Abstract WP193: A Novel Vascular Neurology Fellow-Led Approach to Enhance Informed Consent and Boost Stroke Trial Recruitment

Introduction: Success of stroke clinical trials depends on efficient and sustained recruitment of trial eligible participants. Vascular Neurology Fellows, by virtue of their frontline clinical presence, play a pivotal role in presenting clinical trials to stroke patients. Patients are more likely to be willing to participate if a trained sub-specialist involved in their clinical care introduces a research study. However, there is a paucity of studies highlighting the role of fellows in clinical trial recruitment. Participation in clinical trials is considered a program specific requirement for Vascular Neurology Fellows at our institution. We assessed the impact of formal clinical trial training of Vascular Neurology Fellows (Fig. 1) supplemented with support from a novel Clinical Research Associate (CRA) program. Methods: We reviewed stroke trial enrollments in NIH and industry sponsored stroke trials from 2019 to mid-2024 at Northwell Health. Data was stratified based on the health care provider who obtained informed consent, as well as the month and year of consent. We then evaluated the proportion of consents obtained by fellows. Mann-Kendall test was used to assess the yearly trend of enrollments by fellows. We analyzed the impact of a novel initiative using a dedicated CRA to enhance fellow engagement and compared enrollment patterns before and after implementation using the Mann-Whitney U test. Results: Fellows consistently enrolled >25% stroke trial patients (Fig.2), with the highest enrollment in the academic year 2022-2023 (47.82%). The Mann-Kendall test did not demonstrate a significant trend for increasing proportion of recruitment by fellows during the study period (p = 0.624), however there was a significant increase in the total number of patients consented by fellows over the years (p <0.001). Even though the introduction of the CRA program was for a short duration, it led to a significant increase in the monthly median number of patients consented by fellows (p < 0.001, Fig. 3). Conclusion: Formal training of Vascular Neurology fellows leads to sustained enrollment of patients into stroke clinical trials. Introduction of innovative models such as an on-site CRA enhances consistent fellow engagement in clinical trial training and recruitment.