As the population of middle-aged and elderly persons with schizophrenia increases over the coming decades, more treatment research will be needed in this population. Because of factors such as age-related cognitive impairment, it is important to study methods for evaluating and enhancing consent procedures for treatment research in these patients. The proposed investigation will be a randomized, controlled comparison of an innovative procedure for providing informed consent - a Digital Video Disc DVD)-based, multimedia consent procedure with a routine consent procedure (supplemented with a short """"""""control"""""""" DVD). The multimedia consent procedure is based on cognitive models of learning. Participants will be persons 40 years or older with schizophrenia (N=192) and normal comparison subjects (N=192). Each subject will be randomly assigned to receive informed consent for one of two studies, one entailing a relatively lower and lower complexity risk (cognitive training), or one involving substantially higher risk and greater complexity (a randomized, double-blind, placebo-controlled trial of a cognitive-enhancing drug with potential for serious adverse effects). The primary outcome measure will be the subjects' decisional capacity assessed with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), at baseline and again at a one-month follow-up. We will also evaluate subject and protocol characteristics associated with usefulness of DVD versus routine consent procedure. The DVD-based consent is not intended to supplant, but rather to supplement, the researcher-participant in-person interaction involved in consent process.
| Jeste, Dilip V; Palmer, Barton W; Golshan, Shahrokh et al. (2009) Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Schizophr Bull 35:719-29 |
| Dawes, Sharron E; Palmer, Barton W; Jeste, Dilip V (2008) Adjudicative competence. Curr Opin Psychiatry 21:490-4 |
| Dunn, Laura B; Nowrangi, Milap A; Palmer, Barton W et al. (2006) Assessing decisional capacity for clinical research or treatment: a review of instruments. Am J Psychiatry 163:1323-34 |
