1. Some Initial Comments Re. Health Care Quality and Research: David J. Ballard, M.D., Ph.D., F.A.C.P. First Conference on Health Regione Marche 22, 2001 June 22, 2001

2. Health care research is the study of the benefits of health care interventions in relation to their hazards and costs Kerr L. White, M.D. Founding Chairman (1964) Department of Health Care Organization Johns Hopkins University Member, Institute of Medicine/US NAS

3. Clinical Effectiveness Research and Quality of Care Research: Aligning and Expanding Research to Advance Best Care Across the Baylor Health Care System David J. Ballard, M.D., Ph.D., F.A.C.P. Senior Vice President Health Care Research and Improvement Baylor Health Care System Dallas, Texas June 22, 2001

4. Teaching and research contribute to curing illness, alleviate suffering and disability, and promoting health, and they must be supported within the health care system. Shared Statement of Ethical Principles for the Health Care System, October 5, 1999 Donald M. Berwick, M.D. President and C.E.O. Institute for Healthcare Improvement

5. Have a little statistical compassion and take a look at the quantitative information before providing inadequate care or wasting millions of dollars Kerr L. White, M.D.

6. Baylor Health Care System History 1903-2001  1903 - Founded as renovated 14-room home  1981 - Becomes a multi-hospital system  1994 - Starts employed physician group, HealthTexas Provider Network (HTPN)  14 Hospitals (8 owned); 85,519 admissions/year; Annual Budget $1.4 Billion  13,200 employees(263 employed physicians)  2,850 affiliated physicians

7. Baylor Health Care System New Vision Statement, 2000 Baylor Health Care System will, before the end of this decade, become the most trusted source of comprehensive health services.

8. Baylor Health Care System New Mission Statement, 2000 Founded as a Christian ministry of healing, Baylor Health Care System exists to serve all people through exemplary health care, education, research and community service.

9. BHCS Strategic Objectives 2000 1.Create and Enhance Physician Relationships 2.Grow the System 3.Connect Consumers, Clinicians and Other Stakeholders 4.Deliver the Best Care Available Anywhere 5.Deliver Superb Customer Service 6.Develop People at Baylor 7.Produce Optimal Cash Flow 8.Be One of the Preferred Organizations in the Southwest for Health Care Philanthropy 9.Align and Expand Education and Research to Advance “ Best Care ”

10. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research & Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives

11. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research & Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives First In Humans Research

12. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research & Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives Clinical Efficacy Research First In Humans Research

13. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research & Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

14. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research & Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives Quality Of Care Research Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

15. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research &Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives Quality Of Care Research Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

17. VHA CEO Network for Clinical Excellence Workgroup Standard as per CEOs 100% accuracy on treatment of eligible patients based on HCFA 6th Scope of Work criteria

18. Texas Medical Foundation Inpatient Medicare Quality Initiatives Acute Myocardial Infarction Aspirin within 24 hours of arrival Beta blocker within 24 hours of arrival Timely reperfusion: Thrombolytics within 60 minutes of arrival or PTCA within 90 minutes of arrival ACE Inhibitor at discharge for patients with LVEF < 40% Smoking cessation counseling during hospitalization Aspirin at discharge Beta blocker at discharge

19. Process of Care Measure State of Texas Medicare Random Sample Average Value Performance In Median State Average Value Total BHCS Average Value VHA Green Light Threshold VHA Best Practice Hospital Average Value for Process Early Use of Aspirin 78%84%92% 141/154 90%100% 31/31 Early Reperfusion (TTT)* Median 39 min. Median 40 min. Median 83% 34 min. 25/30 80% Median 100% 15 min 11/11 Discharge on Aspirin84%85%93% 117/126 90%100% 27/27 Discharge on Beta Blockers 58%72%82% 89/108 80%100% 21/21 Discharge on ACEI 63%71%72% 23/32 80%100% 3/3 Smoking Cessation Counseling during Hospitalization 19%40%54% 28/52 90%100% 10/10 Table 1.1 Distribution of Average Values for Hospital Process of Care Measures for Patients with Acute Myocardial Infarction * Based on percentage of patients with time from ER arrival to thrombolytic therapy of less than 60 minutes.

20. Table 1.2 Distribution by BHCS Hospital Identification Number of Average Values for Hospital Process of Care Measures for Patients with Acute Myocardial Infarction Process of Care Measure115111114107116 Early Use of Aspirin85% 23/27 87% 33/38 97% 37/38 100% 35/35 81% 13/16 Early Reperfusion (TTT)* Median 50% 55 min 2/4 Median 100% 35 min 9/9 Med 100% 15 min 11/11 Median 40% 65 min 2/5 Median 100% 42 min 1/1 Discharge on Aspirin96% 44/46 94% 33/35 71% 5/7 94% 30/32 83% 5/6 Discharge on Beta Blockers84% 31/37 74% 28/38 40% 2/5 100% 21/21 100% 7/7 Discharge on ACEI68% 13/19 100% 3/3 0% 0/1 88% 7/8 0% 0/1 Smoking Cessation Counseling during Hospitalization 63% 12/19 47% 7/15 100% 1/1 50% 7/14 33% 1/3 *Based on Percentage of patients with time from ER arrival to thrombolytic therapy of less than 60 minutes.

21. HTPN Quality Committee Vision The vision of the Quality Committee of HTPN is to enhance clinical outcomes, improve patient satisfaction, and increase quality-related cost efficiency from evidence based standards of care.

22. HTPN Quality Committee Mission The mission of the Quality Committee of Health Texas Provider Network is to provide leadership in the definition and coordination of evidence based quality patient care across the Baylor Health Care System and communities served by HealthTexas practices by developing, implementing, and achieving improvement opportunities related to “Quality Initiatives.”

23. HTPN Clinical Preventive Services Sample Practice 23 of 27 85.2% Physicians 111 of 157 70.7% Patients 4,591 of 138,000 3.3%

24. HealthTexas Provider Network Preventive Health Services Baseline Study Results

25. Clinical Preventive Services Benchmarks

26. State of Texas Medicare Random Sample Average Value Performance In Median State Average Value Total HTPN Average Value National Best Practice Benchmark Average Value HTPN Best Practice/ Achievable Benchmark of Care Influenza Vaccine66% Telephone Survey 68% Telephone Survey 49% Medical Records 63%90% Pneumococcal Vaccine 44% Telephone Survey 46% Telephone Survey 40% Medical Records 72%89% Mammography51% 2 years, Claims 56% 2 years, Claims 56% 1 yr, Med Records 75% 1 year 86% 1 year Annual HgbA1c for DM patients 73%71%86% 98%97% Eye Exam for patients with DM 68% 2 years 69% 2 years 59% 1 year 84%78% Lipid Profile for patients with DM 66% 2 years 57% 2 years 67% 1 year ?%90% Table 4.1 Distribution of HCFA 6 th Scope of Work Outpatient Process of Care Measures for HTPN Patients

27. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research &Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research: Baylor Institute for Immunology Research Director Clinical Quality Improvement Initiatives Quality Of Care Research Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

28. Health Texas Provider Network A Randomized Trial of Strategies to Improve Diabetes Care: Effectiveness and Costs of Physician Profiling and Care Coordination by a Diabetes Resource Nurse Sponsored by American Diabetes Association Performed in Partnership by Health Texas Provider Network, Baylor Health Care System, and Texas Medical Foundation

29. PURPOSE To evaluate the effect of three quality improvement interventions on the processes and outcomes of care for Medicare beneficiaries with diabetes in a multi-site, fee-for-service, primary care group practice setting.

30. INTERVENTION 1 Medicare Claims-Based Physician Profiling Aggregate patient data at individual physician level received from TMF Measures include performance of hemoglobin A 1c, lipid profile, and eye examination

31. INTERVENTION 2 A. Medicare Claims-Based Physician Profiling B. Diabetes Quality Improvement Project (DQIP) Physician Profiling Aggregate patient data at individual physician level received from Medicare for performance of hemoglobin A 1c, lipid profile, and eye examination. Individual patient data at individual physician level as abstracted from HTPN claims and/or medical records. DQIP measures include (1) performance of hemoglobin A 1c, lipid profile, eye examination, diabetic nephropathy monitoring, and foot exam; and (2) results of hemoglobin A 1c, LDL, and blood pressure.

32. INTERVENTION 3 A. Medicare Claims-Based Physician Profiling B. Diabetes Quality Improvement Project (DQIP) Physician Profiling C. Patient Care Coordination Provided by Diabetes Resource Nurse (DRN) Aggregate patient data at individual physician level received from Medicare for performance of hemoglobin A 1c, lipid profile, and eye examination. Individual patient data at individual physician level as abstracted from HTPN claims and/or medical records. DQIP measures include (1) performance of hemoglobin A 1c, lipid profile, eye examination, diabetic nephropathy monitoring, and foot exam; and (2) results of hemoglobin A 1c, LDL, and blood pressure.

33. 32 Internal Medicine and Family Practice Sites Screened 22 Practice Sites Were Randomized 7 Assigned to TMF Claims- Based Feedback Plus DQIP-Based Feedback 8 Assigned to TMF Claims- Based Feedback Plus DQIP-Based Feedback in Conjunction with Care Coordination By Diabetes Resource Nurse 7 Assigned to TMF Claims-Based Feedback 10 Exclusions: 2 <1 Year Old 4 <10 DM Patients 2 Previous DRN Exposure 1 Residency Program 1 Practice Closed Figure 1. Flow Diagram of Study Practice Sites - Summary

34. 101 Internal Medicine and Family Practice Physicians Screened 88 Physicians Qualified 42 Assigned to TMF Claims- Based Feedback Plus DQIP-Based Feedback 23 Assigned to TMF Claims-Based Feedback Plus DQIP-Based Feedback in Conjunction with Care Coordination By Diabetes Resource Nurse 23 Assigned to TMF Claims-Based Feedback 13 Exclusions 5 TMF Claims-Based Feedback Claims 1 Not in Practice Prior to 1/1/00 1 No DM Patients Meeting Study Criteria 1 Terminated HPTN Employment 2 Moved Locations During Reporting Year 6 TMF Claims-Based Feedback Plus DQIP- Based Feedback 1 Not in Practice Prior to 1/1/00 2 No DM Patients Meeting Study Criteria 2 Terminated HPTN Employment 1 Moved Locations During Reporting Year 2 TMF Claims-Based Feedback Plus DQIP- Based Feedback in Conjunction with Care Coordination By Diabetes Resource Nurse 1 Not in Practice Prior to 1/1/00 1 Terminated HPTN Employment Internal Medicine and Family Practice Physicians Practicing Within the 22 Randomized Practice Sites Summary

35. 88 Excluded 47 by TMF 26 Deceased 9 Missing from Database 6 State Residency Not Met 6 Coverage Requirements 41 by Nurse Abstractor 25 No DM Dx 16 Deceased Number of Patients Screened is Unknown 1,987 Patients Qualified 729 Assigned to TMF Claims- Based Feedback Plus DQIP-Based Feedback 606 Assigned to TMF Claims- Based Feedback Plus DQIP-Based Feedback in Conjunction with Care Coordination By Diabetes Resource Nurse 652 Assigned to TMF Claims-Based Feedback 85 Excluded 56 by TMF 20 Deceased 20 Missing from Database 13 Coverage Requirements 3 State Residency Not Met 29 by Nurse Abstractor 17 No DM Dx 10 Deceased 1 No Longer a Patient 1 Patient Not Seen During Reporting Year 89 Excluded 59 by TMF 26 Deceased 14 Coverage Requirements 13 Missing from Database 6 State Residency Not Met 30 by Nurse Abstractor 20 No DM Dx 9 Deceased 1 Patient Changed Practice Site 563 Patients in Final Inception Cohort as of Jan 1, 2001 644 Patients in Final Inception Cohort as of Jan 1, 2001 518 Patients in Final Inception Cohort as of Jan 1, 2001 Patients Seen by Qualifying Physicians During Study Reporting Year (July 1, 1999 – June 30, 2000) Summary

36. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research &Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research: Baylor Institute for Immunology Research Director Clinical Quality Improvement Initiatives Quality Of Care Research Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

37. Defining Health Care Quality for the Baylor Health Care System The Gray Zone of Clinical Care Most Frequent Clinical Characteristics of Abdominal Aortic Aneurysm Surgery Patients by Appropriateness Category among 1,092 Patients at 12 Academic Medical Center Consortium Institutions, 1987-1990 Appropriateness Category No. of Patients % Uncertain: 412 Uncomplicated infrarenal abdominal aortic aneurysm, 160 39 5.0-5.9 cm, high surgical risk Uncomplicated infrarenal abdominal aortic aneurysm, 106 26 4.0-4.9 cm, intermediate surgical risk Inappropriate: 34 Uncomplicated infrarenal abdominal aortic aneurysm, 11 32 4.0-4.9 cm, high surgical risk Uncomplicated infrarenal abdominal aortic aneurysm, 6 18 <4.0 cm

38. Introduction Aortic aneurysm: 13th leading cause of death in US –9000 AAA rupture deaths/year 33,000 elective AAA repairs per year in US –2800 operative deaths/year ( 8.4%) AAA diameter is strongest known predictor of rupture 1992: SVS/ISCS rec. elect. repair of AAA  4.0 cm Of AAA  4.0 cm, 79% < 5.5 cm (ADAM screening) UKSAT: NS, operative mort 5.8% (Lancet 1998;352:1649)

39. Objective To determine, in a randomized trial, which of two strategies is superior for managing small AAA (4.0-5.4 cm in diameter): 1) immediate open surgical repair of the AAA, or 2) imaging surveillance at 6 month intervals, reserving surgery for those that enlarge to 5.5 cm, enlarge rapidly (0 pts), or become symptomatic

40. CUMULATIVE SURVIVAL BY TREATMENT DeathsPatientsTREATMENTS SURGERY 141 569 SURVEILLANCE 121 567 p<0.14

41. Conclusions Long-term survival is not improved by repairing AAA < 5.5 cm, even when operative mortality is very low……1.7% Deferring repair until the AAA enlarges does not increase operative mortality 20-30% of Surveillance group never require repair Rupture is rare in this population (0.5%/yr at risk) same as reported in NEJM 1989 by Ballard et al. Late mortality may be increased by major vascular surgery. (Bergan, Arch Surg 1992;127:1119-24

42. Defining BHCS Health Care Quality: Recommendations for AAA <= 5.5 cm? 50% of all AAA Surgery in United States Most Frequent Clinical Characteristics of Abdominal Aortic Aneurysm Surgery Patients by Appropriateness Category among 1,092 Patients at 12 Academic Medical Center Consortium Institutions, 1987-1990 Appropriateness Category No. of Patients % Uncertain: 412 Uncomplicated infrarenal abdominal aortic aneurysm, 160 39 5.0-5.9 cm, high surgical risk Uncomplicated infrarenal abdominal aortic aneurysm, 106 26 4.0-4.9 cm, intermediate surgical risk Inappropriate: 34 Uncomplicated infrarenal abdominal aortic aneurysm, 11 32 4.0-4.9 cm, high surgical risk Uncomplicated infrarenal abdominal aortic aneurysm, 6 18 <4.0 cm

43. Linkage of BHCS Best Care and Research & Education Objectives Improving Health CareImproving Health Care 1.Underuse…$ 850K ADA-Funded Randomized Controlled Trial (RCT) of Quality Improvement Strategies to Improve Use of Effective DM-Related Care for BHCS/HTPN Patients with DM 2.Overuse….Development of BHCS Elective AAA Surgery Appropriateness Criteria Linked to Results of VA RCT of Immediate Surgery vs. Watchful Waiting for 4.0 – 5.5 cm Infrarenal AAA 3.Outcomes….Testing Models to Improve Chronic Illness Care Outcomes via the RAND/IHI/GHC/RWJ Improving Chronic Illness Care Initiative for Asthma Improving Patient Safety…Evaluating the Results of Web-Based Error Reporting Across the BHCS to be Pursued further via AHRQ Patient Safety Developmental Center ProposalImproving Patient Safety…Evaluating the Results of Web-Based Error Reporting Across the BHCS to be Pursued further via AHRQ Patient Safety Developmental Center Proposal Enhancing Clinical Operational Efficiency..Abbott-funded Focus on Reducing Time to Initial Antibiotic for CAP Across BHCS HospitalsEnhancing Clinical Operational Efficiency..Abbott-funded Focus on Reducing Time to Initial Antibiotic for CAP Across BHCS Hospitals

44. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research &Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Clinical Quality Improvement Initiatives Quality Of Care Research Clinical Effectiveness Research Clinical Efficacy Research First In Humans Research

45. Best Care Objective Deliver the Best Care Available Anywhere Research Component of Research &Education Objective Align and Expand Research to Advance “Best Care” Physician Leadership Council SVP Clinical Integration Chief Operating Officers Baylor Research Institute President SVP Health Care Research and Improvement Chief Executive Officer Quality & Research Operations Advisory Committee Basic Science Research Health Care Research Resources Centers of Research Excellence Biostatistics Resource Group Health Care Research Group Clinical Informatics Research Clinical Trials Office Best Care Operational Resources

46. Have a little statistical compassion and take a look at the quantitative information before providing inadequate care (underuse of effective care) or wasting millions of dollars (overuse of inappropriate care) Kerr L. White, M.D.