Monthly Webinar Series June 2019
Today’s Agenda Announcements & Trial Updates Sandi Cassard Recent Enrollments Christina Grabarits Rowing Competition & Top Enroller Christina Grabarits Best Consent Practices Scott Newsome & Ellen Mowry Q&A All
Announcements & Trial Updates SANDI CASSARD
Study Updates – Enrollment THANK YOU to activated sites for continuing to screen and enroll patients! We have 43 sites activated and 196 patients enrolled as of 5/31/19! Please try to find at least 1 new candidate each week so we can accelerate enrollment!!! ______________________________________________________________________________
Study Updates - Reminders 1) Beginning this month, VISION will be generating emails to study coordinators each Monday to remind you to address open queries. 2) Responding to queries in a timely manner helps your site and team in the rowboat challenge! 3) Please save and submit for review any page where you have entered data, made a change or responded to a query. Each page that appears “blue” must be submitted for review so the test tube turns “orange” in order for the page to be monitored. THANK YOU for submitting data and uploading source documents promptly!
LAST CALL! Mt Everest Survey REMINDER: Mt Everest Survey due by Friday June 7 th Shannon Hillery will email the link to the 2 minute survey. Your feedback is extremely valuable in iteratively improving our processes! Thank you for taking the time to fill it out!
Recent Enrollments *AS OF MONDAY 06/03/19
The Rowing Competition CHRISTINA GRABARITS
Rowing Competition Standings
Rowing Competition Standings Site Points 1. Norton Neurology 136 2. UAB 131 Individual Site 3. UFL Gainesville 103 4. Advanced Neuro Spc 102 Competition 5. Christiana Care 94 6. Swedish Health 80 7. U Kansas Med Ctr 76 8. UCLA 67 9. U Washington 63 10. NYU 61
Rowing Competition https://treat.preludedynamics.com
Monthly Randomization Race May’s Top Performers: Site Randomizations Advanced Neurology Specialists 3 University of Alabama at Birmingham 3 Geisinger Clinic 2 University of California at Los Angeles 2 University of Florida Gainesville 2 Norton Neurology 2
May’s Top Enroller: Advanced Neurology Specialists $50
Best Consent Practices SCOTT NEWSOME ELLEN MOWRY
Recruitment Tip and Trends
What motivates you to help make a change?
The Unexpected Journey Due to Multiple Sclerosis
PROMISE For A Better Tomorrow P- perseverance R- reflection O- opportunities M- mentor(s) I- I is not in team S- sacrifice E- enthusiasm
Overview/Reminder of Rationale for TREAT-MS • There is a great unmet need to identify the most appropriate treatment strategy for people with MS, especially early in the disease course when it may be possible to maximize an individual’s chance for preventing long -term disability. • Whether a more aggressive treatment strategy early in MS prevents longer-term disability is not clear. ◦ In particular, whether there are subgroups of MS patients who would benefit more than others is unknown. • Recently published observational studies hint towards early aggressive therapy minimizing disability and conversion to secondary progressive MS vs. traditional • Harmonized some aspects of trial with DELIVER-MS trial for future comparison and data pooling
Best Practices A Quick Review
Not a seat-of-the-pants approach Have a plan Listen to what the high enrollers do
• Huge challenge to reflect in a brochure what motivates people The limits of • Content is limited in what can be said and approved materials • The right opportunity or not? That’s what we need you to do!
Have a written plan and review weekly with checklists/logs What clinic coverage do you have? ◦ Who ◦ Days/hours What schedules and rosters do you have? Who is assigned to reconnoiter? Who is assigned to explain the consent? Who is assigned to follow-up ?
Write it all down in a screening log… and be sure to enter info into VISION if consent provided to someone, who declined, or if trial participation discussed seriously & declined
Recruitment Goals
Goals: 1. Become expert at the three stages of recruitment • Screen records • Eligibility review • Approach for the consent 2. Weekly Screen Commitment 3. Conversion rate = Number of Enrollments
6+ Screens per month Site Expectations Recruitment 4+ Enrollments Plan per month
01 02 03 04 Robust expectation Use your census SCREEN IN PERSON Talk with your site of 22 enrollments numbers to pace DAILY managers regularly per site per year your monthly about your census, performance recruitment activity and • 6 entries into the log capacity • 4 enrollments Base your performance against your census
Clinic: Daily/weekly EMR based methods Screening • EPIC panels /reports • approach • Electronic alerts (leverage colleagues who are existing and add simple seeing new patients trigger) Methods to Consider Clinic: Blitz use of Notification brochures systems • Patient/public • Manual (triage awareness staff, meetings) • Colleague • Automated awareness (EMR, MyChart) Preview appointment schedules • Current week • Future weeks
Fast-paced June goal, needing as much help as possible • Rivalry/rewards system • Recognition goes a long way Coordinated campaign The larger team • You cannot do it alone • Get buy-in • Single voice for TREAT-MS at your site
Recruit colleagues to help refer patients Be available at any time Coordinated campaign Give the patient several methods of contact and get the same from them Early answers lead to enrollment
• Use each patient approached as a learning tool • Identify obstacles to participation in the study and how to overcome them Revisit the plan • Identify words patients may not often understand • Compile an FAQ list • Decide who are the best consenters on your team
-Start chart screening now -Look ahead to ID newly-diagnosed patients scheduled several months out to try to bring them in sooner/when you think trial may be able to launch Potential -Meet regularly with team to Slow start-up, still strategize how you will catch up, Barriers waiting for internal continue to build enthusiasm from logistics, study team, referring colleague etc. -PI should clear some time in schedule to book TREAT-MS patients so can hit ground running -Re-familiarize yourself with protocol, forms, Vision database - Don’t let perfect get in the way of good
-Reach out to referring providers, guaranteeing fast access for newly- diagnosed appointments (can apply for a really strong referring provider for consideration of named authorship) Potential Not too many -Grand Rounds, neurology newly-diagnosed residents Barriers patients being seen -Ensure schedulers aware of goal to prioritize scheduling newly diagnosed patients with site PI -Mention TREAT-MS in local talks, discuss with patients who may be local “leaders” in MS community -Work with local NMSS chapters
Lack of a single voice in favor of considering the TREAT-MS option/Lack of internal referrals Potential Barriers -Review rationale for trial with colleagues regularly -Remind them that the results will greatly inform THEIR OWN clinical practice in the future in an evidence-based fashion
Site PI doesn’t see any/all new referrals/newly-diagnosed patients Potential Barriers -Site PI will need to set up some “non - traditional” clinic hours to open to new patient -Engage colleague at center who IS seeing new patients (remember, s/he may have opportunity for listed authorship)
Patients seem to want a specific medicine when they come in Potential Barriers -Engage patient in dialogue about equipoise -Provide flier; 2+ visits to allow time for consideration of trial -Continue to practice engaging in consideration of trial -Document in VISION if you have seriously discussed TREAT-MS!
Document and Meet Measure review Measure against the Document and review Meet weekly to review census monthly what types of exclusions cases missed you are seeing and why subjects are declining to participate • Exclusions • Refusals • Coverage • Trial promotion and training Monitor Your Recruitment Efforts
Target your goal: Daily discussions in clinic and review of clinic schedules Multimedia: Grand rounds, posters, website, be creative Recruitment Be precise: Clear and direct messaging Tips Timely and responsive: Meet early Measure results: Meet weekly (we don’t have much time) and track what works
Don’t give up!
Recommend
More recommend
