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A-1331
2003 |
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| Increased Confidence in Research Coordinators Conducting a Clinical Trial Following Simulation Training | ||||||||||||||||||||||||||||
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Jeffrey M. Taekman, M.D., Barbara G. Phillips-Bute, Ph.D., Eugene Hobbs, , Mark F. Newman, M.D., Mark Stafford-Smith, F.R.C.P.C. Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina. |
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Introduction: Training non-medical personnel to acquire the necessary knowledge, skills, and attitudes to perform clinical trials is a critical component of clinical research. Current methods of coordinator training fail to take full advantage of modern adult learning theory. Interactivity has been shown to be a superior method of teaching desired behaviors to medical professionals [1, 2]. Therefore we tested the hypothesis that the addition of an interactive simulation exercise would increase the confidence levels of trial coordinators trained by traditional methods. Methods: A simulation exercise was developed to replicate a complex clinical trial. Following IRB approval 29 study coordinators already familiarized with the trial protocol completed a 9-item questionnaire examining confidence levels before and after the simulation exercise. The questionnaire targeted key components of the trial using a scale from 1 (not confident) to 10 (confident). Each question was categorized into a domain of Bloom’s taxonomy of learning: affective, cognitive, or psychomotor [3]. Primary analysis was performed using a paired t-test comparing mean question responses before and after the simulation exercise. Secondary analyses were also performed using paired t-tests to assess each of the three subscales. Significance was judged as p<0.05. Results: Demographics variables are presented in Table 1. Overall confidence levels increased significantly following the simulation exercise (5.70+/-2.26 to 8.12+/-1.48 ; p<.001; Figure 1). Sub-analyses showed significant increases in the affective ( 6.13+/-2.49 to 8.17+/-1.62: p<.001; Figure 1), cognitive (6.17+/-2.36 to 8.03+/-1.49; p=.003; Figure 1), and psychomotor (4.83+/-2.72 to 8.10+/-1.53: p<.001; Figure 1) domains. Psychomotor confidence showed the greatest relative gain following simulator training. Conclusions: We confirmed the addition of a simulation exercise to the training of clinical trial coordinators increased confidence levels over traditional methods. High-fidelity simulation exercises should be strongly considered when training coordinators for academic clinical trials. 1. Davis, D., et al., Impact of formal continuing medical education: do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes? Jama, 1999. 282(9): p. 867-74. 2. Haynes, R.B., et al., A critical appraisal of the efficacy of continuing medical education. Jama, 1984. 251(1): p. 61-4. 3. Bloom, B.S. and D.R. Krathwohl, Taxonomy of educational objectives : the classification of educational goals. 1956, New York: D. McKay Co. Inc. 2 v. Anesthesiology 2003; 99: A1331 |
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Figure 1
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