Making clinical trials more inclusive by using behavioural science to improve communication: COMMCLUSIVE

Background Clinical trials need to be inclusive to make research findings generalisable, minimise health and social care inequalities, increase trust in research, and avoid research waste. Patients experiencing socioeconomic disadvantage are persistently underserved in trials. Poor communication is a key barrier to their inclusion. Making changes to the content and presentation of verbal communication can increase patient understanding and recruitment. I led the CO-ACT study, which found that recruiters spent less time and used sub-optimal techniques to discuss trials with patients living in socioeconomically disadvantaged areas. Improving how trials are verbally communicated is an unexplored, yet promising approach to make trials accessible. I will develop an online toolkit, including guidance, e-learning, and videos to support recruiters to communicate inclusively. I will use behaviour science theory to develop the toolkit, offering an effective, reproducible, transparent and generalisable approach to addressing trial conduct challenges. I will conduct a feasibility study to refine the toolkit and contribute data to, and inform, a future full-scale evaluation of the toolkit's effect on trial inclusivity and recruitment. Aims and objectives 'COMMCLUSIVE' aims to make trials accessible to patients experiencing socioeconomic disadvantage by optimising communication. Objectives: 1. Establish a) communication preferences of patients experiencing socioeconomic disadvantage and b) communication goals and intentions of recruiters (Phase A). 2. Develop an online toolkit, including guidance, e-learning and videos to support recruiters in communicating inclusively (Phase B). 3. Conduct a feasibility study within four trials (SWATs), including qualitative process evaluation (Phase C). The study will refine the toolkit and contribute data to, and inform, a future full-scale evaluation of the toolkit's effect on trials inclusivity and recruitment. Methods and timelines I will complete the 3-year Fellowship over 45 months at 80% FTE. Behavioural science will guide this mixed methods project. Key stakeholders, particularly patients and recruiters, will inform three phases: A. Qualitative study (21 Months @ 80%FTE [1-21]) Interviews with ~25-30 adult patients experiencing socioeconomic disadvantage and ~15-20 trial recruiters. Findings will inform the development of the toolkit. B. Co-develop toolkit (6 Months @ 80%FTE [22-27]) Consult with stakeholders via meetings and user-testing to develop and package the toolkit, including guidance, e-learning and videos. C. Feasibility study, qualitative process evaluation, and dissemination (18 Months @ 80% FTE [28-45]) Conduct a feasibility SWAT to refine the toolkit and contribute data to, and inform, a future full-scale evaluation of the toolkit. The feasibility study will involve a cluster randomised (by site) controlled design with four host trials and qualitative process evaluation. Anticipated impact and dissemination I will create an open access toolkit, including e-learning, guidance and videos, to support recruiters to communicate inclusively about trials. Longer term, this will improve the quality and accessibility of the evidence-base for trials communication, supporting NIHR's strategies to enhance trials inclusivity and recruitment. I will make research findings generalisable to target populations to minimise inequalities. Outputs will be shared through a webinar, embedding the toolkit in high-profile websites (e.g. NIHR INCLUDE and The Clinical Trials Toolkit), conference presentations, journal articles, patient/public summaries, and infographics.