Assessment of the impact of a patient clinical trials handbook among pharmacy students.

Background: Patient education in the basic concepts of clinical trials is necessary to promote understanding of the informed consent process and enhance patients' decision-making. It has been suggested that patients' knowledge and attitudes are improved by being given general written information about clinical trials.

Objective: This pilot study was conducted to determine the effect of a patient education handbook on the knowledge, attitudes, and motivations of pharmacy students regarding clinical trials.

Methods: A patient clinical trials handbook was developed at a 7th-grade reading level for the Department of Veterans Affairs Cooperative Studies Program and tested in PharmD students. Students were randomized to the experimental group (received handbook) or the control group (no handbook). They were given 15 to 20 minutes to read the handbook, after which they were asked to respond to a questionnaire adapted from previous studies. The questionnaire included 25 true/false questions testing participants' knowledge of clinical trials, 5 questions on attitudes toward clinical trials scored on a 5-point Likert scale, and 6 questions concerning their motivation toward participation in hypothetical clinical trial scenarios scored on a 5-point Likert scale. The experimental group was also asked to rate the informativeness, helpfulness, and clarity of the handbook on a 5-point Likert scale.

Results: There were 40 students in the experimental group and 50 in the control group. Knowledge scores were significantly higher in the experimental group compared with the control group (mean [SD] percentage of correct answers, 88.7% [8.0%] vs 82.6% [9.0%], respectively; P < 0.001). Positive attitudes toward clinical trials were also increased in the experimental group compared with the control group; specifically, participants expressed significantly greater clarity of understanding of clinical trials (mean score, 1.4 [0.5] vs 0.8 [0.6]; P < 0.001) and relief associated with knowing about clinical trials (mean score, 0.8 [0.8] vs 0.4 [0.7]; P = 0.017). There were no between-group differences in students' motivation to participate in the hypothetical clinical trial scenarios. A high proportion of students (95%) found the handbook informative, helpful, and understandable.

Conclusions: The patient clinical trials handbook increased knowledge and positive attitudes regarding clinical trials among pharmacy students participating in this study.