Remote Research Practices Enhance Acute Stroke Clinical Trial Enrollment

Abstract

AbstractBackgroundMany acute stroke clinical trials (ASCTs) are underpowered or terminated early due to poor recruitment. 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 are identified. Remote research practices (RRPs) can facilitate time-critical ASCT enrollment and follow-up assessments, however, the feasibility and effectiveness are unknown.MethodsThis case-control study retrospectively reviewed ASCT enrollment at two institutions. When conventional in-person clinical research was not possible, completion of study specific essential clinical trial events (ECTEs) were attempted via RRPs utilizing telemedicine evaluation or telephone communication. The primary outcome was successful execution of ECTEs by modality: in-person, telemedicine evaluation, or telephone communication. The secondary outcome was protocol violation rate by modality. We utilized Fisher’s Exact Test for primary and secondary outcomes and descriptive statistics to report RRP utilization.ResultsA total of 1603 individual ECTEs were attempted for 171 subjects. RRPs were utilized for 53.9% of ECTEs (19.3% telemedicine, 34.6% telephone communication). ECTEs were more likely to be completed successfully via telemedicine (100%) than in-person (98.2%) or telephone (92.3%), (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). More than half (53.4%) of randomized ASCT enrollments were dependent upon RRPs. Randomization (94.7%) and outpatient assessments (84.6%) were more frequently completed via RRPs compared to eligibility screening (40.7%), informed consent (40.4%), supervision of study intervention (44.6%), and inpatient assessments (18.8%).ConclusionRemote research practices were effective and doubled randomized ASCT enrollments in comparison to conventional research models that are restricted to in-person interaction alone. Telemedicine was associated with the highest rate of successful ECTE execution and the lowest rate of protocol deviations. These findings may be confounded by indication and further definitive study is indicated.