Journal
CLINICAL TRIALS
Volume 16, Issue 3, Pages 306-315Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1740774519839062
Keywords
Prediabetes; diabetes; recruitment; trial; health records
Categories
Funding
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [U34DK091958]
- Intramural Research Program of the NIDDK
- NIDDK
- Office of Dietary Supplements of the National Institutes of Health [U01DK098245]
- American Diabetes Association [1-14-D2d-01]
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Aims To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods. Methods Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods. Results In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level. Conclusion Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.
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