Physician-investigator phone elicitation of consent in the field: a novel method to obtain explicit informed consent for prehospital clinical research.
OBJECTIVE
To describe and report the feasibility of a novel field telephonic strategy to elicit explicit informed consent in prehospital trials for conditions in which patients retain decision-making capacity.


METHODS
In a pilot prehospital neuroprotective stroke therapy trial, ambulances carried written informed consent forms and dedicated trial cellular phones permitting rapid connection to on call physician-investigators. The physician-investigator discussed the trial with the consent provider [patient if competent, on scene legally authorized representative (LAR) if patient not competent] by phone, while paramedics carried out prehospital care duties unimpeded.


RESULTS
32 patients met consent elicitation criteria. 20 (63%) were enrolled. The most frequent reasons for non-enrollment were: patient not competent and no available on-scene LAR-5; patient/LAR declined participation-4. Among enrollees, 15 (75%) were competent and self-enrolled; 5 (25%) were not competent and were enrolled by LAR family members. Site of consent initiation was: patient home-15 (74 = 5%), work-2(10)%, other-3(15)%. Consent was elicited via cell phone in 11 (55%) and site landline in 9 (45%). Compared with patients enrolled in prior studies employing standard in-hospital consent, prehospital consent procedures reduced time from paramedic arrival on-scene to start of study agent (26 vs 139 mins, p < 0.0001), and did not prolong the on-scene to ED arrival time (37 vs 34 min, p = 0.50). No patient/family withdrew consent during the 3-month follow-up period.


CONCLUSIONS
Physician phone elicitation of prehospital research consent from individuals with retained competency or on-scene legally authorized representatives is feasible, permits rapid patient study entry, and does not delay field transport times.
Stroke Center, Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, USA. jsaver@ucla.edu
Jeffrey L
JL
Saver
Chelsea
C
Kidwell
Marc
M
Eckstein
Bruce
B
Ovbiagele
Sidney
S
Starkman
D035843:Biomedical Research; D002140:California; D004632:Emergency Medical Services; D006801:Humans; D007258:Informed Consent; D010820:Physicians; D010865:Pilot Projects; D013689:Telephone