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 andreport 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 anddedicated 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 andno available on-scene LAR–5; patient/LAR declined participation–4. Among enrollees, 15 (75%) were competent andself-enrolled; 5 (25%) were not competent andwere 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%) andsite 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), anddid 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, anddoes not delay field transport times.