Clinical Registries Needs and Solutions Dr. Peter Greene, CMIO Diana Gumas, IT Director 1

2 Needs we January 24 th meeting 1. Mining data from the EMR for research: –Getting data for a known set of patients –Finding patients who meet a set of criteria 2. Tissue Repository 3. Database expertise –Data security: where to securely park data –Course in database basics 4. Tracking consents –e.g. don’t contact me –Written policy of what is allowed regarding use of data 5. Clarify HIPAA waiver 6. Group to do patient follow-up and tracking 7. Access to expertise in study design

3 #1 – Mining data from the EMR for Research (1 of 2) Available Today: Center for Clinical Data Analysis, Dr. David Thiemann, Director Sample-size estimates for grant planning and statistical analysis Case-finding for research. With IRB approval, the CCDA can identify patients with specific combinations of diagnoses and clinical data, and provide names and addresses. The research team than can (if explicitly allowed by IRB approval) use the CCDA file for retrospective chart review or to solicit patients for study enrollment. Research data extracts With IRB approval, the CCDA can provide one-time or periodic (monthly or quarterly) data extracts for research analysis.

4 #1 – Mining data from the EMR for Research (2 of 2) Available Soon: April 15 th : EPR2020 research application which allows you to more easily access clinical data for patients on your study –Slides – more about EPR2020 –DEMO? Evaluating a cohort discovery tool to find patients who meet set of criteria: demographics, diagnosis, lab results. Can do a demo next month. Planned but not yet scheduled: i2b2 - Informatics for Integrating Biology & the Bedside

5 #2 – Tissue Repository caTissue has been chosen as our enterprise specimen tracking system We are building it now, plan to have available for early adopters in Summer 2011 We can do a demo at a future meeting if there is interest Contact Diana Gumas if you are interested in adopting caTissue

6 #3– Database Expertise Available Today: Dr. Kerry Stewart at the JHBMC GCRC provides guidance on database design. Also securely hosts databases. In Progress Yvonne Higgins is doing a needs assessment regarding researchers database needs. We should connect this group with her. REDCap is being considered. Still need to identify: Course in database basics

7 #4 – Tracking Consents Available Now Signed consents can be scanned and uploaded to CRMS Planned for later this year Security model to allow paper consents to be destroyed if desired once the consent is uploaded to CRMS Need to identify, with help from Dr. Ford: –Universal consents? e.g. don’t contact me –Written policy of what is allowed regarding use of data –One-stop-shop for all consents? AMIA

8 #5 – Clarify HIPAA Waiver At upcoming clinical registries meeting: Invite Dr. Ford to speak on this subject

9 #6 – Group to do patient follow up and tracking Need your help to better define the need

10 #7 – Access to Expertise in Study Design At upcoming clinical registries meeting: Invite Dr. Harold Lehmann to speak on this subject. He has done some work in this area, including a “TurboTax-like” application to guide study design.

11 Supplementary Slides

Migration of clinical data to EPR2020 (powered by Amalga) 12 EPR JHH & JHBMC Discharge summaries Operative notes Clinic Notes Problems, Allergies, Meds Lab Results Radiology Results EPR2020 Read-Only Data Discovery for Clinical Care Research Quality Improvement JHCP External Labs Additional Hospitals. Clinical Research Management System Patient Portal CRISP Health Information Network

EPR2020 Data Contents 13 Available today from EPR for JHH & JHBMC - *view-only* 4.4M Patients, 32.6M Visits 16.2M Documents, 8.5M Radiology Reports 78M Lab Tests, 402M Lab Results 1.7M Problems, 2.5M Medications, 159K Allergies, 475K Immunizations 5.8M Inpatient Diagnoses (409K distinct) In progress: Community physician visits and summary documents Outpatient diagnosis codes & procedures Images Improve speed of display Additional clinical research tools

14 Multiple Applications – Including Research Support

15 Research App View: Patients on “My Studies”

16 Now drill down to see Clinical Data for the Research Participant Clinical detail for the Patient: Problems, Allergies, Immunizations, Medications Labs Documents Active Research Study enrollment

17 Research App View: Research Lab Results

18 Exporting Lab Results Saves Significant Researcher Hours!

Researcher App View: Diagnosis “Find my patients who had a cardiac diagnosis in the 1 st quarter of 2010” Provides assistance gathering: Preliminary, anonymous data for feasibility, grant applications and statistical sample-size estimates IRB-approved case-finding--for study enrollment (mailings, phone solicitation), chart review, and cohort/case-control studies Research data extracts - monthly/quarterly integrated extracts from EPR, POE, ORMIS, lab/PDS, billing systems, vaccination/transfusion/culture data, etc. 19

Electronic Patient Record (EPR) and Research 20 One major source of clinical data for JHH/JHBMC Research documentation New EPR clinical research note just for researchers Access to scanned consents & Can look at statistics for race, gender, age, diagnosis description

21 Diag Seq 1 - the primary for this encounter. Notice patient has a pacemaker… so…

22 Search patient’s documents for pacemaker

23 Future Plans My Research Patients’ Outpatient Diagnosis My Research Patients’ Procedures Alerts for significant events –Participant admission –Lab value out of range Evaluate Microsoft cohort discovery tool Evaluate use of i2b2 with data from EPR2020 Provide result data to Case Report Forms in Research System Interface to Specimen Tracking Tool (caTissue) Natural Language Processing to mine documents