Dataset Information

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

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.

SUBMITTER: Kim DH

PROVIDER: S-EPMC4909489 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

Kim Dae-Hyun DH Saver Jeffrey L JL Starkman Sidney S Liebeskind David S DS Ali Latisha K LK Restrepo Lucas L Kim-Tenser May M Valdes-Sueiras Miguel M Eckstein Marc M Pratt Frank F Stratton Samuel S Hamilton Scott S Conwit Robin R Sanossian Nerses N

Stroke 20151210 1

<h4>Background and purpose</h4>The enrollment yield and reasons for screen failure in prehospital stroke trials have not been well delineated.<h4>Methods</h4>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.<h4>Result ...[more]

PMID: 26658446

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Dataset Information

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

Background and purpose

Methods

Results

Conclusions

Clinical trial registration

Publications

Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial.

Similar Datasets

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