TY - JOUR
T1 - Establishing an electronic health record–supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials
T2 - The vitamin D and type 2 diabetes (D2d) study experience
AU - for the D2d Research Group
AU - Aroda, Vanita R.
AU - Sheehan, Patricia R.
AU - Vickery, Ellen M.
AU - Staten, Myrlene A.
AU - LeBlanc, Erin S.
AU - Phillips, Lawrence S.
AU - Brodsky, Irwin G.
AU - Chadha, Chhavi
AU - Chatterjee, Ranee
AU - Ouellette, Miranda G.
AU - Desouza, Cyrus
AU - Pittas, Anastassios G.
N1 - Funding Information:
The planning phase of D2d was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through a multicenter clinical study implementation planning grant (U34) to Tufts Medical Center in Boston, MA (U34DK091958; principal investigator A.G.P.). Planning was also supported, in part, by the Intramural Research Program of the NIDDK. The conduct of D2d was primarily supported by NIDDK and the Office of Dietary Supplements of the National Institutes of Health through the multicenter clinical study cooperative agreement (U01DK098245; principal investigator A.G.P.) to Tufts Medical Center where the D2d Coordinating Center is based. The U01 grant mechanism establishes the NIDDK project scientist (M.A.S.) as a member of the D2d Research Group. The study also received secondary funding from the American Diabetes Association (1-14-D2d-01; principal investigator A.G.P.). Educational materials were provided by the National Diabetes Education Program. No pharmaceutical manufacturers contributed to the planning, design, or conduct of D2d. Study pills were purchased from an independent nutritional supplement manufacturing company that has no association with any members of the D2d Research Group. The D2d investigators and the NIDDK project scientist were responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© The Author(s) 2019.
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
KW - Prediabetes
KW - diabetes
KW - health records
KW - recruitment
KW - trial
UR - http://www.scopus.com/inward/record.url?scp=85064807297&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85064807297&partnerID=8YFLogxK
U2 - 10.1177/1740774519839062
DO - 10.1177/1740774519839062
M3 - Article
C2 - 31007049
AN - SCOPUS:85064807297
SN - 1740-7745
VL - 16
SP - 306
EP - 315
JO - Clinical Trials
JF - Clinical Trials
IS - 3
ER -