Preliminary report on the use of high-fidelity simulation in the training of study coordinators conducting a clinical research protocol.

Training of health care research personnel is a critical component of quality assurance in clinical trials. Interactivity (such as simulation) is desirable compared with traditional methods of teaching. We hypothesized that the addition of an interactive simulation exercise to standard training methods would increase the confidence of study coordinators. A simulation exercise was developed to replicate a complex clinical trial. Eighteen study coordinators completed pre- and postexercise confidence questionnaires. Questions were targeted at key trial components using a 0-10 scale (not confident to confident) and were categorized using Bloom's Taxonomy. The primary analysis compared overall mean pre- and postexercise responses. Secondary analyses assessed affective, psychomotor, and cognitive confidence. Significance was at P < 0.05. A significant increase in overall confidence (8.64 versus 5.77; P < 0.0001) was reproduced in the subcategory analyses (affective, 8.24 versus 4.89; P < 0.0001; cognitive, 8.75 versus 6.42; P = 0.0003; psychomotor, 8.63 versus 5.26; P < 0.0001). A high level of internal consistency and reliability in question responses within domains was observed, validating the questionnaire tool. In this preliminary report, we confirmed that addition of a simulation exercise to the training of study coordinators resulted in increased confidence. Simulation exercises should be considered when training study coordinators for clinical research trials.