267 Research Protocol Training Through an Electronic Learning Module and in Situ Simulation

Abstract

We describe the process of clinical staff training of a complex emergency research study through a layered approach to disseminating study protocol information to clinical staff. The Established Status Epilepticus Treatment Trail (ESETT) seeks to compare effectiveness of fos-phenytoin, levetiracetam, or valproic acid in subjects with benzodiazepine-refractory status epilepticus. ESETT is an EFIC trial in which qualifying subjects can be enrolled by the clinical staff within minutes of ED admission often in the absence of the research team. An e-learning module was created to emphasize crucial clinical care elements of the protocol including: the importance of benzodiazepine dosing and timing, rationale for use of Exception From Informed Consent (EFIC), study drug dosing and administration, the post-infusion assessments, and how to contact the study team. A seizure SIM scenario was drafted based on clinical learning objectives for a successful ESETT enrollment including: recognizing a potential ESETT subject as a patient with seizures despite adequate benzodiazepine dosing (without coordinator prompting); proper study drug administration and follow-up assessments. The study protocol assist device (iPod touch) was set to practice mode and mock-drug (saline) was loaded into the study drug kit. On the day of the SIM, a seizure code was called into ED dispatch and clinical staff to treat a high-fidelity SIM mannequin in status epilepticus. The clinical staff administered mock benzodiazepine doses and then identified the seizing SIM mannequin as a potential ESETT subject. Clinical staff located the ESETT study drug box, verified inclusion/exclusion and study dose, utilized the administered mock study drug and followed the prompts from the protocol assist device through the first post infusion assessment. Immediately after the in situ SIM, a SIM de-brief occurred that included the clinical staff (physicians, nurses and pharmacy staff) and the clinical research team (co-investigator, lead coordinator). The LMS report showed 40/45 (89%) of ED RN staff viewed the e-learning module. During the SIM debriefing, clinical staff and the research team jointly identified logistical barriers to address including: study poster location, slow iPod, procedure to un-blind study drug, proper “next steps for care” in the event of study drug failure. The feedback from the ED staff was that they learn better by doing (kinesthetic learning style). “Hands on is always the best, easier to learn when you get to see and do.” In situ simulation (SIM) is used in clinical education and training, but evidence on its utility for protocol training in research trials is limited. A layered approach to disseminating study protocol information to clinical staff including an e-learning module and kinesthetic learning through an in situ SIM helped the clinical staff incorporate protocol training into their clinical care.