P132 Research in the time of COVID-19: Recruitment to a clinical trial comparing models of NIV implementation in people with MND

INTRODUCTION: A pilot randomised controlled trial (RCT) examining the feasibility of a new model of non-invasive ventilation (NIV) implementation was due to commence in early 2020. Based on previous research, it was anticipated that 100% of people with motor neurone disease (MND) would be eligible, 60% would consent to participate and 20 people would be randomised in five months. The aim of this report is to describe the impact of COVID-19 pandemic contingencies on trial recruitment. METHODS: Report of project progress, participant screening and recruitment. RESULTS: First reports of COVID-19 coincided with study commencement and changed usual healthcare delivery. Lockdowns meant telehealth substituted for face-to-face assessment, respiratory function testing was limited and/or patients were reluctant to seek medical treatment. This modified pathway impacted evaluation of diagnosis, timing of need for NIV and procedural safety, with patients then referred specifically for a single-day hospital NIV implementation to enable face-to-face multidisciplinary assessment to aid decisions. Of 81 potential participants screened in an 8-month period, 64% were ineligible for the RCT. Despite this shift in eligibility rate, 16 people with MND have been recruited as of May 2021. CONCLUSION: The current climate has amplified the significance of this research trial; people with MND have had reduced access to face-to-face services globally and clinicians have had to quickly adapt to a changing landscape of telemedicine and remote monitoring of patients. This trial’s screening data suggest that COVID-19 hasn’t stopped people with MND being implemented on NIV, but it has altered assessment pathways.