Transcript Clinical Registries Needs and Solutions

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
[email protected]
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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
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Migration of clinical data to EPR2020
(powered by Amalga)
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
Patient
Portal
Clinical Research
Management System
JHCP
External Labs
Additional
Hospitals.
CRISP
Health
Information
Network
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EPR2020 Data Contents
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:
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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, Medications
Labs
Documents
Active Research Study enrollment
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Research App View:
Research Lab Results
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Exporting Lab Results Saves Significant
Researcher Hours!
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Researcher App View: Diagnosis
“Find my patients who had a cardiac diagnosis
in the 1st quarter of 2010”
Provides assistance gathering:
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Preliminary, anonymous data for feasibility, grant
applications and statistical sample-size estimates
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IRB-approved case-finding--for study enrollment
(mailings, phone solicitation), chart review, and
cohort/case-control studies
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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
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
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