Remote delivery of complex interventions within trials: understanding and applying knowledge from COVID-19 adaptations to guide future delivery, inclu

(title continued) inclusivity and tailoring of trial interventions.

The COVID-19 pandemic had a major impact on many aspects of the design and delivery of clinical trials, leading to rapid adaptations to enable trials to continue to operate in an unfamiliar and challenging environment. Current research to understand how to address this impact has focused on adaptations to analysis plans and reporting and adaptions to trial procedures, such as managing drug supplies or remote identification, recruitment and data collection processes. Little attention has been paid to methodological challenges arising from adaptations to complex interventions, such as physiotherapy, psychological, behaviour or lifestyle interventions, typically delivered face-to-face by a train therapist to individual patients or groups of patients. These of interventions were often rapidly converted to remote delivery, for instance via telephone or video calls, rather than being developed from the outset to be delivered without face-to-face interactions.

Such adaptations to intervention delivery have the potential to cause unintended consequences and affect important aspects of trial generalisability and interpretation. For instance, there may be issues relating to the implementation of the intervention, such as maintaining fidelity, or allowing tailoring to different individuals.

This project aims to apply knowledge from what happened during the COVID-19 pandemic, to increase our understanding of which interventions can be successfully converted to remote delivery, for whom and how. Results will be used to aid the design of future trials operating in resource-constrained settings, such as the NHS, where remote delivery of healthcare interventions is becoming more commonplace.

This project will involve carrying out a systematic review to identify trials which were adapted to remote delivery during the COVID-19 pandemic. Any associated process evaluations will be reviewed to understand the specific implementation issues that were encountered. Qualitative research will also be conducted with trial staff, intervention designers and intervention deliverers to understand in more detail their experiences of adapting a trial quickly for remote delivery. The use of guidance in practice will also be explored. A stakeholder group of PPIE representatives and trial participants will be convened to understand issues around acceptability and inclusivity. The results of all of this research will inform the development of guidance around how to adapt complex intervention for remote delivery in future trials.