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Children’s National Health SystemWashington, DC
Who we are: Our Research Coordinators
Victor Chatain•Full time RC splitting time between PECARN and non-PECARN studies. •Primary RC of ASSESS Study and HITS for Kids•Staggered monthly schedule: 10 hours days and every weekend
Niall Cochrane•Full time RC splitting time between PECARN and non-PECARN studies. •Primary RC of VP Shunt and PPASS Studies•Staggered monthly schedule: 10-hour days and every weekendSomaiah Ahmed•Full time PECARN RC•Primary RC of DKA and NonDKA Studies•Staggered monthly schedule: 10-hour days and every weekend
Joanna Westerfield•Full time PECARN RC•Primary RC of Probiotics and ESETT Studies•Staggered monthly schedule: 10-hour days and every weekend
Who we are: Our PIs and Management
Shireen Atabaki, MD, MPH
HEDA, Pending Biosignatures, REST
Concussion
James Chamberlain, MD
WBCARN Nodal PI, Registry, Pending:
ESETT
Kathleen Brown, MD
HEDA PI: FLUID, ASSESS, Pending:
ESETT
Bobbe Thomas, CCRP
Nodal Manager
Kate Shreve, MPHNodal Administrator
Karen O’Connell, MD, FAAPHEDA PI: Probiotics
Kemi Badaki, MDMAGiC PI
Stephen Teach, MDED STARRS PIShilpa Patel, MD
ED STARRS PI
• Student interns hired are typically undergraduate or medical students.
• All interns are trained to screen, consent, collect samples, enter and extract patient information from the EMR for all PECARN studies.
• Interns have the opportunity to shadow physicians, attain recommendations, and explore other available educational/research opportunities in the hospital.
• Year-round Program– Semester based– Have the possibility of staying on the team for following
semester if recommended– Schedules are staggered in conjunction with other RC/RAs and
interns to provide full coverage • Summer Intern Program:
– 5-7 research interns during the Summer– They cover day shifts (7a-3p), evening shifts (3p-11p) or mid-
day shifts (10a-4p) weekdays and weekends – Their schedules are also staggered with other RCs and interns
to provide full coverage– Also have the option of continuing on with the team for
following semester/year
Who we are: Other Staff and Coverage
15-hour coverage (8a-11p); 7days/week
CNMC ED Demographics:FY July 2011- June 2012
Patient visits per year: 83862% referral or transfer: 308Hospital admission rate: 12900% Trauma activation: 28%Basic race/ethnicity breakdown: data not collected
Hospital Setting: Urban
Our Research Studies
PECARN Studies Active:• DKA and Non-DKA Studies
• Probiotics Study
• ESETT• Suicide• PPASS• ASSESS
PECARN Study Finished:•MAGiC
Non-PECARN Studies Active:• SHS (Sexual Health Screening)
• HITS for Kids• VP Shunt
Non-PECARN Studies Finished:•APPY•USTI•VDS
Our Office Space• Full access to the ED• Interns shared office located in administrative suite steps away from the ED.
• PI offices located in ED administrative suite
• Other offices and cubicles on 5th floor research suite all within same building
• Double occupancy offices for RC/RA
• For completed studies, we have limited on-site storage as well as off-site archive space for patient files and administrative materials
On-Call• RC/ Interns are only “on call” during a DKA Study enrollment when to ensure a smooth enrollment process.
• Specific RC or Intern will be assigned an ASSESS window to enroll eligible patients.
• No general RC/Intern “on call schedule” for other studies.
• Each morning- an admissions report is run for patients admitted overnight when no RC/ Intern was screening. The morning report is essential for capturing FLUID Study patients given the 4 hour window to enroll. – Unfortunately, studies with a short window will have some missed patients since the enrollment window is not long enough to be captured in the morning if admitted overnight
• ED Staff is aware of how to reach us by phone or pager in case of a possible patient during normal business hours
Administrative Items• IRB Submissions, Renewals and Compliance:
– Study’s Primary RC with help from Research Manager and site PI, if needed
• EDB Upkeep & Follow-up Scheduling:– Study’s Primary RC assisted by research Interns
• Grant Tracking – – Research Manager and Nodal Administrator
• Budget/Spending of Grant Funds:– Nodal Administrator
• OSP/SPO requirements: – Research Financial Coordinator/Nodal Administrator
• General Administrative Items:– Nodal Manager
Our Meetings and Monitoring• Nodal Meetings:
– Includes all WBCARN PIs, Nodal Manager and Nodal Administrator
– Occurs once a month• Site Team Meetings:
– Includes all site RCs, Nodal Manager and Nodal Administrator– Occurs twice a month
• PI-RC meeting:– General meeting every other week
• Study review• Quality control of study workflow
– Patient chart review meeting on a per-patient basis for DKA and Probiotics studies
• Management Meetings:– Includes: James Chamberlain, MD, Kate Shreve, T. Bobbe Thomas– Occurs: Every Monday
• Nodal Monitoring:– Occurs twice a year– Nodal Manager typically conducts the visit– Areas of focus include (but not limited to) review of: EDB,
consents, patient charts, and study endpoint data
Tricks of the Trade: Unique tools we utilize at our site! • EOS:
– After each shift (day, evening, night) the screening team member sends out an email updating the research staff on enrollments
• Research week: – One week each year dedicated to retrain ED staff on studies. Include presentations, jeopardy games, new eligibility cards.
• Study Information Bulletins– Located in the ED lounge to educate ED staff
• Inclusion criteria badges: – These laminated cards include the inclusion criteria for each of our studies
– ED staff can attach these to their personal badge.