Improved understanding and satisfaction with a modified informed consent document: a randomized study

Peter C Raich1,2, Ralph L Kennedy1, Chris Vanoni1, William Thorland2, Naamon Owens1, Charles L Bennett31AMC Cancer Research Center, University of Colorado Comprehensive Cancer Center, Denver, 2Denver Health Medical Center, Denver, Colorado, USA; 3Center for Management of Complex Chronic Care, Hines Veterans Administration Hospital, Hines, IL, USABackground: Informed consent documents need to convey crucial information to prospective study participants. We assessed the impact of an informed consent process designed to be understood by persons with low health literacy skills.Methods: We conducted a randomized controlled trial with ethnically and racially diverse male veterans. Participants were randomly assigned to receive and read the standard consent document for the Selenium and Vitamin E Cancer Prevention Trial prostate cancer prevention trial or a culturally tailored, easy-to-read consent document. Telephone interviews were conducted 2 weeks following consent, assessing comprehension, satisfaction, consent anxiety, state anxiety, decisional conflict, and cultural sensitivity.Results: Of 162 male veterans completing the initial telephone interview, 49.7% were African American, 44.1% were Caucasian, and 6.2% were Hispanic. The mean comprehension score for the consent document and process was significantly increased in the intervention arm participants (17.08) versus the standard consent arm (15.06, P < 0.0001). The satisfaction score with the consent information was higher in participants in the intervention arm (3.67 vs 3.42, P = 0.0009), while the consent anxiety score was reduced (1.31 vs 1.56, P = 0.0067).Conclusion: Modifications in the reading level, format, appearance, interactivity, and cultural sensitivity of an informed consent document in the cancer prevention setting significantly improved comprehension of and satisfaction with the consent document, while decreasing consent anxiety.Keywords: health literacy, informed consent, clinical trial