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

Jeffrey L. Saver, Stella Kidwell, Marc Eckstein, Bruce Ovbiagele, Sidney Starkman

Research output: Contribution to journalArticle

25 Citations (Scopus)

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 (75%), 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.

Original languageEnglish (US)
Pages (from-to)182-185
Number of pages4
JournalPrehospital Emergency Care
Volume10
Issue number2
DOIs
StatePublished - Apr 2006
Externally publishedYes

Fingerprint

Informed Consent
Research Personnel
Physicians
Research
Patient Advocacy
Allied Health Personnel
Cell Phones
Consent Forms
Ambulances
Decision Making
Stroke

Keywords

  • Acute
  • Clinical trial
  • Emergency medical services
  • Informed consent
  • Magnesium sulfate
  • Paramedics
  • Stroke

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Physician-investigator phone elicitation of consent in the field : A novel method to obtain explicit informed consent for prehospital clinical research. / Saver, Jeffrey L.; Kidwell, Stella; Eckstein, Marc; Ovbiagele, Bruce; Starkman, Sidney.

In: Prehospital Emergency Care, Vol. 10, No. 2, 04.2006, p. 182-185.

Research output: Contribution to journalArticle

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title = "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 (75{\%}), 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.",
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N2 - 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 (75%), 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.

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KW - Magnesium sulfate

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KW - Stroke

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