Patients with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or a novel, enhanced informed consent procedure. The outcome measure, comprehension of the consent materials, including understanding of the risks and benefits of participating in the study, will be assessed in each group. It is expected that the normal control group will reach the requisite level of comprehension faster than the schizophrenia group.
Aim 1: To examine the impact of a multimedia DVD-based informed consent process on the decisional capacity for participation in a research treatment protocol immediately after presentation of the information as well as one month later.
Hypothesis 1: Immediately after presentation of the consent information, participants provided with the enhanced DVD consent procedure will demonstrate (across the two subject groups and the lower- and higher-risk protocols) better understanding, appreciation, reasoning, and expression of choice for participation in the research protocol as well as greater satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The enhanced DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.
Hypothesis 2: One month after the baseline testing, participants provided with the enhanced DVD consent procedure will demonstrate (across the two diagnostic groups and the lower- and higher-risk protocols) greater stability of decisional capacity as well as greater stability of satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.
Aim 2: To examine, among middle-aged and elderly individuals with schizophrenia and normal comparison subjects, the association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure.
Hypothesis 3: Effectiveness of DVD consent format will be a function of specific subject demographic, clinical, and cognitive characteristics that are associated with decisional capacity. In particular the following factors will be associated with greater benefit of DVD consent compared to routine paper consent format: Older age, diagnosis of schizophrenia, dependent living situation, severity of negative and depressive symptoms, and cognitive impairment (specifically on tests of attention/ working memory, short-term memory, and certain executive functions.) |