Apex/Epic and Research

Academic Senate Clinical Affairs CommitteeOctober 26, 2011Seth Bokser

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Major Areas Where APeX Will Support Research

Ensure continued support for functions supported by existing

departmental systems

Facilitate the use of clinical data in research (i.e.

retrospective data in the IDR)

Support clinical research

– Compliance

– Billing

– Enrollment

– Clinical Data Capture

Departmental Systems

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Support for Existing Systems

Survey conducted this summer and fall of 2010

– 197 Systems were identified

• 11 duplicates removed, 13 added 198 systems remain.

• 53% systems,47% databases

• 45% patient care, 53% operations,

53% research (most have multiple uses)

Prioritized for review

– Criteria were implementation date, system function and

sensitivity

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Classification of Systems for APeX Implementation

Our goal is to ensure continuity in the functionality

Five categories:

– Replaced by Epic

– Possible scope in optimization phase

– Independent system

– Data and interface conversions - Planned/Underway

– Data and interface conversions - Required

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Systems Review Results

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Replace by Epic

•Epic features can replace system’s functions at go-live.  Description

• Implementation teams to be alerted to this work. Implement replacement of function as part of go-live.Plan

• OB/GYN Access Databases – Used by operations, to report births to state agencies, and for research. Can be replaced by worklists, Clarity reports and IDR.

• AccessANYware – Remote access for Coders. Function to be replaced with Epic Features.

• ED Filemaker system – Replaced by Epic ASAP.

Examples

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Possible Scope in Optimization Phase

•Epic features can replace this system’s functions, but work is impractical at this time due to limited data, timing or scope of implementation. System should be reviewed after the initial implementation.

Description

• Implement without changing system. Keep a list for review after implementation. Plan

• EEG Reader in Epilepsy/Clinical Neurophysiology - EEG Study data. System is currently independent; No IDX or UCare interfaces; Would like integration for viewing and demographics.

• Pediatric Nephrology Database – Screens patients for research recruitment. Consider migration when sufficient data is in Epic.

Examples

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Independent Systems

•The system is not impacted by APeX implementation.  Typically these systems are not linked to clinical data; serve a non-clinical function or where Epic features are not planned for implementation.

Description

• No APeX action needed. Coordinate system with School of Medicine as appropriate.Plan

• QuesGen – collects and stores data about volunteers for pharmaco-genomic studies

• Airway tissue Bank – Tracks samples for research study.• CAPSURE.NET Web-site with public information on

Prostate Cancer• Canfield Scientific – In Plastic Surgery used as an

imaging tool.

Examples

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Data and Interface Conversions - Planned or Underway

•An interface or download of Epic Data is needed to replace an existing download or interface. This work is underway or planned.

Description

• Implementation of replacement interface is underway. Continue on plan.Plan

• Apollo-related systems in cardiology including • Tumor Registry ADT feed• OmniView Download• IDXRAD – Radiologic Systems interfacesExamples

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Data and Interface Conversions - Required

•An interface or download of Epic Data is needed to replace an existing download or interface.  This work is not underway or planned.

Description

• Assess need for data, ensure a plan is in place to support data need.Plan

• Dynamic Clinical System – Used in Urology/Oncology as a pre-appointment screening tool. Currently gets download from IDX.

• Urology/Oncology Database (Prostate) – Master Research Database. Need to replace monthly download from STOR.

Examples

Clinical Research Support

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APeX features at Enterprise go-live (6-2012)

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UCSF will use APeX (Epic) to:– Identify studies – Identify patients who are participating in the studies– Identify which encounters have content for the studies– Place orders for care related to studies – Appropriately bill responsible entities (i.e. Personal Family

account or Research account) for the orders. – Support chart review by clinical monitors– Identify research patients and include or exclude them from

medical center reports, metrics and statistics as appropriate

Research features go-live at Enterprise Roll-out– Interim workflow keeps research orders and billing on

paper. (through June 2012)

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Future directions for Clinical Study Support with APeX

Implement Epic function to indicate when a patient may qualify for

a particular study (Welcome; MyChart; APeX)

Integration with :

– Clinical Trials Management Systems (e.g. OnCore)• We are working with Epic, Forte, U Wisconsin, Yale and U Virginia on HIE Standards-based

approach to interfacing clinical trials activities.

– Research Participant Management System (being scoped and

planned in SOM)

– Clinical trials development process (iMedris, Medicare Charge

Analysis)

APeX/Epic Staff Activities

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Appropriate Research Staff will:– Set up clinical studies with assistance of Apex Team

including:• Identify allowed procedures (including tests and

treatments) for a study• Determine how study-related orders are entered• Identify billable entity at time of order

– Enroll Patients– Identify or confirm that each order is research-related at

time of order entry– Attend training and adhere to policies and procedures that

support research workflows in Apex.

IDR Overview

Integrated Data Repository

School of Medicine based Repository for researchers which integrates data

from many source systems De-identified data is readily available to

appropriate personnel Goal to create research environment that is:

– Accurate, Accessible, Easy to use, Secure

Target inclusion of initial APeX data November 2011.

ReplicaSource Systems

IDR & My Research – Big Picture

Audit DB /IDR

Data Warehouse

End User Tools

Cognos BI

Data Warehousing Business Intelligence

Cohort Selection

Tool (i2b2), SAS,

STATA,SPSS,Alias.ti,

Enterprise Architect

MyR

ese

arc

h P

ort

al

UCare

PICIS

CancerRegistry

MisysIDXrad

Apollo

Worx

CTMS

STOR

MAR

Flowcast

TSI

CoPath

Kaiser

VA

ED

Epic

Extract, Transfe

rP

roxy p

roce

ss an

d L

oa

dAxium

Siemens Radiology

Transplant

Terminal Servers

SGD Web top

Alfresco

REDCap

Epic

LPPIEMR

UCare

Will be replaced by Epic

Will have interfaces to bring data into Epic

SFGH

PICIS

CancerRegistry

CTMS?

TSI

Kaiser

VA

Axium

Transplant?

LPPIEMR

SFGH

Security

Red = Currently Integrated

Shadow Server Clarity

(Microsoft SQL Server)

IDR(HIPAA Limited

Data Set*)

Epic Production Server (Chronicles Caché)

MyResearch(Data Marts / Ontologies)

• Operational and financial reports• Government-mandated reporting

Research

Patient careStagingServer

(MicrosoftSQL Server)

Medical Center Network(Requires CHR Approval for Access)

MyResearch Network(No CHR Approval Required)

* “HIPAA Limited Data Set” = No PHI Except Dates of Service

APeX-IDR Information Flow

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• Operational, financial and government mandated reporting out of Epic’s Operational Data Store ‘Clarity’

• HIPAA Limited Data Set (LDS), i.e. no PHI except dates of service, brought over to IDR for Cohort Selection

• Any PHI data extract for research purposes:• Requires CHR approval • Comes from Med Center, not IDR• Done via separate secure interfaces

IDR and Clarity Environments

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Use existing MOU with Medical Center for data use APeX data available in i2b2 to trained and certified users Use existing IDR data security and governance Key data views or marts mapped

– Demographics– Encounter– Disposition/Discharge– Diagnosis– Medications

Incremental improvements to existing documentation / training / support

Phase 1 Revised Scope and Deliverables

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Questions / Discussion