1. Agenda DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Clinical Research within an EMR What the difference between an EMR and an EHR Define Clinical Research Practical Clinical Networks (Single Source)

2. Why do we want to do this DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Recruitment Patient are recruited from existing local sites Lower Start Up Time and Cost Trails use existing networks and infrastructure Allows for simple trials in clinical setting Patients are more representative of general population Unique information for Longitudinal Data, Registries Lower Cost of Data Collections Eliminates Source Document Verification Eliminates redundant data entry Lower Monitoring Costs Reduces queries and time spent on query resolution Builds in quality checks

3. Agenda DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Clinical Research within an EMR What the difference between an EMR and an EHR. EMR. = Used by a clinician to provide care EHR. = Synopsis of individual health related information Define Clinical Research Practical Clinical Networks

4. Centralized Model – EMR DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences * EMR = Used by a clinician to provide care * EMR = Hosted at a central site * EMR = All data is resides centrally

5. Federated Model – Electronic Health Record DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences * EHR. = Synopsis of individual health related information * EMR. = All data is collected and stored locally * EHR. = Select clinical data (Medications, Allergies) is transferred to central site

6. Federated Model – Electronic Health Record DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences * EHR. = Synopsis of individual health related information * EMR. = All data is collected and stored locally * EHR. = Select clinical data (medications, Allergies) is transferred to central site

7. Agenda DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Clinical Research within an EMR Define Clinical Research ePRO, EDC, Practical Clinical Networks

8. Research - Definitions DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences PaperElectronic Equivalent Source Medical Record Electronic Health Record (‘EHR’) Case Report Form Electronic Data Capture (EDC) Patient Rated ScalesElectronic Patient Reported Outcomes (ePro)

9. Case Report Forms DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

10. Electronic Patient Reported Outcomes (ePRO) How do you feel today? Excellent Good Fair Poor DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

11. SiteQAData EntryMonitorCodingAnalysis (Monitoring Cost > 15% of a trial)(Data Management Cost > 15% of a trial) Present Process Clinical Trials - Paper DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

12. Clinical Trials – EDC (Electronic CRFs) SiteQAData EntryMonitorCodingAnalysis DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

13. SiteQAData EntryMonitorCodingAnalysis Single Source DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

14. SiteQAData EntryMonitorCodingAnalysis Single Source - Advantages DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Increase Recruitment Patient are recruited from existing local sites Lower Start Up Time and Cost Trails use existing networks and infrastructure Allows for simple trials in clinical setting Lower Cost of Data Collections Eliminates Source Document Verification Eliminates redundant data entry Lower Monitoring Costs Reduces queries and time spent on query resolution Builds in quality checks

15. Agenda DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Clinical Research within an EMR What the difference between an EMR and an EHR. Define Clinical Research Practical Clinical Networks Barriers to Implementation

16. The limitations to creating a single source platform are formidable. Technical limitations include: Security issues of traversing both inbound and outbound firewalls at different institutions EMRs are not interoperability EMRs are not research ready, don’t understand concepts like a visit schedule, and ODM protocol Evolving software standards form both HL7, CDISC IHE, CCHIT and other organizations Regularity barriers including meeting both Cost to HIPPA, CCHIT, IHE and Cost to be FDA compliance - 21 Part 11 compliant. Workflow barriers include the need to function both as a EMR – not structured, information based, work flow Case Report Forms are a defined subset of elements Loss of efficiency for busy clinicians who see research patient. Functionality who should build this Unique data requirements of a clinical record and a clinical trail. EDC does not do billing, treatment plans, state and local requirements EDC does not what to host an EMR with liability EDC do not know EMR EMR don’t care about research and market is very small

17. Clinical –What is the differential diagnosis? –What is the best treatment? Management –How many patients did he see? –Am I in regulatory compliance? Research –Are you collecting the data I need? –Is the data accurate? Clinical ManagementResearch Present System – Different Stake Holders DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

18. Role-based Configurability - Clinician End Slide

19. Role Based Configuration – Research Assistant DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

20. Practical Clinical Trial Network - Challenges DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences Central Model Individualizing EMR to Local Needs ADT/Billing at Local Site Regulatory Needs of Local Sites HIPAA issues (Retention of Medical Records Maintenance of EMR Records Federated Model Controlling Local Variations Impact on Clinical Trials Data Manager – Coordinates Data transfer Version Controls – Keeping Application Current Decision Support – Distribution of Requirements Data Transfer – Security and Firewall Issues

21. CRF’s collect data that is not part of an EMR DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

22. Integration of existing software End Slide

23. MindLinc – Registry Manager DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

24. MindLinc DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

25. Single Source DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

26. Improving Clinical Care DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

27. Largest Longitudinal Psychiatric Outcome Data Warehouse in existence Largest Longitudinal Psychiatric Outcome Data Warehouse in existence 180,000 patients and 1,700,000 encounters Outcomes Data Warehouse Outcomes Data Warehouse Data is De-Identified IRB exempt Data is surfed (cleaned) Commercially Available Published data 20+ studies, journal, posters, etc. Industry, Academics, marketing, discovery. CelexaLexaproPaxilPaxil-CR Proza cZoloft Anxiety / Agitation4.2%3.7%8.0%2.8%2.9%1.9% GI Distress Nausea9.5%6.7%5.2%7.0%3.8%5.6% Increase Appetite Weight Gain3.4%5.0%3.9%1.4%4.2%3.3% Sexual Dysfunction7.3%8.4%8.1%1.4%6.5%4.3% Sedation10.7%7.0%9.6%8.5%5.8%6.3% Patients50629938571554793 Outcomes Data Warehouse Example mining for medications side effects – SSRI side effects distribution (%)

28. Visualization DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

29. Decision Support DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

30. The End DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences

31. Clinical Re-imbursement Efficiency Decision Support Management Revenues Regulatory Research/Clinical Trials Quality Data Quicker Trials Lower Costs Clinical Data Research Standards Based Codified Data is the Key Management DUKE UNIVERSITY MEDICAL CENTER Department of Psychiatry and Behavioral Sciences