An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management)

Abstract

Background: Patient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation.

Methods and results: The PALM study (Patient and Provider Assessment of Lipid Management) enrolled 7904 patients at cardiology, endocrinology, and primary care clinics across the United States to evaluate cholesterol management practices. Of 153 participating clinics, 67 (43.8%) secured institutional review board approval to use a tablet-based video informed consent tool that patients could select to navigate through the informed consent process instead of traditional text-based informed consent. At sites without institutional review board approval of video consent, all patients read a text-based informed consent document. Site activation times and enrollment volumes, as well as characteristics of enrolled patients, were compared between sites with and without video consent capability. Sites with video consent capability more often used a central institutional review board (89.6% versus 73.3%), were more often rural (16.7% versus 3.8%), and tended to have fewer providers. Compared with sites without video consent capability, sites with video consent capability had shorter times from site approach to first patient enrollment (median 178 versus 207 days; P=0.02). Sites with video consent capability enrolled similar numbers of patients as sites without video consent capability (P=0.48) but enrolled a greater proportion of patients who were ≥75 years old (27.5% versus 23.6%; P<0.001) and nonwhite (17.7% versus 14.2%; P<0.001).

Conclusions: In this observational study of recruitment in a multicenter registry, sites approved for video consent use enrolled the same number of patients as sites with only traditional text-based informed consent but had faster speed to first patient enrolled and more often enrolled older and nonwhite patients. Future randomized trials are needed to assess the impact of video consent on enrollment mechanics and demographics.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02341664.

Keywords: informed consent; patient participation; primary health care; registries; tablets.

© 2018 American Heart Association, Inc.

Figures

Figure 1

Screen captures from the video consent process. Participants navigated through a series of video vignettes, each lasting 30 to 140 seconds, using a gamified interface (Panel A). Participants were able to flag vignettes that they had additional questions about, and study personnel were required to clear the flags after answering patient questions before proceeding to the signature screen. In the vignettes, study personnel described key elements of the informed consent process (Panel B), and B-roll footage showed patients participating in clinical research (Panel C). Patients and study coordinators both signed the consent form using their finger or a stylus on the tablet (Panel D) before patients proceeded to the PALM study’s patient survey. Patients were provided with a paper or electronic copy of the signed consent form.

Figure 2

Geographic distribution of sites with and without video consent capability. Locations of enrolling sites are shown overlaid on U.S. maps showing county-level proportions of older adults and non-white people

Figure 3

Time from site contact to first patient enrolled at sites with and without video consent capability. Sites with video informed consent capability had shorter time from contact to first patient enrolled, driven by shorter time from site contact to IRB approval, and shorter time from site activation to first patient enrolled. IRB, institutional review board. Median time from contact to first patient enrolled was calculated separately, and thus does not equal the sum of the medians of its components (contact to IRB approval, IRB approval to site activation, site activation to first patient enrolled).

Figure 4

Time from site contact to first patient enrolled at sites with and without video consent capability with central IRBs (A) and local IRBs (B). At central IRB sites, sites with video informed consent available had numerically shorter time from contact to first patient enrolled. At local IRB sites, sites with video informed consent capability had numerically longer time from contact to first patient enrolled.