Monthly Webinar Series April 2019
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
Announcements/Trial Updates SANDI CASSARD
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!!! ______________________________________________________________________________
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.
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.
Activated Sites
Recent Enrollments
Poll Results from the March Webinar KAREN LANE CLINICAL COORDINATING CENTER JOHNS HOPKINS UNIVERSITY
Poll #1: Our site employs the following recruitment tactics (check all that apply): 84.2% 73.7% 52.6% A. APPROACH COLLEAGUES DAILY WHO ARE B. PREVIEW APPOINTMENT SCHEDULES FOR THE C. PREVIEW APPOINTMENT SCHEDULES FOR FUTURE SCREENING NEW PATIENTS CURRENT WEEK WEEKS
Poll #2: Our site uses the following (check all that apply): 77.3% 36.4% 22.7% 13.6% A. AUTOMATED NOTIFICATION B. MANUAL NOTIFICATION SYSTEMS C. EPIC PANELS/REPORTS D. ELECTRONIC ALERTS SYSTEMS (EMR, MYCHART) (TRIAGE STAFF, MEETINGS)
Poll #3: We have a written recruitment plan 72.7% 27.3% A. YES B. NO
Poll #4: Our site has been using a screening log 78.9% 21.1% A. YES B. NO
Poll #5: Our team meets weekly 65.2% 34.8% A. YES B. NO
SAC Meeting Recruitment Ideas SANDI CASSARD
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).
SAC Meeting Recruitment Ideas 1) “Advertising / Networking” Ideas 2) Suggestions for Visit Logistics 3) After Randomization Tips
“Advertising / Networking” Ideas o M ake Grand Rounds announcements o Hang IRB-approved provider flyer in clinic and resident lounges o Provide trial information to Neuro-hospitalists, Neurology Residents, Advanced Practice Providers, General Neurologists, Ophthalmologists, Neuro-ophthalmologists o Provide personal contact info to referring MDs for new MS patients
“Advertising / Networking” Ideas o Train clinical staff who answer phone for center/practice to triage newly-diagnosed MS patients for consideration of early appointment o Engage nurses to educate patients about MS, treatment options, trial
Visit Logistics Suggestions o Prescreen patients before clinics o 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 o Protect time for fast intake of newly diagnosed patients
Visit Logistics Suggestions o 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) o Presume that it will be on second (or third) visit that patients will be ready to hear seriously about DMTs and possible participation o Have all members of team (e.g. EDSS, MSFC) on call at second visit to see patient if consents
After Randomization Tips o Patient Randomized to Higher-efficacy Medication Class o 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)
Tips from our Highest Enrolling Site (Norton Neurology MS Services) o Review enrollment goals at monthly MS Team meeting with providers, medical assistants and ancillary staff o 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 o TREAT-MS brochures available in all exam rooms o 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.
The Rowing Competition CHRISTINA GRABARITS
Rowing Competition Standings JHU
Rowing Competition Standings Site Points 1. Norton Neurology/ UAB 100 2. UFL Gainesville 68 Individual Site 3. Advanced Neurology Spc 67 4. Christiana Care 65 Competition 5. Swedish 61 6. U Kansas Med Ctr 59 7. NYU 54 8. U Washington 48 9. Mayo Clinic 45 10. Allegheny 43
Rowing Competition https://treat.preludedynamics.com
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
March’s Top Enroller: Univ iversit ity of f Ala labama at t Birm Birmin ingham $50
The Mount Everest Awards Ceremony CHRISTINA GRABARITS
Fastest sIRB Approval
Fastest Contract Completion
Fastest Training Completion
Mount Everest Winners
Third Place
Second Place
First Place
$300 Luncheon
Thank you for all of your hard work in reaching the summit!
Op Open en fo for Q r Que uest stio ions ns
Thank You for attending today’s webinar! Encore tomorrow at 9 AM EST! May’s Monthly Webinar will be held on the 1 st at 3 PM and 2 nd at 9 AM EDT
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