Monthly Webinar Series June 2019 Todays Agenda Announcements - - PowerPoint PPT Presentation

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

• rder 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 7th 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

Individual Site Competition

Site Points

• 1. Norton Neurology

136

• 2. UAB

131

• 3. UFL Gainesville

103

• 4. Advanced Neuro Spc

102

• 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 Standings

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

Have a plan

Not a seat-of-the-pants approach Listen to what the high enrollers do

The limits of materials

That’s what we need you to do!

• Huge challenge to reflect in a brochure what

motivates people

• Content is limited in what can be said and

approved

• The right opportunity or not?

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

• 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

Goals:

Site Expectations

6+ Screens per month 4+ Enrollments per month Recruitment Plan

Base your performance against your census

Robust expectation

• f 22 enrollments

per site per year

01

Use your census numbers to pace your monthly performance

• 6 entries into the log
• 4 enrollments

02

SCREEN IN PERSON DAILY

03

Talk with your site managers regularly about your census, recruitment activity and capacity

04

Screening Methods to Consider

Clinic: Daily/weekly

• approach

colleagues who are seeing new patients Clinic: Blitz use of brochures

• Patient/public

awareness

• Colleague

awareness

Preview appointment schedules

• Current week
• Future weeks

Notification systems

• Manual (triage

staff, meetings)

• Automated

(EMR, MyChart) EMR based methods

• EPIC panels /reports
• Electronic alerts (leverage

existing and add simple trigger)

Coordinated campaign

Fast-paced June goal, needing as much help as possible

• Rivalry/rewards system
• Recognition goes a long way

The larger team

• You cannot do it alone
• Get buy-in
• Single voice for TREAT-MS at your

site

Coordinated campaign

Recruit colleagues to help refer patients Be available at any time Give the patient several methods of contact and get the same from them Early answers lead to enrollment

Revisit the plan

• ften
• Use each patient approached as a

learning tool

• Identify obstacles to participation

in the study and how to overcome them

• Identify words patients may not

understand

• Compile an FAQ list
• Decide who are the best

consenters on your team

Potential Barriers

Slow start-up, still waiting for internal logistics, study team, etc.

• Start chart screening now
• Look ahead to ID newly-diagnosed

patients scheduled several months

• ut to try to bring them in

sooner/when you think trial may be able to launch

• Meet regularly with team to

strategize how you will catch up, continue to build enthusiasm from referring colleague

• 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

Potential Barriers

Not too many newly-diagnosed patients being seen

• 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)

• Grand Rounds, neurology

residents

• 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

Potential Barriers

Lack of a single voice in favor of considering the TREAT-MS

• ption/Lack of internal

referrals

• 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

Potential Barriers

Site PI doesn’t see any/all new referrals/newly-diagnosed patients

• Site PI will need to set up some

“non-traditional” clinic hours to

• pen to new patient
• Engage colleague at center who

IS seeing new patients (remember, s/he may have

• pportunity for listed authorship)

Potential Barriers

Patients seem to want a specific medicine when they come in

• 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!

Monitor Your Recruitment Efforts

Meet

Meet weekly to review cases missed

Measure

Measure against the census monthly

Document and review

Document and review what types of exclusions you are seeing and why subjects are declining to participate

• Exclusions
• Refusals
• Coverage
• Trial promotion and training

Recruitment Tips

Target your goal: Daily discussions in clinic and review of clinic schedules Multimedia: Grand rounds, posters, website, be creative Be precise: Clear and direct messaging Timely and responsive: Meet early Measure results: Meet weekly (we don’t have much time) and track what works

Don’t give up!

Lessons Learned and Keys to Success

Spread the TREAT-MS Equipoise love Know site specific barriers and consider different workflows/hybrid workflows Work with central schedulers/triage to funnel potential TREAT-MS new patient referrals Consider blocking off time on non-clinic days as extra time goes a long way (perks of “add-on” model) Important to stress no extra visits above what they would do anyway (we tack on the research-specific activities to usual clinical visits) Treating clinician is not exclusive to PI Reach out to colleagues/typically referring clinics (send brochures) Don’t have to complete everything in one visit

Consent

Using an Informed Consent Self- Evaluation Checklist

A new approach to talking with prospective participants about enrollment in a clinical trial Emphasis on a sequenced approach: Patient/family understanding

• f the disease

Discussion of current standard treatment Possibility of a clinical trial Eder M, Yamokoski A, Wittmann P, Kodish E. Improving informed consent: Suggestions from parents of children with

• leukemia. Pediatrics 2007;119

Why is consent refused?

When a patient said no, what was the reason? Did you know a “no” was coming before it was said? Have you parsed the refusals to develop better talking points?

Do you have talking points for emotional overload?

Sadness/depression Anger Fear Denial

Diagnosis

Shock Unable to process Unknowns Confused Need for more support

Clinical Trial

More people to interact with

Slide courtesy of Jeff Belkora, PhD, UCSF in collaboration with CISN

Cognitive Overload?

Family Concerns Financial Worries Treatment Choices Employment Concerns

Diagnosis

Standard vs. Study Confidentiality Risks/Benefits Randomized

Clinical Trial

Slide courtesy of Jeff Belkora, PhD, UCSF in collaboration with CISN

Physical Overload?

Demands on time Day Care Needs Career demands

Diagnosis

Other Family Commitments Travel Days off Scheduling issues

Clinical Trial

Extra appointments

Slide courtesy of Jeff Belkora, PhD, UCSF in collaboration with CISN

Best Consent Elements

Recognize that there are two elements

• Informing
• Consenting

Simple terms Impressions are everything! Have a plan and be prepared with materials Sit down! Know the protocol & talking points Take your time

Sit Down

• A study showed that patients

view physicians as more compassionate when they sit

• down. Journal of Pain and

Symptom Management 489 Vol 29 No 5 May 2005

• Be prepared to spend a

considerable amount of time

• n the “informing” aspect of

the consent process

Communication

Communication Techniques

Provide an empowering environment by inviting the prospective participant to select who will attend this discussion. Increase your prospective participant’s ability to focus on the discussion by holding the meeting in a private location without interruptions. Communicate respect and the importance of this meeting by acknowledging trauma of diagnosis (if appropriate) and empathizing with emotional reactions. Simplify information by avoiding medical jargon and a laundry list of medications and side effects. Summarize

• ften, and repeat important points.

Invite them to make comments or ask questions at any time, and encourage them to share their thoughts and feelings. Tell them that all questions are good questions.

Communication Techniques Cont.

Stress the importance of information-seeking and elicit questions in an open-ended manner. (“What questions do you have?”) Avoid interrupting. Check that questions were answered to your patients’ satisfaction. Talk about how disease treatments have improved over time due to clinical research and participation of patients in clinical trials/studies. Avoid pushing the recommendation of clinical trial at initial encounter, but if asked, respond accordingly.

Improving Disclosure to Increase Potential Participant Understanding

Follow the sequence of 1) explain disease, 2) describe current best proven treatment, and 3) present option of the clinical trial. Assure that the potential participant has good comprehension of each step before moving to the next one. Break the informed consent conference into two separate meetings if your patient would prefer this or if you think two sessions would help enhance understanding. Use the consent document as a communication tool by providing copies, encouraging reading, and referring to sections of the document during the conference. Discuss treatment options outside of the clinical trial and explain how the study differs from current standard treatment. Explain at least three times that trial participation is voluntary.

Improving Disclosure to Increase Potential Participant Understanding

Explain the right to withdraw at any time. For randomized trials, use examples to clarify the randomization process and avoid potentially misleading descriptions (for instance, a computer randomly assigns alternative treatments). Use a diagram to show differences among the randomization groups of the trial. Discuss any potential conflict of interest you may have as an investigator. Be prepared to give an answer if the prospective participant asks if you personally would enroll in the trial, or if you would advise one of your family members to enroll.

Open-ended conversations

• Target the right person
• Avoid leading questions
• Probe issues in depth

Open-ended questions encourage conversation, not one-worded answers

OPEN

What are your thoughts about the option of entering into the TREAT-MS trial?

CLOSED

Are you interested in learning about the TREAT-MS trial as an

• ption? (choices, limited)

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

Thank You for attending today’s webinar!

Encore tomorrow at 9 AM EDT!

July’s Monthly Webinar will be held on the 10th at 3 PM and 11th at 9 AM EDT