PP23 The packman trial: what has been learnt delivering a CTIMP with an NHS ambulance service

<h3>Background</h3> Yorkshire Ambulance Service NHS Trust (YAS), West Midlands Ambulance Service University NHS Foundation Trust (WMAS) and The University of Warwick (UoW) collaborated to deliver the first clinical trial of an investigative medicinal product (CTIMP) of controlled drugs in the UK: PACKMaN (paramedic analgesia comparing ketamine and morphine in trauma). YAS Research Institute and collaborators reflected on the lessons learnt delivering this CTIMP across two ambulance services with reference to training, logistics, recruitment, and follow-up processes. <h3>Methods</h3> 489 paramedics were trained and recruited 458 participants between Oct-2021 and May-2023. UoW monitored location and timing of paramedics training and patient recruitment, alongside follow-up rates. Paramedics’ pain score collection data (PACKMaN’s primary outcome) was compared to YAS clinical audit compliance adult pain management. Participants recruited by YAS (n=243) were compared to 2015 census data regarding index of multiple deprivation status. <h3>Results</h3> YAS conducted facilitated training resulting in more paramedics trained faster, resulting in higher recruitment. However, an IMP stock shortage impacted YAS’ recruitment more so than WMAS. Both sites used different consenting and follow up models, WMAS resulted in only 22 lost to follow up compared to YAS’ 63. Pain score collection data was high across both sites: 100% for YAS and 96.9% for WMAS, compared to 71% in the YAS-wide clinical audit for adult pain management, evidencing research involvement can improve routine data collection. Descriptive statistics indicated that YAS’ recruitment sample was similar to the population of Yorkshire regarding index of multiple deprivation scores demonstrating the ambulance services’ ability to conduct research with populations commonly underrepresented in research. <h3>Conclusions</h3> This study highlighted the challenges and opportunities two ambulance services encountered when delivering the first CTIMP with controlled drugs in the UK. Devoting time to specific tasks like facilitated training aided recruitment. These reflections will inform best practice for future research delivery.