Integrating a Research Management System & EMR: Motivations and Benefits Host

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1 Integrating a Research Management System & EMR: Motivations and Benefits Host Lisa Haddican, Content Marketing Specialist

2 Specialized Solutions by Forte Developed with the expertise of 20,000 trials Clinical research management, billing compliance, EDC, and more for the enterprise. Cloud-based clinical trial management software for research sites. Hosted electronic data capture system for CROs and sponsors. A technology-enabled community pursuing datadriven excellence in clinical research operations.

3 Levine Cancer Institute a part of Carolinas HealthCare System

4 27 Cancer Care Centers 60,000+ Employees 47 Hospitals North Carolina & South Carolina Phase I Clinical Trials Unit Complementary and Integrative Oncology Programs

5

6 Interface

7 Then Duplication of Effort Lag Time Manual Notification Manual Entry Transcription Error Now Automatic Notification Automatic Updates Configurable Details Instantaneous Streamlined Workflow

8 UCSF Helen Diller Family Comprehensive Cancer Center

9 Translational Informatics (TI) at UCSF Develops and supports informatics applications and shared informatics resources. Provides sophisticated informatics solutions including tissue and specimen tracking, related clinical and patient follow-up information, clinical trials data management, and biomedical informatics based metadata management. Develops, deploys, and maintains data management systems and applications to directly support all clinical, biomedical and translational research goals that span a range of users, from individual investigators, to individual programs within the Cancer Center, and to the University as a whole. Provides customizable informatics solutions for all data needs with special attention to providing first rate data consultation services.

10 Demographics Pull subject demographics information from EMR Laboratory Populate OnCore ecrfs with lab results from lab system RPE Overview : OnCore/EMR Integrations Information from OnCore is pushed to EMR to flag subjects on a research study in OnCore. Protocol Billing Grid Provides an EMR with relative time points of a research study calendar including codes, billing designations and modifiers for assigned charge events & items. Purpose is to support billing compliance.

11 Project Scope ü Phase I Ø Demographics via HL7 ADT (Completed) Ø Lab Values via HL7 ORU (In Progress) Ø CoPath via HL7 (Optional Phase I, or Phase II) ü Phase II Ø RPE (Retrieve Process for Execution) Ø Protocol Billing Grid

12 Challenges of EMR Integration 1. Technical 2. Resource 3. Strategic 4. Policy 5. Process 6. Economic

13 Integration Drivers: a few 1. Eliminating Duplicate Data Entry for all Patient Demographics and Lab Values Institution wide, eliminating errors, discrepancies, and waste of valuable time. 2. Ensuring Quality Control Quality Assurance and Consistency of Patient Records across Systems. 3. Receiving Patient Demographics from EMR via interface quantifies accuracy of reporting of patient/protocol associations by the research system back to the EMR (RPE). 4. RPE Facilitates Patient Billing within the EMR Impacting Billing Compliance, Audits. 5. EMR knowing patient is a research subject streamlines operations and patient management impacting care

14 Yale s Experience: Selection, Implementation and Integration Kelly M. Anastasio Associate Director, Clinical Trial Resources Yale Center for Clinical Investigation

15 We have an interface!

16 Building Blocks of Yale s Integration Patient Demographics This is the fundamental building block of Yale s integration. It pulls the following information from the EMR: MRN, name, race, ethnicity, gender, date of birth, address, and phone number Ensuring that the MRN from the EMR is the SAME primary CTMS subject identi=ier is critical to the remaining, more advanced layers of integration

17 Building Blocks of Yale s Integration Study Record Patient Demographics Study information sent from CTMS to EMR includes: the protocol number, short title, clinical trials number, and principal investigator Additional data manually entered: names of the charge reviewers and study coordinators, Medicare qualifying status, and managing department and section information

18 Building Blocks of Yale s Integration Subject Association with Study Study Record As subjects are registered in the CTMS they are automatically sent to the EMR and identified as Research Active. As subjects go off study, the EMR is updated accordingly. This is currently being addressed. Pt. Demo. Additional data manually entered: start date of the research activity (at consent) end date of research activity (at study completion)

19 Building Blocks of Yale s Integration Study Billing Grid Subject Association with Study Study Record Pt. Demo This allows for calendars to be built ONCE. This information is used to support charge matching and over all billing compliance Billing grid sent from OnCore to the EMR with: Calendar outline, Tolerances/windows per visit, Procedures for each visit charge types (routine vs research) Medicare modifiers Additional required activity in Epic: Link patients to timeline, initially and for select new statuses and events Link an encounter (patient visit) to the research study, Check in the visit (in both OnCore and EMR) and Review and release charges.

20 University of Wisconsin-Madison

21 UW- Madison: EMR Integration Background Integrates OnCore with the UW Hosp. & Clinics Epic System ( Health Link ) Focused on Research Billing Study Account Setup Designating patients as active or inactive study participants Implementation: January May 2013

22 UW: Integration Components ADT (Epic -> OnCore) Patient Demographics, keyed on MRN RPE (OnCore -> Epic) Sets up Study Records in Epic Associates Patients with Studies Includes Status (Consented, Eligible, etc) Sets Research Billing Flag (Active/Inactive) Staggered Implementation: ADT, then RPE

23 UW: Additional Integration Components (Cont d) OnCore Scheduled Reports Error Checking (Failed Transactions, etc) Notification of Demographic Changes Study Review and Validation Workflow

24 UW: Integration Benefits Automatic Entry and Maintenance of Subject Demographics in OnCore Timely updates of subject changes Reduces Epic staff effort to create/maintain study records and subject-study associations Faster Subject/Study associations in Epic Automatic NCT ID Population on Medicare Claim Forms

25 Questions?

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