Abstract
BACKGROUND: The Veterans Affairs Healthcare System implemented a computer-based tool (iMedConsent) to improve the quality of informed consent in 2004. The impact of this tool on the process of informed consent remains unknown. Our aim was to determine the impact of iMedConsent on patient information preference, anxiety, trust in the surgeon, ambivalence about the surgical decision, and comprehension of procedure-specific risk, benefits, and alternatives. MATERIALS AND METHODS: We prospectively enrolled a consecutive cohort of patients presenting to a general surgery clinic for possible cholecystectomy or inguinal herniorrhaphy from October 2009 to August 2010. We administered questionnaires before and after the clinic visit. RESULTS: Seventy-five patients completed pre-visit questionnaires. After evaluation by the surgeon, 42 patients were offered surgery and documented their informed consent using iMedConsent, of whom 38 (90%) also completed a post-visit questionnaire. Among the participants who completed both pre- and post-visit questionnaires, participant comprehension of procedure-specific risks benefits and alternatives improved from 50% at baseline to 60% after the clinic visit (P < 0.001). No differences were noted in ambivalence, trust, or anxiety. After the clinic visit, significantly more patients expressed a preference for participating in decision making with their surgeon (98% versus 71%, P = 0.008). However, significantly fewer expressed a preference for knowing all possible details about their illness (25% to 83%, P ≤ 0.001). CONCLUSIONS: The informed consent process using iMedConsent improves patient comprehension of procedure-specific risks, benefits, and alternatives. It also increases patient preferences for participating more actively in the decision-making process. However, the process may provide more detail than patients want regarding their illness.