Abstract 3: Association of Video- vs. Text-Based Informed Consent With Multicenter Registry Enrollment

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Abstract

Background: Low patient participation in clinical research undermines the generalizability of findings. Conducting informed consent by video rather than a traditional text format may enhance the appeal of research and break down barriers to participation.

Methods: The Patient and Provider Assessment of Lipid Management (PALM) Registry enrolled patients at U.S. cardiology, endocrinology, and primary care clinics to evaluate cholesterol management practices. PALM investigators developed an iPad-based video informed consent tool that included video segments totaling 8 minutes which patients navigated though a “game-ified” interface. At sites whose IRB did not approve the video tool, participants read a 6-page text consent form on the iPad. Characteristics of sites and site activation times were compared between sites that did and did not use the video consent tool using Pearson’s chi-square test for categorical variables and Wilcoxon’s signed rank test for continuous variables.

Results: Of 140 sites that enrolled 7904 patients in PALM, 60 (42.9%) used the video informed consent tool. Compared with sites using text consent, sites using the video consent tool were more often rural (16.7 vs. 3.8%, p = 0.01) and used a central IRB (91.7 vs. 80.0%, p = 0.06). Sites using video consent enrolled a greater proportion of patients who were ≥ 75 years old (27.5 vs. 23.6%, p < 0.001) or non-white (17.7 vs. 14.2%, p < 0.001). Sites using video consent had shorter times from site approach to first patient enrollment (Figure). Median (IQR) enrollment was 33 (12, 98) patients at sites using video consent versus 24 (12, 86) at sites using text consent only (p = 0.54); there was also no significant difference in median weekly enrollment rate (2.9 [1.1, 7.5] vs. 2.8 [1.3, 6.6], p = 0.73).

Conclusions: In this early experience with video consent in a multicenter registry, availability of video informed consent was associated with greater enrollment of older and non-white patients, faster speed to first patient enrolled, and numerically but not significantly more rapid enrollment compared with text informed consent.

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