Telemedicine‐guided remote enrollment of patients into an acute stroke trial

Background and Purpose Enrollment into acute stroke clinical trials is limited to experienced tertiary centers with emergency research infrastructure. Feasibility of remote enrollment via telemedicine into an acute thrombolytic clinical trial has never been demonstrated. Methods Using telemedicine,...

Full description

Saved in:

Bibliographic Details
Published in:	Annals of clinical and translational neurology Vol. 2; no. 1; pp. 38 - 42
Main Authors:	Wu, Tzu‐Ching, Sarraj, Amrou, Jacobs, Amber, Shen, Loren, Indupuru, Hari, Biscamp, Donna, Ho, Victor, Ankrom, Christy, Grotta, James C., Savitz, Sean I., Barreto, Andrew D.
Format:	Journal Article
Language:	English
Published:	United States John Wiley & Sons, Inc 01-01-2015 BlackWell Publishing Ltd
Subjects:	Clinical trials Enrollments Informed consent Patients Physicians Recruitment Stroke Telemedicine Ultrasonic imaging
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	Background and Purpose Enrollment into acute stroke clinical trials is limited to experienced tertiary centers with emergency research infrastructure. Feasibility of remote enrollment via telemedicine into an acute thrombolytic clinical trial has never been demonstrated. Methods Using telemedicine, our hub stroke research center partnered with two spoke community hospitals to jointly participate in a randomized, phase III adjunctive thrombolysis clinical trial in the first 3 h after symptom onset to expand recruitment of the trial. Eligible patients were successfully identified, consented, randomized, and received therapy/placebo at the spoke hospitals under real‐time direction by hub trialists via telemedicine. Results Ten patients were identified from May 2013 to July 2014, and six were enrolled via telemedicine. No study procedure delays, safety events, or major protocol violations occurred. Conclusions It is feasible to randomize and enroll stroke patients via remote telemedicine into an acute thrombolytic clinical trial. This novel approach could expand access and accelerate completion of clinical trials if widely implemented.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Funding Information This work was supported by the Center for Clinical and Translational Sciences, which is funded by NIH Clinical and Translational Award UL1 RR024148 [TL1 RR024147 for the T32 program; KL2 RR0224149 for the K12 program] from the National Center for Research Resources. This work was also supported by the Lone Star Stroke Consortium. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the NIH.
ISSN:	2328-9503 2328-9503
DOI:	10.1002/acn3.150