Abstract TP306: Streamlining the Enrollment Process in Acute Stroke Trials: Perspective From a Comprehensive Stroke Center

Abstract

Introduction: Acute stroke is a stressful time for patients, families, and medical staff. Adding potential clinical trial enrollment to this mix further complicates the situation, and can result in chaos, delaying randomization or losing potential patients due to time constraints. Streamlining processes can decrease enrollment times and improve flow, compliance, and data quality. Methods: Our stroke research team developed multiple processes to improve acute trial enrollments. We developed an enrollment grid that details which trial to offer to patients who qualify for multiple acute trials, allowing us to equitably enroll in all trials without bias. We house enrollment binders in the emergency room with documents to be completed during enrollment, tabbed by research member (MD vs coordinator). These include the current consent form version with a cover sheet requiring the consenter to verify the latest version of the consent is being used and is accompanied by a study-specific script that includes all consent elements. This helps team members to uniformly present information, and not miss important elements due to stress and time constraints. This binder also includes protocol reminders, drug orders, and references to a secure share drive with additional helpful documents. We hold yearly consenting practice sessions for new fellows and research team members. We created electronic health record “smart phrases” including a consent process note and subsequent trial-specific documentation needs. Results: We analyzed 11 enrollments from 2 acute stroke trials that were enrolling between 1/1/16-1/1/18, split into two cohorts of pre- vs post-process implementation on 1/1/17. We found major improvement in our internal workflow and consistency while staying compliant with regulatory requirements. Times from patient arrival to signed consent decreased from 3.2±1.5 to 0.99±0.1 hrs (p<0.005). Additionally, our overall data quality remained excellent with an error rate well below <1%. Conclusion: Our new processes support our vision of efficient trial conduction in the acute setting with reduction of enrollment times and maintained excellent data quality. We are now implementing and disseminating these processes to our spokes and telestroke sites.

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