JMIR Publications

ABSTRACT

Background:

Hydroxyurea is an evidence-based disease-modifying therapy for sickle cell disease (SCD) but is underutilized. The Integration of Mobile Health (mHealth) into Sickle Cell Disease Care to Increase Hydroxyurea Utilization (meSH) multi-center study leveraged mHealth to deliver targeted interventions to patients and providers to foster hydroxyurea utilization. SCD studies often under enroll, and unanticipated events can negatively impact enrollment, making it important to study strategies that ensure adequate study accrual.

Objective:

This paper describes the challenges and adaptive strategies used to secure participant enrollment in the meSH study. Adaptive strategies were crucial to alleviate enrollment disruptions due to the COVID-19 pandemic.

Methods:

Recruitment was anticipated to last 2 months for providers and 6 months for patients. The recruitment strategies used with patients and providers, new recruitment strategies, and recruitment rates were captured and compared. To document recruitment adaptations and their reasons, study staff responsible for recruitment completed an open-ended 9-item questionnaire eliciting challenges to recruitment and strategies used. Themes were extrapolated using thematic content analysis.

Results:

In total, 89 providers and 293 patients enrolled across seven sites. Recruitment duration ranged from 2 to 7 for providers and 7 to 10 months for patients across sites. The study acceptance rate was 86% for both patients and providers. Patients mostly declined participation due to a lack of time and interest in research. Providers declined because of self-perceived high levels of SCD expertise, believing they did not need the intervention. Initially, recruitment involved an in-person invitation to participate during clinic visits (patients and providers), staff meetings (providers), or within the office (providers). Recruitment challenge themes included: 1) lack of interest in research, 2) lack of human resources (e.g., shortage of study staff due to layoffs or resignations during the COVID-19 pandemic), 3) unavailable physical space for recruitment activities due to in-person activity restrictions, and 4) lack of documentation to verify eligibility. Because recruitment was slower than projected, strategies were adapted to include remote approaching and consenting (e.g., telehealth, email and telephone) for patients and providers. Additionally, for patients, recruitment was enriched by simplification of enrollment procedures (e.g., directly approaching patients without a referral from the provider) and a multi-touch method (i.e., warm introductions with flyers, text and patient portal messages). For patients, recruitment rates were similar between the in-person and adapted (virtual with multi-touch) approaches (83.5% and 88.1%, respectively, P=0.23). For providers, however, recruitment rate was higher for in-person versus remote recruitment (96.0% and 70.7%, respectively, P<.001).

Conclusions:

The adapted recruitment strategies, implemented in response to the COVID-19 pandemic, secured a high recruitment rate, which was maintained among patients with SCD using an assortment of enriched remote recruitment strategies. For provider participants, e-mail-alone recruitment methods may not be sufficient to secure study enrollment.