Background/context Simulation is fast becoming an integral part of neonatal clinical training. Publications have demonstrated the diverse use of simulation.1 There is considerable anxiety amongst staff surrounding the implementation of multi-centre research protocols. This has the potential to impact on patient care, especially in a research naive unit. The use of simulation to evaluate the research protocol has been published.2 Simulation has also been proposed as a tool to increase adherence to guidelines, enhance team performance, and increase patient safety.3
We propose of use of low fidelity simulation (LFS) to explain the research protocol and train staff to implement a multi-centre protocol in a research naive unit.
Planned methodology The Elfin4 study involves administration of placebo or Lactoferrin to preterm babies.[A1] A phased training program involving a LFS manikin and prescription charts as well as role play scenarios for taking consent will be used to explain the study protocol to all neonatal staff involved in the study. A questionnaire will be used to assess the confidence and competence of staff before and after the simulation exercise.
Results/ outcomes expected We expect the LFS exercise to reduce anxiety levels amongst staff by familiarising them with the protocol and enhancing their confidence in preparing and administering the IMP. This in turn should prevent potential departures from the protocol typically associated with early phase of trials.4
Potential impact Research simulation using low cost LFS to train staff could enable costly mistakes to be avoided. Enhanced staff training would in turn optimise recruitment. We also expect the LFS based exercise to make staff feel more comfortable within their roles and reduce the anxiety about study interventions impacting on routine patient care.
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
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
Taekman J M, Stafford-Smith M, Velazquez E J. Departures from the Protocol During Conduct of a Clinical Trial: A Pattern from the Data Record Consistent with a Learning Curve. Qual Saf Health Care. 2010; 19(5): 405–410
- Category: Course or curriculum evaluation/innovation/integration
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