Title: Deciding about research for others: a feasibility study and effectiveness trial of a novel decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background Despite having the highest care needs, people with impairing conditions, such as dementia, are frequently excluded from research. This means that there is little evidence underpinning the care of the estimated 2m people in the UK with significantly impaired decision-making. For people who are unable to consent, a family member is usually approached to act as a proxy decision-maker. However, proxy decisions can be problematic, and families report experiencing an emotional and decisional burden as a result. Recent interventions to improve consent processes have focussed solely on individuals providing consent for themselves. This project will evaluate the first intervention to improve proxy decision-making for research developed during my recent NIHR Doctoral Research Fellowship. Aims and objectives This project aims to: - understand the barriers and facilitators to implementing a novel decision-support intervention for families acting as research proxies - explore the feasibility of conducting a Study Within a Trial (SWAT) of the decision aid (DA) - establish whether the DA is effective in improving the quality of decision-making by family members Methods This work follows the Medical Research Council’s guidance for developing and evaluating complex interventions. The project will be conducted through 3 stages: Stage 1. A qualitative exploration to understand the barriers and facilitators to implementing a DA for families acting as proxies. Semi-structured interviews will be conducted with 20-25 key stakeholders including Research Nurses and Principal Investigators, and thematically analysed. Stage 2. A feasibility study of conducting a SWAT of a DA for proxies. The intervention will be piloted with 15 family members and up to 15 implementers to explore the feasibility of the intervention and trial methods, including recruitment. The study will also explore the feasibility and acceptability of outcome measures currently being developed in a study to determine a Core Outcome Set. Stage 3. A SWAT to evaluate the effectiveness of the intervention, embedded in appropriate host health and social care trials. Family members will be randomised to receive the DA in addition to standard study information, or standard information alone. The results from individual trials will contribute to Individual Participant Data (IPD) meta-analyses. A process evaluation will explore issues affecting future implementation such as fidelity, and an economic evaluation will include exploration of the implementation costs of the DA and resource use implications for family members acting as proxies.. In addition, in Year 1 an online toolkit will be developed for researchers and health and social care practitioners to provide resources on assessment of capacity, legal frameworks, and signposting to training. Timelines for delivery The project will be conducted over 48 months (qualitative study months 1-7, feasibility study months 8-17, and SWAT, process and economic evaluation months 18-48). Anticipated impact and dissemination The DA has the potential to support family members of people with impaired capacity to make informed decisions regarding their participation in research. The work outlined in this application will increase awareness of the inclusion of adults lacking capacity in research through creation of an online resource, conference presentations, and academic publications.

Lay abstract: Background There has been a growing focus on improving the informed consent process for research. However, some people with problems with their memory or understanding may lack capacity to provide consent for themselves. In these situations, a proxy decision-maker is needed to help make a decision about whether they take part or not. Involving proxies can be challenging, which contributes to people with incapacity being under-represented in research. There have been calls for innovations to increase the ability to recruit underserved groups. In a recently completed NIHR Doctoral Research Fellowship I explored how family members make decisions about research on behalf of someone unable to provide their own consent. I found that it was difficult for some family members to make a decision, and they experienced an emotional burden as a result. Families thought that greater support and guidance when making decisions would help. I developed the first decision support tool for family members making decisions about research. This has been found to be acceptable to both families and researchers, and now needs to be tested to see whether it is an effective form of support. I am currently conducting further work to explore how to measure its effectiveness through establishing which outcomes matter, to whom, and why (COnSiDER study, see https://bit.ly/2ozgwwY). This Fellowship would be the next stage which is to understand whether the support tool is effective, what factors affect this, and how much it costs. This will be done using a Study Within a Trial (SWAT) which is a selfcontained research study that is embedded within a host trial/trials with the aim of evaluating a particular trial process. Aims This fellowship aims to support the inclusion of adults lacking capacity in research through improving decision-making by the family members involved. This will be achieved through understanding the barriers and facilitators to implementing the novel decision-support tool, exploring the feasibility of the tool and outcome measures being developed, and establishing whether the decision-support intervention is effective in improving the quality of decision-making by family members. Design and methods The project will be conducted in 3 stages: Stage 1. I will interview 20-25 professional stakeholders (e.g research nurses, trial managers) to explore their views about the barriers and facilitators to implementing a decisionsupport intervention for families, and the acceptability of conducting a SWAT. Stage 2. I will conduct a feasibility study (embedded in host trials recruiting adults lacking capacity) to explore the feasibility of the intervention, conducting a SWAT, and the acceptability of outcome measures under development. This will be through piloting the intervention with 15 family members and up to 15 researchers/research nurses. Stage 3. I will conduct a randomised controlled trial as a SWAT to evaluate the effectiveness of the decision-support intervention. Embedded within this trial I will explore how and why the intervention is/isn't effective and evaluate the costs and resource use implications of the intervention. In addition, I will develop an online toolkit for researchers and practitioners to provide resources on assessing capacity, legal frameworks, signposting to training and other resources, and a mechanism for implementation. Public and patient involvement A PPI group who supported my completed fellowship have been involved in the planning of this application. If successful, their involvement would include reviewing the project plan, refining research questions, providing input into the development of Participant Information Sheets, and contributing to the summaries of the results. Dissemination Brief one-page summaries and animations of the findings will be shared with participants, patient and carer support groups, and research and practitioner communities. Outputs will include presentations at national and international conferences and publications in academic journals.

Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: MENTAL HEALTH