Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders.

Individuals with schizophrenia may show impaired capacity to make decisions about participating in research, yet these patients also show considerable heterogeneity in decisional abilities. Problems with procedures contribute to patients' difficulties in understanding consent forms. Few studies have focused on improving comprehension of research consent in older patients with psychotic disorders. In this study, 80 middle-aged and elderly outpatients with schizophrenia or related psychotic disorders and 19 normal comparison subjects were randomized to receive a routine consent (RC) or enhanced consent (EC) procedure. The EC procedure consisted of a computerized slide show incorporating more structure and review of important information. A comprehension test was administered after the consent procedure; subjects were given up to three trials of the post-test to answer all of the questions correctly. Overall, the normal comparison subjects obtained a higher score on the post-consent comprehension test than the patients. Within each of these two groups, those who received EC had better comprehension than those who received RC. Interestingly, EC patients did not differ significantly from RC normal comparison subjects in their post-test scores. Among the patients, comprehension test scores correlated with level of education and cognitive performance.

RCT Entities:   Population Interventions Outcomes