A global pilot comparative, cross-sectional study of clinical research nurses/research midwives: Definition, knowledge base, and communication skills related to the conduct of decentralized clinical trials.

ABSTRACT

Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.