Journal Article

Successful conduct of an acute stroke clinical trial during COVID

Mackey, Jason, Eisshofer, Michael, Grotta, James C., Jones, William, Rajan, Suja S., Nour, May, Parker, Stephanie A., Im, Jenny Fung, Bowry, Ritvij, Gilbert, Greg, Collins, Sarah, Bratina, Patti, Wang, Mengxi, Ornelas, David, Spokoyny, Ilana, Jacob, Asha P., Schimpf, Brandi, Yamal, Jose-Miguel

2021

Overview

Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on acute stroke clinical trial conduct at sites that continued to enroll patients during the pandemic. BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA-eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT technologist, paramedics and emergency medicine technicians on-board. During COVID, consent, 90-day modified Rankin Scale (mRS) and EQ5D were obtained by phone instead of in-person, but other aspects of management were similar to the pre-COVID period. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Five of 6 BEST-MSU sites continued to enroll during COVID. There were no differences in intra- (n = 57) vs pre- (n = 869) COVID enrolled tPA eligible patients’ age, sex, race (38.6% vs 38.0% Black), ethnicity (15.8% vs 18.6% Hispanic), or NIHSS (median 11 vs 9). The percent of screened patients enrolled and adjudicated tPA eligible declined from 13.6% to 6.6% (p < .001); study enrollment correlated with local stay-at-home and reopening orders. There were no differences in alert to MSU arrival or arrival to tPA times, but MSU on-scene time was 5 min longer (p = .01). There were no differences in ED door to CT, tPA treatment or thrombectomy puncture times, hospital length of stay, discharge disposition, or remote vs in-person 90-day mRS or EQ5D. One MSU nurse tested positive but did not require hospitalization. Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. tPA eligibility rates declined, but otherwise there were no differences in patient demographics, deterioration of study processes, or serious infection of study staff. Trial registration: NCT02190500

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Accuracy / Aged / Care and treatment / Clinical trials / Computer programs / COVID-19 / COVID-19 - epidemiology / COVID-19 - virology / Data analysis / Demographics / Drafting software / Editing / Emergency management / Emergency medical care / Emergency medical services / Emergency preparedness / Emergency procedures / Emergency services / Engineering and Technology / Enrollments / Epidemics / Evaluation / Exhausting / Female / Funding / Health care facilities / Hospitals / Humans / Infections / Influence / Leadership / Male / Medical research / Medicine / Medicine and Health Sciences / Methodology / Methods / Middle Aged / Mobile Health Units / Nervous system / Neurological research / Neurology / Orthopedics / Pandemics / Patient Discharge / Patients / People and Places / Personal protective equipment / Personnel / Protective equipment / Protocol (computers) / Public health / Radiology / SARS-CoV-2 - physiology / Schedules / Shutdowns / Software / Stroke / Stroke (Disease) / Stroke - drug therapy / Telemedicine / Time Factors / Tissue Plasminogen Activator - therapeutic use / United States / Visualization