Patient Patient RecruitmentRecruitment

Thomas Devlin, MD PhDThomas Devlin, MD PhDErlanger Southeast Regional Stroke CenterErlanger Southeast Regional Stroke Center

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Figure 3.Figure 3.Erlanger Total Stroke Volume 2004 - Erlanger Total Stroke Volume 2004 - 20102010

1357

1118

1271

t-PA NINDS: 3 Hour WindowBenefit Vs Harm

• For every 8 patients treated, 1 benefits. For every 8 patients treated, 1 benefits.

• For every 16 treated, 1 is harmed by ICH. For every 16 treated, 1 is harmed by ICH.

• For every 34 treated, 1 dies of ICHFor every 34 treated, 1 dies of ICH..

• Thus for every 4 pts who benefit 1 pt diesThus for every 4 pts who benefit 1 pt dies..

ECASS 3: 3 - 4.5 hours: good outcome in ECASS 3: 3 - 4.5 hours: good outcome in only 7% (52% vs. 45%) only 7% (52% vs. 45%)

Know What to SaySad Reality of Current Stroke Treatment:Sad Reality of Current Stroke Treatment:

3 - 5% of Acute Strokes receive IV t-PA

Most stroke patients present past 3 hours. The # of Interventional Centers limited. No substitute for revascularization.

Desperately need a lytic, longer window, which can be given anywhere, with placebo data.

THE MOST IMPORTANT STROKE STUDY

Public Awareness: GET OUT OF THE HOSPITAL

- Publicize the extended time windows.- Health Screenings - Health Fairs- Media is Free Advertisement

“1 Major Story per Month” Synergy between trials.

“Stop Stroke Saturday”- Patient stories.

Rotary Club. Engage Community Leaders.

Pre Hospital - EMS

• Frequent EMS Meetings – Onsite & Frequent EMS Meetings – Onsite & Webinars Webinars (60% pts from EMS directly)(60% pts from EMS directly)

• Clinical trial training – PR talk. Clinical trial training – PR talk. • Monthly Newsletters – get emails Monthly Newsletters – get emails

• Hold them in the ER – give pt f/u.Hold them in the ER – give pt f/u.

• Know all Air Medical CompaniesKnow all Air Medical Companies

Transfer Center – OneCall System

• ““8100” call - > Neuro phone consult Stat.8100” call - > Neuro phone consult Stat.• – – No Divert – Auto Launch No Divert – Auto Launch

• Affable and AvailableAffable and Available• ? IV tPA? IV tPA• ? Neurointervention? Neurointervention• ? Clinical Trial? Clinical Trial

• EVERY CALL IS A MARKETING OPPORTUNITY!!!!!!EVERY CALL IS A MARKETING OPPORTUNITY!!!!!!• Get email address for monthly newsletterGet email address for monthly newsletter• F/U with Patient Outcomes/ get cell phonesF/U with Patient Outcomes/ get cell phones

Network HospitalsNetwork Hospitals• 55 hospitals of various Levels of

sophistication• Form a Strategic Plan to visit hospitals• PAX Network• Monthly Newsletters• Share Protocols• Affiliation Agreements• Telemedicine

Organizing the Emergency Department and Imaging Services

•Summary Trial List on Wall.

•Stoke Alert Pager (alerts all support staff)

•ER MD: MUST Do NIHSS and Read CTA-P

•Physician Stroke Pager (call before CT)

•Residents not involved in key decisions

•Treatment Pathways Very Complicated.

Enrollment Aids

• Yahoo Web site – Powerpoint Summary of I/E

• IPHONE Pics of All I/E Criteria for each trial “PhotoFolders”

• Enrollment books and labeled central lab tubes in ER with clear instructions.

• Have all STAT phone number on your phone.

• Treat Coordinators like GODS!

Patient Throughput

•Determine roadblocks for enrollment (? $)•CT issues (who reads and when).•Repeat CT scans (1 hr plain, 2 hrs CTA)•Remember the DOC PUSHES THE DRUG!•Teach the lab staff what you expect.•Talk to the ICU RN – clear order sets.•Don’t use the tube system for ICU blood.

Make your PI practice the entire study himself.

• BEWARE FDA - Clinical Trial Work is Serious Business• Knowledge is Power – Get certified!• DIAS 4 needs Clean Data – Lives and $$$ are at stake.

STROKE Research Takes Commitment!

As a Team We Can Make History