Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials
Background and Purpose—The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy.
Methods—The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017.
Results—During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P=0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P=0.88) as compared with conventionally consented (n=29). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P=0.002).
Conclusions—e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes.
- Received June 12, 2017.
- Revision received August 25, 2017.
- Accepted August 31, 2017.
- © 2017 American Heart Association, Inc.