Educational and interactive informed consent process for treatment of unruptured intracranial aneurysms.

OBJECTIVE For patients with unruptured intracranial aneurysms (UIAs), the information transfer that precedes informed consent needs to be in-depth and detailed, as most patients with a UIA have no symptoms, yet the risks related to treatment are relatively high. Thus, in this study an educational and interactive program was proposed for patients with UIAs to improve the informed consent process and assess the level of comprehension. METHODS A total of 110 patients with UIAs underwent the proposed educational and interactive informed consent (EIIC) process and were enrolled in this study. The EIIC process combines patient education using information booklets, a cartoon book, a video, an initial physician-patient interview, answering a questionnaire, a second physician-patient interview based on the questionnaire results, and finally consent. After the first physician-patient interview that provides the patient with specific information, including his or her angiographic characteristics, medical condition, and recommended treatment, the patient is requested to answer a questionnaire composed of 3 parts: demographic information, including the patient's age, sex, and years of education; 13 medical questions to assess the patient's knowledge about his or her UIA; and an evaluation of the usefulness of the educational resources. The control group consisted of 65 patients from 3 other tertiary university hospitals where the EIIC process was not used. RESULTS The questionnaire scores of the EIIC group ranged from 7 to 13 (mean ± SD: 11.9 ± 1.3) and were significantly higher than those for the controls (10.2 ± 1.9, p < 0.001). The better comprehension of the patients in the EIIC group was remarkable as they were significantly older than those in the control group (62.7 ± 8.3 years vs 55.9 ± 10.5 years, respectively; p < 0.001). For both the EIIC group and the control group, a Pearson correlation analysis revealed a positive correlation (r = 0.232 for the EIIC group, r = 0.603 for controls) between the years of education and the questionnaire score (p = 0.015 for the EIIC group, p < 0.001 for the controls), whereas no correlation was found between the patient age and the questionnaire score. For the EIIC group, the verbal information from the attending physician was selected by 90 patients (81.8%) as the most useful and informative educational method, while the most effective reinforcement of this verbal communication was the video (n = 86; 78.2%), information booklets (n = 16; 14.5%), the Internet (n = 7; 6.4%), and the cartoon book (n = 1; 0.9%). CONCLUSIONS The proposed standardized EIIC process resulted in good patient comprehension about UIAs. The verbal information from the attending physician was the most informative, and the video was the most effective reinforcement of the verbal communication. The patient level of comprehension was shown to be correlated with years of education.