Research Article: Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study
Abstract:
Background Recruitment for clinical studies is challenging. To overcome barriers, investigators have previously established call-to-entry rates to assist in planning. However, rates specific to low-income minority populations are needed to account for additional barriers to enrolment these individuals face. Objective To obtain a call-to-entry rate in a low-income uninsured Hispanic population with chronic disease. Methods We used data from four of our randomised clinical studies to determine the call-to-entry rate for individuals (n=1075) with or at risk for type 2 diabetes: participants needed/potential participants contacted=recruitment?rate (yield). Research staff contacted potential participants to enrol in a study that evaluated 6?month diabetes programmes at community clinics from 2015 to 2020. We recorded call-to-entry rates, reasons for declining the study, show rates, and attrition. Results The call-to-entry rate was 14.5%. Forty per cent of potential participants could not be contacted, and 30.6%, 19.1%, and 5.4% responded yes , no , and maybe , respectively. No show percentages were 54% for yes and 91.4% for maybe responders. The majority (61.6%) declined due to inability to attend; reasons to decline included work (43%), eligibility (18%), transportation (10%), out of town (9%), did not think they needed the programme (7%) and other/unknown (14%). Being a physician predicted inability to reach participants (adjusted OR 2.91, 95% CI 1.73 to 4.90). Attrition was 6.8%. Conclusions We described a call-to-entry rate and detailed recruitment data, including reasons to decline the study. This valuable information can assist investigators in study planning and overcoming enrolment barriers in low-income populations. Telehealth-based or strategies that limit transportation needs may increase participant involvement. Trial registration number NCT03394456 .
Introduction:
Recruitment is a known challenge in clinical studies, particularly in low-income communities. 1 2 Data from a recent clinical study revealed an under-representation of uninsured participants (n=24,332) and of those living in geographic areas with lower socioeconomic levels. 3 Low-income populations face higher levels of mistrust in the health system, language and cultural concerns, transportation challenges, limited health literacy, and medical record deficiencies. 1 4–7 Investigators have found that socioeconomic…
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