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Randomized Controlled Trial
. 2019 Jun;16(3):306-315.
doi: 10.1177/1740774519839062. Epub 2019 Apr 22.

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

Vanita R Aroda  1   2 , Patricia R Sheehan  3 , Ellen M Vickery  3 , Myrlene A Staten  4 , Erin S LeBlanc  5 , Lawrence S Phillips  6   7 , Irwin G Brodsky  8 , Chhavi Chadha  9 , Ranee Chatterjee  10 , Miranda G Ouellette  11   12 , Cyrus Desouza  13 , Anastassios G Pittas  3 ; D2d Research Group
Affiliations
Randomized Controlled Trial

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

Vanita R Aroda et al. Clin Trials. 2019 Jun.

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.

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Conflict of interest statement

Conflict of Interest

The Author(s) declare(s) that there is no conflict of interest.

Figures

Figure 1.
Figure 1.
Rate of adoption of Electronic Health Records (EHR)-supported recruitment approaches by clinical research sites (A). Total randomizations study-wide (B).
Figure 2.
Figure 2.
Number of participants screened and recruitment efficiency for EHR-supported approaches vs. non-EHR methods overall (A) and over time (B).
See this image and copyright information in PMC

References

    1. American Diabetes A. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes 2018; 36: 14–37. - PMC - PubMed
    1. Treweek S, Lockhart P, Pitkethly M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 2013; 3. - PMC - PubMed
    1. Cook WA and Doorenbos AZ. Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review. Mil Med 2017; 182: e1580–e1587. - PMC - PubMed
    1. Carlisle B, Kimmelman J, Ramsay T, et al. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trials 2015; 12: 77–83. - PMC - PubMed
    1. Weisfeld VD, English RA, Claiborne AB, et al. Public engagement and clinical trials : new models and disruptive technologies : workshop summary. Washington, D.C.: National Academies Press, 2012, p.xvi, 124 p. - PubMed

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