Abstract TMP38: Remote Research Practices Enhance Acute Stroke Clinical Trial Enrollment

Abstract

Background: Many acute stroke clinical trials (ASCTs) are underpowered, inconclusive, or terminated early. A pervasive challenge to ASCT recruitment is the physical separation of patients, their legally authorized representatives, research coordinators, and clinician investigators when trial-eligible patients present emergently. Remote research practices (RRPs) may aid time-critical ASCT enrollment and follow-up, however, their feasibility and effectiveness are understudied. Methods: We retrospectively reviewed ASCT enrollment (NCT03785678, NCT03735979, NCT02072681) at two institutions. Essential clinical trial elements (ECTEs) consisted of eligibility screening, informed consent, randomization, study intervention, and inpatient/outpatient follow-up assessments. When conventional in-person clinical research was not possible, ECTEs were attempted via RRPs utilizing either telemedicine evaluation or telephone communication. The primary outcome was the successful execution of accurate, complete ECTEs by research communication modality (in-person, telemedicine, or telephone). The secondary outcome was the protocol violation rate by modality. We utilized Fisher’s Exact Test for primary and secondary outcomes and descriptive statistics to report RRP utilization. Results: A total of 1600 individual ECTEs were attempted on 169 subjects. RRPs were utilized for 53.7% of ECTEs (19.1% telemedicine, 34.6% telephone). ECTEs were more likely to be completed successfully with telemedicine (100%) than in-person (98.5%) or telephone (92.2%), (p<0.01). Additionally, protocol deviations were less common with telemedicine (0.0%) than in-person (2.6%), or telephone (2.8) (p=0.04). Randomization (94.7%) and outpatient assessments (90.3%) were frequently completed via RRPs compared to eligibility screening (39.1%), informed consent (40.2%), supervision of study intervention (36.8%), and inpatient assessments (21.9%). Conclusion: RRPs were widely utilized. Telemedicine execution of ECTEs was associated with the highest rate of successful completion and lowest rate of protocol deviations. These findings, while retrospective and confounded by indication, suggest RRPs are effective and require confirmatory study.