The Dementia – PersonAlised Care Team (D-PACT) programme is an NIHR funded project, aimed at developing and evaluating a dementia support worker intervention based in general practice for individuals living with dementia and their carers (Our website has full details).
Current NIHR guidance advocates that research should strive to improve the inclusion of individuals with dementia, including those who lack capacity (i.e. the ability to make one’s own decisions). Despite this guidance, D-PACT is one of few studies actively including adults who lack capacity through an innovative ‘inclusive recruitment pathway’ and the use of consultees. In research, a consultee is someone who knows the individual who lacks capacity well enough to be able to communicate their wishes and feelings concerning the research. During the development of our capacity judgement process, we adhered to the Mental Capacity Act (MCA; Department of Health, 2005) which provides a framework to follow if an adult lacks the capacity to make a certain decision. We also worked to the Good Clinical Practice standards for decision making and consent. In addition to these regulatory requirements, our process was informed by the principles of personhood (e.g. Kitwood, 1997) and person-centred care, two concepts at the heart of the D-PACT ethos. These principles focus on the importance of developing relationships based on equality, recognition, respect and trust, and actively involving the individual in their care. We also highly valued Patient and Public Involvement (PPI) contributions (including people with dementia, carers and former carers) which helped us create our comprehensive, step-by-step work instructions for capacity judgements.
Judging capacity and seeking informed consent/consultee agreement with dementia populations is challenging. Although there are the above-mentioned regulations and there are a small number of published recommendations for researchers (e.g., Dewing, 2007; Hegde & Ellajosyula, 2016), there is still a paucity of practical guidance on the real-life application of these principles. In this blog, we wanted to share some of our first-hand experiences, as D-PACT researchers in the Southwest site, around making face-to-face and remote capacity judgements and seeking informed consent/consultee agreement. We wanted to highlight that capacity judgements in research are challenging and the process, in our experience, can cause researchers to sometimes feel uncertain and uncomfortable. We have learnt a great deal during D-PACT’s feasibility stage, and we have refined our capacity process in line with this. This blog by no means attempts to cover the range of challenges surrounding research capacity judgements, and much is only common sense, but we hope our experiences can offer some advice to other researchers working with populations who may lack capacity, particularly during the initial planning stages of a project.
The importance of being human (informal conversations and building good relationships): Every contact is an opportunity to make a connection and build rapport. Informal conversations are vital for putting people at ease and promoting an environment of openness so they feel they can ask questions. As researchers, we are all individuals and our natural conversation style differs, but our approaches all included being warm and friendly, engaging in humour when appropriate, using active listening and asking genuine questions. We responded to individual dynamics to ensure that the individuals with dementia and the carer both had opportunities to engage. These informal conversations also provided useful information for capacity judgements (e.g. whether the carer has power of attorney, details about personal care). Developing and maintaining rapport is also beneficial for studies that may find it challenging to recruit and longitudinal and/or randomised trials which often experience high attrition rates. In our experience, ‘just being human’ helped participants feel more comfortable with the whole research process, and hopefully made the research process a positive experience. We found that by ensuring, where possible, the same researcher maintained contact with a participant throughout the study, rapport building was enhanced through familiarity. It should be noted that this critical process is time-intensive and is often underestimated when developing bids, budgets, and timelines.
Be flexible and give people time: Caring for someone with dementia is challenging and there will be times during the day that are busier than others. We also know that capacity can fluctuate and may be more impaired at certain times. We found it beneficial to ask the individuals with dementia and the carer the best time to contact them, including evenings if the carer was employed. If someone was having a difficult day, we rearranged the appointment. Individuals with dementia sometimes need longer to process information and this entailed having several short conversations with them before they volunteered/declined to take part. It was important to be flexible and give people the time to make informed decisions but, again, this meant the process could be time-consuming and it was difficult to balance when researchers were under tight recruitment deadlines.
Keep information brief and simple: It is constructive to ensure written and verbal information about the study and what participation would entail is as accessible as possible to both the individuals with dementia and the carer. Keeping jargon to a minimum and using a variety of media to share the key information (e.g. pictures, words, verbal explanations) were helpful. Our participant information sheet (PIS) was initially quite lengthy due to the ethical requirements outlined by the Health Research Authority. However, we have worked hard with our PPI group to reduce the information and make it more dementia-friendly, resulting in the information being shared in a range of documents, including a simplified one-page visual document. Using creative ways to make the information as accessible as possible, we were able to develop documents and processes which adhered to ethical regulations, but which also put the participant at the heart of the research. We questioned assumptions about ethical conventions, for example, the need for written consent with populations who experience tremors, visual problems and who were, at the time, self-isolating during COVID-19 lockdown. We received a favourable ethical opinion to use verbal consent, reducing the burden on our participants.
Use of person-centred communication aids and skills: We used our simplified PIS when capacity was being judged, alongside a simple communication tool which allowed the individuals with dementia to point to yes and no answers. We found techniques such as sitting face-to-face (pre-COVID-19 or via video calls), directing talk to the person with dementia by using their name, reducing distractions, active listening and using gestures supported understanding and aided comprehension for informed consent. We also openly accepted the reality of the individuals with dementia, as well as seeing individuals as people first rather than ‘someone with dementia’ or ‘a carer’ (Fazio et al., 2018).
Stick to the principles of the capacity judgement process, but be flexible: We developed clear work instructions, intended to increase researcher confidence, and make our capacity judgements as consistent as possible. During our initial face-to-face meetings, when we were less experienced, we more rigidly followed these. However, over time, we were able to implicitly apply the principles, making the process feel more of a conversation and less like a ‘test,’ which helped put our participants at greater ease and therefore made the process a truer reflection of capacity.
Take people’s personal choices into consideration when arriving at your judgement: As part of our process, we would find out what the ‘domestic administration’ processes were, for example, the PwD might comment that their carer ‘signs everything these days’ as they get too confused. This shouldn’t be the basis of the definitive capacity decision but it can indicate how comfortable a person with dementia might be about introducing the idea of a consultee if that is looking like the direction of travel.
Introduce the idea of a consultee sensitively: When dementia is in the advanced stage, it is usually quite evident that a consultee agreement will be required. The opposite is typically true when dementia is in the very early stage. In those situations where it is greyer, the concept of having a consultee can be introduced in ways that do not undermine a person’s dignity, autonomy, or personhood. An important part of this process is explaining the consultee role to the carer and individual with dementia. This can feel uncomfortable so it can be helpful for researchers to have a clear understanding of the process, to introduce the concept of consultee in early conversations with participants, and to feel prepared to discuss this ‘in the moment.’ This is when previous conversations about how domestic admin is arranged can be helpful. For example, ‘you’ve said X signs everything now as you sometimes struggle with paperwork – X can sign a consultee form about you taking part in this research – would you be happy with this?’. This is a challenging area of practice – another blog for the future!
Even if a PwD is judged not to have the capacity to consent, their assent remains central to the research process: In line with ethical regulations (e.g. Declaration of Helsinki), consultee agreement does not automatically assume assent on the part of the individuals with dementia, their assent still needs to be prioritised. Black et al., (2010) highlighted the challenges facing researchers in this context, and in line with recommendations, we were vigilant to verbal and non-verbal signs of dissent and did not allow the research to continue if there are any signs of unwillingness. Judging assent in individuals with dementia who may be experiencing neuropsychiatric or behavioural symptoms of dementia can be extremely challenging and can require sensitivity on the part of the researcher and an open discussion with the carer to ensure the research process is not causing distress.
Video calls can enhance remote capacity judgements: When gaining consent remotely, researchers reported that video-calls appeared superior compared to telephone calls, due to the researcher being able to identify contextual non-verbal cues for engagement and understanding. Unfortunately, a low proportion of participants chose this mode of communication. Telephone calls were more popular for several reasons including participants not having access to the internet (either through choice or due to poor internet in rural areas of the South West), participants not feeling comfortable/confident with video call platforms, or participants not having access to digital devices. Going forwards, considerations are underway for enlisting the help of digital enablers who could offer devices or solutions (e.g. internet boosters) to alleviate video call barriers.
Don’t underestimate the impact on researchers: Working with individuals with dementia and their carers was sometimes emotionally and mentally demanding, particularly during COVID-19 lockdowns. Before the pandemic, we worked in researcher pairs to conduct face-to-face visits. We found the researchers could support each other (e.g. developing non-verbal cues which enabled us to share our thoughts about capacity and enabled retrospective peer reflection) as well as providing each member of our dyad with individual space to share their thoughts. Dual working was not possible in remote times, and the onus of the capacity judgement was on a sole researcher. Therefore, ongoing peer and team support and supervision is essential.
We continue to refine our recruitment pathway, including our capacity and consent/consultee process. When COVID-19 restrictions are lifted, participants will be offered a shared decision-making process to agree on their preferred recruitment method; face-to-face, remotely or a hybrid of both methods. In this blog, we have attempted to provide a snapshot of the D-PACT capacity and consent process and our current learning. Due to word restrictions, we were not able to do justice to D-PACT’s wider recruitment process, (e.g. exploring how our pre-consent information, such as the PIS, are specifically designed to promote autonomy for Individuals with dementia). If you would like more in-depth details about the larger recruitment process or you have any questions or queries about the project then we would be more than happy to discuss these with you via email or Zoom.
D-PACT are nearly ready to submit a paper for publication on how we remotely judged capacity to provide informed consent during COVID-19. We have also recently had a paper published titled: ‘Do I have the capacity to make capacity judgements?’ Researcher reflections from a person-centred dementia support study.
Black, B. S., Rabins, P. V., Sugarman, J., & Karlawish, J. H. (2010). Seeking assent and respecting dissent in dementia research. The American Journal of Geriatric Psychiatry, 18(1), 77-85.
Department of Health (2005). Mental Capacity Act. London, HMSO.
Dewing, J. (2007). Participatory research: A method for process consent with persons who have dementia. Dementia, 6(1), 11-25. https://doi.org/10.1177/1471301207075625
Fazio, S., Pace, D., Flinner, J., & Kallmyer, B. (2018). The fundamentals of person-centered care for individuals with dementia. The Gerontologist, 58, 10-19. https://doi.org/10.1093/geront/gnx122
Hegde, S., & Ellajosyula, R. (2016). Capacity issues and decision-making in dementia. Ann Indian Acad Neurol, 19, 34-39. https://doi.org/10.4103/0972-2327.192890
Kitwood, T. (1997). The experience of dementia. Aging & Mental Health, 1(1), 13-22.
This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (RP-PG-0217-20004). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Leanne Greene is a Programme Manager at University of Exeter. With a background is in neuropsychology, Leanne spent time as an assistant psychologist in the NHS, including working on a specialist dementia ward offering assessment and treatment of organic mental health problems with dementia. Leanee has worked on a number of studies including Dementia- PersonAlised Care Team (D-PACT) project, which aims to develop and evaluate a system for dementia support based in general practice. She is currently, working on developing and evaluating a primary care TaIlored ManagEment of Sleep (TIMES) tool for people living with dementia or mild cognitive impairment.
Alex Gude is a Research Assistant at University of Plymouth. Having worked as a social worker with children and families for 10 years, Alex moved into research in 2016 and has worked on a number of projects as part of the Community and Primary Care Research Group at the University of Plymouth. All the projects she has chosen to work on are aimed at improving the mental health and wellbeing of the participants involved. Alex has a partner and two daughters, who are 11 and 14, who all keep her on her toes.