IRB: Ethics & Human Research

Impact of a Clinical Trials Information Handbook on Patient Knowledge, Perceptions, and Likelihood of Participation

Researchers at the New Mexico Veterans’ Affairs Health Care System and the University of New Mexico Hospital developed a clinical trials information handbook for patients and conducted a study to gauge its effectiveness. Participants from outpatient clinics were randomized to a control group and an intervention group. Members of the control group were given a questionnaire to complete to assess their knowledge of clinical trials. Members of the intervention group read the handbook prior to completing the questionnaire. The study showed that a clinical trials information handbook used during the informed consent process improved individuals’ knowledge about the process and decreased perceived risk from trial participation. This, in turn, could affect trial enrollment.

Key words/concepts: patient education, clinical trials, health care surveys, informed consent, theoretical models, comprehension