Monthly Webinar Series February, 2019 Todays Agenda - - PowerPoint PPT Presentation

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Monthly Webinar Series February, 2019 Todays Agenda - - PowerPoint PPT Presentation

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Monthly Webinar Series February, 2019 Todays Agenda Announcements/Trial Updates Christina Grabarits Mt. Everest & Rowing Competition Christina Grabarits Top Enroller Christina Grabarits 11 Points for MRI Success Blake Dewey

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Monthly Webinar Series

February, 2019

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Today’s Agenda

Announcements/Trial Updates Christina Grabarits

  • Mt. Everest & Rowing Competition

Christina Grabarits Top Enroller Christina Grabarits 11 Points for MRI Success Blake Dewey Recruitment Tips and Trends Karen Lane Q&A All

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Announcements/Trial Updates

CHRISTINA GRABARITS

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TREAT-MS Trial Study Updates

We now have 34 sites activated and 82 patients enrolled!! 6 more sites have IRB approval! Congratulations to three sites for enrolling 2 patients each in January: Mayo Clinic Swedish Health Services University of Washington Let’s make a big push to enroll 1 patient each week this month! Please reach out for anything we can do to help you!

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Bi-weekly Enrollment Newsletters!

Every 2 weeks sites will be sent enrollment newsletters, breaking down the screening & enrollment progress per site per month. These are a great way to see how your rowing team is doing & how close you are to passing the team ahead of you!

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Monthly Bulletins!

Be on the lookout for the Monthly Bulletins from the Johns Hopkins CCC These Bulletins are full of important trial information & fun facts too! Bulletins are sent our the 3rd week

  • f each month. Print & post copies

around your office or break room & be sure to share copies with your team!

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Save the Date!!!

Next in-person Study Advisory Committee (SAC) meeting will be held in Dallas, TX on February 27, 2019 from 1:30 – 5 pm, preceding the ACTRIMS meeting.

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The Mount Everest Climb

CHRISTINA GRABARITS

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ELEVATION

Mount Everest Contenders

*Not fit to scale

40.5 36.4 32.5

  • 6. Hackensack University Medical Center

25.5 27.7 65.6 30.4

  • 1. RWJ Barnabas Multiple Sclerosis Comprehensive Care Center
  • 5. Oklahoma Medical Research Foundation

23.7 31.1

  • 4. University of Massachusetts Worcester
  • 2. Georgetown University
  • 7. Icahn School of Medicine
  • 8. University of California Los Angeles

23.5

  • 10. University of Michigan

Activated Sites

  • 9. Geisinger Clinic
  • 3. Rush University Medical Center
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Activated Sites

  • 1. Johns Hopkins University
  • 18. University of Louisville
  • 2. Christiana Care
  • 19. Baylor Scott & White Health
  • 3. Advanced Neurology Specialists
  • 20. University of Cincinnati
  • 4. University of Vermont
  • 21. University of Washington
  • 5. New York University School of Medicine
  • 22. Central Texas Neurology Consultants
  • 6. University of Florida Gainesville
  • 23. University of Miami
  • 7. Swedish Medical Center
  • 24. Ohio Health
  • 8. Norton Neurology Services
  • 25. University of Utah
  • 9. University of Alabama at Birmingham
  • 26. University of Maryland
  • 10. University of Rochester
  • 27. Neurology Specialists of Tidewater
  • 11. University of California at San Francisco
  • 28. Dignity Health Sacramento
  • 12. University of Kansas Medical Center
  • 29. Providence Health
  • 13. Columbia Presbyterian
  • 30. Allegheny Health Network
  • 14. Mayo Clinic
  • 31. Billings Clinic
  • 15. University of South Florida Health
  • 32. Massachusetts General Hospital
  • 16. Stony Brook University
  • 33. Cedars Sinai
  • 17. Vanderbilt University Medical Center
  • 34. University of California San Diego
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Rank Activated Sites Final Points

1 Christiana Care 134.5 2 Norton Neurology Specialists 130.9 3 Baylor Scott & White Health 120.3 4 Columbia Presbyterian 112.6 5 Central Texas Neurology Consultants 104.1 6 University of Cincinnati 102.5 7 Dignity Health Sacramento 93.0 8 Allegheny Health Network 91.5 9 University of California San Diego 89.1 10 Advanced Neurology Specialists 85.3

Mount Everest Standings

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The Rowing Competition

CHRISTINA GRABARITS

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Northeast Team G U of Rochester Stony Brook NYU

Rowing Competition Standings

JHU Midwest Team D Baylor Scott & White Health KUMC U of Louisville Norton UFL Gainesville South Team E CentralTx Neuro U of Miami U of South Florida Health Midwest Team C U Cinn Mayo Clinic Ohio Health South Team F UAB U of Maryland Christiana Care Vanderbilt Neuro Spc of Tidewater West Team A Swedish Advanced Neuro Spc U of Utah Providence Billings Clinic Cedars Sinai Northeast Team H U Vermont Columbia Presby Mass Gen Allegheny Health West Team B UCSF U of Washington UCSD Dignity Health

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Individual Site Competition

Site Points

  • 1. Advanced Neurology Spc

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  • 2. Norton

60

  • 3. UFL Gainesville

58

  • 4. Swedish

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  • 5. Christiana Care/ UAB

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  • 6. U Kansas Med Ctr

37

  • 7. NYU/ U of Washington

36

  • 8. Allegheny Health Network

26

  • 9. USouth FL Health

20

  • 10. Mayo Clinic

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Rowing Competition Standings

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Rowing Competition

https://treat.preludedynamics.com

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Activated Sites

*AS OF FRIDAY, 02/01/19

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Recent Enrollments

*AS OF FRIDAY, 02/01/19

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Monthly Randomization Race

January Top Performers:

Site Randomizations

Johns Hopkins University 4 Swedish Medical Center 2 Mayo Clinic 2 University of Washington 2

Total in January 18

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January’s Top Enrollers: Swedish Medical Center Mayo Clinic University of Washington

$50

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TREAT-MS: 11 Points for MRI Success

Blake Dewey

TREAT-MS Image Analysis Group Johns Hopkins University

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#1: Imaging Overview

  • Standard of Care!
  • Billed to Insurance
  • As few changes as possible
  • High quality imaging
  • For you and your patients!
  • A powerful tool for MS observation
  • And for research!

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#2: MRI Manual (v6)

  • Read through the MRI Manual (v6)
  • On treat-mstrial.org
  • Minor changes to file naming in Vision Upload
  • Clarification about Scan Record Email
  • Ask any and all questions!
  • Email us at treatmsimaging@jhmi.edu
  • Send the manual to your MRI team
  • Remember to include our email address!

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#3: Imaging Priorities

  • 1. Consistency, consistency, consistency!
  • Same scanner as 6 month scan
  • 2. 3T Scanner
  • 3. Follow the MRI Guidelines
  • Section 4 of the MRI Manual

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Communicate Early and Often! We are here to help you get great images! treatmsimaging@jhmi.edu

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#4: Imaging Timeline

  • Baseline
  • Doesn’t have to be at TREAT-MS site
  • PLEASE SEND IT ANYWAY!!
  • Month 6
  • After 6-8 months on DMT!!
  • Looking for breakthrough activity
  • Our true “baseline”
  • Yearly follow-ups (12, 24, 36, 48 months)
  • Continued follow-up…

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Baseline Month 48 Month 24 Begin DMT Month 36 Month 12 Month 6

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#5: Re-baseline

  • Not the “Month 6” Scan
  • Ordering an additional baseline scan for comparability
  • Possible reasons to order a re-baseline:
  • 1. Too old (possible activity before DMT)
  • 2. Poor quality (difficult to compare to Month 6)
  • 3. Incomplete (hard to compare/risk stratify)
  • Better evaluation after DMT starts
  • Good way to get “First Patient Option” scan (#8)

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#6: Month 6 Scan

  • Most critical scan to have (and time correctly)
  • Can switch therapy for ANY NEW breakthrough disease AFTER 6 mos.
  • Incorrect timing reduces support for claim of breakthrough disease
  • Timing
  • ≤ 6 months: only able to confirm new lesion after 6 mos. if enhancing
  • 6-8 months: can confirm new lesions by comparing to baseline
  • > 8 months: enhancing lesions must have occurred after 6 mos.
  • New lesions (non-enhancing) can also be compared
  • Advice: If the patient controls scheduling, don’t order until

after 6 mos. on therapy

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#7: Dummy Scan

  • Not every site will perform a dummy scan
  • Healthy control or MS patient
  • Gadolinium only if clinically indicated
  • Still run any post gad scans!
  • Upload to Dummy MRI form for your Site
  • Send an email to treatmsimaging@jhmi.edu to receive

feedback

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#8: The First Patient Option

  • Must be completed before first “Month 6” scan
  • Allows for evaluation and feedback before “true baseline”

Checklist:

1. Email Imaging Group (treatmsimaging@jhmi.edu) that you will be using first patient option, including:

  • MRI Contact Information
  • Print-out from scanner showing protocol (ask MRI team, if unsure)
  • JH Imaging will return any requested changes

2. Include “Dummy Run” in the Scan Record Email for the patient to flag for QA

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#9: Vision Uploads

  • Upload the entire scan!
  • Images, not radiological reports
  • Zip the whole folder
  • Naming convention XXXX-YYY-ZZ.zip
  • XXXX – Site ID
  • YYY – Patient ID
  • ZZ – Baseline ID (00 for baseline, 06 for Month 6, …)

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#10: Scan Record Email

  • Every time a scan is uploaded
  • Template in Appendix D of MRI Manual

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To: treatmsimaging@jhmi.edu From: email@example.com Subject: TREAT-MS Scan Upload Receipt – Scan 0100-010-00 Patient ID: 0100-010 Timepoint: Baseline Date of Scan: 8/1/2018 Imaging Center: Johns Hopkins Outpatient Center Comments: No comments Upload Completed By: Blake Dewey Telephone Number: (301) 555-5346

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#11: Quality - Grey/White Matter (T1)

  • Looking for structural

abnormalities

  • Masses, deformations, etc.
  • Qualitative
  • Differences in tissue sizes
  • Needs GM/WM contrast
  • Quantitative
  • Requires additional processing
  • Atrophy is an important

biomarker for MS

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2D Spin-Echo T1 3D MPRAGE

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#11: Quality - Resolution

  • Nothing is free in MRI
  • Higher resolution:
  • More time
  • Increased noise
  • Resolution is important in MS!
  • Details of the cortex
  • Accurate atrophy measures
  • 3T magnets allow higher

resolution (same noise)

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#11: Quality - Lesions

  • Resolution is crucial for

lesion identification

  • Finding small focal lesions
  • Quantifying lesion volume
  • Determining lesion edges

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Thanks for your attention!

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Recruitment Tips and Trends

KAREN LANE CLINICAL COORDINATING CENTER JOHNS HOPKINS UNIVERSITY

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Treat-MS

Recruitment Tip and Trends

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How are we using our excellent trial materials?

Tell us about your site

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Physician Flyer

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POLL #1: Physician flyers are/were sent to

(check all that apply)

  • a. Community clinicians at activation
  • b. Community clinicians repeatedly

c. Department clinicians at activation

  • d. Department clinicians continuously
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POLL #2: Physician flyers are distributed at rounds and departmental meetings continuously

  • a. Yes, at every meeting
  • b. Yes, occasionally

c. Yes, at activation

  • d. Not yet used this technique
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POLL #3: Physician flyers have been

(check all that apply)

  • a. Printed in numbers >100 copies
  • b. Printed with local team contact info

c. Approved by my local IRB

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POLL #4: Physician Flyers have been effective at my site

  • a. Strongly agree
  • b. Agree

c. Too early to know

  • d. Disagree
  • e. Strongly disagree
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Patient Brochure

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POLL #5: New patients get the patient brochure

(check all that apply)

  • a. With recently diagnosed appointment mailers
  • b. In waiting areas

c. From clinicians during the 1st visit

  • d. After referral to study team
  • e. If requested
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POLL #6: How many patient brochures have you distributed

  • a. None
  • b. Less than 10

c. 11-25

  • d. 25-50
  • e. >50
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POLL #7: New patients may be first aware of the TREAT-MS study when a

(check all that apply)

  • a. Triage nurse hands a brochure in the new

patient kit at MS visit

  • b. Coordinator reviews clinic schedule 1 wk.

ahead & calls the patient c. Coordinator mailing

  • d. Physician during the first appointment
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Deck Card

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POLL #8: Deck cards have been

(check all that apply)

  • a. Sent once to department colleagues
  • b. Continuously put out at rounds/meetings

c. Sent to community clinicians

  • d. Given to residents monthly
  • e. Considered but not yet used
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POLL #9: Deck cards have been

(check all that apply)

  • a. Distributed in numbers >20 copies
  • b. Printed with local contact info

c. Approved by my local IRB

  • d. Considered but not yet used
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Protocol

The treating physician does not have to be the PI!

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Hopkins patient care examples

Providers keep their patients

  • One provider keeps patients
  • Remains the treating physician

Providers transfer patient care

  • Sends all possible candidates to

Ellen or Scott

  • If enrolled, Ellen or Scott

become the treating physician going forward

  • If not eligible, the patient

returns to referring physician

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Results & Call for Your Contributions

Thank you for helping TREAT-MS know more about your recruitment methods. We will tally the trends you just shared and report back to you in March. Send an email with your best tip or suggestion! For instance, have you used MyChart of Cohort ID for screening?

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Thank you and keep going!!

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Your Commitment is KEY!

Activated sites as of 12/11/18 have received this commitment letter from the trial PIs at Johns Hopkins along with this commitment pledge Sign and send back your commitment pledge ASAP

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Sites Returned Commitment Pledge

Site Date Letter Sent to Site Date Signed Letter Received from Site

University of Vermont 11-Dec-18 3-Jan-19 Mayo Clinic 11-Dec-18 4-Jan-19 University of Alabama at Birmingham 12-Dec-18 9-Jan-19

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Sites Pending Return of Commitment Pledge

Site Date Letter Sent to Site Date Signed Letter Received from Site

University of Cincinnati 11-Dec-18 University of California at San Francisco 11-Dec-18 Vanderbilt University Medical Center 11-Dec-18 University of Louisville 11-Dec-18 Baylor Scott & White Health 11-Dec-18 Stony Brook University 11-Dec-18 University of Rochester 11-Dec-18 Swedish Medical Center 12-Dec-18 University of Utah 12-Dec-18 Christiana Care 12-Dec-18 Norton Neurology Services 12-Dec-18 Neurology Specialists of Tidewater 12-Dec-18 Ohio Health 12-Dec-18 University of Florida Gainesville 12-Dec-18

Please sign the commitment pledge, emailed to your site during the second week of December, to secure your dedication to this very important trial!

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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!

March’s Monthly Webinar will be held on the 6th at 3pm and 7th at 9am Eastern