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If the paramedic feels that the patient meets all the criteria to be included in the IMMEDIATE Trial, what happens?
- The Paramedic will read an information card to the patient (and/or family member if they are available) about the study. Patients may already be aware of the study as a result of the community consultation, however, some patients will not have heard of the study. This notification will act as a reminder to patients already aware of the study and as information and notification by the paramedic to those patients unaware of the study. Full informed consent will not occur prior to receiving the study drug.
- Patients will be given a chance to tell the paramedic that they decline to participate before the study drug is started.
- If the patient does not decline to participate, the study drug will be administered.
- Once at the emergency department, a detailed description (informed consent form) of the study will be given to the patient or family member to read and ask questions. If the patient agrees to continue in the study and signs the informed consent form, the study drug will continue for 12 hours; If the patient does not want continue receiving the study drug and does not sign the informed consent form, the study drug will be stopped.
- The patient can withdraw from the study at any time by telling any medical personnel.
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