Application of Innovative Subject Recruitment System for Batch Enrollment: A Pilot Study

Author:

Wi Chung-Il12ORCID,King Katherine S.3,Ryu Euijung24,Natoli Traci L.12,Miller Ryan P.5,Spiten Matthew J.12,Borah Bijan J.6,Takahashi Paul Y.7,Yao Xiaoxi89,Noseworthy Peter A.9,Pignolo Robert J.10,Juhn Young J.12ORCID

Affiliation:

1. Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA

2. Precision Population Science Lab, Mayo Clinic, Rochester, MN, USA

3. Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, USA

4. Division of Computational Biology, Mayo Clinic, Rochester, MN, USA

5. Department of Information Technology, Mayo Clinic, Phoenix, AZ, USA

6. Department of Health Services Research, Mayo Clinic, Rochester, MN, USA

7. Division of Community Internal Medicine, Mayo Clinic, Rochester, MN, USA

8. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

9. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA

10. Department of Medicine, Divisions of Hospital Internal Medicine, Endocrinology, and Geriatric Medicine and Gerontology, Mayo Clinic, Rochester, MN, USA

Abstract

Introduction: Using a digital process that leverages electronic health records (EHRs) can ease many of the challenges presented by the traditional enrollment process for clinical trials. We tested if automated batch enrollment using a technology-enabled subject recruitment system (TESRS) enhances recruitment while preserving representation of research subjects for the study population in our study setting. Methods: An ongoing community-based prospective adult cohort study was used to randomize 600 subjects who were eligible by age and residential address to TESRS (n = 300) and standard mailing method (n = 300), respectively, for 3 months. Then, TESRS was initiated and included automatic identification of patients’ preference for being contacted (online patient portal vs postal mail) from EHRs and automatic sending out of invitation letters followed by completion of a short online survey for checking eligibility and the digital consent process if eligible. We compared (1) median time to consent from invitation sent out per subject and total subjects recruited after a 3-month recruitment period, (2) the estimated study staff’s time, and (3) representation of sociodemographic characteristics (e.g., age, sex, race, SES measured by HOUSES index, and rural residence) between subjects recruited via TESRS and those via traditional mailing methods. Results: Median age of randomized subjects (n = 600) was 63 years with 52.0% female and 89.2% non-Hispanic White. Over a 3-month period, results showed consent rate via TESRS was 13% (39/297) similar to 11% (31/295) via standard mailing. However, recruitment was significantly faster with the TESRS approach (median 7 vs 26 days) given the study staff’s effort. Study staff’s time saved by using TESRS compared to standard mailing approach was estimated at 40 min per subject (equivalent to 200 h for 300 subjects). No significant differences in characteristics of research subjects from the study population were found. Conclusion: Our study demonstrated the utility of TESRS as a subject recruitment digital technology which significantly enhanced the recruitment effort while reducing the study staff burden of recruitment while maintaining the consistency of characteristics of recruited subjects. The strategy and support for implementing and testing TESRS in other study settings should be considered.

Funder

GlaxoSmithKline Biologicals

Publisher

SAGE Publications

Subject

Public Health, Environmental and Occupational Health,Community and Home Care

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3