Electronic Data Capture Healthcare perspective C.Daniel 1, 2, N. El Fadly 1, C.Bousquet 2, N.Lucas2, P-Y. Lastic3, P.Degoulet1, 2, G.Chatellier2 1 INSERM, U872 team20, Paris Descartes University, France 2 AP-HP,Hôpital Georges Pompidou,Paris,France 3 Sanofi-aventis R&D and CDISC Board of Directors INSERM (French National Institute for Health and Medical Research) 13,000 people (6000 researchers) - 360 units 85% housed within university hospital or cancer treatment centers U872 – team 20 : Knowledge engineering in Public Health and Medical Informatics Developing information systems and medical knowledge bases & approaches for the evaluation of such systems. Terminology systems for EHR indexation & secondary use of clinical data (registries, clinical research)

Secondary use of clinical data Can EHR replace the need for eCRF? What is the impact on the investigator or monitor roles? What is the impact on: Physicians/Nurses roles IT staff role How should the interaction model change between clinical care and clinical research actors to accelerate usage of IT solutions? And secondary usage of clinical data?

Context : AP-HP Patient care Most important French University Hospital Organization with 1,000,000 hospitalized patients 38 hospitals with round 23,000 beds + 1400 day care and 850 home care capacity 90,000 employees including 19,000 physicians Single HIS/EHR: CareByThales® (Thales©) (2009) Clinical information Nurse notes Discharge summaries, DRGs Flow sheets, Care plans Medical order Imaging reports Lab results Patient focus (Point-of-Care) This month AP-HP has just chosen its future single EHR which be provided by the french consortium Thales-Medasys. The name of the solution will be CareByThales. This is the application dedicated to patient care. EHR EHR

Context : AP-HP Medical research Medical Research is carried out in 18 Research Institutes, 8 Clinical Investigation Centers (phase I & IIa, PK/PD, etc.) and 10 Clinical Research Units 100 INSERM teams eCRF provider : ClinWeb® (TelemedicineTechnologies©) Population focus (Retrospective) In AP-HP Medical Research is carried out in 18 Research Institutes, 8 Clinical Investigation Centers (phase I & IIa, PK/PD, etc.) and 10 Clinical Research Units 100 INSERM teams Until 2010, the ECRF solution chosen by AP-HP is ClinWeb from TM supposed to be largely used for clinical trials Clinical Trials

Multiple applications Multiple data forms => Redundant data entry Context and problems Patient focus (Point-of-Care) Population focus (Retrospective) EHR EHR Multiple applications Multiple data forms => Redundant data entry Clinical Trials Clinical Research Patient Safety One of the current issues in CDISC is to adresse the redundancy of data entry. A physicians have to deal with lmltiple applications and forms for both patient care and external agencies (clinical trials, clinical research, patient safety, etc) Adapted from E.D.Helton (HL7 RCRIM Co-Chair) & L.Bain (CDISC Liaison to Healthcare)

Integrating Patient Care & Clinical Research at HEGP Development and deployment of IT in CRU With respects to standards (HL7, CDISC) Secondary use of clinical data? Collaboration Clinical Research Unit (Pr G.Chatellier – Dr N.Lucas) Hospital Informatics Department (Pr P.Degoulet – Dr C.Daniel) INSERM UMRS 872 eq 20 (M-C.Jaulent) THALES (middleware solutions) 2 persons PhD student – THAKES Engineer

Our strategy Understanding each other’s needs Clinical Research needs Patient Care needs Understanding existing standards (HL7, CDISC, IHE RFD, etc) Iterative and incremental integration process Use case driven : use cases capture the functional requirements and define the contents of the iterations Standard-based (HL7, CDISC) Syntactic alignment (HL7/CDA to CDISC/ODM) avoids double data entry, based on XForms

Understanding “Clinical Research (CR)” needs Actors Actors of Clinical Research Sponsor Clinical Research Coordinator (CRC) Monitor Principal investigator / Physician Clinical trial technician Data manager  IT staff Newly involved in secondary uses of clinical data Feeding clinical data repositories, registries, datawarehouses

Understanding CR needs Use cases Use cases of Clinical Research Clinical trial coordination Clinical trial design (including EDC solution design) Patient recruitment Data capture (patient care/clinical research) Data monitoring Safety monitoring Databases and interfaces administration

Understanding CR needs Comparing workfows with/without EHR Using eCRF (CleanWeb) Integrating EHR (DxCare) & eCRF Use cases of clinical trial coordination

Understanding CR needs Comparing workfows with/without EHR Using eCRF (CleanWeb) Integrating EHR (DxCare) & eCRF Use cases : patient scheduling, data capture, etc

Understanding CR needs Interaction diagrams Data capture during the visit

Understanding CR needs Interaction diagrams Patient care/clinical research interface management

Understanding “Patient Care” needs Integrating the eCRF to EHR Providing a method for gathering data within a user’s application to meet the requirements of an external system Data could be automatically extracted from the EHR database The form (for the external system) is designated as a clinical trial form and saved as a document in the patient’s record. EHR The RFD … Thanks to a clinician uses a single In fact if a physician,Chris Clinician has to provide data to differeznt external agency (more than one clinical trials, pateint safety solution, etc) he STILL has to ..within his EHR he will have to fill the form for the patient considered as a patient for patient care AND then to open fill a new forms for his patient considered as a study subjects. If he is lucky some fields (at least the demographics) will be automatically prepopulated by EHR mapped data.

Understanding “Patient Care” needs Patient focus (Point-of-Care) Population focus (Retrospective) EHR EHR Alerts Decision Support system Clinical Trials/Patient safety/ Governmental agencies RFD is nice of course especially wonderfull for clinical research But from the EHR point of view Gathering data within a user’s application to meet the requirements of an external systems is definitively NOT ENOUGH The purpose is not only to ease data capture for external systems BUT ALSO to be sure that among these data those that may be usefull , usefull faor patient care, are properly stored in the EHR and NOT AS DOCUMENT but in a structured computable format available for Alert and Decision support system within EHR before being a subject study A PATIENT is a PATIENT Chris clinician records an AE that Paul Patient has had an Adverse event Samule Sponsor, Patricia Pharmacovigilant WILL KNOW that Paul Patient has had an Adverse event SINCE Carolyn clinician (chris collegue)won’t be aware of this. Franck FBI WILL KNOW that Paul Patient has an anthrax or influenza due to AH5N1 SINCE Chris Clinician will not be aware of this. Carolyn Clinician Samuel Sponsor Patricia Pharmacovigilant Chris Clinician Franck FBI Chris Clinician

Understanding “Patient Care” needs Providing methods for gathering data within a user’s application to meet the requirements of BOTH external systems AND EHR » EHR is not only a « host application » SHARING medical data for both patient care (EHR) and clinical research WHAT WILL BE REALLY GREAT

Preliminary conclusions about needs Patient Care & Clinical Research : 2 different complex and parallel organizations and workflows (Kahn 2007) Redundancy Completion of the main record of a patient visit and transcribing patient information in the corresponding CRF for the clinical trial Patient safety Overlap between reporting forms or system(s) Avoiding reporting SAE to the sponsor before/instead of completing EHR Understanding workflow is critical to the design of the right IT solutions and their ultimate adoption Columbia University’s INterTrial project (as part of the NIH Roadmap initiative to reengineer the national clinical research enterprise) Kahn S.A. A day in the life of a clinical research coordinator : observation from community practice settings. Medinfo 2007

Conclusion Understanding workflows is critical to the design of the right IT solutions and their ultimate adoption Integrating Patient Care and Clinical Research “Integrating the Healthcare Enterprise” (IHE) Forum : users, IT vendors, academia Definition of needs and of integrated workflows Best use of existing standards (HL7, CDISC) (IHE “Integration Profiles”) Compliance needs to be ensured (IHE Connecthatons) Specific IHE domain : Clinical Research