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CS53
How Far Will Technology Take Us? The Nurses’ Role In The Successful Implementation Of Field Telephonic Informed Consent
By T. Haley, D. Tatgenhorst, G. Gaughran, J. Saver, & S. Starkman; University of California Los Angeles, CA
For further information, please contact: thaley@mednet.ucla.edu
Purpose: An early goal directed, ambulance treatment study can offer tremendous opportunity to improve patient outcomes, but requires a new process for obtaining research consent from patients. This report’s purpose is to describe required training and preliminary experience with a novel field telephonic strategy to elicit informed consent from the first 27 patients in a prehospital stroke trial.
Description: Because the majority of acute stroke patients remain lucid, informed consent is conducted prior to study drug initiation. Cellular phones connect the paramedics to an enrolling physician who is a stroke neurologist. Given that the paramedic role has not typically included facilitation of consents, clinical research nurses, in collaboration with the Emergency Medical Service (EMS) nurse educators, trained the paramedics in stroke recognition, facilitation of consent and study procedures. Stroke recognition was taught using a standardized stroke screen, the Los Angeles Prehospital Stroke Screen (LAPSS). Facilitation of consent included training the paramedics how to access enrolling physicians 24/7. Only after completion of the consent process can paramedics continue with the study procedures. Given that the consent process is an on-going responsibility, hospital staff were also trained.
Evaluation/Outcomes: A team of 16 nurses trained 3000 paramedics and staff nurses at 21 hospitals. To date, 51 patients who met consent elicitation criteria were provided access to the enrolling investigators, and 27 (53%) were enrolled. Consent was obtained in a variety of locations, the patient’s home, restaurants and accident scenes. The prehospital consent procedure reduced paramedic arrival to study agent delivery time to a median of 25 minutes compared to 139 minutes in standard in-hospital acute studies. The authors’ discussions will include strategies for teaching the elements of explicit informed consent, outcomes of education and early study enrollment.
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