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: 28 August 2019 12 – 1:00 p.m.
1. Attendance (Laura Bateman)
2. Upcoming calendar of events (Sharon Ramey)
3. Site “readiness” update
a. CTAs (Sharon Ramey)
b. CIRB (Sharon Ramey)
c. Therapist study-certification (process and update) – Stephanie DeLuca
d. Assessor study-certification (process and update) – Jill Heathcock
4. WebDCU update
5. Parent Council update – Amy Darragh
6. Brief reminders about Recruitment and Consenting
7. 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
We will send out Calendar Invites later this week
Most will be on Wednesdays at 12 – 1 p.m. (All PowerPoints loaded onto I-ACQUIRE Website for “Webinars”) – with exception in November (from 3 to 4 p.m.)
Specific dates for remainder of 2019: Sept 25, October 23, November 13, and December 18
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
Ramey and Lo participate in subgroup meetings related to Recovery and Rehabilitation and Pediatrics (Note: there is now a second pediatric study pending review fro StrokeNet– acute treatment)
StrokeNet centers can bring the investigators they would like. Each center is in charge of how they select or fund individuals. If you are interested, speak with you PI(s).

7. Webinar for Research Coordinators about Parent Report Tools
Invitations have been sent to those Research Coordinators at the close-to-ready sites (i.e., CIRB materials pending final approval and other regulatory documents approved)
This will be a one hour review (led by Amy Darragh from OSU at the Assessment Center)
Other webinars will be set up when additional sites are closing to “launching”

8. Webinar for Training in Use of the WebDCU
This will be scheduled closer to the finalization of the I-ACQUIRE WedDCU (scheduled for the 12 October 2019 – or possible earlier)
There will be a training video for this as well
Individual site assistance will be available – if needed – but hopefully the training will be comprehensive and sufficient
One study-specific topic may concern uploading of the clinical MRIs for individual children (some hospitals or clinics may have firewalls or other electronic obstacles). Warren Lo can help you with us.

9. Additional training Webinars for Therapists and Assessors
These are arranged directly with therapists and assessors.
“Office hours” have been available for individual assessors (4 time periods so far)
Any PIs who would like more information about these, please discuss with your research staff and feel free to Stephanie DeLuca at the Treatment Implementation Center or Jill Heathcock at the Assessment Center
PIs are welcome to listen in, if you would like

10. National Meetings Upcoming
Our goal is to take advantage of professional meetings where some of our I-AQCUIRE PIs and other research personnel may be available to hold in-person meetings/get together
American Academy on Cerebral Palsy and Developmental Medicine Association is meeting in Anaheim in September
Child Neurology Society is meeting in Charlotte in October
We have already asked who might be attending and will distribute to you specific dates and times when we will get together
We also will share with you scientific presentations from anyone in I-AQCUIRE at these meetings

11. CTAs and CIRB Updates
CTAs -Baltimore (Kennedy-Kreiger Institute) – Pending, all others approved
Local CIRBS approved: Cincinnati, Chicago, Roanoke
Local CIRBs submitted and responses/final approval still pending: Philadelphia, Houston, San Diego, Columbus, New Haven
HIGH PRIORITY: for all local sites to submit to CIBR (at NCC) their local IRB information. DOES ANYONE NEED HELP? Contacts: Jennifer Golan and Emily (Regulatory Compliance Specialists)

12. I-ACQUIRE Central Personnel changes
Kim Bernstein – new interim I-ACQUIRE Project Manager from National Coordinating Center (NCC) (Teresa Murrell-Bohn resigned effective 16 August 2019)
Yuko Palesch – will be retiring and Catherine Dillion at MUSC will become one of the 3 Multiple Investigators/Co-PIs for the National Data Management Center (NDMC)

13. 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
Next slide shows therapists per site with study-certification thus far
Additional training webinar scheduled – all therapists (even those approved) are asked to join
Individual site mentoring and assistance will be provided

14. 12 Clinical Performing Sites: # of Study-Certified Therapists
Ann Arbor, MI - 3
Baltimore, MD - 0
Boston, MA - 2
Chicago, IL -1
Cincinnati, OH - 0
Cleveland, OH - 0
Columbus, OH - 1
Houston, TX - 0
La Jolla, CA - 0
New Haven, CT - 3
Philadelphia, PA - 1
Roanoke, VA -3

15. Assessment Training and Study-Certification
Model uses self-guided training modules – total time required about 12 hours.
Ideally, most assessors have had considerable standardized assessment experience, including many of the tools in our assessment battery.
Reminders: no treating therapists are assessors; also, each site needs to have plans for maximizing blindness of assessors; every assessment gets scored about possible unblinding (hopefully, very rare).
MAJOR CHANGE: Bayley-4 is being issued 12 September (new kits and admin guidelines on order). Relatively small changes for Motor Items – but many excellent improvements overall. We obtained pre-release of items.
Early review of Inter-rater reliability from local sites indicates a lot more work is needed for many of the assessors.

16. Assessment Training and Study Certification (cont’d)
Electronic office hours (4 sessions held thus far) will continue to be offered
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)

17. WebDCU Update
All CRFs (all of our study assessment and monitoring tools and forms) were finalized and approved.
Standard programming time/checking system takes 8 weeks.
Official date is 12 October 2019.
MUSC is working to see if this possibly can be completed earlier.
Possibility that a few of the most ready-to-launch sites (3 identified) might consent and enroll/randomize prior to the official WebDCU opening date. This may be very helpful to all sites!
Training will be provided for all key staff. PIs must learn about this as they accept final responsibility for all data entered. Training tapes as well as live sessions – and help as needed from MUSC.
Sara Butler is lead contact at MUSC at this time.

18. Parent Council Report
Highly active Parent Council (2 sites still missing representatives)
Working on Format for Quarterly I-AQCUIRE Newsletters for Families
Prepared and distributed to therapists a “Sensitivity training” set of slides
Preparing and will distribute another set of “Sensitivity training” materials for other research staff
Working on design and specific content for a Parent Council Survey – to be administered at end of I-ACQUIRE trial participation. (CRIB will have to approve, of course.) Primary topics are: Feedback on participation in this clinical trial; Information for future scientific studies (how to improve; things to avoid/minimize)

19. Recruitment and Consenting
Being sure all sites are knowledgeable about the option for long distance consenting that involves phone/FAX
All sites should be reaching out to local organizations, providers, advocacy groups to inform them about the trial
As soon as at least 1 site is totally approved for consenting and enrollment, the NIH clinicaltrials.gov website for our trial will indicate it is active in enrollment
NY Times reporter is highly interested in describing the study - purpose, rationale, etc. – and likely to publish news story once enrollment is officially open

20. Q and A session