Effect of Opt-in versus Opt-out Framing on Trial Recruitment: A Study Within A Trial of the GAMEPAD Randomized Trial.
Publication/Presentation Date
10-3-2025
Abstract
Directly contacting eligible participants with an offer to join a randomized clinical trial (RCT) is an efficient recruitment method, but the effect of different outreach strategies on enrollment fraction and completion of the trial protocol is uncertain. In a study within a trial (SWAT) of an RCT testing a physical activity intervention in patients with peripheral artery disease, eligible patients were randomized to receive an email with an invitation to join the study and a link to the trial's online platform ("opt-in") or to receive an email framing participation as part of the standard of care followed by telephone outreach from a study coordinator ("opt-out"). Among 5176 participants contacted by unsolicited email (3909 opt-in, 1267 opt-out), enrollment fraction was 1.0% in the opt-in arm (n = 39) versus 3.6% in the opt-out arm (n = 45) (OR 3.65, 95% CI 2.37-5.64); there were no significant differences between opt-in and opt-out participants in the rate of completion of trial protocol steps. This SWAT of recruitment strategies demonstrates the potential for opt-out framing and active outreach to increase enrollment fraction without compromising protocol completion in direct-to-participant RCTs.
First Page
107285
Last Page
107285
ISSN
1097-6744
Published In/Presented At
Shah, T., Coratti, S., Farraday, D., Norton, L., Rareshide, C., Zhu, J., Levin, M. G., Park, S. H., Damrauer, S. M., Giri, J. S., Chokshi, N. P., Jackson, B. M., Patel, M. S., & Fanaroff, A. C. (2025). Effect of Opt-in versus Opt-out Framing on Trial Recruitment: A Study Within A Trial of the GAMEPAD Randomized Trial. American heart journal, 107285. Advance online publication. https://doi.org/10.1016/j.ahj.2025.107285
Disciplines
Medicine and Health Sciences
PubMedID
41046994
Department(s)
Department of Surgery
Document Type
Article