1. PI and Coordinator Webinar
September 24, 2019

2. Site startup 124 sites released to enroll
91 sites with at least one randomization
122 sites with at least one consent

3. Enrollment
1,216 patients consented
313 randomized

4. Top enrolling sites – by # randomized
Consented
United 14 40
Cincinnati 12 36
Iowa 9 38
OHSU 35
Intercoastal 8 30
Kentucky 27
Memorial Hermann 25
Penn
Mayo San Mary's 23

5. Top enrolling sites – by randomization rate
Randomized/Month
Consented/Month
North Shore
1.00
1.3
Mississippi
0.95
2.6
United
0.83
2.4
Emory
0.64
2.5
Cincinnati
0.61
1.8
Kentucky
0.56
1.9
OHSU
0.54
2.1
Mayo San Mary's
0.53
1.5
Greenville
0.51
Iowa

6. Coordinator hero
Jay Sherman, WVU Healthcare Ruby Memorial Hospital, WV
A consented patient who was eligible for randomization lived quite far, but that didn’t deter him. Jay contacted us to make sure he could properly handle the samples during the long trip to and fro and got the job done!

7. Coordinator hero Khadean Moncrieffe, Montefiore
Worked with the ARCADIA team to consent and randomize an outpatient potential subject in less than 24 hours!

8. Emergency unblinding
Please reinforce importance of subject having wallet card with them at all times—unblinding without Subject ID will be challenging and may lose valuable time!
Unblinding should only be considered when there is an implication for immediate emergency treatment
Study medications can be stopped temporarily for planned medical procedures (unblinding is not needed, and study meds can be restarted once safe)

9. Reminders
Please don’t “pre-screen”. You will lose out on eligible patients!
LAR vs. witness consent. LAR if no cognitive capacity, witness if no physical capacity, illiteracy, or translator use.
Concomitant enrollment in observational studies is okay (please check in with us though).

10. The Road to Success!
Most important and first step “Why are we doing this study?”
Getting your department on board!
-Lunch & Learn
-Pocket cards with inclusions/exclusions for residents & NP’s
Streamline Consent process
Making the most of the participants time while inpatient
Maintain communication after they leave hospital
If the SC can’t address any concerns, involve the PI right away!
Maintain a positive attitude throughout the study process
PI: Dr. Shashank Shekhar
Study Coordinator: Susan Hetzel, RN

11.  Talk… PI/ Residents Research Coordinator Consent NP’s Attending
Screening
Yes
Educate about stroke and why we suspect ESUS in that patient
Show pictures, draw figures and explain the mechanism of stroke
Breakdown the benefit of the study in 4-5 points
Aspirin may not be best treatment
Will receive special attention from research team
Will get treatment free of cost
If has atrial cardiopathy then 50% more chance of receiving Apixaban if participate in the study and eligible for study
Will still do tests to rule out Afib/aflutter etc.
Patient gets initial heads up treatment team about the study

12. DOA Process
cIRB is no longer requiring DoA log changes to be sent for approval
PM is now approving changes
Process
Have “people documents” in hand ready to be uploaded
CV, HSP Training, License, mRS, NIHSS, Protocol & SC Trainings, etc…
Complete modification on DoA log in WebDCU
PM will get notification of DoA log change and will review for approval
Site will receive WebDCU alert that the change has been approved
Site to immediately upload all “people documents”
PM will check WebDCU for documents, review, and approve
After documents are approved the new team member is approved to work on the study

13. fCOI Responsibilities
StrokeNet will only be collecting the fCOI form for the following:
All PIs
Any team member that has a positive disclosure
New Process
Follow your institution’s policy on fCOI and maintain forms at your site
If your institution does not have a policy it is suggested that the fCOI be tracked yearly
If a team member has a positive disclosure, that fCOI form is ed to the PM for submission to the cIRB for review
All PIs will complete the StrokeNet fCOI form yearly and upon start of any new study.
The fCOI form is uploaded into WebDCU for review

14. FAQs
Question: Our patient had a run of SVT on their post-stroke Holter monitor. No evidence of afib or aflutter. Is it OK to enroll?

15. FAQs
Question: Our patient had a run of SVT on their post-stroke Holter monitor. No evidence of afib or aflutter. Is it OK to enroll?
Answer: Yes. Only afib or aflutter on heart-rhythm monitoring is an exclusion.

16. FAQs
Question: The patient’s most recent echo EF was 43%; however, her previous EF history was around 30%. Can we move forward with consenting this patient tomorrow?

17. FAQs
Question: The patient’s most recent echo EF was 43%; however, her previous EF history was around 30%. Can we move forward with consenting this patient tomorrow?
Answer: Yes. As long as EF is 30% or greater and reasonably expected to stay that way. The current value is used to determine eligibility.

18. FAQs Question: How long after stopping Plavix can we start study drug?
Answer:
A. Immediately.
B hours.
C hours.
D. 1 week.

19. FAQs Question: How long after stopping Plavix can we start study drug?
Answer:
B hours (per site PI’s discretion).

26. Feel free to reach out! 24-hour telephone hotline
Please use it for any urgent questions
Eligibility, randomization, unblinding, etc
( AR-CADI): useful to save in your cell phone
The hotline automatically calls the four PIs in succession
Please let it ring
And call back if no luck—one of us will pick up!
Please with non-urgent questions