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2 We will begin the MaRISS Coordinator Call shortly Please place your phone line on mute. 8/8/2016 2

3 Overview Consent forms Pre-hospital fluctuation Baseline NIHSS Indicating Mild Stroke on RISS form TOAST 24 hour window for consent CRF Forms Answering GWTG-Stroke Clinical Trial question for MaRISS Patients MaRISS PRO Tool Recruitment update

4 Consent forms Should only be kept in patient chart at your hospital Do not them to University of Miami or AHA

5 Pre-Hospital Fluctuation Form Only select no if there are no fluctuations in medical chart If there is indication of improvement or worsening in ER record/medical chart from i.e. patient, family or healthcare giver, please make sure to note fluctuation on the form. For example: Medical record from ER states that family says patient got worse once symptoms started. When patient was en route in ambulance, paramedic noted patient got better. Upon arrival, patient said they felt better. Patient fluctuation: Worsened, then Improved

6 Pre-hospital Form 8/8/2016 6

7 Post-Hospital Arrival Fluctuation Form Only select no if there are no fluctuations in medical chart If there is indication of improvement or worsening in ER record/medical chart from i.e. patient, family or healthcare giver, please make sure to note fluctuation on the form. For example: Patient baseline NIHSS is 10. At 24 hours, NIHSS is 5. At discharge, NIHSS is 3. Patient improved; thus one fluctuation should be indicated on the form.

8 Post-hospital Arrival Form 8/8/2016 8

9 Baseline NIHSS Date on the form should be date of clinical assessment For example: If patient arrived on April 1, 2016 and consented on April 2, 2016, the date on the form should be April 1, Enter date of clinical assessment The Baseline NIHSS (at hospital arrival and/or at the time of treatment decision) are clinical assessments done as part of the stroke standard of care. The information should be collected AFTER the patient signed ICF but the date should show when the assessment was actually done.

10 Indicating Mild Stroke on RISS Form If patient has a mild stroke and no rapid improvement, please complete RISS Form by writing on form: No rapid improvement since patient had a mild stroke Please complete form and still send to U of Miami.

11 24 hour consent window If it is standard of care at your hospital to conduct the 24 hourr NIHSS, then YES, the MaRISS protocol allows you to consent patients beyond 24 hours of hospital arrival If the NIHSS at 24 hours is NOT standard of care, then a potential MaRISS patient must be consented before 24 hours +/-4 hours, in order to obtain consent and enrollment before 24 hour assessment. MaRISS protocol requires NIHSS at 24 hours +/- 4 hours (from symptom onset) on ALL study subjects.

12 TIAs in MaRISS Upon arrival, if patient is known to have a TIA, the patient is not eligible for MaRISS. If there is suspicion of a TIA or stroke and there is uncertainty, then patient may be eligible for MaRISS. If the final diagnosis is a TIA and you know the cause of the TIA, you can record it in the TOAST. If the final diagnosis was not stroke or TIA, there is no need to document.

13 TOAST Select NOT DOCUMENTED only for cases where the final diagnosis was NOT an Ischemic event In all other cases, please select other options on the form. Use annotations to provide any necessary clarifications or useful information. The Stroke of undetermined etiology option must be selected if the cause of the ischemic event cannot be determined despite having a complete stroke evaluation, or if the cause is not known because the evaluation was incomplete. Select Other determined etiology only if the cause of stroke was found to be one of the specific situations listed under this category in the TOAST classification form (Hypercoagulable state, iatrogenic or artery dissection).

14 MaRISS Data Collection forms Please make sure the version of forms you are using are the MaRISS Data Collection Forms on the: MaRISS Patient Recruitment Page.

15 Answering GWTG-Stroke Clinical Trial question for MaRISS Patients If your hospital is participating in MaRISS and/or ARAMIS studies, please make sure your hospital s Get With The Guidelines -Stroke Abstractor is aware of how to answer the following question in the Get With The Guidelines Patient Management Tool: NOTE: Mild and Rapidly Improving Stroke Study (MaRISS) and Addressing Realworld Anticoagulant Management Issues in Stroke (ARAMIS) are both observational research studies with NO experimental design or intervention and are NOT Clinical Trials. For any MaRISS or ARAMIS Patients who are not enrolled in any other clinical trial, please answer NO for the above question. 8/8/

16 Identifying MaRISS PRO patients Day 1-Day 3 Consent Patient Conduct MaRISS assessments Confirm Eligibility for PRO For each eligible PRO patient MaRISS ID to mariss@heart.org Confirm Day 30, Day 90 process with patient before discharge Identify PRO Patient in PMT Reminders: You still need to do the Day 90 phone call with a PRO patient. The survey is active for 8 days from the time the patient is entered into the HealthCall web portal. Please remember to remind the patient to complete the survey before it expires. Please let us know if you have any questions about the PRO. 8/8/

17 MaRISS Recruitment Goals Overall Goal: 2650 Recruits 6 Recruits per Quarter 2 recruits per Month 100 hospitals recruit from May 2015 to 2017 Each hospital recruits 6 patients every 3 months Each hospital recruits 2 patients per month 17

18 MaRISS Enrollment Current: 325

19 Q & A 8/8/

20 ROLL CALL Please to let us know you attended this coordinator call. MARK YOUR CALENDARS Next MaRISS Coordinator call: Wednesday Aug 24, at 1:30 pm PT / 3:30 pm CT / 4:30 pm ET We will send out the calendar invite today. 8/8/