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.