Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience.

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Aroda, VR; Sheehan, PR; Vickery, EM; Staten, MA; LeBlanc, ES; Phillips, LS; Brodsky, IG; Chadha, C; Chatterjee, R; Ouellette, MG; Desouza, C; Pittas, AG; D2d Research Group,

Published Date

  • June 2019

Published In

Volume / Issue

  • 16 / 3

Start / End Page

  • 306 - 315

PubMed ID

  • 31007049

Pubmed Central ID

  • PMC6764596

Electronic International Standard Serial Number (EISSN)

  • 1740-7753

Digital Object Identifier (DOI)

  • 10.1177/1740774519839062


  • eng

Conference Location

  • England