Deneil Kolk MPH, MSW HSP Coordinator University of Michigan Meeting The EFIC Regulations CC & PD Update - The RAMPART Trial January 6, 2010

Summary of CC Events

CC - Geographical Community Public events/locations State fairs Street fairs Health expo/conf/fairs Hospital (lobby waiting room, ED patients) Football games Public libraries Existing meetings/groups Places of worship Senior centers Employment fair Rotary clubs Neighborhood associations Substance abuse centers Homeless shelters Online/Telephone Internet/website surveys Telephone surveys

CC - Seizure Related Community Seizure Related Community: Epilepsy Bowl-A-Thon Epilepsy Walk Epilepsy support groups Epilepsy clinics Epilepsy conferences Epilepsy monitoring unit (hospital setting)

CC - Special Focus Parents/Teachers/Kids: PTSA meetings School health advisory councils High school classrooms A middle school awards breakfast Ethnicity/Race: Latino Festival NAACP Freedom Weekend Root & Heritage Festival African American Health Coalition Latino Book & Family Festival Chinese Health Coalition Meeting Telephone survey Medical Professionals: Hospital internal survey ED staff meetings Medical conferences

Community Comments Common Comments & Questions “If it works, how long before it will be available?” “As long as patient safety and welfare is always the priority, I would support the study” “Hard to judge whether benefits outweigh the risks as all the information is not available. I suspect that this lack of knowledge is the reason for the study.” “That’s just progress. You have to have continuing study to have the best medications” “Without research such as this, there is no mechanism to move forward. It is the right thing to do.”

Community Comments Common Concerns “How does the medication know where to target in the brain?” “Alarm bells are going off in me. Maybe it’s because of lack of understanding. But, if my boy is having a seizure, I don’t want someone messing around with saline solution.” “My daughter suffers from epilepsy. Although I delight in the idea of finding a cure, I am apprehensive of researching someone without their consent” “Are the medics well trained?” “How do you know if someone is allergic to one of these medicines?” “What about drug allergies or interaction with these study medications?”

CC Conclusion

Summary of PD Events

PD – Geographical Community Online/Print/TV/Radio Advertisements Twitter Facebook Hub public relations website Hub clinical research website Hub Study website Radio pod cast Local news websites National press release through PR newswire Local major newspapers Religious affiliated bulletins & mailings Local TV (PSA & interviews) Press releases Public radio (PSA & interviews) Billboards City employee paycheck insert

PD – Geographical Community Brochure/Flyer/Poster Distribution Local pharmacies Buses (city bus posters) Homeless shelters Neurologist offices Religious organizations Booth Football games Farmers markets State fair Street fair Employment fair Disabilities expo

PD - Seizure Related Community Online/Print Advertisements EF Website – local chapter EF Newsletter – local chapter EF Mailing – local chapter EF blast – local chapter Brochure/Flyer/Poster Distribution TBI rehab clinics Seizure clinics EF centers - local chapter Booth Brain Injury Association Conf. (local) EF Conference EF Walk & EF Stroll

PD – Special Focus Race/Ethnicity Print/TV Advertisements African-American News & Issues Newspaper Spanish language newspaper Spanish language TV channel Booth Latino Festival Roots & Heritage Festival Latino Book & Family Festival

PD – Special Focus Medical Professionals Presentations Grand Rounds EMS staff trainings Print/Online Advertisements Hub internal circular EMS newsletter Local Neurologist clinics (notification letter) Booth Medical professional’s mtg./expo/conf. Hub staff events

Public Disclosure Conclusion 16 hubs have reported 245 total events Ongoing PD events (Time & Cost effective) –Brochure/Flyer/Poster distributions at community centers, medical clinics, places of worship, etc. – circulars –Update presentations with groups attended during CC

Questions? Deneil Kolk (734)