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Some Initial Comments Re. Health Care Quality and
Research:
David J. Ballard, M.D., Ph.D., F.A.C.P.David J. Ballard, M.D., Ph.D., F.A.C.P.First Conference on Health
Regione Marche June 22, 2001 22, 2001
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
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.David J. Ballard, M.D., Ph.D., F.A.C.P.Senior Vice PresidentSenior Vice President
Health Care Research and ImprovementHealth Care Research and ImprovementBaylor Health Care SystemBaylor Health Care System
Dallas, Texas Dallas, Texas June 22, 2001June 22, 2001
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
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.
Baylor Health Care SystemHistory 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
Baylor Health Care SystemNew Vision Statement, 2000
Baylor Health Care System will, before the end of this decade, become the most trusted source of comprehensive health services.
Baylor Health Care SystemNew 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.
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”
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research
Clinical Quality
ImprovementInitiatives
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
ResearchClinical Quality
ImprovementInitiatives
First In
HumansResearch
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research
Clinical Quality
ImprovementInitiatives
Clinical Efficacy Research
First In
HumansResearch
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
ResearchClinical Quality
ImprovementInitiatives
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research
Clinical Quality
ImprovementInitiatives
QualityOf CareResearch
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
ResearchClinical Quality
ImprovementInitiatives
QualityOf CareResearch
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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
Texas Medical FoundationInpatient 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
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
Aspirin 84% 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 1.1Distribution 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.
Table 1.2Distribution by BHCS Hospital Identification Number of Average Values for Hospital Process of
Care Measures for Patients with Acute Myocardial Infarction
Process of Care Measure 115 111 114 107 116
Early Use of Aspirin 85%
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 Aspirin 96%
44/46
94%
33/35
71%
5/7
94%
30/32
83%
5/6
Discharge on Beta Blockers 84%
31/37
74%
28/38
40%
2/5
100%
21/21
100%
7/7
Discharge on ACEI 68%
13/19
100%
3/3
0%
0/1
88%
7/8
0%
0/1
Smoking Cessation Counseling during
Hospitalization63%
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.
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.
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.”
HTPN Clinical Preventive Services HTPN Clinical Preventive Services SampleSample
Practice 23 of 27 85.2%
Physicians 111 of 157 70.7%
Patients 4,591 of 138,000 3.3%
HealthTexas Provider NetworkHealthTexas Provider NetworkPreventive Health Services Baseline StudyPreventive Health Services Baseline Study
Results Results Services Eligible Patients Observed Performance S1 Colorectal Cancer Screening 2,125 980 46.1% S2 Cervical Cancer Screening 2,178 1,026 47.1% S3 Breast Cancer Screening 1,236 696 56.3% S4 Hypertension Screening 4,591 4,392 95.7% S5 Cholesterol Screening 3,012 2,261 75.1% S6 Diptheria-Tetanus immun. 4,591 1,354 29.5% S7 Pneumo-coccus immun. 878 349 39.7% S8 Influenza immun. 878 433 49.3% S9 Tobacco Use Screening 4,591 2,896 63.1% S10 Tobacco Use Counseling 2,749 891 32.4% Overall 26,829 15,278 56.9%
Clinical Preventive Services Clinical Preventive Services BenchmarksBenchmarks
0%
25%
50%
75%
100%
S1
S2
S3
S4
S5
S6
S7
S8
S9
S10
Health Texas Preventive Health 2000Baseline Study
Mayo Austin
Achievable Benchmarks of Care
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 Vaccine 66%
Telephone Survey
68%
Telephone Survey
49%
Medical Records
63% 90%
Pneumococcal Vaccine 44%
Telephone Survey
46%
Telephone Survey
40%
Medical Records
72% 89%
Mammography 51%
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 4.1Distribution of HCFA 6th Scope of Work Outpatient Process of Care Measures for HTPN Patients
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research:Baylor
Institute forImmunology
ResearchDirector
Clinical Quality
ImprovementInitiatives
QualityOf CareResearch
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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
PURPOSETo 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.
INTERVENTION 1
Medicare Claims-Based Physician Profiling
•Aggregate patient data at individual physician level received from TMF
•Measures include performance of hemoglobin A1c, lipid profile, and eye examination
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 A1c, 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 A1c, lipid profile, eye examination, diabetic nephropathy monitoring, and foot exam; and (2) results of hemoglobin A1c, LDL, and blood pressure.
INTERVENTION 3A. 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 A1c, 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 A1c, lipid profile, eye examination, diabetic nephropathy monitoring, and foot exam; and (2) results of hemoglobin A1c, LDL, and blood pressure.
32 Internal Medicine and Family Practice Sites
Screened
22 Practice Sites Were Randomized
7 Assigned to TMF Claims-Based Feedback PlusDQIP-Based Feedback
8 Assigned to TMF Claims-Based Feedback PlusDQIP-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
101 Internal Medicine and Family Practice Physicians
Screened
88 Physicians Qualified
42 Assigned to TMF Claims-Based Feedback PlusDQIP-Based Feedback
23 Assigned to TMF Claims-Based Feedback PlusDQIP-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 PracticingWithin the 22 Randomized Practice Sites
Summary
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 PlusDQIP-Based Feedback
606 Assigned to TMF Claims-Based Feedback PlusDQIP-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, 2001518 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
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research:Baylor
Institute forImmunology
ResearchDirector
Clinical Quality
ImprovementInitiatives
QualityOf CareResearch
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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
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)
Objective
To determine, in a randomized trial, which of two strategies is superior for managing smallAAA (4.0-5.4 cm in diameter): 1) immediate open surgical repair of the
AAA, or2) imaging surveillance at 6 month intervals,
reserving surgery for those that enlarge to 5.5 cm, enlarge rapidly (0 pts), or become symptomatic
CU
MU
LA
TI V
E S
UR
VI V
AL
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
YEARS OF STUDY0 1 2 3 4 5 6 7 8
CUMULATIVE SURVIVAL BY TREATMENT
Deaths PatientsTREATMENTSSURGERY 141 569
SURVEILLANCE 121 567
p<0.14
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
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
Linkage of BHCS Best Care and Linkage of BHCS Best Care and Research & Education ObjectivesResearch & Education Objectives
• Improving Health CareImproving Health Care1.1. UnderuseUnderuse…$ 850K ADA-Funded Randomized Controlled Trial (RCT) of …$ 850K ADA-Funded Randomized Controlled Trial (RCT) of
Quality Improvement Strategies to Improve Use of Effective DM-Related Quality Improvement Strategies to Improve Use of Effective DM-Related Care for BHCS/HTPN Patients with DMCare for BHCS/HTPN Patients with DM
2.2. OveruseOveruse….Development of BHCS Elective AAA Surgery Appropriateness ….Development of BHCS Elective AAA Surgery Appropriateness Criteria Linked to Results of VA RCT of Immediate Surgery vs. Watchful Criteria Linked to Results of VA RCT of Immediate Surgery vs. Watchful Waiting for 4.0 – 5.5 cm Infrarenal AAAWaiting for 4.0 – 5.5 cm Infrarenal AAA
3.3. OutcomesOutcomes….Testing Models to Improve Chronic Illness Care Outcomes via ….Testing Models to Improve Chronic Illness Care Outcomes via the RAND/IHI/GHC/RWJ Improving Chronic Illness Care Initiative for the RAND/IHI/GHC/RWJ Improving Chronic Illness Care Initiative for AsthmaAsthma
• Improving Patient SafetyImproving Patient Safety…Evaluating the Results of Web-Based Error …Evaluating the Results of Web-Based Error Reporting Across the BHCS to be Pursued further via AHRQ Patient Safety Reporting Across the BHCS to be Pursued further via AHRQ Patient Safety Developmental Center ProposalDevelopmental Center Proposal
• Enhancing Clinical Operational Efficiency..Enhancing Clinical Operational Efficiency..Abbott-funded Focus on Abbott-funded Focus on Reducing Time to Initial Antibiotic for CAP Across BHCS HospitalsReducing Time to Initial Antibiotic for CAP Across BHCS Hospitals
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
Research
Clinical Quality
ImprovementInitiatives
QualityOf CareResearch
Clinical Effectiveness
Research
Clinical Efficacy Research
First In
HumansResearch
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 IntegrationChief Operating Officers
Baylor Research InstitutePresident
SVP Health Care Research and Improvement
Chief Executive Officer
Quality & Research Operations Advisory Committee
BasicScience
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
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.