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

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.