Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: A cohort study

Elizabeth M. Vaughan, Salim Virani, Mahmoud Al Rifai, Victor J Cardenas, Craig A. Johnston, Laura Porterfield, Zuleica Santiago Delgado, Susan L. Samson, Vanessa Schick, Aanand D. Naik

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article numbere077819
JournalBMJ open
Volume13
Issue number10
DOIs
StatePublished - Oct 28 2023

Keywords

  • clinical trial
  • community health workers
  • diabetes
  • low-income
  • recruitment
  • telehealth

ASJC Scopus subject areas

  • General Medicine

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