Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method

Bryant J Rosell; Kristina Shkirkova; Jeffrey L Saver; David S Liebeskind; Sidney Starkman; May Kim-Tenser; Marc Eckstein; Latisha Sharma; Robin Conwit; Scott Hamilton; Nerses Sanossian

doi:10.1159/000500851

Subject Retention in Prehospital Stroke Research Using a Telephone-Based Physician-Investigator Driven Enrollment Method

Cerebrovasc Dis Extra. 2019;9(2):72-76. doi: 10.1159/000500851. Epub 2019 Jul 25.

Authors

Bryant J Rosell¹, Kristina Shkirkova², Jeffrey L Saver³, David S Liebeskind^{3

4}, Sidney Starkman³, May Kim-Tenser^{1

5}, Marc Eckstein¹, Latisha Sharma³, Robin Conwit⁶, Scott Hamilton⁷, Nerses Sanossian^{1

5}

Affiliations

¹ Keck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA.
² Keck School of Medicine, Department of Neurology, University of Southern California, Los Angeles, California, USA, [email protected].
³ Stroke Center, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
⁴ Neuroimaging Research Core, Department of Neurology, University of California, Los Angeles, Los Angeles, California, USA.
⁵ Roxanna Todd Hodges Comprehensive Stroke Clinic, Department of Neurology, University of Southern California, Los Angeles, California, USA.
⁶ National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Massachusetts, USA.
⁷ Department of Neurology, Stanford University, Palo Alto, California, USA.

Abstract

Background and purpose: Subject retention into clinical trials is vital, and prehospital enrollment may be associated with higher rates of subject withdrawal than more traditional methods of enrollment. We describe rates of subject retention in a prehospital trial of acute stroke therapy.

Methods: All subjects were enrolled into the NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) phase 3 clinical trial. Paramedics screened eligible subjects and contacted the physician-investigator using a dedicated in-ambulance cellular phone. Physician-investigators obtained explicit informed consent from the subject or on-scene legally authorized representative (LAR) who reviewed and signed a consent form. Exception from informed consent (EFIC) was utilized in later stages of the study.

Results: There were 1,700 subjects enrolled; 1,017 provided consent (60%), 662 were enrolled via LAR (39%), and 21 were enrolled via EFIC (1%). Of the 1,700 patients, 1,413 (83%) completed the 90-day visit, 265 (16%) died prior to the 90-day visit, and 22 (1.3%) withdrew from the study before completion. There were no differences in rates of withdrawal by method of study enrolment, i.e., self-consent (n = 14), 1.4%; LAR (n = 8), 1.2%; EFIC (n = 0) 0%.

Conclusion: There was a high rate of retention when subjects were enrolled into prehospital stroke research using a phone-based method to obtain explicit consent.

Keywords: Consent; Emergency medical services; Stroke.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial

MeSH terms

Ambulances*
California
Cell Phone*
Emergency Medical Services / methods*
Emergency Medical Technicians*
Humans
Informed Consent*
Magnesium Sulfate / administration & dosage
Neuroprotective Agents / administration & dosage
Patient Dropouts
Patient Selection*
Research Personnel*
Stroke / diagnosis
Stroke / drug therapy*
Stroke / physiopathology
Time Factors
Treatment Outcome

Substances

Neuroprotective Agents
Magnesium Sulfate