1. APAN-Hawaii 24/January/2008 in Honolulu Naoki Nakashima, M.D., Ph.D. Department of Medical Informatics Kyushu University Hospital A Japanese model of disease management for diabetes mellitus from primary to tertiary prevention

2. Background of the project Pre-Diabetes Not Cared Specialist Doctors Cared 130 millions citizen in Japan 10 millions 4 millions 1million Family doctors Dropout Acute and Chronic Diabetic Complications Increase of Medical Cost 3millions Diabetes Mellitus Problems １． Continuously increasing patients and complications ２． Low hospitalization rate of patients (51%) ３． Shortage of specialist Drs. (=3,300 ） for diabetes Patients QOL Medical cost

3. Japanese Government will start “ Particular Health Check-up System (PHCS = Tokutei Kenshin)” from April 2008 All of 40 ～ 74yo Japanese citizen (56 million) will have to take standardized health examination All of 40 ～ 74yo Japanese citizen (56 million) will have to take standardized health examination List of basic examination List of basic examination Questionnaire (weight change, smoking, exercise) Questionnaire (weight change, smoking, exercise) A physical examination A physical examination Height, Weight (BMI), Waist, Blood Pressure Height, Weight (BMI), Waist, Blood Pressure Blood chemistry Blood chemistry TG, HDL-C, LDL-C, GOT, GPT, γ-GTP, Cre, Blood glucose (fasting or postprandial), HbA1c, Uric acid TG, HDL-C, LDL-C, GOT, GPT, γ-GTP, Cre, Blood glucose (fasting or postprandial), HbA1c, Uric acid Moderate and high risk groups are required to receive standard health instruction Moderate and high risk groups are required to receive standard health instruction

4. Data Accumulation And Stratification Arrangement of Health Check-up Health Check- up Arrangement of Health Instruction Navigation system of Instruction Health Instruction Dunning of Health Check-up Planning next year Data analysis Daily Health Instruction and Support Encourage to attend a clinic Dunning of Health Instruction Information Provided Motivation Support Aggressive Support Affected by Life Style Diseases Yearly Work Flow of Particular Health Check-Up System Start ! Stratificatio n Interventio n AnalysisPlan Assessment

5. Stratification Logic for Particular Health Check- up and Healthcare Instruction system Big Waist （ M ≧ 85cm, F ≧ 90cm) Normal Waist Obese （ M<85cm, F<90cm) （ BMI ≧ 25 ） Normal Waist Normal Weight （ M<85cm, F<90cm) （ BMI<25 ） Waist and Obesity Grouping for Healthcare Instruction Aggressive Support Group Motivation Support Group Informatio n provided Group ≧2≧2 1 ≧3≧3 1, 2 0 Number of Risk Factors* 65-74y.o. 0 *Risk Factors ① Blood Glucose ： Fasting ≧ 100 mg/dl HbA1c ≧ 5.2 % Under medication ② Lipidemia ： Triglyceride ≧ 150 mg/dl HDL-cholesterol<40 mg/dl Under madication ③ BP ： Systoric ≧ 130 mmHg Diastoric ≧ 85 mmHg Under medication ④ Smoking history ： + * ④ is counted if there is one point at least in ①～③.

6. Decision line to attend a clinic/hospital The Result of Physical and Blood Examination was: １） Blood Glucose a Fasting ≧ 126mg/dl or b HbA1c ≧ 6.1 % ２） Lipidemiaa TG ≧ 300mg/dl or b HDL-Chol ＜ 35mg/dl ３） BPa Systoric ≧ 140mmHg or b Diastoric ≧ 90mg/dl ４） LDL-Chol ≧ 140mg/dl

7. Rate of stratification group by the “Particular Health Check-up and Healthcare Instruction Program” estimated by Ministry of Health, Labor and Welfare information provided motivation supportaggressive support total (low risk group) (moderate risk group) (high risk group) Male ：６５．７１５．５ １８．８ １００％ Female ：８４．０１１．５ ４． ５ １００％ Total ：７５．１１３．４ １１．５ １００％

8. What does “ Specified Examination for Health and Relations ” mean? Including healthcare instruction and encouragement of medication, in addition to health examination Including healthcare instruction and encouragement of medication, in addition to health examination Insurers ’ duty, which is based on the law Insurers ’ duty, which is based on the law Cost is depend on insurers Cost is depend on insurers If insurers neglect their duties, they have to pay bigger shares of the support for medical cost of the latter high ages as a penalty If insurers neglect their duties, they have to pay bigger shares of the support for medical cost of the latter high ages as a penalty Target number is about 56 million (45% of the population) in Japan. Target number is about 56 million (45% of the population) in Japan. It intends to make the results of health examination by standardized electronic data. It intends to make the results of health examination by standardized electronic data.

9. DTD of HL7 CDA-R2 L3

10. Circulation of medical and insurance information after 2011 Medical institutes Citizens (patients) Insurance medical fee payment fund Insurers (payers) Reimbursement info （ medical action info ） Medical info (medical result info ） Healthcare info （ health exam result info ） To organize “National DB of Electronic Health Record (EHR)” Reimbursement info （ medical action info ） Reimbursement info （ medical action info ） 2011 ～ 2008 ～

11. What is “Carna Project” ? The Carna project is a newly developed Japanese disease management for life style disease. It aim the primary and secondary/tertiary prevention of diabetes mellitus/complication through prior interventions by the call-center. Carna ’ s goal is to establish a high quality medical care system with reasonable cost.

12. Carna Consortium Kyushu University Diabetes Specialist Doctors Saiseikai Kumamoto Hospital Kyushu Electronic Power Co. and group （ QIC ， QBS ） Tokio Marine & Nichido Fire Insurance Co. Fukuoka Prefecture Medical Association Fukuoka City Medical Association The Authorization document from Fukuoka Prefecture Medical Association Members Assented by 2003-2005Japan Science and Technology Agency (Ministry of Education, Culture, Sports, Science and Technology ) 2005 Ministry of Economy, Trade and Industry 2006 Ministry of Economy, Trade and Industry 2003-Kyushu Electronic Power Co. Total fund = 4 million US$ / 5years Funded by

13. Carna project has highly regarded for; Quality management Quality management -Standard guideline of medical/health care courses -Standard guideline of medical/health care courses -Algorithm of all work flows in the call center -Algorithm of all work flows in the call center -ICT -ICT Appropriate matching of services to individuals Appropriate matching of services to individuals -Patient profiling -Patient profiling -Matching of member and health instructor -Matching of member and health instructor Adaptation to the Japanese political measure and medical system Adaptation to the Japanese political measure and medical system Efficient and secure data management Efficient and secure data management Ethical considerations Ethical considerations -Privacy policy -Privacy policy

14. Summary of Carna Project Outbound Call Center Patients Mail Phone Family Drs. （ Company Drs. ） Points Coupon Strengthen Relationship Strengthen Relationship DM Dentist Kidney Ophthalmologist Specialists Team Care Service Clinics Critical Pathway Edutainment Tourism Co. Restaura nts Service Providers Gymnasiu m Private Insurance Co. Carna Office Individuals Local Government Company Public Health Insurance + Secondary, Tertiary Prevention ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway for Diabetes ） ⑤ Question to Find Complications Earlier ⑥ Question to Check knowledge ・ Education ⑦ Push to go to Clinic ・ Avoid to Drop Out ⑧ Quick Report of HbA1c to Patient Service ＜＜ Service ｓ＞＞ Primary Prevention ① Life style instruction program (Critical pathways for 5 action stage for self-care) ② Data Management and Analysis ③ Individual “Target” to Get Carna Points ① Services with Critical Pathways

15. We have developed 5 kinds of critical pathway (CP) for 5 stages. We decided the specific outcomes in each CP (outcome oriented CP). ＊ The CP for upper stage can be applied by achievement of outcomes (goal) in each CP. We continue same intervention until we get outcomes in each CP Life Style Instruction Program with Critical Pathways for 5 stages Precontemplation Requirement for apply Condition of escape Outcomes for goal Contemplation Requirement for apply Condition of escape Outcomes for goal Preparation Requirement for apply Condition of escape Outcomes for goal Action Requirement for apply Condition of escape Outcomes for goal Maintain Requirement for apply Condition of escape Outcomes for goal PRIMARY PREVENTION

16. Summary of Carna Project Outbound Call Center Patients Mail Phone Family Drs. （ Company Drs. ） Points Coupon Strengthen Relationship Strengthen Relationship DM Dentist Kidney Ophthalmologist Specialists Team Care Service Clinics Critical Pathway Edutainment Tourism Co. Restaura nts Service Providers Gymnasiu m Private Insurance Co. Carna Office Individuals Local Government Company Public Health Insurance + Secondary, Tertiary Prevention ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway for Diabetes ） ⑤ Question to Find Complications Earlier ⑥ Question to Check knowledge ・ Education ⑦ Push to go to Clinic ・ Avoid to Drop Out ⑧ Quick Report of HbA1c to Patient Service ＜＜ Service ｓ＞＞ Primary Prevention ① Life style instruction program (Critical pathways for 5 action stage for self-care) ② Data Management and Analysis ③ Individual “Target” to Get Carna Points ③ Provide the Carna Points

17. （patient） Nothing happen by my efforts on diet and exercise ・・・ Point system Achievement to the target line Constant answer to e-mail to e-mail Improvement of Body weight DECNOVOCTSEPAUGJULJUNMAYAPRMARFEBJAN 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point 100 point As like as “mileage system” in flight companies, patient can exchange the accumulated points with coupons of various healthy service or item. You got 2200 points ！！ We Provide and Manage the Carna Points

18. Summary of CARNA Project Out Bound Call Center Patients Mail Phone Primary Dr. （ Company Dr. ） Points Coupon Strengthen Relationship Strengthen Relationship DM Dentist Kidney Ophthalmologist Specialists Team Care Service Clinics Relational Critical Pathway Edutainment Tourism Co. Restaura nts Service Providers Gymnasiu m Private Insurance Co. CARNA office Individuals Local Government Company Public Health Insurance Service SECONDARY/TERTIARY PREVENTION + Secondary, Tertiary Prevention ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway for Diabetes ） ⑤ Question to Find Complications Earlier ⑥ Question to Check knowledge ・ Education ⑦ Push to go to Clinic ・ Avoid to Drop Out ⑧ Quick Report of HbA1c to Patient ＜＜ Service ｓ＞＞ Primary Prevention ① Life style instruction program (Critical pathways for 5 action stage for self-care) ② Data Management and Analysis ③ Individual “Target” to Get Carna Points ④ ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway ）

19. Out Bound Call Center Patients Mail Phone Primary Dr. （ Company Dr. ） Points Coupon Strengthen Relationship Strengthen Relationship DM Dentist Kidney Ophthalmologist Specialists Team Care Service Clinics Relational Critical Pathway Edutainment Tourism Co. Restaura nts Service Providers Gymnasiu m Private Insurance Co. CARNA office Individuals Local Government Company Public Health Insurance Service SECONDARY/TERTIARY PREVENTION + Secondary, Tertiary Prevention ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway for Diabetes ） ⑤ Question to Find Complications Earlier ⑥ Question to Check knowledge ・ Education ⑦ Push to go to Clinic ・ Avoid to Drop Out ⑧ Quick Report of HbA1c to Patient ＜＜ Service ｓ＞＞ Primary Prevention ① Life style instruction program (Critical pathways for 5 action stage for self-care) ② Data Management and Analysis ③ Individual “Target” to Get Carna Points ⑤⑥⑦ Call Center Service (Phone Call Question to Find Complications Earlier) Summary of CARNA Project

20. Out Bound Call Center Patients Mail Phone Primary Dr. （ Company Dr. ） Points Coupon Strengthen Relationship Strengthen Relationship DM Dentist Kidney Ophthalmologist Specialists Team Care Service Clinics Relational Critical Pathway Edutainment Tourism Co. Restaura nts Service Providers Gymnasiu m Private Insurance Co. CARNA office Individuals Local Government Company Public Health Insurance Service SECONDARY/TERTIARY PREVENTION + Secondary, Tertiary Prevention ④ Provide Care Plan, Outcome Management （ Relational Critical Pathway for Diabetes ） ⑤ Question to Find Complications Earlier ⑥ Question to Check knowledge ・ Education ⑦ Push to go to Clinic ・ Avoid to Drop Out ⑧ Quick Report of HbA1c to Patient ＜＜ Service ｓ＞＞ Primary Prevention ① Life style instruction program (Critical pathways for 5 action stage for self-care) ② Data Management and Analysis ③ Individual “Target” to Get Carna Points ⑧ Quick Report of HbA1c to Patent Summary of CARNA Project

21. Carna’s two programs of disease management Service for insurers (outsourcing of Tokutei Kenshin) prevention health promotion association Family doctorsSpecialists doctors Health promotion for healthy people Service for clinics (outsourcing of lifestyle management fee in medical payment) Intervention by an initial health instruction and repeated instructions Diagnosis of Diabetes Mellitus Secondary/tertiary prevention without cooperation of family doctors (DM light service) Primary prevention program Secondary/tertiary prevention program for diabetes mellitus medication Secondary/tertiary prevention with cooperation of family doctors (DM regular service)

22. Schedule of Carna’s Diabetes Project Final formation of the diabteic project Secondary/tertiary prevention （ Capitalized from 2010 ） Information provided Motivation support Aggressive support Encouragement of hospitalization Classic Diabetes program ・ Management of Critical path ・ Support of hospitalization ・ Support to find early complication ・ Data Management of diabetes indicator ・ Support of education ・ Intensive program for DM ・ Consultation program Verified test from 2006 Business target; insurers We will start capitalization from primary prevention at first and extend the target to secondary/tertiary prevention later. Primary prevention （ Capitalized from 2008 ） Verified test from 2005 Business target; clinics

23. Future Directions Tokyo Kumamoto Pref. Regional development Primary prevention Disease kinds Post ope of cancerDepressionIHDHeart FailureCOPDAsthma Secondary/ Tertiary Prevention of Diabetes Mellitus In Fukuoka Prefecture Carna in 2008 in 2008 Data management = 100,000 people Health instruction = 2,000 people

24. 0 20 40 60 80 100 Quick eating Group of non-healthcare instruction Group of Healthcare instruction Night eating Skip breakfast Eating before sleep Eating out Eating more than same generation Walking for 1 hour Faster walking than same generation Exercise twice/a week Daily exercise Feel better by sleeping Sleeping well Daily alcohol taking Smoking Smoking number Stress Method to release stress Persisting present lifestyle Want to improve present lifestyle Soft drink Improved at least one item 4018144197268045866317984026 763132183 102 26981942244227423414492921 392195249 (%) Effect of Face to Face Healthcare Instruction on the Healthcare Instruction Group (Motivation Support + Aggressive support) by an e-mail questionnaire

25. Conclusion The bill to reorganize the public medical insurance, which will be enforced in 2008, and the project of 100% online reimbursement, which will be achieved in 2011, will change the circumstances of circulation and accumulation of medical, healthcare and insurance information. We need to establish secure and patient-centeredsocial system for the alterations. As a model of the social system, we presented a newly developed Japanese disease management for diabetes mellitus “Carna”. The bill to reorganize the public medical insurance, which will be enforced in 2008, and the project of 100% online reimbursement, which will be achieved in 2011, will change the circumstances of circulation and accumulation of medical, healthcare and insurance information. We need to establish secure and patient-centered social system for the alterations. As a model of the social system, we presented a newly developed Japanese disease management for diabetes mellitus “Carna”. If you have any questions, call to Carna office, +81-92-642-6459 Or carna@med.kyushu-u.ac.jpcarna@med.kyushu-u.ac.jp