe, Kate Walters, Kirsten Moore, Karen Harrison Dening and Jane Ward contributed to data analysis and interpretation. Tanisha DeSouza acquired data, and contributed to analysis and interpretation. All authors contributed to drafting the manuscript and revising for critically important intellectual content.
All authors have approved the version to be published and agree to be accountable for all aspects of the work.

DATA AVAILABILITY STATEMENT
Data sharing not applicable to this article as no data sets were generated or analysed during the current study.