Experiential Learning to Teach Informed Consent and Clinical Trials: A Randomized Controlled Trial

The enrollment of patients into clinical trials is considered essential in order to advance treatment and define the standard of care for cancer patients. Several reports have identified patient barriers to enrollment, including patient demographics and stage of disease. However poor communication by physicians, due to lack of knowledge and lack of skills, has also been identified as a significant barrier to enrollment. We conducted a randomized trial on trainees at Vanderbilt University Medical Center comparing the impact of didactic workshop, an experiential workshop or both on trainees knowledge of clinical trials and comfort with the informed consent process. We hypothesized that the combination of a didactic workshop in conjunction with an experiential workshop would result in improved fellows’ self-efficacy and attitude in these areas and improved performance of these skills compared to either session alone. Although participants in workshops that included an experiential workshop were more likely to say they would take what they heard learned back to their clinical practice. We found no significant improvement in fellows’ self-assessment scores in any group. In this study despite using different educational strategies including a teacher-center approached, a learner centered approach and a combination of the two approaches, trainees failed to show an improvement in their verbal and nonverbal communication skills or their ability to discuss a clinical trial with a patient.