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the Frequently Asked Questions. (pdf file)
Thank you for your recent query related to the Resuscitation Outcomes Consortium (ROC) study of hypertonic saline resuscitation fluid. This study was designed by physicians working for the National Institutes of Health and Canadian Institute for Health Research to improve the survival of patients with severe injuries. Patients who would be eligible for this study as a group have a 30% chance of dying from their injuries. Hence, from a public health standpoint, both the Canadian and U.S. governments believe it is critical to undertake research studies that promise to guide life-saving emergency treatment for such patients. I encourage you to review the OHSU ROC site on the web for further important details about how the ROC study will provide important information and critical care thus helping injured patients in the greater Portland area and other parts of North America.
What is the medical emergency vehicle company used and exactly how are its technicians informed of the opt-out bracelet?
The vehicles are local EMS agency ambulances, fire trucks, and air ambulances (helicopters). The agency personnel are trained Paramedics, Emergency Medical Technicians, and Nurses. The personnel delivering the study intervention have been trained on the study protocol and intervention in addition to their normal training. Part of this training included education related to study exclusion criteria including identification of standard medic alert bracelets, and recognition of what “NO STUDY” inscribed on a bracelet means. Identification and recognition of medic alert bracelets is part of standard EMS training, and hence chose by the study physicians for this purpose
The training, skills verification, and certification of individuals performing this study intervention is monitored by the participating agencies. These individuals have been and will remain the same individuals who respond emergency 911 calls throughout the region.
Do these ER vehicles stock routine drugs and equipment in addition to the study fluids? Are their EMTs required to maintain routine ER skills?
There are currently 16 prehospital fire and EMS agencies in Multnomah, Clackamas, Washington, and Clark counties involved in this study. These agencies are all primary 911 response vehicles, there are approximately 290 vehicles involved with Portland ROC and 140 of these vehicles carry the HS study intervention; the remainder of vehicles are staffed by qualified and trained EMS professionals who have also been trained in enrolling patients in this study. The same region-wide involvement of EMS agencies is occurring in other North American ROC communities.
Are opt-out patients treated with routine non-study procedures/meds/apparati when appropriate?
Those severely injured patients who are entered in the study receive a 250 mL bag of study resuscitation fluid in addition to (or in place of) standard saline resuscitation fluid. The severely injured patient who has opted out by wearing the opt-out bracelet is treated in exactly the same manner, EXCEPT she/he does not receive the special 250 mL of study resuscitation fluid in their IV. Thus the study has been designed such that all paramedic treatment is exactly what the severely injured patient needs whether in the study or not - other than the one-time use of the special resuscitation fluid for those enrolled in the study.
Is non-consent recorded in a centrally accessible location?
To opt out you must be wearing the bracelet. We have a record of requests for opt-out bracelets; access to this is limited and is not publicly available. As some individuals have notified us after receiving the bracelet - and learning more about this important study - that they now do not intend to opt-out, we leave it to the bracelet to guide the paramedics.
Thank you for your questions,
Jerris Hedges, MD
Principal Investigator
Portland ROC Site
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