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

Clin Trials. 2019 Jun;16(3):306-315. doi: 10.1177/1740774519839062. Epub 2019 Apr 22.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01942694.

Keywords: Prediabetes; diabetes; health records; recruitment; trial.

Publication types

  • Clinical Trial Protocol
  • Multicenter Study
  • Observational Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, N.I.H., Intramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Blood Glucose
  • Cholecalciferol / administration & dosage
  • Cholecalciferol / therapeutic use*
  • Comorbidity
  • Diabetes Mellitus, Type 2 / prevention & control*
  • Dietary Supplements
  • Double-Blind Method
  • Electronic Health Records / organization & administration*
  • Glycated Hemoglobin A
  • Humans
  • Middle Aged
  • Patient Selection*
  • Prediabetic State / drug therapy*
  • Research Design

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Cholecalciferol

Associated data

  • ClinicalTrials.gov/NCT01942694