Closing the CHD Treatment GAP Saving Lives Through Better Implementation of Secondary Prevention Measures

The Impact of Coronary Heart Disease in the United States 14 million Americans alive today have a history of myocardial infarction, angina, or both ,000 recurrent myocardial infarction occur each year, most of which could have been prevented 25% of men and 38% of women will die within 5 years of presenting with a AMI 2 Studies suggest that a large number of CAD patients do not receive the therapies that can prevent recurrent events and save lives AHA Heart and Stroke Facts: 1996 Statistical Supplement 2 Rossouw, et al., N Engl J Med, 323: Cohen, et al., Circulation, 83(4): , Nieto, et al., Arch Intern Med, 155: , Giles, et al., JAMA, 269 (9): , 1993

AHA/ACC Guidelines to Risk Reduction For Patients With CHD and Other Vascular Disease u Cessation of smoking u Lipid Management Goals u Primary Goal: LDL < 100 mg/dl u Secondary: HDL > 35 mg/dl TG 35 mg/dl TG < 200 mg/dl u Physical activity: 30 minutes 3-4 times per week u Weight management u Antiplatelet/anticoagulants:ASA 80 to 325 mg/day (or warfarin) (or warfarin) u ACE inhibitors (post-MI for LVD) u Beta blockers for high-risk patients post-MI  Blood pressure control: goal < 140/90 mm Hg Adapted from Smith, Circulation 1995;92:3

Comprehensive Medical Therapy For Patients with CHD or Other Vascular Disease Adapted from the UCLA CHAMP Guidelines 1994 Risk Reduction Risk Reduction ASA 20-30% Beta Blockers 20-35% ACE inhibitors 22-25% Statins25-42% The four medications every atherosclerosis patient should be treated with, unless contraindications exist and are documented

“Despite compelling scientific evidence and national treatment guidelines supporting the use of secondary prevention medical therapies, these treatments continued to be underutilized in CVD patients receiving conventional care”

Provider awareness does not equal successful implementation Pearson Arch Intern Med 2000;160: CAD Treatment Gap - Community Physician Awareness of NCEP Guideline Patient Treated to Goal

An academic environment does not equal successful implementation CAD Treatment Gap - Academic Centers Brigham and Women’s Hospital: 2003 outpts with CAD Arch Intern Med 2001:161:53-58 LDS Hospital: 600 CAD patients discharged post cath Am J Card 2001;87: Cleveland Clinic: 537 Diabetics with CAD Post PTCA JACC 1999;33: PURSUIT Trial Centers: 8515 ACS patients JACC 2000;35:411A The Brigham LDS Hospital Cleveland Clinic PURSUIT Trial Centers Lipid Lowering Medication Treatment Rates

Quality Assurance Program (QAP) No LDL-C Documented “No Therapy” 43% At Goal “On Therapy” 7% At Goal “No Therapy” 4% Not at Goal “On Therapy” 18% Not at Goal “No Therapy” 14% No LDL-C Documented “On Therapy” 14% n = 48,586 Sueta C, et al. Am J Cardiol. 1999;83:

CAD Treatment Gap - Hospital ACC Evaluation of Preventive Therapeutics (ACCEPT) Data - Hospital data (N=50)  Treatment Gap of 80 % NRMI 3 Data  32 % of Post-MI patients discharged on a lipid lowering agent (N = 138,001) Treatment gap is not a deficit of knowledge, rather it is a deficit of implementation Pearson, T.A. et al., Supplement to Circulation: Oct, 1997;96:8:1733 Fonarow Circulation 2001;103:38-44.

ACCEPT: Most Hospitalized CHD Patients are Not at Goal 6 Months Post Discharge Risk Factor Goal OnAdmission At Discharge 6 mo. Post Discharge LDL-C < 100mg/dL 0%0%24% Lipid Lowering Drug 21%24%59% Aspirin44%86%87% Beta Blocker 34%58%63% Pearson, T.A. et al., Supplement to Circulation: Oct, 1997;96:8:1733.

138,001 patients discharged post AMI from 1470 US hospitals, July 1998 to June 1999 Fonarow Circulation 2001;103:38-44 Independent Predictors Teaching Hospital Smoking Cessation Catheterization Use of Beta Blocker CABG decreasedincreased Utilization of Lipid-Lowering Medications at Discharge in Patients with AMI

"Use of Lipid-Lowering Medications at Discharge in Patients With Acute Myocardial Infarction" Fonarow Circulation 2001;102:38-44 < Age (Years) Male (N=83,806) Female (N=54,195) % Discharged on Lipid Therapy P< P=NS Utilization of Lipid-Lowering Medications at Discharge in Patients with AMI

OFFICE SETTING QAP DATA 30-40% Documented Treatment Rate Treatment Gap of 66% BURDEN OF DISEASE 23 million CHD patients in the US HOSPITAL SETTING NRMI / ACCEPT DATA 20-32% Documented Treatment Rate Treatment Gap of 68-80% BURDEN OF DISEASE 2.7 million annual CHD discharges in the US CVD Treatment Gap

National Hospital Discharge Rates for Secondary Prevention Report from 7/99 to 6/00 NRMI Registry Discharge Medications at 1552 National NRMI III Hospitals (n=167,312) Includes all patients (no exclusions for contraindications or intolerance) Cessation

Physician is focused on acute problems Time constraints and lack of incentives, including reimbursement Lack of training including inadequate knowledge of benefits and lack of prescription experience Lack of resources and facilities Lack of specialist-generalist communication; passing on responsibility Barriers to Implementing Risk Factor Management in Patients with Documented Coronary Artery Disease Guidelines and treatment pathways which delay therapy and call for multiple steps, laboratory tests, and time points

Incentives for Change NCQA/HEDIS/JCAHO/GOA reporting measures – Hospitals – Managed Care – Physicians Consumer demand for quality care / report cards Graded on – ASA after AMI – Beta blocker after AMI – ACEI after AMI and CHF – LDL evaluated/Rxed post cardiac hospitalization

CVD Treatment System Goals Implement initiatives to put evidence based guidelines into action Improve the quality of care for patients with established cardiovascular disease Reduce secondary events - and save lives

Optimal Hospital Discharge Rates for Secondary Prevention IndicatorRateOptimal ASA85%*100% Beta Blocker72%*100% ACE-I71%*100% Smoking Cessation40%*100% Lipid Lowering32%** 100% *HCFA 1998 and **NRMI 1999 Optimal: UCLA Cardiology Performance Improvement Committee (patients without contraindications or medical intolerance)

Why a Hospital Based System? Patients – Patient Capture Point – Have patients/family attention: “teachable moment’ – Predictor of care in community Hospital Structure – Standardized processes/protocols/orders/teams – JCAHO Process Improvement Examples Process Improvement Examples – HCFA--Peer Review Organizations Six Scope of Work Six Scope of Work

In-Hospital Initiation of Risk Factor Modification and Cardioprotective Therapies Initiation of interventions for smoking cessation while patients are hospitalized with AMI has been shown to result in higher cessation rates then similar interventions initiated in the outpatient setting (1 year cessation rate of 71% vs 45%, P<0.01) The UCLA Comprehensive Heart Failure Management Program demonstrated a 96% utilization rate of ACEI at 6 months when treatment was initiated at the time of hospitalization, a rate which was significantly higher as compared to conventionally managed outpatients Taylor Annals Intern Med 1990;113: Fonarow JACC 1997;30:

CHD Patient Flow in the Hospital Lab ER Cath ICU/CCU Cardiology Medicine Telemetry Pharmacy Quality Control Discharge Nurse Inpatient Rehab 6 Million Discharged 2.7 Million Outpatient Rehab Group Practice 10% Cardiologist Family Practice LOST Advocate/Champion Acute Coronary Event Inpatient Care Outpatient Care Protocol development process Implementation

Challenges to In-Hospital Initiation of Lipid Lowering Treatment BARRIERS 1. Communication gaps - cardiologists vs PCPs 2. Lack of ownership - acute vs chronic disease dilemma 3. Poor lab standardization and reporting 4. Lack of financial incentives 5. Lack of tools/resources 6. Lack of proof of concept SOLUTIONS 1. Education and mobilizing case management teams 2. Hospital is the capture point for patients with acute disease 3. Routine lipid testing for CHD patients by protocol 4. Joint Commission, NCQA, PROs will be measuring and reporting 5. HCFA - 6 scope of work, Joint Commission, ORYX are standardizing measurement tools 6. UCLA CHAMP demonstrates improved treatment rates and outcomes

the lipid panel in not accurate when drawn in the hospital the primary care physicians will not agree to this this will not work in a community hospital the physicians at my hospital do not like cookbook medicine the cardiologists will not agree to this it may not be safe to start lipid lowering medications in hospitalized patients the patients should all be followed in my lipid clinic patients do not want to be on a lot of medications the hospital administration will not pay for it the managed care organization will not pay for it we can not get a consensus it will cost too much we do not have anyone to collect this data it will take too much time it is too hard to get things through the hospital committee this will benefit the competition there is not enough time there are exceptions x, y, and z what about the liability Challenges to a Hospital Based System

Design of the UCLA Cardiovascular Hospitalization Atherosclerosis Management Program :CHAMP Based on hypothesis that physician use of and patient compliance with secondary prevention therapies could be improved with a hospital based treatment initiation program Focused on initiation of aspirin, beta blocker, ACE inhibitor, and statin dosed to achieve LDL < 100 mg/dl in all cardiovascular disease patients prior to hospital discharge Use of preprinted orders, simple guidelines, educational lectures, discharge forms, and prospective monitoring of treatment use. Started in 1994 and continues to be the standard of care at UCLA Fonarow Circulation 1997;96(8):I-67

CHAMP Algorithm for Patients with Clinically Evident Atherosclerosis

Implementation of CHAMP Fonarow Circulation 1997;96(8):I-67

Patient ID # Standardized Admission Order Sheets

Implementation of CHAMP

Impact of CHAMP on Treatment Rates

The UCLA-CHAMP Experience The UCLA-CHAMP Experience CAD Patient Treatment Rates *Fonarow, G. et al. “Improved Treatment of Cardiovascular Disease by Implementation of a Cardiac Hospitalization Atherosclerosis Management Program: CHAMP,” Abstract #364 from the 70th Scientific Sessions, American Heart Association, November, Proof of Concept

Results: Adherence to NCEP Treatment Goals in Patients One Year Post Myocardial Infarction Fonarow Am J Cardiol 2001;87:

Pre and Post CHAMP Clinical Event Rates Follow-up for one year after discharge after acute myocardial infarction Fonarow Am J Cardiol 2001;87: * * * * * P < 0.05

RR 0.43 p< AMI pts discharged in 92/93 pre-CHAMP compared to 302 pts in 94/95 post-CHAMP ASA 78% vs 92%; Beta Blocker 12% vs 61%; ACEI 4% vs 56%; Statin 6% vs 86% Fonarow Am J Cardiol 2001;87; CHAMP ~ Impact on Clinical Outcomes in the First Year Post Hospital Discharge

77 NRMI Registry Discharge Medications at UCLA compared to 1437 NRMI Hospitals NRMI UCLA 98/99 CHAMP ~ Sustained Impact Over a 6 Year Period Comparison to National Rx Rates

The CHAMP Protocol was associated with a significant increase in treatment utilization at the time of hospital discharge of medications previously demonstrated to improve survival in patients with CAD. Initiation of cholesterol lowering medications prior to hospital discharge is safe, results in a high rate of utilization during longer term follow-up, and results in a significant increase in patients reaching LDL < 100 mg/dl. CAD risk factor modification and treatment can be systematically integrated into the treatment received during cardiac hospitalizations without additional resources or medical personnel and is considerably more effective than conventional guidelines and care. Implementation of a Cardiovascular Hospitalization Atherosclerosis Management Program: CHAMP

19,599 men and women < 80 yo discharged post AMI, 58 Swedish Hospitals, (28%) statin rx vs (72%) no statin rx, highest hospital rates of use 48%; lowest 12% Stenestrand JAMA 2001;285; Early Statin Treatment and Survival in AMI RR 0.75 ( ) P= % Risk Reduction

In-Hospital Lipid Lowering Therapy is Associated with Markedly Lower Mortality

Clinical Implications At present, a large number of patients with coronary artery and other atherosclerotic vascular disease are not receiving treatments that have been demonstrated to reduce recurrent cardiovascular events and mortality. Widespread application of hospital based treatment programs such as GWTG could dramatically effect CVD treatment rates with proven cost-effective therapies and thus substantially reduce the risk of future coronary events and prolong life in the large number of patients hospitalized each year with CVD.

Problem: Large CVD treatment gap and poor patient compliance with conventional management Solution: In-hospital initiation of therapy with excellent treatment rates and long term patient compliance Simple, Rapid, and Most Importantly Effective

Sidney Smith MD AHA Chief Science Officer “The CHAMP study shows that the key to keeping heart disease patients alive is providing them with immediate and thorough treatment before they walk out of the hospital” “This study provides the scientific foundation for programs similar to CHAMP such as the AHA’s new hospital-based quality improvement program called Get With The Guidelines”

What’s Involved in Starting a Hospital Based Treatment Program Collect baseline data or use existing data source – i.e. NRMI IV or collect data with discharge nurse, medical student, etc. Appoint team to develop treatment algorithm, preprinted orders, discharge forms Present at lectures and staff in-services – present results – review successes and failures – lead discussion regarding recommendations on protocol improvement Revise Protocol to close Gaps Communicate Revisions to Key departments Repeat cycle every quarter = CQI

Assess CHD Treatment Rates Evaluate Assessment Refine Protocol Implement Refined Protocol Continuous Quality Improvement (CQI) Process

Mobilize GWTG Initiative Establish “Buy In” Identify “Champions” Build Team Plan & Prep Program Attend CME Program Develop Hospital Plan Assign Roles & Responsibilities Implement Program Establish D/C Protocol Collect Baseline Data Obtain consensus Monitor & Support Collect & Report f/u Data Review & Improve Process Hospital Based Continuous Quality Improvement (CQI) Process Hospital Based Continuous Quality Improvement (CQI) Process

What is the AHA“Get With the Guidelines” Program ? Implemented by AHA Affiliates/Volunteers who will mobilize advocacy networks at the Affiliate level to: Implement CME-driven educational programs Provide workshops for dissemination of guidelines Develop care maps Formalize a national discharge protocol Implement discharge protocols in hospital setting Identify best practices for AHA recognition awards Develop and disseminate reports and publications Measure changes and report outcomes data Drive impact into communities

GWTG Tools and Resources AHA/ACC Guidelines AHA National Discharge Protocol/Discharge Form Template Care maps - ED, cath lab, etc. CME programs AHA National teleconferences Public Service Announcements National and regional advocates

Secondary Prevention: Making it a Reality A major CHD treatment gap still exists The hospital is the ideal capture point, provides a teachable moment, and predicts care in the community Programs like CHAMP improve treatment rates and saves lives, making it essential that each hospital implement a prospective process to help improve CHD patient care immediately Measure and report treatment rates to ensure CHD patient care is optimal