Abstract P5-19-01: The impact of streamlined processes and patient-directed messaging to improve enrollment in a remote, pragmatic clinical trial
Authors: Choy Patricia , Lewis Tomiyuri , Flores Stephanie , Sabacan Leah , Thannickal Halle , Goodman Steffanie , Shieh Yiwey , Madlensky Lisa , Tice Jeffrey A. , Ziv Elad , Eklund Martin , Blanco Amie , Tong Barry , Goodman Deborah , Anderson Nancy , Harvey Heather , Fors Steele , Park Hannah Lui , Petruse Antonia , Stewart Skye , Raouf Samrrah , Wernisch Janet , Koenig Barbara , Kaplan Celia , Hiatt Robert , Wenger Neil , Lee Vivian , Heditsian Diane , Brain Susie , Moorehead Dolores , Parker Barbara A , Borowsky Alexander , Anton-Culver Hoda , Naeim Arash , Kaster Andrea , van 't Veer Laura , LaCroix Andrea Z , Olopade Olufunmilayo I. , Sheth Deepa , Garcia Agustin , Lancaster Rachel , James Jennifer , Joseph Galen , Study Wisdom ,   Athena Breast Health Network Investigators and Advocates, Fiscallini Allison Stover , Esserman Laura 
Published: March 2022

Abstract
Background Recent advances in technology have made it possible to conduct remote clinical trials that allow individuals to participate from home with comfort, privacy, and ease. Despite these advances, challenges persist in running remote trials, such as survey question redundancies, lack of patient-initiated data-sharing tools, and unclear patient communication around critical enrollment steps. The Women Informed to Screen Depending on Measures of risk (WISDOM) Study is a pragmatic, preference-tolerant randomized control breast cancer screening trial comparing personalized risk-based screening to traditional, annual screening. The study population includes women ages 40-74 without a history of breast cancer or DCIS. Since 2016, study enrollment has been available to all women in the U.S. who meet study eligibility criteria. Since October 2020, WISDOM has implemented multiple strategies to improve participant experience: participant-initiated data-sharing tools and clear participant messaging. This abstract presents the efficacy of these interventions as they relate to increasing patient enrollment in remote, pragmatic clinical trials. Methods The WISDOM Study online enrollment process includes registration, participant study arm selection or randomization, online consent, and enrollment (submission of multiple study surveys over a secure, online platform). Barriers to online enrollment were uncovered through an internally-conducted needs assessment of participants who enrolled between 2019-2020, and participant feedback obtained through phone interviews conducted by WISDOM’s embedded ethics study. Improvements to our online enrollment procedures were executed in October 2020 and included: improving the clarity of study arm selection options, streamlining data collection surveys, and enacting a secure, patient-initiated online data-sharing tool and an online portal feature with auto-launch of critical information. Study metrics were obtained through Google Analytics and Salesforce. Results Prior to the end of 2020, only 62% of the 30,046 participants who registered for the WISDOM Study completed study enrollment. After improving the enrollment process, of the 5,334 participants registered for the study between Jan-June 2021, 69% completed the enrollment process finishing both the online consent and survey forms. Conversion from consent to enrollment went from 78% in January 2020 to 93% in June 2021. Currently, 56% participants complete enrollment in one day. Streamlining online patient questionnaires led to an increase in completion rates, with 75% of participants completing their yearly surveys, compared to 59% prior to April 2021. A secure patient upload feature for data sharing led to 1,054 participants successfully sharing their mammogram reports with WISDOM between March - June 2021. Previously, mammogram reports were missing for 20% of enrolled participants. This feature has enabled WISDOM to process 300 additional mammogram reports per month. Integration of an auto-launch feature in the participant’s portal in Feb 2021 has led to a 17% increase in participants viewing their screening recommendations in Yr 1. Prior to auto-launch, only 59% (n=6328) of Yr 1 screening recommendations and 61% (n=3681) of genetic testing reports were viewed by participants. Since implementation, the numbers increased to 78% (n=8406) and 85% (n=5160), respectively. Conclusions. Streamlining data to the most essential elements, and minimizing the steps required to share clinical documents, complete questionnaires and open key study notification is essential to improving enrollment rates in virtual, pragmatic trials. Patient-initiated data-sharing tools such as the ability for participants to share documents through secure, online portals is one example of success.
Citation Format: Patricia Choy, Tomiyuri Lewis, Stephanie Flores, Leah Sabacan, Halle Thannickal, Steffanie Goodman, Yiwey Shieh, Lisa Madlensky, Jeffrey A. Tice, Elad Ziv, Martin Eklund, Amie Blanco, Barry Tong, Deborah Goodman, Nancy Anderson, Heather Harvey, Steele Fors, Hannah Lui Park, Antonia Petruse, Skye Stewart, Samrrah Raouf, Janet Wernisch, Barbara Koenig, Celia Kaplan, Robert Hiatt, Neil Wenger, Vivian Lee, Diane Heditsian, Susie Brain, Dolores Moorehead, Barbara A Parker, Alexander Borowsky, Hoda Anton-Culver, Arash Naeim, Andrea Kaster, Laura van 't Veer, Andrea Z LaCroix, Olufunmilayo I. Olopade, Deepa Sheth, Agustin Garcia, Rachel Lancaster, Jennifer James, Galen Joseph, Wisdom Study, Athena Breast Health Network Investigators and Advocates, Allison Stover Fiscallini, Laura Esserman. The impact of streamlined processes and patient-directed messaging to improve enrollment in a remote, pragmatic clinical trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-19-01.