An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment

摘要: Background: Patient participation in clinical research is low, part because of the length and complexity informed consent process. Video may enhance appeal help break down barriers to participation. Methods Results: The PALM study (Patient Provider Assessment Lipid Management) enrolled 7904 patients at cardiology, endocrinology, primary care clinics across United States evaluate cholesterol management practices. Of 153 participating clinics, 67 (43.8%) secured institutional review board approval use a tablet-based video tool that could select navigate through process instead traditional text-based consent. At sites without consent, all read document. Site activation times enrollment volumes, as well characteristics patients, were compared between with capability. Sites capability more often used central (89.6% versus 73.3%), rural (16.7% 3.8%), tended have fewer providers. Compared capability, had shorter from site approach first patient (median 178 207 days; P =0.02). similar numbers ( =0.48) but greater proportion who ≥75 years old (27.5% 23.6%; Conclusions: In this observational recruitment multicenter registry, approved for same number only faster speed older nonwhite patients. Future randomized trials are needed assess impact on mechanics demographics. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02341664