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

Autor:	Vaughan EM; Department of Internal Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA emvaugha@UTMB.EDU.; Department of Medicine, Baylor College of Medicine, Houston, Texas, USA., Virani S; Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.; Houston Center for Quality of Care and Utilization Studies, Center for Innovations in Quality Effectiveness and Safety, Houston, Texas, USA., Al Rifai M; Michael E DeBakey VA Medical Center, Houston, Texas, USA.; Houston Methodist Debakey Heart & Vascular Center, Houston, Texas, USA., Cardenas VJ Jr; Department of Internal Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA., Johnston CA; Health and Human Performance, The University of Houston, Houston, Texas, USA., Porterfield L; Department of Family Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA., Santiago Delgado Z; Department of Family Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA., Samson SL; Department of Internal Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA., Schick V; Deparrtment of Management, Policy, and Community Health, University of Texas School of Public Health, Houston, Texas, USA., Naik AD; Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.; Deparrtment of Management, Policy, and Community Health, University of Texas School of Public Health, Houston, Texas, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Oct 28; Vol. 13 (10), pp. e077819. Date of Electronic Publication: 2023 Oct 28.
DOI:	10.1136/bmjopen-2023-077819
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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