Journal of the American College of Cardiology © 2008 by the American College of Cardiology Foundation Published by Elsevier Inc.
Vol. 51, No. 17, 2008 ISSN 0735-1097/08/$34.00 doi:10.1016/j.jacc.2008.01.028
Quality of Care of and Outcomes for African Americans Hospitalized With Heart Failure Findings From the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) Registry Clyde W. Yancy, MD, FACC,* William T. Abraham, MD, FACC,† Nancy M. Albert, PHD, RN,‡ Robert Clare, MS,§ Wendy Gattis Stough, PHARMD,储¶ Mihai Gheorghiade, MD, FACC,# Barry H. Greenberg, MD, FACC,** Christopher M. O’Connor, MD, FACC,†† Lilin She, PHD,§ Jie Lena Sun, MS,§ James B. Young, MD, FACC,‡‡ Gregg C. Fonarow, MD, FACC§§ Dallas, Texas; Columbus and Cleveland, Ohio; Durham and Research Triangle Park, North Carolina; Chicago, Illinois; and San Diego and Los Angeles, California Objectives
We sought to examine the characteristics, quality of care, and clinical outcomes for a large cohort of AfricanAmerican patients hospitalized with heart failure (HF) in centers participating in a quality improvement initiative.
Background
Heart failure in African Americans is characterized by variations in natural history, lesser response to evidencebased therapies, and disparate health care. We hypothesized that a performance improvement program will achieve similar adherence to quality measures in African Americans admitted with HF compared with non–African Americans.
Methods
The OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) registry-based performance-improvement program includes a pre-specified 10% subgroup with 60- to 90day follow-up. Data on quality of care measures and outcomes were analyzed for 8,608 African-American patients compared with 38,501 non–African-American patients.
Results
African Americans were significantly younger and more likely to receive evidence-based medications but less likely to receive discharge instructions and smoking cessation counseling. In multivariable analyses, AfricanAmerican race was an independent predictor of lower in-hospital mortality (odds ratio 0.71; 95% confidence interval 0.57 to 0.87; p ⬍ 0.001) but similar hospital length of stay. After multivariable adjustment, postdischarge outcomes were similar for American-American and non–African-American patients, but AfricanAmerican race was associated with higher angiotensin-converting enzyme inhibitor prescription and left ventricular function assessment; no other HF quality indicators were influenced by race.
Conclusions
In the context of a performance-improvement program, African Americans with HF received similar or better treatment with evidence-based medications, less discharge counseling, had better in-hospital survival, and similar adjusted risk of follow-up death/repeat hospital stay. (Organized Program to Initiate Lifesaving Treatment In Hospitalized Patients With Heart Failure [OPTIMIZE-HF]; NCT00344513) (J Am Coll Cardiol 2008;51:1675–84) © 2008 by the American College of Cardiology Foundation
From the *Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Texas; †Division of Cardiology, Ohio State University, Columbus, Ohio; ‡George M. and Linda H. Kaufman Center for Heart Failure and §Duke Clinical Research Institute, Durham, North Carolina; 储Department of Clinical Research, Campbell University School of Pharmacy, Research Triangle Park, North Carolina; ¶Department of Medicine, Duke University Medical Center, Durham, North Carolina; #Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; **Department of Medicine, University of California San Diego Medical Center, San Diego, California; ††Division of Cardiology, Duke
University Medical Center/Duke Clinical Research Institute, Durham, North Carolina; ‡‡Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio; and the §§ Department of Medicine, University of California Los Angeles Medical Center, Los Angeles, California. GlaxoSmithKline funded both the OPTIMIZE-HF registry and this analysis of registry data. For full author disclosures, please see the end of this paper. John R. Teerlink, MD, served as Guest Editor for this article. Manuscript received July 30, 2007; revised manuscript received January 24, 2008, accepted January 29, 2008.
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Marked population differences exist in the prevalence, morbidity, and mortality associated with ACC/AHA ⴝ American cardiovascular disease. In conCollege of Cardiology/ junction with biological risk facAmerican Heart Association tors, social and environmental ACE ⴝ angiotensinconverting enzyme determinants of cardiovascular disease might contribute to the ARB ⴝ angiotensin receptor blocker treatment and outcome inequiBNP ⴝ B-type natriuretic ties seen in different populations peptide (1). These differences have the CI ⴝ confidence interval potential to contribute to observed gaps in the overall life HF ⴝ heart failure expectancy and quality of life and LVEF ⴝ left ventricular ejection fraction are felt to be partly responsible for health care disparities. AfriLVSD ⴝ left ventricular systolic dysfunction can Americans are among those OR ⴝ odds ratio most seriously affected by disparate health care in the U.S. (2). Recent statistics confirm that cardiovascular disease is the leading cause of death for African Americans (3,4). Heart failure (HF) is especially problematic for African Americans. Both the prevalence of HF and mortality due to chronic HF are increased in African Americans compared with the general population (4,5). The etiology of left ventricular dysfunction leading to HF in African Americans is also different, and the natural history is more aggressive than that seen in other populations. Among African-American patients with HF and left ventricular systolic dysfunction (LVSD), only one-fourth of patients have a known ischemic etiology of LVSD, with the remainder experiencing a putative nonischemic etiology of LVSD (6). In addition, HF occurs at an earlier age in African-American patients, with more advanced LVSD and worse clinical class at the time of diagnosis than seen in the population at large (7). Despite being at high risk for cardiovascular morbidity and mortality, prior studies have indicated that African Americans are less likely than non-African Americans to receive guideline-recommended, evidence-based care such as diagnostic testing, drug therapy, and interventional procedures (8 –10). The reasons for these disparities in health care are multifactorial, however, and might be related to access to care, patient preference, or bias (11). Recent studies also document that African-American patients are more likely to be treated at hospitals that provide poor quality of care with lower use of systematic processes, protocols, and evidence-based treatments (12–14). Moreover, even when treated at the same hospital, AfricanAmerican patients might not receive the same standard of care delivered to white patients (12,15). The quality of care for African Americans admitted with HF has not been well studied in the context of an HF quality improvement program. The OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) registry provides an Abbreviations and Acronyms
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opportunity to capture quality indicators as a function of race and investigate their association with outcomes. The OPTIMIZE-HF program is designed to improve medical care and education for hospitalized HF patients and to accelerate use of evidence-based, guideline-recommended therapies by initiating them before hospital discharge. These process-of-care intervention strategies might standardize care for all patients with HF and test whether African Americans with HF who are treated similarly will experience the same outcomes as other HF populations (16). Our analyses investigated the influence of this qualityimprovement initiative in a large African-American subgroup and the association with quality of care, post-discharge HF management, survival, and repeat hospital stay. Methods Study design. The study design and rationale of the OPTIMIZE-HF registry has been previously published (17–20). Briefly, OPTIMIZE-HF is a registry and performance-improvement program for patients hospitalized with HF. This nationwide patient registry was used to gather data on various patient characteristics with a webbased information system. Participating hospitals had the ability to view national aggregate hospital data as well as daily patient and performance data benchmarked with similar hospitals. The OPTIMIZE-HF process-of-care improvement program provided participating hospitals with materials for improving treatment and discharge plans for optimal patient management and included evidence-based best-practice algorithms (detailed algorithms on indications, contraindications, dosing, and monitoring steps for each evidence-based HF therapy) along with comprehensive patient education materials and resources. To be eligible for OPTIMIZE-HF, patients had to be adults hospitalized for an episode of HF as the primary cause of admission or with significant HF symptoms that developed during hospital stay with a primary discharge diagnosis of HF. With methodology similar to national cardiovascular registries and many randomized trials, race and ethnicity were collected for the purpose of evaluating subgroup differences. Admission and/or medical staff recorded race/ethnicity, usually as the patient was registered. Patients were assigned to race and ethnicity categories with options defined by the study protocol. A pre-specified subgroup (10%) had 60- to 90-day follow-up data collected. Participating sites had the option of participating in the hospital registry only or hospital registry and follow-up data collection. Site participation in the follow-up portion required obtaining informed consent. This follow-up cohort was demographically similar to patients in the overall registry (Online Table 1). Process-of-care improvement tool use was defined by use of either preprinted order sets or discharge checklists as documented in the medical record. Left ventricular systolic dysfunction was defined as a documented left ventricular ejection fraction (LVEF) ⬍40% or qualitative assessment of
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Patient Characteristics Table 1
Patient Characteristics
Characteristic
African American (n ⴝ 8,608)
Non-African American (n ⴝ 38,581)
p Value
63.6 ⫾ 15.4
75.2 ⫾ 12.7
⬍0.0001
Age, mean ⫾ SD, yrs Female, %
52.7
51.4
0.0287
Hypertensive etiology, %
39.2
19.3
⬍0.0001
Ischemic etiology, %
29.5
49.4
⬍0.0001
Atrial arrhythmia, %
16.3
33.8
⬍0.0001
Patients with LVF assessed, n (%)
7,399 (86.0)
LVEF (in those measured), mean ⫾ SD, %
32,648 (84.6)
0.002
35.4 ⫾ 17.8
39.7 ⫾ 17.5
⬍0.0001
LVSD (LVEF ⬍40% or moderate/severe LVD), %
56.9
47.1
⬍0.0001
Left heart catheterization, %
10.1
8.5
⬍0.0001
CABG, %
0.4
1.0
⬍0.0001
Dialysis, %
9.0
4.2
⬍0.0001
CAD/IHD, %
37.6
52.2
⬍0.0001
Hyperlipidemia, %
24.7
33.8
⬍0.0001 ⬍0.0001
Insulin-treated diabetes, %
19.4
16.2
Non–insulin-treated diabetes, %
25.7
24.7
0.0345
COPD, %
21.6
28.9
⬍0.0001
6.4
11.4
⬍0.0001
27.3
14.2
⬍0.0001 ⬍0.0001
Depression, % Cigarette smoker within past yr, % Serum creatinine, mean ⫾ SD, mg/dl Serum creatinine, mean ⫾ SD, mol/l Serum creatinine ⬎2 mg/dl, % Hemoglobin, mean ⫾ SD, g/dl Hemoglobin, mean ⫾ SD, g/l Patients with BNP measured, n (%) BNP, median (25th, 75th), pg/ml
1.6 ⫾ 1.0 141.8 ⫾ 90.4
⬍0.0001
21.7
19.2
⬍0.0001
12.0 ⫾ 2.1
12.1 ⫾ 2.0
⬍0.0001
120.1 ⫾ 20.5
121.2 ⫾ 20.4
4,349 (50.5)
26,086 (67.6)
⬍0.0001 ⬍0.0001
965 (450, 2,130)
785 (403, 1,600)
⬍0.0001
0.2 (0.1, 0.5)
0.1 (0.0, 0.3)
⬍0.0001
Troponin I, median (25th, 75th), ng/ml Troponin I, median (25th, 75th), g/l
0.2 (0.1, 0.5)
Admission weight, mean ⫾ SD, kg Weight change from admission, mean ⫾ SD, kg
1.8 ⫾ 1.3 156.5 ⫾ 113.8
90.67 ⫾ 29.99
0.1 (0.0, 0.3)
⬍0.0001
80.79 ⫾ 25.03
⬍0.0001
⫺2.59 ⫾ 5.33
⫺2.53 ⫾ 4.67
Admission SBP, mean ⫾ SD, mm Hg
153.06 ⫾ 35.98
140.34 ⫾ 31.73
⬍0.0001
Discharge SBP, mean ⫾ SD, mm Hg
0.4332
129.27 ⫾ 23.37
123.74 ⫾ 22.10
⬍0.0001
Admission HR, mean ⫾ SD, beats/min
90.27 ⫾ 20.85
85.76 ⫾ 21.48
⬍0.0001
Discharge HR, mean ⫾ SD, beats/min
77.73 ⫾ 14.15
75.62 ⫾ 14.12
⬍0.0001
Admission jugular venous pressure elevation, %
36.9
31.6
⬍0.0001
Admission rales, %
63.7
64.0
0.5493
BNP ⫽ B-type natriuretic peptide; CABG ⫽ coronary artery bypass graft; CAD/IHD ⫽ coronary artery disease/ischemic heart disease; COPD ⫽ chronic obstructive pulmonary disease; HR ⫽ heart rate; LVD ⫽ left ventricular dysfunction; LVEF ⫽ left ventricular ejection fraction; LVF ⫽ left ventricular function; LVSD ⫽ left ventricular systolic dysfunction; SBP ⫽ systolic blood pressure.
moderate/severe dysfunction. The registry coordinating center was Outcome Sciences, Inc. (Cambridge, Massachusetts), which provided data collection, management, and source data verification. Statistical analyses. Discrete data are reported as the number and frequency of eligible patients treated at the time of hospital discharge, excluding patients with documented intolerance/contraindications to specific therapies. The HF medication use and contraindications/intolerance were assessed at discharge from the index hospital stay and during follow-up. Race was analyzed according to AfricanAmerican and non–African-American status. Patient characteristics and evidence-based treatments at hospital discharge were compared with the Pearson chi-square test for categorical variables and analysis of variance for continuous variables. Models of in-hospital mortality, mortality from
hospital discharge to 90 days, and the combination of post-discharge mortality or repeat hospital stay have been developed to determine significant factors to use when applying adjusted models (Online Table 2) (19,20). Baseline clinical and treatment factors were applied to model selections. To model in-hospital mortality, 45 potential predictor variables were used in a logistic model. To model postdischarge mortality in the follow-up period, 19 potential predictor variables were used in a Cox proportional hazards model. To model repeat hospital stay and the combination of post-discharge mortality or repeat hospital stay, 69 variables were used in a logistic model. To model conformity with quality of care measures, 69 variables were considered, and those retained for each model are listed in Online Table 2. A p value of 0.05 was used as the criterion for variables to remain in the model. The assumption of
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linearity was checked in each model for the continuous variables by using restricted cubic splines. When the relationship was found to be nonlinear, appropriate transformations were applied. When the association between race and repeat hospital stay was examined, all variables from the post-discharge death or repeat hospital stay model were included. Generalized estimating equations were used to account for the correlation of data within the same hospital in the adjusted models. The SAS version 8.2 (SAS Institute, Cary, North Carolina) was used for all statistical analyses, which were performed independently at Duke Clinical Research Institute (Durham, North Carolina). Results Patient characteristics. The OPTIMIZE-HF registry enrolled patients from March 1, 2003 through December 31, 2004 and included 48,612 patients from 259 hospitals, with pre-specified follow-up data available from 91 centers and 5,791 patients. Race was available for 47,190 (97.1%) patients. Of these, 8,608 (17.7%) were African Americans; follow-up data were collected from 1,044 African-American patients. Patient characteristics are detailed in Table 1. The characteristics of African Americans hospitalized for HF differed from those of non–African Americans in the registry. African-American patients tended to be female and younger and were more likely to have systolic dysfunction and renal insufficiency. Systolic blood pressure (SBP), B-type natriuretic peptide (BNP), and admission weight were all higher in hospitalized African Americans. Additionally, the presumed etiology of HF differed significantly between African-American and non–African-American patients. Whereas HF etiology in African-American patients was more likely to be hypertensive (39.2% vs. 19.3%; p ⬍ 0.0001), in non–African-American patients it was more likely to be ischemic (49.4% vs. 29.5%; p ⬍ 0.0001). Etiology attributable to other causes (postpartum, valvular, familial, alcohol/other drug, chemotherapy, viral, unknown/ idiopathic, and other) did not differ between AfricanAmerican and non–African-American patients (31.3% for each group). Importantly, 70.5% of the African-American patients with HF had a nonischemic etiology, either related to hypertension or causes other than ischemic heart disease. The mean LVEF was significantly lower in AfricanAmerican patients (35.4% vs. 39.7%; p ⬍ 0.0001), and the percentage of African-American patients with LVSD was significantly higher than that observed in non–AfricanAmerican patients (56.9% vs. 47.1%; p ⬍ 0.0001). Quality of care. Comparison of the use of process-of-care measures between racial populations analyzed in this study demonstrated significant differences. African-American patients were significantly less likely to receive complete discharge instructions and smoking cessation advice, but they were more likely to receive LVEF assessment and a prescription for angiotensin-converting enzyme (ACE) inhibitors in the absence of contraindications and intolerance
Figure 1
Heart Failure Measures at Hospital Discharge
Percent of patients who received heart failure measures at hospital discharge by race. ACE ⫽ angiotensin-converting enzyme; LVEF ⫽ left ventricular ejection fraction.
(Fig. 1). At discharge, eligible African Americans with LVSD were more likely to be prescribed ACE inhibitors or angiotensin receptor blocker drugs (ARBs) (p ⬍ 0.0001), aldosterone antagonists (p ⬍ 0.0001), and hydralazine (p ⬍ 0.0001) but just as likely as other patients to be prescribed beta-blocker drugs, warfarin, and nitrates (p ⫽ 0.225, p ⫽ 0.118, and p ⫽ 0.674, respectively) (Fig. 2). African Americans were less likely to receive statin therapy. Whereas African Americans were more likely to be prescribed hydralazine, the percentage of African Americans with LVSD that received a combination of hydralazine/isosorbide dinitrate was only 4.5%. There was documented use of the process-of-care improvement tools in 39.5% of AfricanAmerican patients compared with 46.9% non–AfricanAmerican patients (p ⬍ 0.0001). Hospital stay and mortality. In unadjusted analyses, African-American HF patients experienced a modestly shorter length of stay (5.58 days vs. 5.71 days; p ⬍ 0.001), significantly lower in-hospital mortality (2.2% vs. 4.1%; p ⬍ 0.0001), and lower follow-up mortality (6.5% vs. 9.1%; p ⫽ 0.009) (Table 2). However, this patient population had similar readmission events (31.7% vs. 29.3%; p ⫽ 0.12) and similar death/repeat hospital stay events (35.3% vs. 36.6%; p ⫽ 0.44). In multivariable analyses, African-American race was an independent predictor of lower in-hospital mortality (odds ratio [OR] 0.71, 95% confidence interval [CI] 0.57 to 0.87, p ⬍ 0.001) but was not predictive of follow-up mortality (hazard ratio 1.12, 95% CI 0.80 to 1.58, p ⫽ 0.50), follow-up repeat hospital stay (OR 1.14, 95% CI 0.93 to 1.40, p ⫽ 0.22), or death/repeat hospital stay (OR 1.02, 95% CI 0.86 to 1.22, p ⫽ 0.79) (Table 2). A subgroup analysis revealed African-American patients with LVSD experienced a shorter length of stay, significantly lower in-hospital mortality, and similar follow-up
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Figure 2
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Other Medications at Hospital Discharge
Eligible patients receiving other medications at hospital discharge by race. ⴱACE inhibitor and/or ARB use in patients with left ventricular systolic dysfunction (LVSD), excluding patients with contraindications to ACE inhibitor and/or ARB. †Beta-blocker use in patients with LVSD, excluding patients with contraindications to beta-blocker drugs. ‡Statin use in patients with medical history of coronary artery disease, cerebral vascular accident/transient ischemic attack, diabetes, hyperlipidemia, or peripheral vascular disease. §Aldosterone antagonist, hydralazine, and nitrate use in patients with LVSD. 储Warfarin use in patients with chronic or paroxysmal atrial fibrillation. ACE ⫽ angiotensin-converting enzyme; ARB ⫽ angiotensin receptor blocker; HYDR/ISDN ⫽ hydralazine/isosorbide dinitrate.
mortality but more readmission events (Figs. 3A and 3B). Analysis of African-American patients without systolic dysfunction revealed that this group also had lower inhospital mortality but similar length of stay, repeat hospital stay, and post-discharge mortality compared with that experienced by non–African-American patients (Figs. 4A and 4B). Race as an independent predictor of quality of care. Additional multivariable analyses were performed to assess the association between African-American race and conformity with the American College of Cardiology/American Heart Association (ACC/AHA) performance measures and other quality indicators for patients hospitalized with HF. African-American race was independently associated with higher ACE inhibitor prescription and left ventricular function assessment; all other HF quality indicators were not influenced by race (Table 3).
Discussion The OPTIMIZE-HF is a registry-based performance improvement program that enables quality care for patients with HF through performance improvement tools and feedback on patient characteristics, treatments, quality measures, and clinical events. Our findings from this OPTIMIZE-HF analysis of African Americans with HF demonstrate that, among participating hospitals, provision of most but not all quality measures were similar to other races. Furthermore, when treated similarly, AfricanAmerican patients have a lower risk-adjusted inpatient mortality but a similar adjusted 60- to 90-day postdischarge morbidity and mortality risk due to HF. Process-of-care quality-improvement strategies represent one potential mechanism for addressing and reversing racial disparities in cardiovascular care and outcomes (21–23). The
Clinical Outcomes for African-American Compared With Non–African-American Patients Table 2
Clinical Outcomes for African-American Compared With Non–African-American Patients Unadjusted
Hospital Cohort
Odds, Hazard, or Length-of-Stay Ratio
Adjusted
95% Confidence Interval
p Value
Odds, Hazard, or Length-of-Stay Ratio
95% Confidence Interval
p Value
In-hospital mortality
0.49*
0.41–0.59
⬍0.0001
0.71*
0.57–0.87
⬍0.001
Length of stay
0.97†
0.96–0.99
0.002
0.98†
0.96–1.01
0.193
Post-discharge mortality
0.76‡
0.58–0.99
0.041
1.12‡
0.80–1.58
0.508
Repeat hospital stay
1.13*
0.96–1.32
0.146
1.14*
0.93–1.40
0.215
Post-discharge mortality/repeat hospital stay
0.96*
0.82–1.12
0.591
1.02*
0.86–1.22
0.789
Follow-up cohort
*Odds ratio. †Length-of-stay ratio. ‡Hazard ratio.
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ciency, African-American patients in the OPTIMIZE-HF registry might have been expected to fare less well. However, African Americans with HF had lower rates of in-hospital mortality, regardless of systolic function. Although this might reflect the younger age of AfricanAmerican patients, these findings persisted after multivariable adjustment, although the OR for in-hospital mortality moved from 0.49 to 0.71 after adjustment for observed covariates. Residual confounding by measured variables and confounding by unmeasured variables must still be considered in accounting for these observations. It is also notable that African-American patients hospitalized with HF were on average 11 years younger than non–African-American patients. This finding underscores the need for increased HF prevention efforts in this population. Uncertain differences in the pathophysiology of HF in African Americans remain a potential explanation for these differences in presentation and are perhaps driven by subtle biological differences including certain genomic variances (26).
Figure 3
Outcomes in Patients With Left Ventricular Systolic Dysfunction
(A) In-hospital outcomes in heart failure patients with left ventricular systolic dysfunction (LVSD) by race. (B) The 60- to 90-day post-discharge outcomes in heart failure patients with LVSD by race.
results of the current study suggest that process-of-care intervention programs might benefit African-American as much as non–African-American patients, with similar use of certain evidence-based therapies for HF. Importantly, within the context of a performance-improvement program, patient race did not influence the quality of HF care delivered. This is an important observation in light of recent findings suggesting that patients with HF or acute myocardial infarction treated at hospitals that disproportionately treat African-American patients are at high risk for adverse outcomes and lower quality of care (24,25). Although not designed to improve disparate health care, it is plausible that OPTIMIZE-HF or other similar performance improvement programs might represent a unique tool to address health care disparities in HF. Given a higher cardiovascular risk profile as measured by several clinical variables, including a lower mean LVEF, higher BNP levels, and greater incidence of renal insuffi-
Figure 4
Outcomes in Patients Without LVSD
(A) In-hospital outcomes in heart failure patients without left ventricular systolic dysfunction (LVSD) by race. (B) The 60- to 90-day post-discharge outcomes in heart failure patients without LVSD by race.
Yancy et al. African Americans Hospitalized With HF: The OPTIMIZE-HF Registry
JACC Vol. 51, No. 17, 2008 April 29, 2008:1675–84 Independent of African-American Association Race and Quality of Care Independent Association Table 3 of African-American Race and Quality of Care Performance Measures and Other Quality Indicators
Odds Ratio
95% Confidence Interval
p Value
HF-1: delivery of HF discharge instructions
1.02
0.94–1.10
0.701
HF-2: left ventricular function assessment
1.19
1.05–1.34
0.007
HF-3: ACE inhibitor at discharge
1.18
1.01–1.39
0.039
HF-4: smoking cessation counseling
0.87
0.75–1.02
0.093
ACE inhibitor or ARB at discharge
1.16
0.97–1.39
0.104
Beta-blocker at discharge
0.89
0.71–1.11
0.292
ACE ⫽ angiotensin-converting enzyme; ARB ⫽ angiotensin receptor blocker; HF ⫽ heart failure.
Prior studies have shown higher rates of hospital stay in African Americans with HF, but the data on mortality rates have varied. Analysis of the SOLVD (Studies of Left Ventricular Dysfunction) treatment trial suggested that African Americans with chronic systolic dysfunction HF have increased mortality risk (5). Deswal et al. (27), examining 4,901 African-American and 17,093 Caucasian Veterans Affairs patients discharged from the hospital for HF, found a lower risk-adjusted OR for mortality at 30 days and 2 years in African Americans with similar readmission rates. A study of 29,372 Medicare beneficiaries hospitalized with HF in 1998 and 1999 also revealed higher repeat hospital stay rates but lower mortality in African-American patients compared with Caucasians (28). Because a substantial proportion of African-American patients hospitalized with HF are younger than 65 years of age, Medicare datasets might not be sufficient to characterize the demographic status, quality of care, and outcomes for this patient population. The adequacy of medical therapy is often impugned as an explanation for racially disparate outcomes. In the OPTIMIZE-HF registry the differences between AfricanAmerican and non–African-American patients cannot be explained by medication prescription, because appropriate evidence-based therapies were prescribed at similar levels at the time of hospital discharge. Actual medication compliance, however, might have impacted repeat hospital stays. African-American patients were less likely to receive complete discharge instructions and smoking cessation advice at discharge. Several studies have shown that pre-discharge programs that enhance patient education and consultation and conduct follow-up reminders for medical adherence are associated with fewer readmissions and with reductions in HF symptoms (29 –31). The OPTIMIZE-HF performance-improvement program was associated with remarkably high ACE inhibitor/ ARB and beta-blocker prescription rates at hospital discharge, regardless of race. Notably, African Americans were more likely to be prescribed ACE inhibitors and ARBs than non–African Americans in this registry, and this might have been responsible in part for better inpatient and short-term outcomes in African Americans with HF than previously observed. In addition to ACE inhibitor usage, clinical trials
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and other registries have shown the importance of betablocker use in the African-American population with HF. In the community-based COHERE (Carvedilol Heart Failure Registry), carvedilol treatment produced similar results, reducing hospital stays, HF, and mortality in African-American and Caucasian patients (32). The most recent update of the ACC/AHA clinical practice guidelines for the management of chronic HF recommends that the AfricanAmerican population receive the same application of evidence-based therapies as the general population (33). Our findings would support that statement. The A-HeFT (African-American Heart Failure Trial) study tested isosorbide dinitrate/hydralazine as adjunctive therapy for HF in African Americans and demonstrated a substantial 43% mortality benefit and a 33% reduction in hospital stays for HF over background therapy with ACE inhibitor/ARB and betablocker drugs (6). Despite these substantial benefits, only 4.5% of African Americans in the OPTIMIZE-HF registry were treated with isosorbide dinitrate/hydralazine. Recent guidelines from the Heart Failure Society of America give the adjunctive use of isosorbide dinitrate/ hydralazine the highest-tier recommendation, with expectations that outcomes for African-American patients will improve with adherence to guideline-based care (34). Given the poor adoption of isosorbide dinitrate/hydralazine, further opportunities remain to improve care for AfricanAmerican HF patients (6). Study limitations. Although the OPTIMIZE-HF registry represents an opportunity to study HF patients in a realworld setting, there are several limitations to a registrybased study that call for careful interpretation of results. Data were collected by medical chart review and are dependent upon the accuracy and completeness of documentation and abstraction. Race was not a self-reported variable but rather was determined as that documented in the medical record, thus errors in racial determination could have occurred. Because of the large number of patients in the registry, some small differences that might be of little clinical relevance have p values indicating a high degree of statistical significance. These findings might not apply to hospitals that differ in patient characteristics or care patterns from OPTIMIZE-HF hospitals. The 60- to 90-day follow-up data are only in a subset of patients in the overall registry and might not be representative of the entire aggregate in the database. Medication use was as reported by patients and as documented in the medical record. Actual adherence rates might have been lower than reported, and compliance with medical therapy is not a certainty. Decreased compliance with medical therapy due to access of care issues affecting the African-American cohort might well have been a contributing factor to the readmission experiences noted in the OPTIMIZE-HF registry. Contraindications and intolerance were as documented in the medical record, but a proportion of patients reported to be eligible for treatment but not treated might have had contraindications or intolerance that were present but not documented. There were no direct measures of
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socioeconomic status or bias in OPTIMIZE-HF, thus the contribution of certain elements affecting similar or disparate health care can only be inferred but not proven with these data. This study was not a prospective randomized trial, and residual measured and unmeasured confounders might have influenced clinical outcomes. Prospective randomized studies will be required to further test the influence of performanceimprovement programs on markers of health care disparities. Conclusions African-American HF patients, when exposed to a process-ofcare improvement initiative, had better-than-previously observed treatment with evidence-based therapies. Furthermore, African-American HF patients when treated according to guidelines had similar or better outcomes compared with non–African-American patients. In adjusted analyses, patient race did not influence hospital-based delivery of high-quality care, as defined by current ACC/AHA HF performance measures. Further research is required to test the benefit of a performance-improvement program on narrowing evidence of health care disparities in African Americans with cardiovascular disease. In the interim, all appropriate evidence-based therapies should be employed to improve outcomes in all patients with HF. The OPTIMIZE-HF program suggests that an in-hospital process-of-care improvement program might help to achieve similar conformity with quality measures for African Americans with HF. Author Disclosures Dr. Yancy reported that he has received research grants from GlaxoSmithKline, Medtronic, NitroMed, and Scios, Inc. He is also a consultant or on the Speakers’ Bureau for AstraZeneca, GlaxoSmithKline, Medtronic, NitroMed, Novartis, and Scios, Inc. He was previously on the advisory board for CHF Solutions. He currently serves on the Food and Drug Administration (FDA) cardiovascular device panel and study section for the National Institutes of Health (NIH). He has received honoraria from AstraZeneca, GlaxoSmithKline, Medtronic, Novartis, and Scios, Inc. He reports editorial board involvement for American Heart Journal, American Journal of Cardiology (Associate Editor), Circulation (Guest Editor), Congestive Heart Failure, Current Heart Failure Reports, Journal of Acute Cardiac Care, and Journal of Urban Cardiology. Dr. Abraham reported that he has received a research grant from Amgen, Biotronik, CHF Solutions, GlaxoSmithKline, HFSA, Medtronic, Myogen, NIH, Orqis Medical, Otsuka Maryland Research Institute, Paracor, and Scios, Inc. He is/has been a consultant/is on the Speakers’ Bureau for Amgen, AstraZeneca, BoehringerIngelheim, CHF Solutions, GlaxoSmithKline, Guidant, Medtronic, Merck, Pfizer, ResMed, Respironics, Scios, Inc., and St. Jude Medical. He is on the advisory board of CardioKine, CardioKinetix Inc., CHF Solutions, Department of Veterans Affairs Cooperative Studies Program,
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Inovise, NIH, and Savacor, Inc. He has received honoraria from AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Guidant, Medtronic, Merck, Pfizer, ResMed, Respironics, Scios, Inc., and St. Jude Medical. He reports editorial board involvement with Congestive Heart Failure, Current Cardiology Reviews, Current Heart Failure Reports, Expert Review of Cardiovascular Therapy, Journal Watch Cardiology, PACE—Pacing and Clinical Electrophysiology, The American Heart Hospital Journal, and The Journal of Heart Failure. Dr. Albert reported that she is a consultant for GlaxoSmithKline and Medtronic. She is also on the Speakers’ Bureau for GlaxoSmithKline, Medtronic, NitroMed, and Scios, Inc., and is employed by the Cleveland Clinic Foundation. She reports editorial board involvement for Progress in Cardiovascular Nursing (Senior Editor), Journal of Cardiovascular Nursing, and Critical Care Nurse. Mr. Clare is an employee of DCRI. Dr. Stough reported that she has received research grants from Actelion, GlaxoSmithKline, Medtronic, Otsuka, and Pfizer. She is a consultant or on the Speakers’ Bureau for Abbott, AstraZeneca, GlaxoSmithKline, Medtronic, Novacardia, Otsuka, Protein Design Labs, RenaMed, Sigma Tau, and Scios, Inc. She has received honoraria from Abbott, AstraZeneca, GlaxoSmithKline, Medtronic, and Pfizer. Dr. Gheorghiade reported that he has received research grants from the NIH, Otsuka, Sigma Tau, Merck, and Scios, Inc. He is/has been a consultant for Debbio Pharm, Errekappa Terapeutici, GlaxoSmithKline, Protein Design Labs, and Medtronic. He has received honoraria from Abbott, AstraZeneca, GlaxoSmithKline, Medtronic, Otsuka, Protein Design Labs, Scios, Inc., and Sigma Tau. He reports editorial board involvement with Acute Cardiac Care Journal (Associate Editor), American Heart Journal, American Journal of Therapeutics (Associate Editor), Archives for Chest Disease (Associate Editor), Current Cardiology Reviews, Expert Review of Cardiovascular Therapy, Heart Disease: A Journal of Cardiovascular Medicine, Heart Failure Reviews, Heart International, Journal of Cardiac Failure, Journal of the American College of Cardiology, Italian Heart Journal, The American Journal of Cardiology, The Journal of Heart Disease, and The Journal of Heart Failure. Dr. Greenberg reported that he has received research grant support from Amgen, Cardiodynamics, GlaxoSmithKline, Millennium, Novacardia, Otsuka, Pfizer, Sanofi-Aventis, and Titan. He is on the Speakers’ Bureau/is a consultant for Amgen, AstraZeneca, GlaxoSmithKline, Guidant Corp., Medtronic, Merck & Co., NitroMed, Pfizer, Remon Medical Technologies, and Scios, Inc. He has served on advisory boards for CHF Solutions, GlaxoSmithKline, and NitroMed. He has received honoraria from AstraZeneca, GlaxoSmithKline, Medtronic, Merck & Co., NitroMed, Novartis, Pfizer, and Scios, Inc. He reports editorial board involvement for Congestive Heart Failure and Journal of the American College of Cardiology. Dr. O’Connor reported that he has received research grant support from the NIH. He is on the Speakers’ Bureau and/or a consultant for Amgen, Astra-
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Zeneca, Bristol-Myers Squibb, GlaxoSmithKline, Guidant, Medtronic, Merck, NitroMed, Novartis, Otsuka, Pfizer, and Scios, Inc. He has received honoraria from GlaxoSmithKline, Pfizer, and Otsuka. Dr. She is an employee of DCRI. Ms. Sun is an employee of DCRI. Dr. Young reported that he has received research grants from Abbott, Acorn, Amgen, Artesion Therapeutics, AstraZeneca, Biosite, GlaxoSmithKline, Guidant, Medtronic, MicroMed, NIH, Scios, Inc., Vasogen, and World Heart. He is a consultant for Abbott, Acorn, Amgen, Biomax Canada, Biosite, Boehringer-Ingelheim, Bristol-Myers Squibb, Cotherix, Edwards Lifescience, GlaxoSmithKline, Guidant, Medtronic, MicroMed, Novartis, Paracor, Proctor & Gamble, Protemix, Scios, Inc., Sunshine, Thoratec, Transworld Medical Corporation, Vasogen, Viacor, and World Heart. He reports editorial board involvement for Journal of Heart and Lung Transplantation, Evidence-Based Medicine, Journal of the American College of Cardiology, American Heart Journal, Cleveland Clinic Journal of Medicine, Cardiology Today, Graft, TheHeart.org, Transplantation and Immunology Letter, and American Society of Transplantation Newsletter. Dr. Fonarow reported that he has received research grants from Amgen, Biosite, Bristol-Myers Squibb, Boston Scientific/ Guidant, GlaxoSmithKline, Medtronic, Merck, Pfizer, Sanofi-Aventis, Scios, Inc., and the NIH. He is/has been on the Speakers’ Bureau or has received honoraria in the past 5 years from Amgen, AstraZeneca, Biosite, Bristol-Myers Squibb, Boston Scientific/Guidant, GlaxoSmithKline, Kos, Medtronic, Merck, NitroMed, Pfizer, Sanofi-Aventis, Schering-Plough, Scios, Inc., St. Jude Medical, Takeda, and Wyeth. He is or has been a consultant for Biosite, BristolMyers Squibb, Boston Scientific/Guidant, GlaxoSmithKline, Medtronic, Merck, NitroMed, Orqis Medical, Pfizer, Sanofi-Aventis, Schering-Plough, Scios, Inc., and Wyeth. He reports editorial board involvement with American Heart Journal, Circulation, Journal of Cardiac Failure, Journal of the American College of Cardiology, and Reviews of Cardiovascular Medicine. Reprint requests and correspondence: Dr. Clyde W. Yancy, Baylor Heart and Vascular Institute, Baylor University Medical Center, 3500 Gaston Avenue, Suite H-030, Dallas, Texas 75246. E-mail:
[email protected].
REFERENCES
1. Ofili E, Igho-Pemu P, Bransford T. The prevention of cardiovascular disease in blacks. Curr Opin Cardiol 1999;14:169 –75. 2. Mensah GA, Mokdad AH, Ford ES, Greenlund KJ, Croft JB. State of disparities in cardiovascular health in the United States. Circulation 2005;111:1233– 41. 3. American Heart Association. African Americans and Cardiovascular Diseases—Statistics. Dallas, TX: American Heart Association, 2005. 4. American Heart Association. Heart Disease and Stroke Statistics— 2007 Update. Dallas, TX: American Heart Association, 2007.
Yancy et al. African Americans Hospitalized With HF: The OPTIMIZE-HF Registry
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5. Dries DL, Exner DV, Gersh BJ, Cooper HA, Carson PE, Domanski MJ. Racial differences in the outcome of left ventricular dysfunction. N Engl J Med 1999;340:609 –16. 6. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004;351:2049 –57. 7. Yancy CW. Heart failure in African Americans: a cardiovascular engima. J Card Fail 2000;6:183– 6. 8. Davis SK, Liu Y, Gibbons GH. Disparities in trends of hospitalization for potentially preventable chronic conditions among African Americans during the 1990s: implications and benchmarks. Am J Public Health 2003;93:447–55. 9. Manhapra A, Canto JG, Barron HV, et al. Underutilization of reperfusion therapy in eligible African Americans with acute myocardial infarction: role of presentation and evaluation characteristics. Am Heart J 2001;142:604 –10. 10. Bertoni AG, Goonan KL, Bonds DE, Whitt MC, Goff DC Jr., Brancati FL. Racial and ethnic disparities in cardiac catheterization for acute myocardial infarction in the United States, 1995–2001. J Natl Med Assoc 2005;97:317–24. 11. Yancy CW, Sica DA. Cardiovascular disease in African Americans. J Clin Hypertens (Greenwich) 2004;6:54 – 6. 12. Kressin NR. Separate but not equal: the consequences of segregated health care. Circulation 2005;112:2582– 4. 13. Konety SH, Vaughan Sarrazin MS, Rosenthal GE. Patient and hospital differences underlying racial variation in outcomes after coronary artery bypass graft surgery. Circulation 2005;111:1210 – 6. 14. Bradley EH, Herrin J, Wang Y, et al. Racial and ethnic differences in time to acute reperfusion therapy for patients hospitalized with myocardial infarction. JAMA 2004;292:1563–72. 15. Kressin NR, Petersen LA. Racial differences in the use of invasive cardiovascular procedures: review of the literature and prescription for future research. Ann Intern Med 2001;135:352– 66. 16. Yancy CW. Heart failure therapy in special populations: the same or different? Rev Cardiovasc Med 2004;5 Suppl 1:S28 –35. 17. Fonarow GC, Abraham WT, Albert NM, et al. Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF): rationale and design. Am Heart J 2004; 148:43–51. 18. Fonarow GC, Abraham WT, Albert NM, et al. Influence of a performance-improvement initiative on quality of care for patients hospitalized with heart failure: results of the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF). Arch Intern Med 2007;167:1493–502. 19. Gheorghiade M, Abraham WT, Albert NM, et al. Systolic blood pressure at admission, clinical characteristics, and outcomes in patients hospitalized with acute heart failure. JAMA 2006;296:2217–26. 20. Fonarow GC, Abraham WT, Albert NM, et al. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA 2007;297:61–70. 21. Fiscella K, Franks P, Gold MR, Clancy CM. Inequality in quality: addressing socioeconomic, racial, and ethnic disparities in health care. JAMA 2000;283:2579 – 84. 22. Lavizzo-Mourey R, Jung M. Fighting unequal treatment: the Robert Wood Johnson Foundation and a quality-improvement approach to disparities. Circulation 2005;111:1208 –9. 23. Watson SD. Equity Measures and Systems Reform as Tools for Reducing Racial and Ethnic Disparities in Health Care. New York: The Commonwealth Fund, 2005. 24. Mehta SK, Toto KH, Nelson LL, Drazner MH. Therapy of heart failure in African Americans: lessons from an urban public hospital. Congest Heart Fail 2004;10:40 –3. 25. Skinner J, Chandra A, Staiger D, Lee J, McClellan M. Mortality after acute myocardial infarction in hospitals that disproportionately treat black patients. Circulation 2005;112:2634 – 41. 26. McNamara DM, Tam SW, Sabolinski ML, et al. Aldosterone synthase promoter polymorphism predicts outcome in African Americans with heart failure: results from the A-HeFT Trial. J Am Coll Cardiol 2006;48:1277– 82. 27. Deswal A, Petersen NJ, Souchek J, et al. Impact of race on health care utilization and outcomes in veterans with congestive heart failure. J Am Coll Cardiol 2004;43:778 – 84.
1684
Yancy et al. African Americans Hospitalized With HF: The OPTIMIZE-HF Registry
28. Rathore SS, Foody JM, Wang Y, et al. Race, quality of care, and outcomes of elderly patients hospitalized with heart failure. JAMA 2003;289:2517–24. 29. Kornowski R, Zeeli D, Averbuch M, et al. Intensive home-care surveillance prevents hospitalization and improves morbidity rates among elderly patients with severe congestive heart failure. Am Heart J 1995;129:762– 66. 30. Shah NB, Der E, Ruggerio C, Heidenreich PA, Massie BM. Prevention of hospitalizations for heart failure with an interactive home monitoring program. Am Heart J 1998;135:373– 8. 31. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med 1995;333:1190 –5. 32. Abraham WT, Massie BM, Franciosa JA, et al. Tolerability, safety, and efficacy of beta-blockade in black patients with heart failure in the
JACC Vol. 51, No. 17, 2008 April 29, 2008:1675–84 community setting: insights from a large prospective beta-blocker registry. J Card Fail 2003;9:S94. 33. Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol 2005;46:1116 – 43. 34. Adams KF, Lindenfeld J, Arnold JMO, et al. HFSA 2006 comprehensive heart failure practice guideline. J Card Fail 2006; 12:e1–22. APPENDIX
For supplementary tables, please see the online version of this article.