Physician-investigator phone elicitation of consent in the field: a novel method to obtain explicit informed consent for prehospital clinical research

Abstract

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.

Conclusion: 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.