Longitudinal informed consent competency in stable community patients with schizophrenia: A one-week training and one-year follow-up study

Objective: This study explores the efficacy of a one-week informed consent information training process for improving competence to provide consent in stable community patients with schizophrenia over a one-year follow-up period.

Method: A one-week training session designed to enhance competence to provide informed consent for research was conducted. The training was guided by a research protocol that provided detailed explanations of each major conceptual unit. Participants were followed for one year, and comprised 50 stable community outpatients with schizophrenia who were randomly assigned to either an intervention group (IG, n=33) or a control group (CG, n=17) that did not receive any training. The Chinese Mandarin MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) was used to assess competence for informed consent pre-training (baseline), post-training (one week later), and at the end of one year.

Results: A repeated measures analysis comparing the IG and CG at pre-training, post-training and the one-year follow-up revealed significant improvements in the Understanding and Appreciation subscale following the one-week training. However, by the end of one year, scores returned to baseline levels, with the exception of the Appreciation subscale, which was below baseline. There were significant main effects across time on the Appreciation and Reasoning subscales, indicating considerable changes over time. The CG showed no significant changes from pre-training to one week later or at one-year follow-up for all subscales.

Conclusions: The capacities of understanding and appreciation can be improved in stable community patients with schizophrenia after one week of training; however, this training effect is not sustained one year later. The results suggest that more intensive or periodic trainings may be needed to maintain long-term competence levels in patients with schizophrenia, particularly with regard to their capacity to appreciate the nature and consequences of study participation.