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

Prehospital Emergency Care : Official Journal of the National Association of EMS Physicians and the National Association of State EMS Directors
Jeffrey L SaverFAST-MAG Pilot Trial Investigators

Abstract

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. 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. 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 conse...Continue Reading

References

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Nov 19, 2003·Circulation·Philippe Gabriel StegUNKNOWN Comparison of Angioplasty and Prehospital Thrombolysis In acute Myocardial infarction (CAPTIM) Investigators
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Citations

Jul 29, 2010·Cerebrovascular Diseases·Nerses SanossianUNKNOWN FAST-MAG Trial Investigators
Mar 26, 2013·American Journal of Respiratory and Critical Care Medicine·Karen E A BurnsUNKNOWN Canadian Critical Care Trials Group
Mar 6, 2012·Annals of Emergency Medicine·Duika L Burges WatsonMadeleine J Murtagh
Mar 1, 2008·Neuropharmacology·Myron D Ginsberg
Jul 13, 2007·Clinical Neurology and Neurosurgery·Bartosz KaraszewskiWalenty M Nyka
Jan 22, 2014·International Journal of Stroke : Official Journal of the International Stroke Society·Jeffrey L SaverUNKNOWN FAST-MAG Investigators and Coordinators
Nov 3, 2010·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Stacey S CofieldJames Quinn
Aug 19, 2008·International Journal of Stroke : Official Journal of the International Stroke Society·Hen Hallevi, Jaroslaw Aronowski
Nov 29, 2007·Clinical Trials : Journal of the Society for Clinical Trials·Claudia S RobertsonBaruch Brody
Sep 12, 2013·Stroke; a Journal of Cerebral Circulation·Michael Tymianski
Jan 19, 2008·Stroke; a Journal of Cerebral Circulation·Muhammad S Hussain, Ashfaq Shuaib
May 9, 2009·Stroke; a Journal of Cerebral Circulation·Lee H SchwammUNKNOWN Interdisciplinary Council on Peripheral Vascular Disease
Sep 29, 2007·Stroke; a Journal of Cerebral Circulation·Joe E AckerUNKNOWN American Stroke Association Expert Panel on Emergency Medical Services Systems, Stroke Council
Apr 9, 2017·Stroke; a Journal of Cerebral Circulation·Nerses SanossianUNKNOWN FAST-MAG Investigators and Coordinators
Oct 6, 2007·European Neurology·Ashfaq Shuaib, Muhammad S Hussain
Aug 11, 2020·Prehospital Emergency Care : Official Journal of the National Association of EMS Physicians and the National Association of State EMS Directors·Jason McMullanChristopher Lindsell
Oct 15, 2011·Current Neurology and Neuroscience Reports·Gisele Sampaio Silva, Lee H Schwamm
Apr 24, 2019·Current Cardiology Reports·Jennifer Juhl Majersik

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