Overview of Outcomes, Training Process and QA Procedures for ProTECT III

1. Overview of Outcomes, Training Process and QA Procedures for ProTECT III Prepared for the ProTECT Investigator Meeting November 13, 2012 Angela Caveney, Ph.D. University of Michigan Felicia Goldstein, Ph.D. Emory University

2. Site List • Sites reporting to Dr. Goldstein • Arizona • Stanford • UCSF • Emory • Minnesota • Sites reporting to Dr. Caveney • Kentucky • University of Maryland • Henry Ford • Wayne State • Oregon • Temple (including Geisinger, Hershey, Jefferson, Drexel) • Wisconsin • NY Presbyterian Hospital • Cincinnati • UPENN • Texas (Including Houston and Austin sites) • Virginia

3. TBD • Massachusetts General Hospital • The Ohio State University • SUNY Downstate Medical Center • University of California, Los Angeles • University of Pittsburgh

4. Where do I find everything?www.protectiii.com • Investigator Tools • Toolbox Resources (will be asked for ID and Password) • Manual of Operations and Procedures • Appendix 4: CRFs • Appendix 6: Outcomes Manual Other Useful Links -Education (GOSE, DRS, NOS-TBI, and GOAT Training Modules) -FAQ-Neuropsych

5. What are the 6 month outcomes? • Typically Administered by Coordinator • ***Glasgow Outcome Scale – Extended (GOSE) • Neurological Outcome Scale – Traumatic Brain Injury (NOS-TBI) • Disability Rating Scale (DRS) • Galveston Orientation and Amnesia Test (GOAT) - Depending

6. A few comments about initial GOSE, DRS, NOS-TBI and GOAT certification • Who has to get certified? • Anyone who will do the test • Must keep certification active by doing ≥2 every 6 months • Primary Site Investigators (GOSE only) • Can change yourself to “Waived” in WebDCU following initial certification if you will not/no longer administer the GOSE • Primary Site Coordinators (All 4 Certifications) • Can change yourself to “Waived” in WebDCU following initial certification if you will not/no longer administer the GOSE • When should I get certified? • We recommend you wait until about 1-2 months prior to your first outcome visit. • NIHSS 2 years

7. A few MORE comments about initial GOSE, DRS and NOS-TBI certification • Advice? • Don’t take it too early. You will forget what you learned and certification will expire. • Take it seriously • Warning: If you fail, you have to talk to us before you can try again. • We strongly recommend only maintaining certification for the number of people your enrollment can support. One primary and 1 back up is probably good.

8. Test List • Administered by Neuropsychologist/Technician • Galveston Orientation and Amnesia Test (GOAT) • Buschke Selective Reminding Test • Trail Making Test • Grooved Pegboard Test • Digit Span • 6 Month Follow-Up Form • Selective Reminding: 20 + 5 minute delay • Controlled Oral Word Association Test • PHQ-8 • Frontal Systems Behavior Scale (FrSBe): Either Coordinator or NP

9. Emory • Study Coordinator: Obtains Consent to be videotaped; performs GOSE/DRS with patient • NP: Then Administers Tests At the same time, the SC interviews LAR, has them complete FrSBe At end of testing, the SC completes remainder of outcomes (NOS-TBI, etc.).

10. Training and Initial Certification Procedure for all NP Raters • Let Angi or Felicia know who your NP will be at least 2 months before your first 6 month visit • For NP outcomes, primary training was at the October 2010 Outcomes Meeting • New sites’ NPs will need to do the following: • Observe video of meeting • Work with Angi or Felicia on testing procedures (intensity depends on experience with tests)

11. Training and Initial Certification Procedure for all NP Raters (2) • Pass “test out” at site visit or send mock video BEFORE you test your first patient (plan to do this at least 1 month before your first visit to allow for additional practice/submissions) • Dr. Caveney or Goldstein will visit your site as close to your first testing as possible • Receive Testing Certificate • Coordinator uploads this to WebDCU (2 places – also GOAT)

12. Quality Plan (GOSE, DRS and NP) • All Testing will be digitally recorded (ok if patient refuses) • Forms from selected visits will be requested for review • The first 5 visits for each Rater (or more if needed) • A 10% sampling throughout the trial • Recordings, forms and data entry will be reviewed centrally • Feedback will be given for all reviewed tests (even if no errors)

13. Expiration of Certification • If you do not test twice in 6 months, your certification will expire • We will use the dates of May 1st and November 1st as static expiration dates • The first period may be shorter (or longer) for you, depending on when you certify initially • Re-training may also be required if you make repeated errors • If you will not test another patient or will not “test out” a trainee, you can allow your certification to expire • You do not need to re-certify until you need to do testing or training again (but, please plan ahead)

14. Avoiding Expiration of Certification • As May 1 or Nov 1 approach, if you have not done 2 evaluations since the last static expiration date, you can either: • (Includes NP) Test real or “dummy” patients (record) before expiration date • Total of 2 (i.e., do either 1 or 2 more depending on how many you have done so far) OR • (GOSE/DRS only) Re-do online training

15. Retraining • Re-training includes • Observation of videotaped sessions (website) • Additional review of materials • “Test Out” with certified individual (or video submitted to Angi or Felicia) • Potentially additional site visits in a few cases • Common reasons to re-visit a site include • NP Examiner turnover (No one on-site to train, inexperienced new rater) • Past difficulties • Long period of site inactivity

16. Questions? Angela Caveney angif@umich.edu Felicia Goldstein fgoldst@emory.edu