Monthly Webinar Series April 2019 Todays Agenda - - PowerPoint PPT Presentation

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Monthly Webinar Series April 2019 Todays Agenda - - PowerPoint PPT Presentation

Monthly Webinar Series April 2019 Todays Agenda Announcements/Trial Updates Sandi Cassard March Polling Results Karen Lane SAC Meeting Recruitment Ideas Sandi Cassard Rowing Competition and Top Enroller Christina Grabarits Mt Everest


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Monthly Webinar Series

April 2019

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Today’s Agenda

Announcements/Trial Updates Sandi Cassard March Polling Results Karen Lane SAC Meeting Recruitment Ideas Sandi Cassard Rowing Competition and Top Enroller Christina Grabarits Mt Everest Awards Ceremony Christina Grabarits Q&A All

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Announcements/Trial Updates

SANDI CASSARD

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Study Updates – Enrollment

THANK YOU to activated sites for continuing to screen and enroll patients! We now have 43 sites activated and 139 patients enrolled as of 4/1/19! March was our best enrollment month to date and we hope April will be even stronger! Please try to find at least 1 new candidate each week so we can accelerate enrollment!!!

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Study Updates - Reminders

1) When consenting patients for the trial, please document the consent process, as detailed in the protocol and MOP, and upload signed consent form and completed DOC process form to VISION database under Source Docs tab, item # 10. 2) PLEASE ENTER VISIT DATA WITHIN 1 WEEK OF THE VISIT AND UPLOAD PDFs of SOURCE DATA SO WE CAN MONITOR THE DATA! We need all visit CRFs to verify the data. CRFs may be scanned as a single PDF, if preferred, and uploaded under Source Docs tab, item # 9.

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Study Updates - Reminders

3) Please see study website for most up-to-date case report forms (CRFs), including version 2.0 for many of the baseline CRFs. Please ensure EDSS examiners use our study’s EDSS CRFs and NOT the neurostatus form. 4) Please capture MS Signs and Symptoms experienced by the patient at the baseline visit. Then, at follow-up visits, only create new entries if new or worsening signs and symptoms are reported. Do not change the baseline signs and symptoms already captured, and do not provide data related to resolution of symptoms. Please reach out to Sandi (scassar1@jhmi.edu) or Madiha (mqutab1@jhmi.edu) if you have questions.

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Activated Sites

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Recent Enrollments

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KAREN LANE CLINICAL COORDINATING CENTER JOHNS HOPKINS UNIVERSITY

Poll Results from the March Webinar

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52.6% 84.2% 73.7%

  • A. APPROACH COLLEAGUES DAILY WHO ARE

SCREENING NEW PATIENTS

  • B. PREVIEW APPOINTMENT SCHEDULES FOR THE

CURRENT WEEK

  • C. PREVIEW APPOINTMENT SCHEDULES FOR FUTURE

WEEKS

Poll #1: Our site employs the following recruitment tactics (check all that apply):

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36.4% 77.3% 13.6% 22.7%

  • A. AUTOMATED NOTIFICATION

SYSTEMS (EMR, MYCHART)

  • B. MANUAL NOTIFICATION SYSTEMS

(TRIAGE STAFF, MEETINGS)

  • C. EPIC PANELS/REPORTS
  • D. ELECTRONIC ALERTS

Poll #2: Our site uses the following (check all that apply):

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27.3% 72.7%

  • A. YES
  • B. NO

Poll #3: We have a written recruitment plan

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78.9% 21.1%

  • A. YES
  • B. NO

Poll #4: Our site has been using a screening log

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65.2% 34.8%

  • A. YES
  • B. NO

Poll #5: Our team meets weekly

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SAC Meeting Recruitment Ideas

SANDI CASSARD

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SAC Meeting Recruitment Ideas

The in-person Study Advisory Committee (SAC) was held in late February and we want to thank all investigators and stakeholders who participated! Ideas to improve recruitment were shared and we have begun to implement some of them:

  • NMSS sent another trial alert email to new states with activated sites on

3/27/19 and many patients across the country have been reaching out to learn more!

  • We added a map to our trial website showing cities/states with participating

sites, as well as a state by state listing of sites, PIs and lead coordinators.

  • We are exploring with the CMSC an outreach effort aimed at private

practice neurologists and clinicians who may refer to the trial (utilizing our IRB approved provider flyer).

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SAC Meeting Recruitment Ideas

1) “Advertising / Networking” Ideas 2) Suggestions for Visit Logistics 3) After Randomization Tips

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“Advertising / Networking” Ideas

  • Make Grand Rounds announcements
  • Hang IRB-approved provider flyer in clinic and resident

lounges

  • Provide trial information to Neuro-hospitalists, Neurology

Residents, Advanced Practice Providers, General Neurologists, Ophthalmologists, Neuro-ophthalmologists

  • Provide personal contact info to referring MDs for new MS

patients

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“Advertising / Networking” Ideas

  • Train clinical staff who answer phone for center/practice

to triage newly-diagnosed MS patients for consideration of early appointment

  • Engage nurses to educate patients about MS, treatment
  • ptions, trial
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Visit Logistics Suggestions

  • Prescreen patients before clinics
  • Look far ahead to patients booked out to see if you can ID

those who look to be treatment-naïve RRMS and offer earlier appointments

  • Protect time for fast intake of newly diagnosed patients
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Visit Logistics Suggestions

  • Create an automatic 2 to 4-week follow-up appointment for

patients when they are scheduling a new patient appointment as a possible MS diagnosis (cancel if not needed)

  • Presume that it will be on second (or third) visit that patients will

be ready to hear seriously about DMTs and possible participation

  • Have all members of team (e.g. EDSS, MSFC) on call at second

visit to see patient if consents

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After Randomization Tips

  • Patient Randomized to Higher-efficacy Medication Class
  • Concerns about ocrelizumab approval:
  • Use Genentech Access to Care after first denial to secure

medication

  • Example Letters of Medical Necessity / References

Found on http://treat-mstrial.org (Documents tab)

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Tips from our Highest Enrolling Site (Norton Neurology MS Services)

  • Review enrollment goals at monthly MS Team meeting with providers, medical assistants and

ancillary staff

  • PI implemented “fast track” appt scheduling for new MS referrals; PI reviews records before

scheduled visit and notifies study coordinator when patient may meet I/E criteria. Medical assistant ensures all records are available at time of office visit so no information related to study participation is missing. PI personally introduces study opportunity to patient and provides patient/family an opportunity to meet with research coordinator to discuss study participation

  • TREAT-MS brochures available in all exam rooms
  • Coordinator updates ancillary providers (MS Nurse Navigator, MS Pharmacist) weekly on newly

diagnosed study patients

This site is fortunate to have great communication between the research team and the clinical staff and most importantly, the site PI advocates for research and improving patient outcomes.

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The Rowing Competition

CHRISTINA GRABARITS

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Rowing Competition Standings

JHU

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Individual Site Competition

Site Points

  • 1. Norton Neurology/ UAB

100

  • 2. UFL Gainesville

68

  • 3. Advanced Neurology Spc

67

  • 4. Christiana Care

65

  • 5. Swedish

61

  • 6. U Kansas Med Ctr

59

  • 7. NYU

54

  • 8. U Washington

48

  • 9. Mayo Clinic

45

  • 10. Allegheny

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Rowing Competition Standings

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Rowing Competition

https://treat.preludedynamics.com

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Monthly Randomization Race

March’s Top Performers:

Site Randomizations

University of Alabama at Birmingham 6 University of California at Los Angeles 4 University of Kansas Medical Center 4 Christiana Care 3

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March’s Top Enroller: $50

Univ iversit ity of f Ala labama at t Birm Birmin ingham

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The Mount Everest Awards Ceremony

CHRISTINA GRABARITS

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Fastest sIRB Approval

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Fastest Contract Completion

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Fastest Training Completion

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Mount Everest Winners

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Third Place

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Second Place

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First Place

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$300 Luncheon

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Thank you for all of your hard work in reaching the summit!

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Op Open en fo for Q r Que uest stio ions ns

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Thank You for attending today’s webinar!

Encore tomorrow at 9 AM EST!

May’s Monthly Webinar will be held on the 1st at 3 PM and 2nd at 9 AM EDT