Recent Study on a new way to enroll-consent prehospital

[Ace844]

Hello Everyone,

Here's an abstract to an interesting study which uses a unique way to enroll patients into a 'clinical study'. If you work in a progressive system this may be worth looking into...

Hope this helps,

ACE844

(Physician-Investigator Phone Elicitation of Consent in the Field: A Novel Method To Obtain Explicit Informed Consent For Prehospital Clinical Research; Jeffrey L. Saver A1 @ A2, A6, Chelsea Kidwell A1, A2, A6, Marc Eckstein A3, A6, Bruce Ovbiagele A1, A2, A6, Sidney Starkman A1, A2, A4, A6;

A1 Stroke Center, Keck School of Medicine of the University of Southern California

A2 Department of Neurology, Keck School of Medicine of the University of Southern California

A3 Department of Emergency Medicine, Keck School of Medicine of the University of Southern California

A4 Los Angeles Fire Department, Geffen School of Medicine the University of California, Los Angeles

A5 Department of Emergency Medicine, , Geffen School of Medicine the University of California, Los Angeles

A6 (for the FAST-MAG Pilot Trial Investigators))

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.

[AZCEP]

I thought that the FDA had relaxed study entry regulations for potentially life saving treatments?

This makes pretty good sense.

[Ace844]

I thought that the FDA had relaxed study entry regulations for potentially life saving treatments?

This makes pretty good sense.

I also think this would benefit those systems who already had liberal clinical practice parameters and clinical judgement. This could change some things and make it easier to do research.

Out here,

ACE