Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial
Dae-Hyun Kim, Jeffrey L Saver, Sidney Starkman, David S Liebeskind, Latisha K Ali, Lucas Restrepo, May Kim-Tenser, Miguel Valdes-Sueiras, Marc Eckstein, Frank Pratt, Samuel Stratton, Scott Hamilton, Robin Conwit, Nerses Sanossian, Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators, Dae-Hyun Kim, Jeffrey L Saver, Sidney Starkman, David S Liebeskind, Latisha K Ali, Lucas Restrepo, May Kim-Tenser, Miguel Valdes-Sueiras, Marc Eckstein, Frank Pratt, Samuel Stratton, Scott Hamilton, Robin Conwit, Nerses Sanossian, Field Administration of Stroke Therapy–Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators
Abstract
Background and purpose: The enrollment yield and reasons for screen failure in prehospital stroke trials have not been well delineated.
Methods: The Field Administration of Stroke Therapy-Magnesium (FAST-MAG) trial identified patients for enrollment using a 2 stage screening process-paramedics in person followed by physician-investigators by cell phone. Outcomes of consecutive screening calls from paramedics to enrolling physician-investigators were prospectively recorded.
Results: From 2005 to 2012, 4458 phone calls were made by paramedics to physician-investigators, an average of 1 call per vehicle every 135.7 days. A total of 1700 (38.1%) calls resulted in enrollments. The rate of enrollment of stroke mimics was 3.9%. Among the 2758 patients not enrolled, 3140 reasons for screen failure were documented. The most common reasons for nonenrollment were >2 hours from last known well (17.2%), having a prestroke condition causing disability (16.1%), and absence of a consent provider (9.5%). Novel barriers for phone informed consent specific to the prehospital setting were infrequent, but included: cell phone connection difficulties (3.2%), patient being hard of hearing (1.4%), insufficient time to complete consent (1.3%), or severely dysarthric (1.3%).
Conclusions: In this large, multicenter prehospital trial, nearly 40% of every calls from the field to physician-investigators resulted in trial enrollments. The most common reasons for nonenrollment were out of window last known well time, prestroke confounding medical condition, and absence of a consent provider.
Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00059332.
Keywords: cell phones; clinical trial; informed consent; physician; stroke.
© 2015 American Heart Association, Inc.
Source: PubMed