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

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.

Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19

“…[10][11][12][13][14][15][16][17] The inadequate representation of underrepresented populations in clinical trials may have also led to a lack of understanding of the effect of these factors on acceptance of treatment and resultant healthcare inequities. 18 Second, we observed that the social support system appears to be associated with the decision to accept or decline monoclonal antibody therapies. Social capital may be defined as how reciprocal social networks provide support and opportunities for achievement of mutual goals.…”

“… 10 - 17 The inadequate representation of underrepresented populations in clinical trials may have also led to a lack of understanding of the effect of these factors on acceptance of treatment and resultant healthcare inequities. 18 …”

A Randomized Pilot Study of DASH Patterned Groceries on Serum Urate in Individuals with Gout

“…Participants were recruited by identifying patients with a diagnosis of gout in the Johns Hopkins Medicine medical record, newspaper advertisements, Facebook advertisements, and mass mailings to adults living in the communities surrounding the research center [ 17 ]. After completion of two in-person visits at the Johns Hopkins ProHealth Clinical Research Unit (Woodlawn, Maryland, USA), eligible adults were randomized to one of two 4-week intervention sequences: the provision of DASH-patterned groceries followed by self-directed grocery purchases or self-directed grocery purchases followed by the provision of DASH-patterned groceries.…”

Integrating special and underserved populations in translational research: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award (CTSA) program hubs

“…With electronic medical records (EMR) becoming omnipresent in health care and electronic-based recruitment methods used widely to boost participation in clinical trials, there is a concern that an overreliance on electronic/online technology may diminish access for eligible and interested underrepresented participant populations. In the research funded by the Johns Hopkins Institute for Clinical and Translational Research, a hybrid outreach strategy combining use of EMRs with postal mailings demonstrated enhanced cost-effectiveness and participation of under-represented groups, including Black participants and women [28].…”