Background: A major barrier to enrollment into acute stroke clinical trials is timely access to a tertiary care center conducting the study. Tertiary centers often receive the majority of their patients through broad referral networks. Remote consent via telephone, telemedicine or web-based technology are strategies that have been suggested to broaden enrollment. There is limited data on the feasibility and efficacy of those methods.
Methods: There are 19 telemedicine sites and 23 non-telemedicine sites in our network. We describe our experience with screening and enrolling patients into acute stroke clinical trials via our referring network. Based on mode of presentation, we divided all patients enrolled in trials into 3 cohorts; direct presentation with no prior consultation, transfer after consultation by telephone only and transfer after full telemedicine consultation. We classified trials based on required timeframe of enrollment into urgent and non-urgent. We used two-way ANOVA to compare the differences between the three cohorts across both types of trials.
Results: Between January 2013 and July 2015, 175 patients were enrolled into 13 clinical trials, 8 of which were urgent. Telephone consults resulted in the highest volume of enrollment (46.3%). Telemedicine consults resulted in higher enrollment into urgent vs non-urgent trials (18.6% vs 11%). Combined; telephone and telemedicine consults comprised the majority of enrollment volume (61.7%). The results were statistically significant (Urgency of Enrollment, p = 0.02. Type of Consult, p = 0.002).
Conclusion: Tele-consultation is a feasible and efficacious resource for recruitment into acute stroke trials. Wide implementation of this method can achieve broader recruitment and more rapid completion of trials. Although no major protocol violations or delays were reported in our study, future trials can assess the reliability of the different methods.