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Use of electronic recruitment methods in a clinical trial of adults with gout

Author

Clin Trials. 2021 Feb;18(1):92-103. doi: 10.1177/1740774520956969. Epub 2020 Sep 15.

Hailey N Miller 1 2Jeanne Charleston 2 3Beiwen Wu 3Kelly Gleason 1 2Karen White 3Cheryl R Dennison Himmelfarb 1 2Daniel E Ford 2 3Timothy B Plante 4Allan C Gelber 3 5Lawrence J Appel 2 3 5Edgar R Miller 3rd 2 3 5Stephen P Juraschek 6

Author Information

1 School of Nursing, Johns Hopkins University, Baltimore, MD, USA.

2 Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.

3 Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

4 Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.

5 Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

6 Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.

Abstract

Background/aims: Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods.

Methods: We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method.

Results: Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans.

Conclusion: An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.