Abstract WP7: Critical Importance Of Enrollment Hours For Successful Recruitment In Acute Stroke Trials

Abstract

Introduction: Recruitment into hyperacute stroke trials is challenging but ultimately depends on on-call availability of treating investigators, study coordinators, and pharmacists. These data may not be considered in initial decision-making for site selection and estimates of site recruitment are frequently based upon registry data from sites that includes all clinical cases. Hypothesis: Site recruitment on a per month basis is associated with time open for enrollment. Methods: We surveyed all Multi-arm Optimization of Stroke (MOST) trial centers open for enrollment to determine which were open for trial recruitment during business hours during Monday through Friday only, business hours 7 days a week, extended hours beyond business hours, or 24 hours/7 days a week. We also surveyed about pharmacy availability. Descriptive statistics were used to compare the average monthly enrollment by survey responses. Results: Sites open for enrollment only during business hours, Monday through Friday recruited at a rate of 0.14 participants per month compared to 0.36 per month for sites that enroll 7 days a week (see graphic). Restriction of pharmacy availability to business hours Monday through Friday was associated with decreased recruitment rate as well. Conclusions: Ability to recruit trial participants 7 days a week should be the standard for site selection, successful acute stroke trial recruitment, and estimates of needed sites. Methods to increase financial support for hours outside of week-day business hours is a potential method to enhance recruitment into acute stroke trials.