Towards an Adaptable Framework for Modeling, Verifying, and Executing

Medical Guidelines

Janos Mathe and Jason B. Martin

Vanderbilt University

Outline

1. Project Motivation– IT in Health Care – Why do we need it?– How can it help?

2. Model-Based Design

3. Use of Model-Based Design in Health Infrastructures

4. Policy-driven Architectures: Deep Integration of Privacy Policies and Information System Architectures

− Privacy modeling− Semantic Composition of Architecture and

Privacy Policy Models

5. Privacy and security in In-Home Patient Monitoring

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The Research Team

Multi-disciplinary collaboration

“A solution in search of a problem”

Objectives– Establish an evidence-based protocol

approach– Model the protocol– Create, iterate, and deploy– Measure the benefits and changed practices

(we hope)

In Search of a Clinical Paradigm

“Do something that matters.”

“Study sepsis.”Arthur Wheeler, M.D.

What is sepsis?

Infection : a micro-organism occupies a normally sterile site

Systemic inflammatory response syndrome (SIRS): • temperature > 38 or < 36• heart rate > 90• respiratory rate > 20• WBC count > 12,000 or < 4,000

Sepsis : the systemic inflammatory response syndrome secondary to a known (or suspected) infection

3 = 1 + 2

Burns

SIRS

Sepsis

Trauma

Pancreatitis

Other

CNN.comThursday, January 29, 2009

Epidemiology

1. Common

2. Deadly

3. Expensive

4. Treatable

• 1-3 cases per 1000 per year

• 750,000 cases in the US in 2001

• No age, social, geographic, or racial boundaries

• 1-3 cases per 1000 per year

• 750,000 cases in the US in 2001

• No age, social, geographic, or racial boundaries

Epidemiology

1. Common

2. Deadly

3. Expensive

4. Treatable

• 200,000 + US deaths in 2001

• 25-35% mortality

• 200,000 + US deaths in 2001

• 25-35% mortality

Epidemiology

1. Common

2. Deadly

3. Expensive

4. Treatable• $17B US

• 40% of all ICU costs

• 3-5 weeks of hospitalization

• $17B US

• 40% of all ICU costs

• 3-5 weeks of hospitalization

Epidemiology

1. Common

2. Deadly

3. Expensive

4. Treatable• Validated treatment protocols established• Validated treatment protocols established

Current Treatment

Surviving Sepsis Campaign

Reviewed, graded evidence; formulated guidelines

Suggests use of treatment protocols and bundles

– Multiple interventions– Time-sensitive– Frequent follow-up and re-assessment

The ICU Environment

Information-intensive, stressful environment

– Multiple patients– Revolving practitioners– Large volume of data– Temporally discontinuous

Ideal environment for a technology intervention

Hypothesis

Implementation of an electronic process

management tool will result in increased

adherence to evidence-based practices,

improvement in objective quality

indicators, and better clinical outcomes for

septic patients.

Objectives

Develop a comprehensive clinical protocol for the management of septic patients

Design and deploy the process management tool

Study the impact on physician practices, cost, and patient outcomes

Technical Barriers

Operational protocols, healthcare policies, and treatment guidelines are rarely phrased in a mathematically sound manner

Medical protocols are not “law”– Customizable?– Processes, triggers need to be flexible

Clinical Barriers

Disproportionate impact of anecdotal experience

Failure to appreciate the limits of human decision-making capacity

Exclusion of practitioners from the development process

Tendency to focus on unlikely, but possible, clinical scenarios

Clinical Barriers

Imposing undue burdens on the end-user

Concern about accuracy of protocol elements

Pride among practitioners defending their autonomy

Knowledge-based Systems in the ICU

Commonly available “workflow systems”– Results systems– EMRs– POE

Support systems – Reminders– Pathways– Decision-support– Process management

Decision Support vs. Process Management

Process Management Comprehensive guide;

has the ability to recalculate if you deviate

Decision Support Answers to specific

questions at independent points

DSDS

Process Management at Vanderbilt

Vanderbilt is pioneering process management applications in critical care environments

The dashboard approach graphically displays the status of various tasks in a protocol

Has been applied to VAP in ICUs

Preliminarily showing clinical benefits

Our Sepsis Process Management Tool

Integrated with the critical care dashboards

Identifies patients who might have sepsis

Prompts evaluation by clinical teams

If septic, provides real-time management recommendations

Architectures for Trustworthy Health Information Systems (THIS)

Vanderbilt (Ledeczi, Lee, Sztipanovits) investigates a formalized design approach to model-based development of Health Information Systems.

• Formal system modeling

• Formal policy modeling

• Model verification for security and privacy properties of the modeled architecture

• Model-based generation of run-time components

• Model-based system integration

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Clinical protocols are not new; differential diagnosis protocols have been common since the 60’s

Use of approved clinical guidelines is becoming widespread, especially in the UK & Australia

Evidence-based medicine informs best practices and is the basis for modern clinical protocols

Protocols are not customized patient plans Missing step: generating individualized patient plans from

evidence-based clinical protocols:– Most patients have multiple co-morbidities– Components of a protocol may conflict with patient’s other problems– Example: Giving a vasopressor to a person with underlying

congestive heart failure– Potential conflicts, like drug interactions must be recognized both in

plan generation and execution

Application of MIC in STEEP: Evidence-Based Clinical Protocols

Protocol Design Phase

Treatment Planning Phase

Treatment Phase

MICGenerators

Verification Methods• Clinical Correctness

• Well-formedness

(completeness, consistency)

• Structural Correctness

– coordination

– timing

– resource

Verification Methods• Clinical Correctness

• Plan Correctness

(compatibility, consistency)

• Parametric Correctness

– treatment

– timing

– resource

Verification Methods Clinical Limits • Parametric Limits• Interference Checking• Exception handling

MICGenerators

SOA Platform

MIC Platform

Who• Attending Physicians • Fellows

When• Knowledge breakthroughs• Periodic review of quality

Who• Sepsis team

When• Patient admittance to ICU

Who• Fellows• Residents• NursesWhen• Daily rounds• Treatment steps

STEEP Information Architecture

Representation of the Sepsis Protocol

Inside the Sepsis Management System

PatientPhysician

Protocol Execution Engine

Patient Management

Dashboard

SurveillanceTool

Treatment Management Console

Protocol ModelsGME

Derived Protocol Representation

XML

T

Clinical Information System Components

DB

EMRWizOrderTHIS

STEEP

• Protocol-driven • Evidence-based

• Customizable • IntegratedGoals:

Summary

Health Information Systems are key for improving quality and efficiency for health care delivery

Complexity of these systems is a major concern: model-based design can help

Policy and architecture models need to be merged: the search for a common semantic framework is on ….

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