Adil E Bharucha, Michelle L Bublitz, Robert A Vierkant, Tony C Luehrs, Karen A Konzen, David A Weiss, Tony A Hart, Christine M Boos, Alina M Allen, Kent R Bailey, Konstantinos N Lazaridis
{"title":"Factors Associated With Enrollment to a Decentralized Study.","authors":"Adil E Bharucha, Michelle L Bublitz, Robert A Vierkant, Tony C Luehrs, Karen A Konzen, David A Weiss, Tony A Hart, Christine M Boos, Alina M Allen, Kent R Bailey, Konstantinos N Lazaridis","doi":"10.1016/j.mayocp.2024.03.022","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To assess whether the mode and formatting of invitations affect enrollment in a large, decentralized study.</p><p><strong>Patients and methods: </strong>Between July 1, 2022, and October 30, 2022, we prospectively compared various approaches to enroll patients in the Tapestry DNA Sequencing Research Study, a decentralized exome-sequencing study. In phase 1, patients were randomized to receive invitations via the electronic health record (EHR) patient portal or email (cohort 1, 69,852 patients). Phase 2 randomized in a 2×2 factorial design to receive (by portal or email) standard or enhanced (ie, more visually appealing) invitations (cohort 2, 26,198 patients). Factors that predicted enrollment rates were analyzed.</p><p><strong>Results: </strong>The enrollment rate was greater in cohort 2 (1,785 of 24,550, 7.27%) than 1 (1,758 or 69,765, 2.52%) and remained significant after multivariable adjustment (odds ratio, 1.31; 95% CI, 1.19-1.45). Enrollment rates were greater in women than men, patients 50 to 70 years of age than younger patients, White or non-Hispanic or Latino patients than those in other racial categories, urban than rural residents, and patients who had more health care encounters or more recent health care before this study (P<.02). The enrollment rate was also greater when invitations were delivered via EHR than email (odds ratio, 1.56; 95% CI, 1.44-1.68; P<.001).</p><p><strong>Conclusion: </strong>Invitations via EHR rather than email facilitate enrollment to large, decentralized studies. Enhanced display of invitation material did not increase enrollment. Lower enrollment rates in men, younger individuals, non-White and Hispanic individuals, and rural residents highlight a continued need to focus enrollment strategies on these subgroups.</p>","PeriodicalId":18334,"journal":{"name":"Mayo Clinic proceedings","volume":" ","pages":""},"PeriodicalIF":6.9000,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mayo Clinic proceedings","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.mayocp.2024.03.022","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Objective: To assess whether the mode and formatting of invitations affect enrollment in a large, decentralized study.
Patients and methods: Between July 1, 2022, and October 30, 2022, we prospectively compared various approaches to enroll patients in the Tapestry DNA Sequencing Research Study, a decentralized exome-sequencing study. In phase 1, patients were randomized to receive invitations via the electronic health record (EHR) patient portal or email (cohort 1, 69,852 patients). Phase 2 randomized in a 2×2 factorial design to receive (by portal or email) standard or enhanced (ie, more visually appealing) invitations (cohort 2, 26,198 patients). Factors that predicted enrollment rates were analyzed.
Results: The enrollment rate was greater in cohort 2 (1,785 of 24,550, 7.27%) than 1 (1,758 or 69,765, 2.52%) and remained significant after multivariable adjustment (odds ratio, 1.31; 95% CI, 1.19-1.45). Enrollment rates were greater in women than men, patients 50 to 70 years of age than younger patients, White or non-Hispanic or Latino patients than those in other racial categories, urban than rural residents, and patients who had more health care encounters or more recent health care before this study (P<.02). The enrollment rate was also greater when invitations were delivered via EHR than email (odds ratio, 1.56; 95% CI, 1.44-1.68; P<.001).
Conclusion: Invitations via EHR rather than email facilitate enrollment to large, decentralized studies. Enhanced display of invitation material did not increase enrollment. Lower enrollment rates in men, younger individuals, non-White and Hispanic individuals, and rural residents highlight a continued need to focus enrollment strategies on these subgroups.
期刊介绍:
Mayo Clinic Proceedings is a premier peer-reviewed clinical journal in general medicine. Sponsored by Mayo Clinic, it is one of the most widely read and highly cited scientific publications for physicians. Since 1926, Mayo Clinic Proceedings has continuously published articles that focus on clinical medicine and support the professional and educational needs of its readers. The journal welcomes submissions from authors worldwide and includes Nobel-prize-winning research in its content. With an Impact Factor of 8.9, Mayo Clinic Proceedings is ranked #20 out of 167 journals in the Medicine, General and Internal category, placing it in the top 12% of these journals. It invites manuscripts on clinical and laboratory medicine, health care policy and economics, medical education and ethics, and related topics.