0103 Using Low Fidelity Simulation To Set Up And Implement A Multi-centre Rct On A Neonatal Unit

Background/context Simulation is fast becoming an integral part of neonatal training. Publications have demonstrated the diverse use of simulation. 1 Setting up a multi-centre trial within a research naive unit is challenging. The use of high fidelity simulation to evaluate the research protocol has been published. 2,3 We describe our experience of using low fidelity simulation (LFS) to implement a research protocol in a research naive neonatal unit. Methodology The Elfin 4 study involves administration of placebo or Lactoferrin to preterm babies. A LFS simulation exercise involving the core research group was run to explore the potential problems in implementing the trial using a LFS manikin, prescription charts and Elfin software followed by role play scenarios for taking consent. Results/outcomes The simulation exercise identified challenges surrounding prescribing, IMP storage and timing of IMP administration which have now been resolved. The research coordinators feel more confident in implementing the protocol. The approach of using LFS to set up this research study has resulted in early recruitment into the trial and should enable recruitment targets to be achieved promptly. Conclusions and Recommendations The use of cheap LFS for setting up a research trial has enabled costly mistakes to be avoided. Enhanced staff training amongst the core research team is optimising recruitment. The use of LFS in the context of setting up a research trial has so far been productive and is recommended to other units who plan on being involved in trials like Elfin. The next stage involves a phased roll out of LFS exercises to neonatal staff involving the preparation and administration of the IMP. This process should enhance confidence amongst staff and prevent the study intervention impacting on routine patient care. References Howard C, Shore H, Talbot H, Harrop A, Winston J. Preparing for a low incidence-high risk event with conjoined twins. Infant 2014;10(3):95–96 Wright MC, Taekman JM, Barber L, et.al. The use of high-fidelity human patient simulation as an evaluative tool in the development of Clinical research protocols and procedures. Contemporary Clinical Trials 2005;26:646–659 Takeman J M, Hobbs G, Barber L, et.al. Preliminary Report on the Use of High Fidelity Simulation in Training of Study Coordinators Conducting a Clinical research Protocol. Anaest Analg 2004; 99: 521–7 https://www.npeu.ox.ac.uk/elfin/neonatal-staff