Simultaneous ring voice-over-Internet phone system enables rapid physician elicitation of explicit informed consent in prehospital stroke treatment trials.
BACKGROUND
Cellular phone conversations between on-scene patients or their legally authorized representatives (LARs) and off-scene enrolling physician-investigators require immediate and reliable connection systems to obtain explicit informed research consent in prehospital treatment trials.


METHODS
The NIH Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial implemented a voice-over-internet protocol (VOIP) simultaneous ring system (multiple investigator cell phones called simultaneously and first responder connected to call) to enable physician-investigators to elicit consent immediately from competent patients or LARs encountered by 228 ambulances enrolling patients in a multicenter prehospital stroke trial. For 1 month, the number, origin, duration, and yield of enrolling line calls were monitored prospectively.


RESULTS
Six investigators were connected to 106 enrolling line calls, with no identified unanswered calls. Thirty-five percent of new patient calls yielded an enrollment. The most common reasons for non-enrollment were last known well >2 h (n = 7) and unconsentable patient without LAR available (n = 7). No non-enrollments were directly attributable to the VOIP system. In enrollments, consent was provided by the patient in 67% and a LAR in 33%. The duration of enrollment calls (mean +/- SD: 8.4 +/- 2.5 min, range 6-14) was longer than non-enrollment calls (5.5 +/- 3.5, range 2-13; p < 0.001). The median interval from last known well to study agent start was 46 min, and 70% were enrolled within 60 min of onset.


CONCLUSIONS
The simultaneous ring system was reliable and effective, permitting enrollment of a substantial number of patients within the first hour after stroke onset. VOIP cellular networks with simultaneous ring are a preferred means of facilitating consent in prehospital treatment trials.
Department of Neurology, University of Southern California, 1200 N. State St., Los Angeles, CA 90033, USA. sanossia@yahoo.com
Nerses
N
Sanossian
Sidney
S
Starkman
David S
DS
Liebeskind
Latisha K
LK
Ali
Lucas
L
Restrepo
Scott
S
Hamilton
Robin
R
Conwit
Jeffrey L
JL
Saver
D000368:Aged; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D040421:Cell Phone; D005260:Female; D006801:Humans; D007258:Informed Consent; D020407:Internet; D015141:Los Angeles; D008278:Magnesium Sulfate / Q000627:therapeutic use; D008297:Male; D009316:National Institutes of Health (U.S.); D010820:Physicians; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D020521:Stroke / Q000188:drug therapy*; D013997:Time Factors; D014481:United States
D002121:Calcium Channel Blockers; D008278:Magnesium Sulfate