Lessons from ADAPTABLE: Aspirin Study at the Montefiore Site
Giselle Alvarado1, Oana A. Sandu1, Jorge Kizer1, 2, Ythan Goldberg1. 1Montefiore- Albert Einstein Medical College, Bronx, New York, United States, 2Cardiology, UCSF- VA Health Care System, San Francisco, California, United States
Purpose of Study ADAPTABLE is an ongoing multicenter, pragmatic trial comparing the effectiveness of aspirin 81mg vs. 325 mg daily for secondary prevention in patients with atherosclerotic cardiovascular disease. Novel features of this clinical trial include leveraging of electronic health records, participation by patients via internet connectivity, and low cost. Our objective is to analyze interim recruitment and patient follow-through data at Montefiore Medical Center (MMC), located in the Bronx, NY, focusing on methods used and lessons learned.
Methods Used Patient eligibility lists using the computable phenotype were linked with clinic schedules, and voice, text, and email invitations sent ahead of patient visits after checking opt-out by providing cardiologist. Patients were then approached by a research assistant immediately before or after their visit. With the cardiologist's approval, patients were enrolled online with the assistance of research staff, and follow-up information obtained electronically or by study personnel. Data are presented as percentages and analyzed with the chi-squared test.
Summary of Results After two years, 450 participants were enrolled at our institution (74.7% non-white, 15.8% white). Overall, non-internet enrollment was 57.3%, compared to the national non-internet enrollment rate of 17.4% (p<.01). The follow-up visit retention declined more at MMC than at all sites nationally as follows: 70% vs. 88.5% (p=0.58) completed the initial Early Visit Form, 46% vs. 74.7% (p<.01) completed follow-up at six months, 32% vs. 71.1% (p<.01) at 12 months, and 17% vs. 71.2% (p<.01) at 18 months.
Conclusions In this socioeconomically disadvantaged community composed predominantly of race/ethnic minorities, recruitment had the highest yield with in-clinic efforts, suggesting the importance of direct patient interaction and physician involvement. These findings reflect barriers to the conduct of pragmatic clinical trials among populations lacking access and knowledge about the internet and clinical research. Patient-centered research in areas with underrepresented populations is highly dependent on direct physician engagement, and may benefit from outreach methods to help educate patients about the benefits of clinical research.
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