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
2 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
3 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
4 Process Overview - Prescreening Function IRB Process Consultation Feasibility Rule Creation Begin Prescreening Optimization Training/ Access *May occur concurrently
5 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
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 6
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 7
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 8
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 9
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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 11
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 12
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 13
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