Content: Slides 2-10 Anna Winkowski Slides 11-20 David Madison Slides 21-26 David Mishler

1. Content: Slides 2-10 Anna Winkowski Slides 11-20 David Madison Slides 21-26 David Mishler

2. Patient Adaptive Diabetic CDS (PAD-CDS) David Madison David Mishler Anna Winkowski MED INF 406 – Spring 2009

3. Project Description The Patient Adaptive Diabetic Clinical Decision System (PAD-CDS) better known as MyDM, delivers a comprehensive web-based patient-centric clinical decision system based on a longitudinal care record. Major features include: • User interface hosted on Apple iPhone™ (you carry the CDS with you). • Access to expert community via SMS messaging. • Maintenance of a consistent & longitudinal health record via Microsoft HealthVault™ - eliminating hand-off errors. • Integration with wireless glucose meters for automatic transfer of readings to the iPhone using Bluetooth™. • Modular & installable clinical decision trees on the server side – accessible to the user via application update push. • A1C estimation & trending algorithm – viewable by user. • Clinical data transfer to EHR (if supported)

4. Diabetes Facts • A disease in which the body does not produce or properly use insulin (a hormone needed to convert sugar, starches and other food into energy) • Cause remains a mystery but genetics and environmental factors (obesity, lack of exercise) play roles • Diagnoses based on Fasting Plasma Glucose Test or an Oral Glucose Tolerance Test Source: American Diabetes Association

5. Types of Diabetes Type 1 Diabetes Type 2 Diabetes

6. Diabetes Complications Heart disease and stroke account for 75% of deaths in people with diabetes High blood pressure-73% of diabetics have a blood pressure of 130/80 or higher Blindness 12,000-24,000 new cases each year. Keeping BS close to normal reduces damage to the eye by 76% Nervous system disease 60% to 70% of diabetics have mild or severe nerve damage. 30% have impaired sensation in their feet Kidney disease-diabetes is the leading cause of kidney disease Amputations-diabetes is the cause for >60% of non-traumatic lower limp amputation Complications of pregnancy-birth defects in 5%-10% of pregnancy. 15% to 20% of spontaneous AB

7. Economics of Diabetes $174 billion-total annual economic cost of diabetes in 2007 • $58 billion indirect costs (increased absenteeism, reduced productivity, disability, etc.) • $116 billion for medical expenditures ($27 billion diabetes care, $58 billion for chronic diabetes-related complications, $31 billion for excess general medical costs) 23.6 million or nearly 8% of the US population have diabetes w/ nearly one-third undiagnosed

8. Goals Support Selected Healthy People 2010 Diabetes Goals • [5-1] Increase the the proportion of persons with diabetes who receive formal diabetes education. Target: 60% (baseline 45%). • [5-6] Reduce diabetes related deaths among persons with diabetes. Target: 7.8 deaths per 1000 (baseline 8.8). • [5-7] Reduce deaths from cardiovascular disease in persons with diabetes. Target: 309 deaths per 100,000 persons with diabetes (baseline: 343 deaths). • [5-10] Reduce the rate of lower extremity amputations in persons • with diabetes. Target: 1.8 lower extremity amputations per 1,000 persons with diabetes per year (baseline 4.1 lower extremity amputations). • [5-12] Increase the proportion of adults with diabetes who have a glycosylated hemoglobin measurement at least once a year. Target: 50% (baseline: 24%). • [5-13] Increase the proportion of adults with diabetes who have an annual dilated eye examination. Target: 75% (baseline: 47%) • [5-14] Increase the proportion of adults with diabetes who have at least an annual foot examination. Target: 75% (baseline 55%). • [5-17] Increase the proportion of adults with diabetes who perform self-blood-glucose-monitoring at least once daily. Target: 60% (baseline: 42%). Source: Healthy People 2010 Report, Objective Section 5.

9. Goals Support ADA Diabetes Clinical Practice Recommendations for 2009 • Self-monitoring of blood glucose (SMBG) should be carried out three or more times daily for patients using multiple insulin injections or insulin pump therapy. • Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control). • Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. • Use of point-of-care testing for A1C allows for timely decisions on therapy changes, when needed. • Lowering A1C to below or around 7% has been shown to reduce microvascular and neuropathic complications of type 1 and type 2 diabetes. Therefore, for microvascular disease prevention, the A1C goal for nonpregnant adults in general is 7% Source: ADA Standards of Medical Care in Diabetes for 2009, Position Statement

10. Stakeholders & Objectives Diabetics: Validation group, ADA, prospective new users - Improve HbA1c management. - Reduce medical errors due to episodic complications. - Provide portable longitudinal care record. - Reduce ER visits • Clinical Care: CMO, CQO, Care Providers • Reduce medical errors at diabetic patient handoff points • - Reduce incidence of diabetic co-morbidity by improved disease management and insulin compliance. • - Improve patient’s ability to self-manage diabetes through in-hospital deployment of MyDM. Senior Management: CEO, CFO - Reduce cost of chronic diabetes disease management. - Improve hospital capacity by reduction in resources necessary to manage diabetes. - Improve hospital’s ability to meet increasingly restrictive PPS DRG standards. - Increase “best place to work” metrics. - Reduce costs and complexity of HIT infrastructure.

11. iPhone MyDM Medical Appliance Familiar Convenient Portable Long battery life Expandable

12. iPhone MyDM Medical Appliance Blood Sugar button Receive glucose reading, date and time via Bluetooth Separately set Alarms for glucose checks as desired

13. iPhone MyDM Medical Appliance HbA1c correlates with blood sugar control MyDM device calculates estimated HbA1c from average of blood sugar readings

14. iPhone MyDM Medical Appliance • American Diabetes Association • Dietary advice • Support groups • Newsletters • Self-assessment exams • Exercise programs

15. iPhone MyDM Medical Appliance EXPERT answers provided in sms text messages Similar to www.chacha.com

16. iPhone MyDM Medical Appliance • GUIDE ME—Advice: • Ill unable to eat • Undergoing medical testing • Change in physical activity

17. iPhone MyDM Medical Appliance Scattergram Blood sugars by time of day HbA1C trend overtime-reflects control

18. iPhone MyDM Medical Appliance • PHR • Patient Health Record • Medications • Allergies • Surgeries • Family history

19. iPhone MyDM Medical Appliance • MD Setup • Medication, dose • Goal blood sugars, HbA1c • Responses to elevated blood sugars

20. CDS Diagram MyDM iPhone

21. Model availability Available now Need development Extensible model to include: Lipid management Exercise programs Additional guideline alarms based on age, sex, ethnicity Enrollment in research studies Earn discounts from insurer based on documentation of compliance

22. Architecture Community cha-cha experts Always-on feedback MyDM Web Portal Microsoft HealthVault PHR HL7 CDA CCR MyDM App (on iPhone) Clinical User Data (Multi-user) Alerts, reminders Database Glucose Meter TreeAge Pro Interactive HL7 CDA CCR Pulse Ox Clinical User Data (Multi-user) TreeAge Decision Tree Library EHR Weight Scale Data Crawler HL7 XDR (IHE reliable Cross-enterprise document Sharing) Clinical Records & Applications Clinical Decision Support User Interface

23. Architecture (A day in the life…) MyDM on iPhone captures glucose readings using Bluetooth enabled devices. Readings are sent to MyDM web portal. Glucose management CDS monitors readings, computes trends, and develops quality metrics (A1C < 7%, glucose reading compliance, …) A crawler application on the server periodically processes new data information, converting it to HL7 CDA CCR format. New CCR records are published to PHR. If EHR support is available, CCR is sent in IHE reliable cross-enterprise document mode (XHR) to the EHR. MyDM and/or EHR can generate alerts and reminders, which are pushed to the iPhone. A Longitudinal health record (from PHR) is available from the iPhone. Expert guidance & episodic diabetes management are available to the user 9 1 8 2 5 2 3 1 7 6 4 3 4 5 6 7 8 9

24. Evaluation Philosophy Friedman’s “smallball” with a twist – the addition of principles fromThe Agile Manifesto (www.agilemanifesto.org). “Agile” projects start with small feature sets, build that functionality, test, deploy and obtain feedback. Each successive iteration adds new features and feedback. Keep repeating until sufficient marketable functionality – and for building future product releases. “Smallball” adds evaluation feedback at every step. MyDM runs on an iPhone – why not use a cell phone metaphor for “instant on” feedback? Source: Friedman et al, Evaluating Measures of Success using Clinical Decision Support, AHRQ National Resource Center for HIT web seminar, January 21, 2009. Continuous multi-media feedback – send a text message, leave voice mail, send e-mail. Provides a highly satisfying and intuitive evaluation mechanism for all stakeholders. Captures problems as well as improvements and new features. Creates a sense of community in that all users feel highly involved in the product evolution.

25. Limitations • Applications • Need to partner with Apple and the glucometer manufacturers to have the applications added and available to patients • Price • At $199 for a 8G and $299 for a 16G, not many patients would be able to afford the device. However, majority have a cell phone so maybe have a downloadable application that could interface with most cell phones • Complexity • System has comprehensive approach that could slow development and deployment – although a “community” could build up by user adoption. • Implementation skill set • Software skills: Apple iPhone, Cocoa, Objective-C, TreeAge decision tree interfacing, database, data mining & analytics, HL7 CDA and XDR, and Microsoft HealthVault (SDK, C#), and EHR interfacing. • Clinical skills: Development and evaluation of decision trees, management of expert cha-cha community, EHR order-entry and alarming development.

26. Questions?