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Abstract Details

Remote Research Practices to Increase Acute Stroke Clinical Trial Enrollment
Cerebrovascular Disease and Interventional Neurology
Cerebrovascular Disease and Interventional Neurology Posters (7:00 AM-5:00 PM)
062

Assess the frequency and necessity of remote clinical research practices during acute stroke clinical trial enrollments. 

Enrollment in acute stroke clinical trials is complex and time-sensitive, often requiring dedicated research teams.  Individual team members may not be available “on-site” at the time of an enrollment, a limitation that may be overcome through remote research practices such as telemedicine and electronic informed consent. 

We retrospectively reviewed clinical trial enrollments in two phase-III acute stroke trials (NCT03735979, NCT03785678) at two high-volume stroke centers that routinely use telemedicine and remote research practices. We assessed the frequency of remote research and the primary reason remote research was employed for the following clinical trial elements: screening, consent, randomization, and intervention.

Fifty-four patients (42 enrolled patients, and 12 screened/consented-only patients, median age 75 [IQR 64-83], 54% female, and median NIHSS 13 [IQR 8-22]) were included in our study.  Twenty-six (48%) patients were screened vial telemedicine (primary reason: 12 [22%] provider off-site, 6 [11%] patient at remote hospital, 4 [7%] study coordinator remote, 3 [6%] COVID precautions, and 1 [2%] other).  Twenty-seven (50%) patients or their legally authorized representatives were consented remotely via telemedicine or phone with electronic consent (primary reason: 12 [22%] provider off-site, 6 [11%] patient at remote hospital, 3 [6%] study coordinator remote, 5 [9%] COVID precautions, and 1 [2%] other).  Twenty-eight (67%) patients were randomized remotely (primary reason: 4 [10%] provider off-site, 19 [45%] study coordinator remote, 5 [12%] COVID precautions). Twelve patients (28%) had their study intervention overseen remotely (primary reason: 7 [17%] provider off-site, 2 [5%] study coordinator remote, 2 [5%] COVID precautions, and 1 [2%] other.

Completing clinical trial enrollment elements remotely was common and facilitated enrollments that would not have otherwise occurred.
Authors/Disclosures
Denise Gaffney, RN (Kaiser Permanente Los Angeles Medical Center)
PRESENTER
Ms. Gaffney has nothing to disclose.
Christopher Streib, MD (Department of Neurology) Dr. Streib has nothing to disclose.
Navdeep Sangha, MD (Kaiser Permanente) Dr. Sangha has nothing to disclose.
No disclosure on file
Abbey Staugaitis Abbey Staugaitis has nothing to disclose.