Award Title: Engaging care home residents in research: identification of barriers and facilitators and the development of an intervention to support residents in decision-making and advance planning for research (ENGAGE Study)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: •	Background
Although twice as many people live in care homes as there are hospital beds, far less research is conducted in care homes [1]. This exclusion is partly due to practical difficulties and ethical concerns about including this ‘vulnerable’ group in research [2]. This has resulted in a poorer evidence base for the care provided for frail older people who often have complex care needs but are under-represented in health and care research. It is also important that older people living in care homes have opportunities to participate in research as members of society. The impact of COVID-19 on populations such as care home residents has highlighted the stark inequalities in health outcomes experienced by groups who are least likely to be involved in research [3].
Care homes are less research active than NHS settings, have access to less research training and support, and may benefit from interventions to support the development of an environment where opportunities for residents to participate are integrated into care [1]. One of the additional challenges in involving residents in research is the high prevalence of conditions such as dementia which results in around 70% of residents lacking capacity to provide consent to take part in research [4]. In these situations, a family member will be consulted to help make a decision about their participation based on the resident’s wishes and preferences about taking part. Residents without a family member to act as consultee may require an alternative decision-maker – usually a nominated member of the care team – to represent the resident’s wishes and preferences [5]. Knowing the resident’s wishes may help families and staff acting as consultees in the event of a loss of capacity [6]. However, discussions with older people about their preferences about research, including in the event of a loss of capacity, are rare and there are currently no legal mechanisms for prospectively appointing who acts as ‘consultee’ [7]. The Nuffield Council on Bioethics has long recommended the commissioning of research on the feasibility of developing a (non-binding) advance statement on research participation which could influence decisions on research participation after loss of capacity (Recommendation 18) [8].
Advance Care Planning (ACP) is increasing being used with care home residents to ensure that the care and treatment they receive when they are no longer able to make their own decisions is in accordance with their wishes and preferences prior to the loss of capacity [9]. The contents of ACP conversations can be recorded in the form of an advance statement or directive and may include choosing a proxy decision-maker (e.g someone to hold Power of Attorney). Extending these discussions to explore their research preferences may support residents’ autonomy through providing an opportunity to express their wishes about future research participation and who makes decisions about research on their behalf [6]. Discussions about complex issues under conditions of uncertainty, such as future research preferences, may benefit from additional support.
Supported decision-making is particularly valuable for people with dynamic cognitive function and fluctuating capacity that place them at the margins of autonomy [10]. The development of tools to facilitate conversations may encourage residents to explore their views about participating in research and support them to make informed decisions about research opportunities. This may take the form of ‘Conversation Cards’ which are cards featuring pictures or statements that can facilitate putting thoughts and feelings into words. They have previously been developed for use in various contexts such as with palliative care patients discussing end-of-life issues and for people living with dementia [11] but have not previously been developed for use in research contexts. The views of older people living in care homes, and those who care for them, about the acceptability and utility of advance planning for research, including the use of supportive interventions such as Conversation Cards, have not previously been explored.
•	Aims and objectives:
Building on existing links with organisations such as Social Care Wales and ENRICH Cymru (Enabling Research in Care Homes), the aim of this PhD Studentship is to identify ways in which to engage and support care home residents to make informed decisions about participation in research and to develop an intervention to support residents’ inclusion in research at a time when they may no longer have capacity to make a decision. 
This will be achieved through:
- identifying resident-level barriers and facilitators to care home residents’ participation in research, including residents who are able to provide their own consent and those whose capacity to consent is impaired.
- exploring care home residents’, families’, and staff’s views about encouraging early discussions to elicit residents’ preferences about research participation and facilitate Advance Care Planning for research.
- developing a communication intervention to help care home residents discuss their preferences about participation in research.
•	Design and method:
This PhD Studentship project will consist of three stages:
Stage 1: Identifying barriers and facilitators to care home residents participating in research
1a. A scoping review of existing literature will be conducted to identify the barriers and facilitators to involving older people living in UK care homes in research. It will be conducted using established scoping review methods [12]. The review will focus primarily on resident-level factors that enable or prevent residents engaging with research, with the aim of identifying potentially modifiable barriers and facilitative interventions that will form the basis for the following work.
1b. Informed by the review findings, a survey will be conducted with residents, families, and care home staff across Wales, including those already part of the ENRICH Cymru network and those who are less/not currently research active. Participants will be recruited through organisations such as ENRICH Cymru, care provider organisations such as Care Forum Wales, and social media and those identified from the Care Inspectorate Wales database of care providers. The survey will be available in both online and paper-based formats to enable participation from a broad range of participants. Care home residents will be supported to participate through the provision of accessible information about the survey and the development of guidance documents for residents and the relatives and staff who will support their inclusion. Questions will be designed to explore participants’ views about current opportunities for residents to participate in research, decisions about participation, and the barriers and facilitators to their involvement. There will be a particular focus on issues related to equality, diversity and inclusion. Participants will also be invited to indicate if they are happy to be contacted to participate in an interview to be conducted in Stage 2.
The findings from Stages 1a. and 1b. will inform the further stages of the project and identify areas for the development of future interventions.
Stage 2: Exploring views about advance planning for research participation by care home residents
Semi-structured interviews will be conducted with approximately 20-25 residents, families, and care home staff across Wales. The total sample size of 20-25 is based on the numbers anticipated to achieve sufficient saturation and information power (as determined by the research team) to address the research question and is informed by similar studies conducted previously. Participants will be recruited through the survey in Stage 1b and other routes such as research networks and social media. Participants will be purposively sampled to ensure maximum variation using a sampling frame developed a priori. Interviews will be conducted either in person or remotely (by telephone or a video conferencing platform such as Zoom) depending on factors such as visiting restrictions in place at the time. A sampling frame will be developed to ensure a broad range of stakeholders are included. The interviews will explore their views about residents participating in research and encouraging early discussions in order to elicit residents wishes and preferences and facilitate advance planning for research. Interviews will be audio-recorded and transcribed verbatim. Thematic analysis [13] will be used to qualitatively explore participants’ views and attitudes towards advance planning for research, including identifying barriers and facilitators and appropriate timing for these discussions. The findings will inform the next stage of the project.
Stage 3: Development of a communication support intervention for care home residents
Using intervention development methods (e.g MRC guidance on developing complex interventions [14](updated version pending)), a communication and/or decision support intervention will be developed to facilitate discussions with care home residents about research participation which will support informed decision-making and ACP for research. This may take the form of ‘Conversation Cards’ which will be developed to feature pictures or statements about the key concepts that are relevant to decisions about participation in care home research studies. These concepts will be obtained from Stages 1a, 1b and 2 and the wider literature on research participation decisions. The intervention will include mechanisms for recording the outcomes of conversations, with the potential for residents to record these formally as their advance statement of wishes about research in the event that they lose capacity to consent to future research studies. The intervention will be produced in collaboration with care home residents, families, and staff and undergo small scale piloting to explore the initial acceptability of the intervention using established acceptability tools [15]. To support the use of the intervention, an education/training resource will be developed for care home staff that will increase their knowledge and awareness about their role in supporting residents to access research opportunities.
•	Planning and use of resources:
The use of project management support and tools will ensure that the project is conducted using maximal time and resources available. Project planning will include time and resources for skills development and training, the development of research protocols, and obtaining appropriate ethical opinion and other approvals/permissions as required. Sufficient time will be built into the research plan to allow for the recruitment of participants and data collection, which can be a challenge in some settings such as care homes. 
Costs have been requested to support travel to conduct interviews (where appropriate), a digital audio-recording device, vouchers to be offered to participants as a token of thanks, and costs to support Public Involvement through meeting attendance and travel costs for the Lay Advisory Group. Costs have also been requested for the student’s attendance at specific training courses (with travel) and conference costs to support the dissemination of the findings. Additional costs for this project, such as external transcription costs, graphic design input, and a stakeholder co-design event, are supported through a parallel application to Cardiff University’s School of Medicine PhD Studentship Consumables fund.
•	Method of analysis:
This mixed methods project will combine evidence synthesis, survey, qualitative research, and intervention development methods. The survey data will be reported using descriptive statistics with open response data coded thematically. The qualitative data from interviews will be analysed using Thematic Analysis which, through identifying patterns and themes, enables a rich and detailed account to be provided which captures participants’ views and experiences [13]. The findings from the scoping review, survey and qualitative research will be triangulated to inform the development of the intervention. This will include identifying the intended recipient and implementer of the intervention, its component(s), content and format. Established intervention development theories and frameworks - including the MRC guidance on developing complex interventions – and the development of a logic model will underpin the intervention development process.
•	Expected outputs and outcomes:
Initial prototype intervention
The key output from this project is an initial draft of an intervention to support care home residents to have facilitated discussions about their research preferences and enable advance planning for research where appropriate. The form and content of the intervention will be informed by the earlier stages of the project, and following consultation with organisations such as Sight Cymru, but may take the form of ‘Conversation Cards’. The prototype intervention will be developed in preparation for future testing. Costs are included for expert graphic design support to ensure that the intervention is acceptable and accessible for care home residents. An application for further funding to evaluate the feasibility and effectiveness of the intervention will be developed towards the end of the project.
Stakeholder summaries
‘One page’ summaries will be created for stakeholders including researchers, care home staff, and social and health care practitioners to share the key messages from the project. In addition, creative methods will be used to design accessible summaries for care home residents and their families using alternative formats such as graphic design or audio-visual media.
Educational/training materials
An additional output for this project will be the creation of a training and learning resource for care staff to complement the existing training for ‘research ready’ care homes currently under development by ENRICH Cymru Wales. This will be created towards the end of the project and will share the key findings from this project using a pedagogically focused approach to help care home staff understand the practicalities of supporting residents to access research opportunities. To enable access to the resource across Wales, the materials will be hosted on/made accessible through a sustainable online platform. This may be through the ENRICH Cymru website to complement resources around involving residents with limited capacity (invited contribution from Shepherd in 2019, https://www.swansea.ac.uk/enrich-cymru/enrich-cymru-for-care-home-staff/ ) or Social Care Wales’ curated research pages to complement to a curated page on research and capacity to consent (invited contribution from Shepherd in 2020, https://socialcare.wales/curated-research/research-and-capacity-to-consent ). Future research will evaluate and further refine the learning resource in collaboration with ENRICH Cymru and their network of ‘research ready’ care homes.
Planned publications:
1 Scoping review findings on the barriers and facilitators to involving older people living in UK care homes in research: Journal of Nursing Home Research
2 Stakeholders’ views about current opportunities for residents to participate in research, decisions about participation, and the barriers and facilitators to their involvement from the survey: Journal of Social Care
3 Views about residents participating in research and facilitating advance planning for research from the qualitative interviews: Health and Social Care in the Community
4 Reporting of the intervention development process: Trials or BMC Research Methodology
•	Dissemination and impact:
Dissemination
In liaison with organisations such as Centre for Ageing and Dementia Research (CADR), and in addition to publications in academic journals, the research findings will be disseminated through a series of academic conference presentations. These will include:
-	International Clinical Trials Methodology Conference
-	British Society of Gerontology (Care Homes Special Interest Group) Symposium 
-	National Social Care Conference
-	PRIME Centre Wales conference
Research blogs will also be used to disseminate the findings, including through:
-	Centre for Trials Research
-	PRIME Centre Wales
-	NIHR Enabling Research in Care Homes (ENRICH)
-	NIHR Dementia Researcher
-	Institute Welsh Affairs (IWA)
Impact
Implementation planning will be informed by the Knowledge to Action (K2A) Framework [16], with the iterative development of a ‘pathway to impact’ plan during the duration of the project. Short term impacts will include increasing awareness about research with care home residents, families and staff both within the ENRICH Cymru network and care homes yet to join the network. Longer term impacts include supporting care home residents to participate in research and contributing to research capacity building in care homes in Wales and beyond. The ENRICH Cymru network has recently been funded by Health and Care Research Wales for the next three years as part of a planned expansion and development of the network. ENRICH Cymru have formally confirmed their support for the project. Opportunities will also be sought to share and develop this area of research with social care research organisations across the UK such as the NIHR School for Social Care Research.

Lay Abstract: Older people living in care homes, particularly those with dementia and similar conditions, are less likely to be involved in research than other populations despite often having the highest and most complex care needs. This is primarily due to the complex ethical and practical issues surrounding the inclusion of people unable to provide informed consent, which affects about 70% of care home residents. It is also because care homes are less ‘research active’ than other care settings. The current lack of research involving care home residents results in a poorer evidence-base for their care. The impact of COVID-19 on care home residents has highlighted the stark inequalities experienced by groups who are least likely to be involved in research. Care home residents are increasingly being encouraged to have advance care planning discussions about their care preferences. These could be extended to include discussions about research participation, although these more complex conversations may benefit from interventions to support and facilitate discussion. Effectively engaging care home residents in discussions about their views towards research may enable those who care for them to support their decision-making about involvement. It also provides an opportunity for their families and carers to represent their wishes and preferences in the event that they are unable to make their own decisions about participation in the future.  This mixed-methods PhD project aims to explore how care home residents and their carers can be better engaged in research, and the barriers and facilitators to their inclusion. Using established intervention development methods, an intervention will be developed to support conversations about research with care home residents and facilitate advance planning for research participation. The findings will support opportunities for care home residents to participate in research, have their voices heard, and receive quality evidence-based care in the future.

Research Activity Codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health Categories: GENERIC HEALTH RELEVANCE;NEUROLOGICAL