1. I-ACQUIRE Webinar for Site PIs and Study Coordinators
Sharon Ramey and Warren Lo, I-ACQUIRE PIs
Stephanie Deluca and Craig Ramey, Directors for the Treatment Implementation Center
Jill Heathcock and Amy Darragh, Directors for the Assessment Center

2. Agenda for Monthly I-ACQUIRE Webinar: 25 September 2019 12 – 1:00 p.m.
1. Upcoming calendar of events (Sharon Ramey)
2. Therapist study-certification (process and update) – Stephanie DeLuca
3. Assessor study-certification (process and update) – Jill Heathcock
4. Parent Council update – Amy Darragh
5. Overview of Site Readiness Conference calls– Sharon Ramey
6. Q & A (Warren Lo)

3. 12 Clinical Performing Sites
Ann Arbor, MI
Baltimore, MD
Boston, MA
Chicago, IL
Cincinnati, OH
Cleveland, OH
Columbus, OH
Houston, TX
La Jolla, CA
New Haven, CT
Philadelphia, PA
Roanoke, VA

4. I-ACQUIRE Calendar Updates

5. I-ACQUIRE Monthly Calls for PIs & Study Coordinators
Specific dates for remainder of 2019:
Wednesday 23 October (12-1pm EST)
Wednesday 13 November (3-4pm EST)
Wednesday 18 December 18 (12-1pm EST)
All PowerPoints loaded onto I-ACQUIRE Website for “Webinars”
Very important to have at least one lead representative and for that person to communicate with others at the local sites about any new information

6. Annual StrokeNet Meeting
To be held in Atlanta on Tuesday 29 October 2019 (all day)
Sharon Ramey and Warren Lo will present update on I-ACQUIRE
Joe Broderick emphasized that our shared goal is have at least several sites with subjects enrolled and being treated by then
Warren Lo has been appointed to the Recovery and Rehabilitation Committee

7. Child Neurology Society Meeting Upcoming
Child Neurology Society is meeting in Charlotte, NC October 2019
There will be an I-ACQUIRE meeting FRIDAY 25 October from 12:30 – 1:30pm; Room number TBD; Dr Lo will be available for site specific questions and to answer any questions or concerns
Poster #244 “A Multisite Blinded Comparative Efficacy Trial of CIMT Dose Levels and Constraint Variations for 2 – 8 Year Olds with Hemiparetic Cerebral Palsy” will be displayed in the Exhibit Hall (Wednesday 6:00pm – 7:30PM, Thursday 11:30am – 6:00pm, Friday 7:00am – 10:30am)

8. Webinar for Research Coordinators about Parent Report Tools
Research Coordinators either attended or have been invited to view a recording of an Parent Measure Overview on August 23rd. That webinar covered parent measures, and how to facilitate parent completion.
An additional webinar is scheduled on September 26th to review scoring procedures for the IMAL and the MacArthur Bates.
This will be a one hour review (led by Amy Darragh and Angela Rittler from OSU at the Assessment Center)

9. Therapist Study-Certification Process
In July, all sites submitted scoring from distributed videotapes. Therapists apply the Fidelity of I-ACQUIRE Tool to the videotapes to identify deviations as well as acceptable treatment-compliant therapist-child interactions
First round of assessments resulted in 60% approved, 40% needing additional training and re-submission of materials
After second webinar training – 81% of all trained therapist now meet study certification
Houston – has completed training but not fidelity (study certification) process
91% of therapists who have completed training and study certification have met criteria
2 Therapists will have individualized assistance and further training

10. 12 Clinical Performing Sites: # of Study-Certified Therapists
Ann Arbor, MI - 3
Baltimore, MD – 2
Boston, MA - 2
Chicago, IL - 2
Cincinnati, OH - 2
Cleveland, OH - 0
Columbus, OH - 2
Houston, TX - 0
La Jolla, CA – 2
New Haven, CT - 3
Philadelphia, PA - 2
Roanoke, VA - 3
Second Therapist Training Dec. 3rd-6th, 2019 – Open to any site who would like to have additional therapist trained, at site expense, with the exception of Cleveland, OH

11. Assessment Training and Study-Certification
2 blinded assessors are study certified
Model uses self-guided training modules
total time is reported at 6 – 20 hours (somewhat higher than anticipated); GMFM
*Ideally, most assessors have had considerable standardized assessment experience, including many of the tools in our assessment battery.
MAJOR CHANGE: Bayley-4 has been shipped!
Ann Arbor, Houston and La Jolla – did you get yours?
Early and continuing review of Inter-rater reliability from local sites indicates a lot more work is needed for many of the assessors.

12. 12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (GMFM)
Ann Arbor, MI - 2
Baltimore, MD - 0
Boston, MA - 0
Chicago, IL - 0
Cincinnati, OH - 1
Cleveland, OH - 1
Columbus, OH - 3
Houston, TX - 0
La Jolla, CA - 0
New Haven, CT - 0
Philadelphia, PA - 1
Roanoke, VA - 1

13. 12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (Bayley)
Ann Arbor, MI -
Baltimore, MD - 0
Boston, MA - 0
Chicago, IL - 0
Cincinnati, OH -
Cleveland, OH - 0
Columbus, OH - 2
Houston, TX - 0
La Jolla, CA - 0
New Haven, CT - 0
Philadelphia, PA - 0
Roanoke, VA - 1

14. 12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (with a child)
Ann Arbor, MI - 0
Baltimore, MD - 0
Boston, MA - 0
Chicago, IL - 0
Cincinnati, OH -
Cleveland, OH - 0
Columbus, OH - 3
Houston, TX - 0
La Jolla, CA - 0
New Haven, CT - 0
Philadelphia, PA - 0
Roanoke, VA - 0

15. Assessment Training and Study Certification (cont’d)
Welcome session
Electronic office hours (4 group sessions)
Individual contact with assessors is active and ongoing
Goal: that most sites will be study-certified for assessors by end of October
Reminders: All assessment sessions are videotaped in full; the tapes are sent to OSU for centralized review and for scoring for two of the outcome-related measures – namely, the Emerging Behaviors Scale (EBS) and the Use of the Hemiparetic Upper Extremity in Bimanual Activities (from the Mini AHA structured play session)

16. Parent Council Report Highly active Parent Council
Invitations extended to parents from 2 additional sites
Preliminary Quarterly I-AQCUIRE Newsletter completed – forwarded to study investigators for review
Preliminary Parent Survey topics complete and will now be sent to Craig Ramey and Amy Darragh to transform into survey questions
Sensitivity Training ed to Research Coordinators and Assessors

17. Site Readiness Calls – Sample form

18. CTAs and CIRB Updates
CTAs -Baltimore (Kennedy-Kreiger Institute) – Pending, all others approved
CIRBs approved: Chicago, Cincinnati, Columbus, Houston, New Haven, Philadelphia, and Roanoke
CIRBs submitted – approval pending: Ann Arbor, Boston
CIRB submitted - site response pending: La Jolla
DOES ANYONE NEED HELP? Contacts: Jennifer Golan and Emily Stinson (Regulatory Compliance Specialists)

19. Site Readiness Calls Ann Arbor, MI – Pending CIRB approval
Baltimore, MD – Pending executed CTA; Pending submission of CIRB packet
Boston, MA – Pending CIRB approval
Chicago, IL – Scheduled 9/30
Cincinnati, OH – Scheduled 9/30
Cleveland, OH - Pending submission of CIRB packet
Columbus, OH – Scheduled 10/4
Houston, TX – Scheduling in process
La Jolla, CA - Pending CIRB approval
New Haven, CT – Scheduled 10/10
Philadelphia, PA - Scheduling in process
Roanoke, VA - Completed 09/13

20. Q and A session