Clinical Registries Needs and Solutions

Dr. Peter Greene, CMIO

Diana Gumas, IT Director

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Needs we heard @ January 24th 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

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#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.

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#1 – Mining data from the EMR for Research(2 of 2)

Available Soon:• April 15th: EPR2020 research application which allows you to

more easily access clinical data for patients on your study– Slides 12-23 – 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

https://www.i2b2.org/

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#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

dgumas1@jhmi.edu

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#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

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#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? Seen @ AMIA

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#5 – Clarify HIPAA Waiver

At upcoming clinical registries meeting:

Invite Dr. Ford to speak on this subject

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#6 – Group to do patient follow up and tracking

Need your help to better define the need

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#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.

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Supplementary Slides

Migration of clinical data to EPR2020 (powered by Amalga)

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EPRJHH & JHBMCDischarge summaries

Operative notes

Clinic Notes

Problems, Allergies, Meds

Lab Results

Radiology Results

EPR2020Read-Only

Data Discovery

for

Clinical Care

Research

Quality Improvement

JHCP

External Labs

Additional Hospitals.

Clinical Research Management System

Patient Portal

CRISPHealth

InformationNetwork

EPR2020 Data Contents

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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

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Multiple Applications – Including Research Support

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Research App View:Patients on “My Studies”

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Now drill down to see Clinical Data for the Research Participant

Clinical detail for the Patient:Problems, Allergies, Immunizations, MedicationsLabsDocumentsActive Research Study enrollment

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Research App View:Research Lab Results

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Exporting Lab Results Saves SignificantResearcher Hours!

Researcher App View: Diagnosis“Find my patients who had a cardiac diagnosisin the 1st 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.

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Electronic Patient Record (EPR) and Research

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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

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

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Search patient’s documents for pacemaker

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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