Abstract Details

Title Telemedicine Acute Stroke Clinical Trial Enrollments are Feasible and Effective

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) Cerebrovascular Disease and Interventional Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 161

Objective To study whether acute stroke clinical trial enrollments via telemedicine are feasible and effective.

Background Acute stroke clinical trial enrollments are challenging due to the extreme time-sensitive nature of screening, consent, randomization, and study intervention. Coordinating complex enrollments requires rapid assessment of the patient to determine trial eligibility, activate research protocols, and administer standard of care stroke treatment.

Design/Methods We retrospectively reviewed all patients consented for a Phase III acute stroke neuroimaging and delayed-window thrombolysis trial (NCT03785678) at two high-volume stroke centers that routinely incorporate telemedicine into clinical research. We analyzed the following time metrics: 1) stroke code activation to completed clinical trial consent (code-to-consent time), 2) stroke code activation to clinical trial randomization (code-to-randomization time), and 3) stroke code activation to clinical trial intervention (code-to-intervention time). Time metrics for patients evaluated and screened via telemedicine were compared to patients evaluated in-person via Wilcoxon Rank Sum Test.

Results Fifty-four patients were included (42 enrolled patients, and 12 screened and consented patients who were not randomized due to imaging exclusion, median age 75 [IQR 64-83], 54% female, and median NIHSS 13 [IQR 8-22]) in our study. Twenty-four patients were evaluated via telemedicine and 30 were evaluated in-person. The following time metrics were observed (telemedicine versus in-person, median [IQR]): code-to-consent time 47 (IQR 33-96) minutes versus 62 (IQR 50-100) minutes, p=0.25; code-to-randomization time 71 (IQR 53-118) minutes versus 72 (IQR 62-98) minutes, p=0.20; and code-to-study intervention time 86 (IQR 62-135) minutes versus 92 (IQR 84-113) minutes, p=0.32.

Conclusions Our study revealed no difference in code-to-consent time, code-to-randomization time, and code-to-study intervention time between acute stroke patients evaluated via telemedicine versus in-person. Telemedicine may be feasible and effective for optimizing acute clinical trial enrollments at institutions with sufficient experience and expertise.

Authors/Disclosures
PRESENTER	No disclosure on file
Abbey Staugaitis	Abbey Staugaitis has nothing to disclose.
Abbey Staugaitis	Abbey Staugaitis has nothing to disclose.
Navdeep Sangha, MD (Kaiser Permanente)	Dr. Sangha has nothing to disclose.
Christopher Streib, MD (Department of Neurology)	Dr. Streib has nothing to disclose.

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Abstract Details