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 2

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 Infection SIRS Sepsis Trauma Pancreatiti s Other

CNN.com Thursday, 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 % mortality 200,000 + US deaths in % 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 DS

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

25 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 MIC Generators 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 MIC Generators 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 Nurses When Daily rounds Treatment steps STEEP Information Architecture

Representation of the Sepsis Protocol

Inside the Sepsis Management System STEEP Protocol-driven Evidence-based Customizable Integrated Goals:

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 …. 29