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)
Alexander Fanaroff;Shuang Li;Laura Webb;Vincent Miller;Ann Navar;Eric Peterson;Tracy Wang;
Department of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
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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