ITWorks Strategic Alignment
Jeff Townsend
Executive Vice President and Chief of Staff
PowerTrials: Prescreening Function
John Peterzalek
Senior Vice President, President Cerner Atlantic
Debbie Yantis
Vice President and General Manager Pediatric and Academic
Elise Aney
Director, Client Results Executive
Feb 25, 2013
Overview - PowerTrials
•
A Cerner application consisting of two
primary functions:
• Enrollment Function:
•Entering patient enrollment data & study
information
•
Prescreening Function:
•Prescreening of potential study patients
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Overview - Prescreening Function
HIPAA compliant application (Uses same standards
as for EMR)
Enables Investigators to search for research
participants within the EMR
Based on pre-established IRB approved recruitment criteria
Access limited strictly to Children’s National
investigators, health providers, and study
nurses/coordinators
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Process Overview - Prescreening Function
IRB Process
Consultation
Feasibility
Rule
Creation
Begin
Prescreening
Optimization
Training/
Access
*May occur concurrently
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Process Overview - Consultation
www.ctsicn.org  SPARC Request
Create account – needed to request all CTSI-CN resources
Select “Recruitment of Research Participants” to request consultation
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Process Overview - Feasibility
Initial Assessment of Criteria by PowerTrials Support Team
Type of criteria (e.g. laboratory values, ICD-9, CPT, etc.)
Type study (prospective only)
In-depth Feasibility Assessment
Meeting with Study, Cerner Development, and CTSI-CN Recruitment
Teams
•
•
•
•
Further assess Prescreening rule criteria
Narrow (or Broaden) search
Receive instant feedback from Cerner Team
Q/A
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Process Overview - Training
CHEX Learning Management System
Accessible via CNHS Intranet
Search “PowerTrials” for course registration
In-person Training Course
Approximately 1 hour
Learn how to:
• Access and navigate the Patient Protocol Manager (PPM) application
• Enroll patients to your specific protocol
• Prescreen patients located in PowerChart for potential recruitment
Brief exam located in CHEX
• Need at least 80% correct answers to pass
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Process Overview - Access
All study staff require PPM training to use PowerTrials
Includes Investigators, Study Nurses, Study Coordinators, etc.
PPM application
Accessed via Intranet/Citrix (Same as EMR)
Current PowerChart access is required to obtain PPM access
Once training and exam completed:
• Clinicians – PPM application automatically loaded in Citrix
• Research Nurses - require eWorks request from nurse manager
• Research Coordinators/Other - eWorks request placed by PowerTrials
support team
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Process Overview – IRB Process
Only studies that have received IRB approval and have been
approved by the IRB to use the Prescreening function will
be allowed to create a Prescreening rule
Copy of IRB approval letter must be provided to PowerTrials team
IRBs of Record
Children’s National IRB (IRBear)
Western IRB (WIRB Connexus)*
Network/Consortium IRB (e.g. a different institution)*
*NOTE: Require facilitated review by Children’s National IRB
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Process Overview – IRB Approval
IRB Approval Process
Children’s National IRB and WIRB - An established process has been
developed for the approval of PowerTrials as a recruitment method
 New Study vs. Study Amendment
 See Cerner PowerTrials Standards and Procedures documents on the IRBear website
 Note: Requires ancillary review (PR and Marketing; Medical Records, etc.)
Network/Consortium IRB
• New Study
 Requires Facilitated Review submission within IRBear + any additional approval
requirements by network/consortium IRB
• Study Amendment
 Requires submission of amendment to IRBear (use established procedure) + any additional
approval requirements by network/consortium IRB
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Process Overview – Begin Prescreening
Once all previous steps are accomplished
Study Team and PowerTrials support team will test Prescreening rule
• “Dummy Data”  Actual CNHS Patients
• Prescreening function will be fully activated
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Process Overview – Optimization
In-depth review of Prescreening rule functionality
Meeting with Study, Cerner Development, and CTSI-CN Recruitment
Teams
• Assess accuracy of Prescreening rule
• Modifications (as needed)
• Q/A
Ongoing technical and regulatory support available
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? Questions ?
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