TY - JOUR
T1 - Use of electronic recruitment methods in a clinical trial of adults with gout
AU - Miller, Hailey N.
AU - Charleston, Jeanne
AU - Wu, Beiwen
AU - Gleason, Kelly
AU - White, Karen
AU - Dennison Himmelfarb, Cheryl R.
AU - Ford, Daniel E.
AU - Plante, Timothy B.
AU - Gelber, Allan C.
AU - Appel, Lawrence J.
AU - Miller, Edgar R.
AU - Juraschek, Stephen P.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by The Rheumatology Research Foundation and the Johns Hopkins Institute for Clinical and Translational Research, which is funded in part by the National Center for Advancing Translational Sciences (NCATS) (Grant No. ULITR003098). S.P.J. was supported by the National Heart, Lung, and Blood Institute (Grant No. 7K23HL135273). H.N.M. was supported by the National Institute of Nursing Research (Grant No. T32NR012704).
Publisher Copyright:
© The Author(s) 2020.
PY - 2021/2
Y1 - 2021/2
N2 - 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.
AB - 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.
KW - Recruitment methods
KW - clinical trials
KW - disparities
KW - electronic medical records
KW - randomized control trial
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U2 - 10.1177/1740774520956969
DO - 10.1177/1740774520956969
M3 - Article
C2 - 32933342
AN - SCOPUS:85091072921
SN - 1740-7745
VL - 18
SP - 92
EP - 103
JO - Clinical Trials
JF - Clinical Trials
IS - 1
ER -