agenda duke university medical center department of psychiatry and behavioral sciences clinical...

Agenda

DUKE UNIVERSITY MEDICAL CENTERDepartment of Psychiatry and Behavioral Sciences

• Clinical Research within an EMR• What the difference between an EMR and an EHR• Define Clinical Research• Practical Clinical Networks (Single Source)

Why do we want to do this


• Recruitment • Patient are recruited from existing local sites

• Lower Start Up Time and Cost• Trails use existing networks and infrastructure

• Allows for simple trials in clinical setting• Patients are more representative of general population• Unique information for Longitudinal Data, Registries

• Lower Cost of Data Collections• Eliminates Source Document Verification• Eliminates redundant data entry

• Lower Monitoring Costs• Reduces queries and time spent on query resolution• Builds in quality checks

Agenda


• Clinical Research within an EMR• What the difference between an EMR and an EHR.

• EMR. = Used by a clinician to provide care• EHR. = Synopsis of individual health related information

• Define Clinical Research• Practical Clinical Networks

Centralized Model – EMR


* EMR = Used by a clinician to provide care* EMR = Hosted at a central site* EMR = All data is resides centrally

EMR

Monti

Bronx Leb

PorterStarke

U of CO

Boulder

Columbia

Duke

Aurora

Federated Model – Electronic Health Record


* EHR. = Synopsis of individual health related information* EMR. = All data is collected and stored locally* EHR. = Select clinical data (Medications, Allergies) is transferred to central site

DataWarehouse

Columbia Duke Colorado Aurora SVTN Bronx Leb PorterStarke Monti WCMC

Firewall

Federated Model – Electronic Health Record


Data Warehouse


Firewall

* EHR. = Synopsis of individual health related information* EMR. = All data is collected and stored locally* EHR. = Select clinical data (medications, Allergies) is transferred to central site

Agenda


• Clinical Research within an EMR• Define Clinical Research

• ePRO, EDC, • Practical Clinical Networks

Research - Definitions


Paper Electronic Equivalent Source Medical Record Electronic Health Record (‘EHR’) Case Report Form Electronic Data Capture (EDC) Patient Rated Scales Electronic Patient Reported Outcomes (ePro)

Inclusion CriteriaMalesAge 18 – 40Type I DiabetesOral Hypoglycemic

Hamilton Depression ScaleINSOMNIA EARLY

0. No difficulty falling asleep1. Complains of occasional difficulty falling asleep, i.e. more than 1/2 hour2. Complains of nightly difficulty falling asleep

INSOMNIA MIDDLE0. No difficulty1. Patient complains of being restless and disturbed during the night

2. Waking during the night - any getting out of bed rates 2 (except for purposes of voiding)

Case Report Forms


Electronic Patient Reported Outcomes (ePRO) How do you feel today?ExcellentGoodFairPoor


Site QAData EntryMonitor Coding Analysis

(Monitoring Cost > 15% of a trial) (Data Management Cost > 15% of a trial)

Present Process Clinical Trials - Paper


(Monitoring Cost > 15% of a trial)(Data Management > 15% of a trial)

Source(EMR)

CRF(EDC)

MonitorQA

DDEQueries Coders Analysis

Double DataEntry

Double DataEntry

Clinical Trials – EDC (Electronic CRFs)



Source(EMR)

CRF

MonitorQA

DDEQueries Coders Analysis

Double DataEntry

EDC

XX


Single Source


Single Source

CRF

Monitor

QADDE

Queries Coders Analysis

Double DataEntry

EDC

XX

XX


Single Source - Advantages


Single Source

Monitor

Queries

Coders

Analysis

• Increase Recruitment •Patient are recruited from existing local sites

• Lower Start Up Time and Cost•Trails use existing networks and infrastructure •Allows for simple trials in clinical setting

• Lower Cost of Data Collections•Eliminates Source Document Verification•Eliminates redundant data entry

• Lower Monitoring Costs•Reduces queries and time spent on query resolution•Builds in quality checks

Agenda


• Clinical Research within an EMR• What the difference between an EMR and an EHR.• Define Clinical Research• Practical Clinical Networks

• Barriers to Implementation

Barriers to ImplementationThe limitations to creating a single source platform are formidable.

• Technical limitations include: • Security issues of traversing both inbound and outbound firewalls at different institutions• EMRs are not interoperability • EMRs are not research ready, don’t understand concepts like a visit schedule, and ODM protocol• Evolving software standards form both HL7, CDISC IHE, CCHIT and other organizations

• Regularity barriers including meeting both • Cost to HIPPA, CCHIT, IHE and • Cost to be FDA compliance - 21 Part 11 compliant.

• Workflow barriers include the need to function both as a • EMR – not structured, information based, work flow • Case Report Forms are a defined subset of elements• Loss of efficiency for busy clinicians who see research patient.

• Functionality who should build this• Unique data requirements of a clinical record and a clinical trail.• EDC does not do billing, treatment plans, state and local requirements• EDC does not what to host an EMR with liability • EDC do not know EMR• EMR don’t care about research and market is very small

• Clinical– What is the differential diagnosis?– What is the best treatment?

• Management– How many patients did he see?– Am I in regulatory compliance?

• Research– Are you collecting the data I need?– Is the data accurate?

Clinical

Management Research

Present System – Different Stake Holders


Role-based Configurability - Clinician

End Slide

Role Based Configuration – Research Assistant


Practical Clinical Trial Network - Challenges


• Central Model• Individualizing EMR to Local Needs

• ADT/Billing at Local Site• Regulatory Needs of Local Sites• HIPAA issues (Retention of Medical Records• Maintenance of EMR Records

• Federated Model• Controlling Local Variations Impact on Clinical Trials

• Data Manager – Coordinates Data transfer• Version Controls – Keeping Application Current• Decision Support – Distribution of Requirements • Data Transfer – Security and Firewall Issues

CRF’s collect data that is not part of an EMR

EMR Common EDC

EMR Common EDC

Diagnosis

Medications

Medical History

Adverse Reaction

Severe Adverse Reaction

Visit Schedule

Treatment Plan

Social History

Unique Data Elements


Integration of existing software

End Slide

MindLinc – Registry Manager

Data Warehouse


Firewall

Registry Manager


MindLinc


Local Clinical Repository

Centralized Data Warehouse

Pa

tien

t Pro

fileD

ata

Tra

nsp

ort

Decision Support Engine

Bu

sin

ess

Ru

les

Electronic Medical Record

Interface Engine

Guidelines

Data Analysis

De-identified Data

Study Design

12

34

5

Firewall

Phase 3Phase 2Phase 1

3X

2X

1X

Outcomes Data

Queries

Single Source


Improving Clinical Care


Clinical Care Pateint

Knowledge

Largest Longitudinal Psychiatric Outcome Data Warehouse in Largest Longitudinal Psychiatric Outcome Data Warehouse in existenceexistence

180,000 patients and 1,700,000 encounters Outcomes Data WarehouseOutcomes Data Warehouse

Data is De-Identified IRB exempt Data is De-Identified IRB exempt Data is surfed (cleaned)Data is surfed (cleaned)

Commercially AvailableCommercially AvailablePublished data 20+ studies, journal, posters, etc.Published data 20+ studies, journal, posters, etc.Industry, Academics, marketing, discovery.Industry, Academics, marketing, discovery.

Celexa Lexapro Paxil Paxil-CRProzac Zoloft

Anxiety / Agitation 4.2% 3.7% 8.0% 2.8% 2.9% 1.9%

GI Distress Nausea 9.5% 6.7% 5.2% 7.0% 3.8% 5.6%

Increase Appetite Weight Gain 3.4% 5.0% 3.9% 1.4% 4.2% 3.3%

Sexual Dysfunction 7.3% 8.4% 8.1% 1.4% 6.5% 4.3%

Sedation 10.7% 7.0% 9.6% 8.5% 5.8% 6.3%

Patients 506 299 385 71 554 793

Outcomes Data Warehouse

Example mining for medications side effects – SSRI side effects distribution (%)Example mining for medications side effects – SSRI side effects distribution (%)

Visualization


Expert Consensus

Visualization

Patient

Decision Support Engine

Phase 3Phase 2Phase 1

3X

2X

1X

De-Identified Aggregate Data

Local Clinical Repository

Data Repository

Decision Support


Treatment Dashboard

Substance AbuseBipolar DisorderRelationshipImpulseThought Disorder

CGI I

Profile of like patients and their response

Depression*

Panic Disorder

Filters

Demographics

Age Race GenderAge < 18

Age > 60

Age 18-60

White

Black

Other

Male

Female

Patient MRN # MR1233

Age:80 | Sex: Female | Race Black

Rx # of Pts

2.50 bupropion 1356

3.16 venlafaxine 1897

3.67 sertraline 2345

Risk Factors

Hospitalized

Chronic Illness

History of SI attempt

Treatment Recommendation - Evidence)

Medication – (EBM, CR, CP)

Medication - (CR, CP, DW)

Diagnosis

Exit

3.67 sertraline + CBT 1755

Outpatient Inpatient Stressor

3/96

1997 1998199619951994

S

3/953/94

S

3/97

SSRI

TCA Bupropion

ECT

SNRI

Medication - (CR, CP, DW)

MeD + CBT – (EBM, CR, CP)

3.67 sertraline + CBT 578 ECT – (EBM, CR, CP)

The End


• Clinical• Re-imbursement• Efficiency• Decision Support

• Management• Revenues• Regulatory

• Research/Clinical Trials• Quality Data• Quicker Trials• Lower Costs

Clinical

Data

Research

Standards Based Codified Data is the Key

Management


agenda duke university medical center department of psychiatry and behavioral sciences clinical...

Documents

clinical data medications

clinical research epro

central site slide

outcomes epro slide

clinical setting patients

longitudinal data

care ehr

existing networks