- Email: [email protected]
Interventions to improve guideline compliance following coronary artery bypass grafting
Interventions to improve guideline compliance following coronary artery bypass grafting Felix K. Yam, PharmD,a Wendell S. Akers, PharmD,b Victor A. Ferraris, MD, PhD,c Kelly Smith, PharmD,b Chand Ramaiah, MD,c Phillip Camp, MD,c and Jeremy D. Flynn, PharmD,a,b Lexington, Ky
Background. Lifestyle modification and appropriate medical therapy improve long-term outcomes following coronary artery bypass grafting (CABG). Our institutional experience suggested that evidencebased recommendations were not being followed postdischarge after CABG. We undertook this study to document our rate of compliance with evidence-based guidelines and to correct deficiencies in our discharge practices. Methods. Seven evidence-based interventions were studied after CABG: (1) institution of beta-blocker therapy, (2) angiotensin-converting enzyme (ACE) inhibitor therapy, (3) aspirin, (4) lipid-lowering therapy, (5) smoking cessation intervention, (6) heart-healthy diet therapy, and (7) physical activity recommendations. The rate of compliance with guidelines in 50 control patients was measured at discharge. A multidisciplinary team including cardiac surgeons, nurses, dieticians, physical therapists, and clinical pharmacists evaluated the guideline compliance in the control group and developed interventions to assure guideline compliance at the time of discharge. A subsequent study group of 50 patients was then assessed prospectively to measure the guideline compliance after institution of intervention programs. The multidisciplinary team agreed on predefined acceptable compliance limits as follows: (1) ⬎80% of patients receive ACE inhibitors at discharge, (2) 100% of patients receive betablockers, aspirin, and lipid-lowering agents at discharge, and (3) 100% of patients receive lifestyle modification counseling at discharge. Compliance with guidelines was defined as documentation in the medical record of provision of medications and lifestyle counseling at the time of discharge. Results. In the control group, the rate of guideline compliance was surprisingly low. Rates of compliance with guidelines increased significantly after the multidisciplinary interventions were undertaken. Conclusions. We conclude that compliance with guidelines known to improve long-term outcome is suboptimal after CABG. A multidisciplinary intervention program can improve compliance with currently accepted guidelines and quality indicators in patients following CABG. (Surgery 2006;140:541-52.) From the Department of Pharmacy Services, Kentucky Chandler Medical Center;a Division of Pharmacy Practice & Science, College of Pharmacy;b and Department of Surgery, College of Medicine,c University of Kentucky
Presented at the 63rd Annual Meeting of the Central Surgical Association, Louisville, Kentucky, March 9-11, 2006. Accepted for publication May 18, 2006. Reprint requests: Victor A. Ferraris, MD, PhD, University of Kentucky, C-208 Chandler Medical Center, 900 South Limestone, Suite 320, Lexington, KY 40536. E-mail: [email protected] or [email protected]. 0039-6060/$ - see front matter © 2006 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2006.05.014
INTRODUCTION Secondary prevention is imperative among patients undergoing invasive coronary procedures such as coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA).1 Evidence suggests, however, that there are significant gaps in implementation of secondary prevention these patients receive despite the strong body of evidence that describes optimum medical care and best practice.2-8 The American Heart Association (AHA) initiated a program entitled “Get With the Guidelines” (GTWG) for patients with coronary artery disease (CAD) to identify and implement secondary preSURGERY 541
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vention measures in appropriate patients to improve the quality of care and outcomes following revascularization. These quality indicators are identified in the latest AHA/American College of Cardiology (ACC) guidelines for preventing heart attack and death in patients with known atherosclerotic cardiovascular disease (http://circ.ahajournals. org/cgi/content/full/104/13/1577#TBL1). The hospitalization following an invasive revascularization procedure provides a “teachable moment” during which secondary prevention measures can be effectively implemented.9 Within these guidelines, the AHA/ACC emphasizes specific drug therapies as key quality indicators for secondary prevention. Unless contraindications exist, medications at discharge should include aspirin or clopidogrel, beta-blockers,8,10 HMG-CoA reductase inhibitors,11-13 and angiotensin-converting enzyme (ACE) inhibitors.14-16 The GWTG program also emphasizes the importance of lifestyle modification in improving outcomes in patients with significant CAD. Patient counseling on lifestyle modification issues such as diet, exercise, and smoking cessation are an important part of secondary prevention and should be included in discharge planning in all patients undergoing CABG.17 During the past year, we evaluated adherence to these 7 areas of secondary prevention in CABG patients at our institution. We found that there were several areas for potential improvement. We hypothesized that the establishment of a multidisciplinary intervention program would assure guideline compliance and secondary prevention goals. METHODS Study population. Two groups of patients undergoing CABG at the University of Kentucky Chandler Medical Center were studied. For the control group, a retrospective chart review of 50 consecutive CABG patients was conducted to determine the percentage of AHA/ACC guideline compliance. For the intervention group, 50 consecutive patients who agreed to participate in the study were subjected to various interventions to promote guideline compliance. Only data from the first 50 patients who consented to participate in the study were included in the intervention group. Institutional review and approval were obtained before beginning the study. Program and guideline description. The AHA/ ACC guidelines for prevention of CAD were applied to patients in the treatment group.9 Patients undergoing CABG have significant CAD and are ideal candidates for application of guideline-related interventions to prevent long-term risks of
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CAD. Seven AHA/ACC guideline–recommended interventions were applied to the treatment group of 50 patients. Compliance with these same guideline interventions was assessed by chart review of 50 consecutive patients in the control group. A multidisciplinary team was formed to conduct this quality improvement program. The team consisted of thoracic surgeons, clinical pharmacists, dieticians, physical therapists, and nurse coordinators. The initial task of the team was to develop a comprehensive chart documentation form that was included in the patient’s medical record. This form included a section for surgeons, pharmacists, discharge nurse coordinators, dieticians, and physical therapists (Appendix). The form served as documentation of the implementation of guideline-driven medications, clarification of medication purpose and duration, and counseling for diet, exercise, and smoking cessation. Relevant drug monitoring and appropriate laboratory values also were documented on this form. The pharmacist member of the multidisciplinary team made recommendations for optimizing drug therapy to the surgeon staff in charge of the patient’s hospital care. At discharge, each patient’s medication regimen was reconciled and evaluated for safety and compliance with established guidelines for secondary prevention of CAD, as described earlier. An emphasis was placed on using each healthcare professional’s unique expertise to provide education that was goal-specific and directed at maximizing patient outcomes. Physicians provided initial education on the risk and benefits of CABG surgery. Following surgery, the pharmacist provided drug therapy and smoking cessation counseling. Dieticians were involved immediately following surgery to maximize nutritional status and prior to discharge to discuss the importance of maintaining a heart-healthy diet. Physical therapists were consulted to address exercise needs and to promote increased levels of physical activity (Fig 1). This process was facilitated through the utilization of standard order sets in a computerized physician order entry (CPOE) system, The clinical pharmacist on the cardiovascular service at our facility served as the director of this program given their unique position to communicate with all members of the multidisciplinary team and provide counseling on 5 of the 7 primary guideline components. In addition to ensuring AHA/ACC CABG guideline compliance, patients received educational materials, provided through the institution’s patient education resources department to assist in their understanding of heart disease and the importance of appropriate medication use and healthy living.
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Surgeon: The surgeon is responsible for total care of patient. Nurse: The nurse is responsible for providing nursing care and documenting daily patient activities and vital signs. The nurse also has a vital role in communicating patient needs to the team. Physical therapist: The physical therapist monitors the patient’s physical activity and documents progress and sets goals. Dietician: The dietician counsels the patient on lifestyle changes and dietary goals. Discharge planner: The discharge planner will ensure that follow-up appointments are coordinated with the healthcare team and primary care surgeon. Pharmacist: The pharmacist is responsible for obtaining a detailed medication history upon patient admission, for ensuring that the patient is initiated on all appropriate medication, and for monitoring therapy for any possible drug-drug interactions or adverse drug reactions. The pharmacist also provides medication, smoking cessation counseling, and discharge planning.
Fig 1. Multidisciplinary group members.
Table I. Criteria for ACE inhibitor initiation (angiotensin receptor blockers were considered in patients intolerant to ACE inhibitors) Indications
Contraindications
Post-MI CHF; EF ⬍40 Patients with vascular disease
Allergy or intolerance SBP ⬍100 mmHg at discharge Renal artery stenosis
ACE, Angiotensin-converting enzyme inhibitor; MI, myocardial infarction; CHF, chronic heart failure; EF, ejection fraction; SBP, systolic blood pressure.
The patients had these manuals throughout their hospital stay, and healthcare providers used the manuals to assist in patient counseling and teaching. At discharge, the manuals were used to organize patient education material and discharge instructions provided to the patient. Study endpoints. The primary outcome measured was compliance with 7 recognized interventions to reduce long-term events in patients with known CAD (secondary prevention).9 Seven evidence-based interventions were studied after CABG: (1) institution of beta-blocker therapy, (2) institution of ACE inhibitor therapy, (3) institution of aspirin therapy, (4) institution of lipid-lowering therapy, (5) smoking cessation intervention, (6) heart-healthy diet therapy, and (7) physical activity recommendations. Compliance with medication guidelines was defined as documentation of medication administration or of specific contraindications in the intervention group compared with the control group. All patients requiring CABG surgery were considered to have at least 1 criterion for the initiation of ACE inhibitor therapy. Patients requiring CABG were assumed to have vascular disease and were thus eligible for ACE inhibitors on this basis alone (Table I). Patients who were intolerant of ACE inhibitors were eligible to receive angiotensin receptor blockers (ARBs), and documentation of contraindications would be considered compliant with the guidelines.
Table II. Baseline subject characteristics Control (n ⫽ 50) Male (%) Mean age (y) Mean LOS (d) Meds at admission (d) Meds at discharge (d) Mean EF (%) Mean EF (%) ⬍40 Mean # of grafts Diabetes (%) History of MI (%)
92 64 ⫾ 9.7 7.6 ⫾ 4.6 6.6 ⫾ 2.7 8.3 ⫾ 2.7 50 ⫾ 13.5 26 3 38 42
Intervention (n ⫽ 50)* 61 8.7 6.6 8.6 46
70 ⫾ 11.4 ⫾ 3.9 ⫾ 3.8 ⫾ 3.3 ⫾ 15 32 3 44 38
LOS, Length of stay; Meds, mean number of medications; EF, ejection fraction; MI, myocardial infarction. *No significant differences were identified between groups (P ⬎ 0.05).
Data and statistical analysis. An estimated sample size of 100 patients (50 per group) was required to detect a 20% difference in ACE inhibitor initiation with 80% power using a 2-sided test and a priori level of significance set at 0.05. Between group differences were evaluated using the Student t test for continuous data and the Fisher exact test for dichotomous variables. RESULTS Demographics. Demographics data for the intervention and control arms of the study are shown in Table II. The intervention and control groups did not significantly differ in age, number of medications at admission and discharge, length of stay, mean ejection fraction, or mean number of grafts. Both control and intervention groups had a significant number of patients with diabetes and a history of myocardial infarction (MI), but no between-group differences were detected. There was also no significant difference in the utilization of guideline-recommended medications upon admission (Fig 2). Effect of intervention. ACE inhibitor initiation at discharge increased from 40% in the control group to 84% in the intervention group (P ⫽ 0.00001). A total of 8 patients did not receive ACE inhibitors at discharge with 6 of those a result of legitimate contraindications, resulting in 96% compliance with the guidelines (Table III). Compliance with HMG-CoA reductase inhibitor and aspirin initiation were also significantly increased as compared to the control group (Table III). There was also a non-significant increase in the use of beta-blockers. Compliance with lifestyle modification indicators including dietary, physical activity, and smoking cessation were also significantly improved as compared to control. No documenta-
Percent Compliance
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Table III. Guideline compliance rates
100 90 80 70 60 50 40 30 20 10 0
Percent compliance
ACE
B-blocker
ASA Medications
Statin Control
Clopidogrel Intervention
Fig 2. Medications on admission in intervention (n ⫽ 50) and control group (n ⫽ 50). All groups were not statistically different (P ⬎ 0.05). ACE, angiotensin-converting enzyme; B-blocker, beta-blocker; ASA, aspirin.
tion for smoking cessation counseling was found in the medical records of patients in the control group. DISCUSSION Patients with CAD, cerebral vascular disease, and peripheral atherosclerosis are at high risk for vascular events and cardiac death.1 Combination medication therapy targeting the underlying disease process can markedly improve clinical outcomes in patients following CABG surgery, whereas failure to employ these therapies can increase patient morbidity and mortality.4,7,18,19 Compliance and treatment utilization can be enhanced by employing secondary prevention measures prior to hospital discharge.5 The AHA encourages providers to take advantage of the “teachable moment” in the patient’s care process. The importance of lifestyle intervention is often overlooked in the acute setting and deferred to the patient’s primary care provider. Our retrospective review identified inconsistencies in documentation and provision of these basic services. Through a coordination of efforts between the physician, pharmacist, dietician, and physical therapist, we were able to standardize this process and incorporate it into the care plan of all patients’ post-CABG and prior to discharge. We believe that patients should not be discharged from the hospital without initiation of definitive treatment, with the exception of existing contraindications that are documented in the medical chart. Our study suggests that guideline-recommended therapies are not given to all patients following CABG. This observation reinforces the findings of others. ACE inhibitors, beta-blockers, HMG-CoA reductase inhibitors, and antiplatelet therapy have all been proven to reduce cardiovascular events and mortality in patients with CAD, other vascular
Guideline
Control (n ⫽ 50)
Intervention (n ⫽ 50)
ACE inhibitor Lipid-lowering Aspirin Beta-blocker Dietary counseling Active lifestyle refresher Smoking cessation
42% 76% 92% 95% 49% 54% 0%
84% (P ⬍0.001) 96% (P ⫽ 0.006) 100% (P ⫽ 0.04) 100% (P ⫽ n.s.) 91% (P ⬍0.001) 87% (P ⬍0.001) 100% (P ⬍0.001)
disease, and diabetes.4,7,18,19 Although current guidelines by the AHA/ACC recommend that all patients with CAD, vascular disease, and/or diabetes be treated with all 4 medications, unless contraindications exist or treatment is not tolerated, compliance continues to be suboptimal.5,6 Fonarow et al demonstrated these shortcomings in 2 separate studies that showed compliance rates for ACE inhibitors, aspirin, and HMG-CoA reductase inhibitors were 16%, 68%, and 32%, respectively in patients with known CAD. A retrospective, medication-use evaluation at our institution revealed similar suboptimal guideline compliance rates in our population and prompted the development of a multidisciplinary program to improve compliance. Multidisciplinary teams are essential in providing comprehensive and optimal medical care. Our success with obtaining guideline compliance in 7 key areas reinforces the value of a multidisciplinary team. We obtained significant increases in compliance with all of the relevant guidelines studied. In addition to increasing the rate of ACE inhibitor initiation at discharge, we showed a significant increase in HMG-CoA reductase inhibitor, aspirin, and a nonsignificant increase in beta-blocker initiation at discharge. Lifestyle modification counseling also increased when compared with the control group. Previous studies in this area have shown that pharmacist intervention did not increase ACE inhibitor initiation in patients with CAD at discharge when compared with “usual care” without a pharmacist (68% vs 62%, respectively, P ⫽ 0.85).20 This study, by Chapman et al,20 suggested that convincing physicians of adding ACE inhibitors was difficult due to physician misconception that ACE inhibitors would benefit patients without heart failure or diabetes. In our study, we demonstrated that a pharmacist could have a significant impact in directing multidisciplinary care and improving guideline compliance.
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Our ability to increase ACE inhibitor utilization and other quality indicators in this population underscores the collaborative relationship that clinical pharmacists can develop with surgeons and other healthcare providers and the resultant impact on the provision of quality patient care. This relationship was instrumental in forming a multidisciplinary team and coordinating care for CABG patients, which illustrates the importance of collaborative care and standardized approaches to postoperative management of patients. Furthermore, the Centers of Medicaid and Medicare Services (CMS) proposed the use of quality indicators that will require hospitals to document care provided to receive reimbursement for specific diagnoses. Additionally, the American Society of Health System Pharmacists (ASHP) 2015 Initiative has called for increased pharmacist involvement in ensuring medication therapy reflects current evidence-based practices. These initiatives identify collaborative, multidisciplinary relationships as an essential component of advanced practice and quality patient care. The multidisciplinary team approach to disease management will likely be an important component of so-called “pay for performance.” Despite evidence supporting the use of ACE inhibitors in patients with stable CAD, not all clinicians may be convinced of the benefits in patients without left ventricular dysfunction or comorbidities, such as diabetes. In the HOPE trial, Yusef et al14 demonstrated that patients with stable CAD randomized to receive ramipril had significant reductions in the rate of MI, stroke, and death. A significant number of patients were considered at high risk and included 38% diabetics, 52% with history of MI, and 26% having received CABG intervention.14 This study helped extend the benefits of ACE inhibitors to patients without left ventricular dysfunction or diabetes. More recently, however, the PEACE trial, conducted by Braunwald et al,21 which included a majority of patients on “current standard” cardiovascular treatment regimens who were randomized to trandolapril vs placebo, did not show a reduction in mortality from cardiovascular causes, myocardial infarction, or coronary revascularization. This seemingly contradicts the benefit of ACE inhibitors in patients without left ventricular dysfunction or diabetes. However, it is important to note that the study by Braunwald et al was conducted in patients with “current standard” cardiovascular treatment regimens, which included increased utilization of more potent antiplatelet agents, more aggressive use of HMG-CoA reductase inhibitors, and beta-blockers. Patients in the PEACE trial also had lower rates of
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cardiovascular events when compared with previous trials. As such, the HOPE population14 appears to be more reflective of post-CABG patients and our population in general. In our CABG population, we had a significant number of patients with diabetes (44%) and ejection fraction (EF) ⬍40% (38%), as well as 38% of patients with a history of MI. This further validates the appropriateness of ACE inhibitor use in this population. HMG-CoA reductase inhibitor initiation and titration of doses to reach target low-density lipoproteins (LDL) goals was imperative in our population. All patients in the intervention group were evaluated to receive HMG-CoA reductase therapy, representing 100% compliance with guidelines. Goals for therapy were communicated to the patient and their primary healthcare provider through a combination of verbal and written communication with instructions to titrate LDL to a goal of less than 70 mg/dL. The two patients who did not receive HMG-CoA reductase inhibitors therapy had a documented intolerance, one with a history of rhabdomyolysis and the other with documented liver toxicity. These patients were referred to their primary care provider for alternative LDL-lowering therapies. A significant increase in clopidogrel utilization at discharge also was seen in our intervention population. This likely reflects increasing evidence that clopidogrel can be used safely and effectively in combination with aspirin to reduce secondary cardiovascular events such as non-fatal MI, death, or stroke.22-24 Current CHEST guidelines recommend the use of combination antiplatelet activity in patients who undergo CABG for non-ST–segment elevation acute coronary syndrome for a period of 9 to 12 months following the procedure.23,25 Although long-term outcome data are not available, there is also an increasing trend of dual antiplatelet therapy in off-pump CABG patients.23,26 Although our protocol involved the inclusion of dietary and physical therapy consults for all patients postoperatively, the introduction of CPOE at our hospital resulted in miscommunication of orders for such services during 2 months of the intervention period. Initially, orders that were placed did not appear on the electronic worksheets of the dieticians or physical therapists. As such, that may explain our less then 100% compliance with achieving these quality indicators. When these orders were rectified, 100% of patients postoperatively received both dietary and physical therapy counseling concerning their postoperative cardiac care. Current AHA/ACC guidelines also recommend that all patients receive smoking cessation counsel-
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ing.9 A recent study by Ong et al,27 showed that hospital smoking-cessation counseling of patients was an independent predictor in maintenance of smoking cessation 2 months following discharge. In response, the pharmacist provided smoking cessation counseling to all patients with a history of smoking prior to discharge through verbal counseling, educational literature, and a smoking cessation video developed by the AHA. This included the discussion of nicotine replacement, medication options, and available support groups. Our quality improvement project included limitations that were due to multiple factors inherent in academic medical centers. A pharmacist, who was also the primary investigator, was actively involved in both the control and intervention groups, which has the possibility of introducing selection bias in patients who received selected therapy. Additionally, long-term follow-up for these patients is often difficult to assess due to the nature of a tertiary, referral center and the size of the area to which care is provided. Because our main objective was to improve outcomes through compliance, the ability to measure patient safety, response rates, and compliance to therapy would have increased the validity of our study. Further studies to evaluate the effectiveness of such programs in improving patient outcomes are needed. Currently, we have plans to follow our intervention group after discharge to ensure the communication of important medical information reaches the patients’ primary care providers. Our goal is to establish a relationship with each patient’s primary care provider to facilitate the transition from acute to ambulatory care. This will be done in the form of a consultative letter sent from the attending surgeon on behalf of the multidisciplinary team to the primary care provider. The letter will list patientspecific goals and describe optimal secondary prevention therapy for patients following CABG surgery. STUDY SHORTCOMINGS The short-term nature of this study is a shortcoming. Although the data suggest significant improvement in guideline compliance, there is limited follow-up information about long-term benefit. A secondary phase of the study will include follow-up with referring physicians and assessment of continued compliance with guideline interventions. This part of the study may eventually become very important as “pay for performance” quality interventions are introduced into the reimbursement picture by both governmental and nongovernmental payors.28 First, a clear-cut link needs to be es-
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tablished between intervention programs to assure guideline compliance and long-term benefit. Multiple threads of evidence suggest survival and eventfree survival benefit from guidelines recommended interventions in controlled randomized trials.9 It remains to be shown that active intervention programs such as ours provide additional benefit to normal physician-directed recommendations for guideline adherence. Further studies are required to close this loop. The rate of guideline compliance is relatively low in the control group, especially for nondrugrelated guidelines. One possible explanation for this low rate is that interventions were missed in the retrospective review of the control group charts. The possibility of false-negative guideline compliance was excluded by the multidisciplinary team at the beginning of the study. All of the team members were very aware of how CABG patients were treated up to the point of the prospective study intervention. For example, it was recognized that no patient received formal smoking cessation counseling before the study interventions were initiated. Likewise, physical therapy intervention in CABG patients was “hit or miss” in the control group because of the lack of a standard orders in the CPOE template. Similar considerations existed in the control group for dietary interventions. It was only after standard multidisciplinary interventions, including CPOE templates, were introduced that guideline compliance increased. Because of the familiarity of the multidisciplinary team with the daily patient interventions, it is highly unlikely that there was a significant false-negative rate of control group guideline compliance. CONCLUSION An organized method of postoperative acute care is necessary to provide comprehensive medical care to patients following coronary revascularization. The quality of that care can be maximized through using the specific skill sets of each healthcare provider to maximize patient education and self-understanding of their disease state management. CABG patients in particular are at high risk for secondary coronary events and so treatment should be optimized to reflect current guidelines. In particular, institutions that perform these procedures must take advantage of the “teachable moment” provided by this acute event. REFERENCES 1. Charlson ME, Isom OW. Clinical practice. Care after coronary-artery bypass surgery. N Engl J Med 2003;348(15): 1456-63.
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2. Krumholz HM, Radford MJ, Wang Y, Chen J, Marciniak TA. Early beta-blocker therapy for acute myocardial infarction in elderly patients. Ann Intern Med 1999;131:648-54. 3. Barron HV, Michaels AD, Maynard C, Every NR. Use of angiotensin-converting enzyme inhibitors at discharge in patients with acute myocardial infarction in the United States: data from the National Registry of Myocardial Infarction 2. J Am Coll Cardiol 1998;32:360-7. 4. Ellerbeck EF, Jencks SF, Radford MJ, Kresowik TF, Craig AS, Gold JS, et al. Quality of care for Medicare patients with acute myocardial infarction. A four-state pilot study from the Cooperative Cardiovascular Project. JAMA 1995;273: 1509-14. 5. Fonarow GC, Gawlinski A, Moughrabi S, Tillisch JH. Improved treatment of coronary heart disease by implementation of a Cardiac Hospitalization Atherosclerosis Management Program (CHAMP). Am J Cardiol 2001;87:819-22. 6. Fonarow GC, Ballantyne CM. In-hospital initiation of lipidlowering therapy for patients with coronary heart disease: the time is now. Circulation 2001;103:2768-70. 7. Gottlieb SS, McCarter RJ, Vogel RA. Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction. N Engl J Med 1998;339:489-97. 8. Krumholz HM, Radford MJ, Ellerbeck EF, Hennen J, Meehan TP, Petrillo M, et al. Aspirin for secondary prevention after acute myocardial infarction in the elderly: prescribed use and outcomes. Ann Intern Med 1996;124: 292-8. 9. Smith SC Jr, Blair SN, Bonow RO, Brass LM, Cerquiera MD, Drakup K, et al. AHA/ACC guidelines for preventing heart attack and death in patients with atherosclerotic cardiovascular disease: 2001 update. A statement for healthcare professionals from the American Heart Association and the American College of Cardiology. J Am Coll Cardiol 2001;38:1581-3. 10. Chen J, Radford MJ, Wang Y, Marciniak TA, Krumholz HM. Are beta-blockers effective in elderly patients who undergo coronary revascularization after acute myocardial infarction? Arch Intern Med 2000;160:947-52. 11. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. The post coronary artery bypass graft trial investigators. N Engl J Med 1997;336:153-62. 12. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495-504. 13. Heart Protection Study Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22. 14. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000;342:145-53. 15. Fox KM, Henderson JR, Bertrand ME, Ferrari R, Remme WJ, Simoons ML. The European trial on reduction of cardiac events with perindopril in stable coronary artery disease (EUROPA). Eur Heart J 1998;19(Suppl J):J52-5. 16. Eagle KA, Guyton RA, Davidoff R, Edwards FH, Ewy GA, Gardner TJ, et al. ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association
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Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery). Circulation 2004;110:e340-437. Denton TA, Fonarow GC, LaBresh KA, Trento A. Secondary prevention after coronary bypass: the American Heart Association “Get with the Guidelines” program. Ann Thorac Surg 2003;75:758-60. Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, et al. Long-term graft patency (3 years) after coronary artery surgery. Effects of aspirin: results of a VA cooperative study. Circulation 1994;89:1138-43. Ivancan V, Husedzinovic I, Nikic N, Baudoin Z. [Hemodynamic effects of captopril, an ACE inhibitor, in patients after aortocoronary bypass]. Lijec Vjesn 1995;117(Suppl 2): 103-4. Chapman NR, Fotis MA, Yarnold PR, Gheorghiade M. Pharmacist interventions to improve the management of coronary artery disease. Am J Health Syst Pharm 2004;61: 2672-8. Braunwald E, Domanski MJ, Fowler SE, Geller NL, Gersh BJ, Hsia J, et al. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med 2004; 351:2058-68. Stein PD, Schunemann HJ, Dalen JE, Gutterman D. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(3 Suppl):600S-8S. Shennib H, Endo M, Benhameid O. A feasibility study of the safety and efficacy of a combined clopidogrel and aspirin regimen following off-pump coronary artery bypass grafting. Heart Surg Forum 2003;6:288-91. Mehta SR, Yusuf S. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial programme; rationale, design and baseline characteristics including a metaanalysis of the effects of thienopyridines in vascular disease. Eur Heart J 2000;21:2033-41. Fox KA, Mehta SR, Peters R, Zhao F, Lakkis N, Gersh BJ, et al. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-ST-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial. Circulation 2004;110:1202-8. D’Ancona G, Donias HW, Karamanoukian RL, Bergsland J, Karamanoukian HL. OPCAB therapy survey: off-pump clopidogrel, aspirin or both therapy survey. Heart Surg Forum 2001;4:354-8. Ong KC, Cheong GN, Prabhakaran L, Earnest A. Predictors of success in smoking cessation among hospitalized patients. Respirology 2005;10:63-9. Bufalino V, Peterson ED, Burke GL, LaBresh KA, Jones DW, Faxon DP, et al. Payment for quality: guiding principles and recommendations: principles and recommendations from the American Heart Association’s Reimbursement, Coverage, and Access Policy Development Workgroup. Circulation 2006;113:1151-4.
DISCUSSION Dr Peter K. Henke (Ann Arbor, Mich): Compliance with those medications probably makes a much bigger difference in long-term outcomes than any surgical interventions that we do for the most part. Have you determined what the long-
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term compliance rate is? I would be interested in your plans for long term follow-up. Dr Charles Yowler (Cleveland, Ohio): One of the problems with ACE inhibitors is that many of these patients are elderly. We have noticed that our cardiologists have put patients on ACE inhibitors only to have their geriatric physicians discontinue them because of complaints of dizziness and low blood pressure. Did you ever look to see if some of the patients who were not discharged on ACE inhibitors had relative contraindications to their use? Dr Jonathan M. Saxe (Dayton, Ohio): You are making a basic assumption that the statins are completely necessary in every patient. How do you know that is actually true? Dr Jeremy D. Flynn: We have looked into longterm medication use. We are in the process of developing some type of continuous quality improvement database so that we can see these patients in the future. With a large tertiary referral center with a very wide area of practice, many times those patients are lost to follow-up, at least to our practice, after the 2- to 3-week postop follow-up. One of our main goals is to really improve communication with community cardiologists and internal
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medicine physicians so that we can follow-up and discuss with them what our goals were and what our intended outcomes were. As for appropriateness of therapy, protocol compliance was documented if there was a confirmed contraindication, of which there were several instances. Several patients had been on statins in the past with documented lipid abnormalities but had had either myalgias or had LFT increases and had been taken off, so those patients were not put back on. So each patient was evaluated for appropriateness by the physician as well as the pharmacist. As far as the elderly and ACE inhibitors, we were hesitant to initiate therapy for any patients at discharge if they had any significant renal dysfunction in the hospital, if they had problems with ACE inhibitors in the past, or if their blood pressure at the time of discharge was not back to their baseline blood pressure, which happens quite often. In those cases, we documented that in the patient’s medical record and tried to communicate with their internal medicine physician or their cardiologist so that, in the future, they could begin therapy.
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APPENDIX Multidisciplinary discharge form to document guidelines adherence.
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Background. Lifestyle modification and appropriate medical therapy improve long-term outcomes following coronary artery bypass grafting (CABG). Our institutional experience suggested that evidencebased recommendations were not being followed postdischarge after CABG. We undertook this study to document our rate of compliance with evidence-based guidelines and to correct deficiencies in our discharge practices. Methods. Seven evidence-based interventions were studied after CABG: (1) institution of beta-blocker therapy, (2) angiotensin-converting enzyme (ACE) inhibitor therapy, (3) aspirin, (4) lipid-lowering therapy, (5) smoking cessation intervention, (6) heart-healthy diet therapy, and (7) physical activity recommendations. The rate of compliance with guidelines in 50 control patients was measured at discharge. A multidisciplinary team including cardiac surgeons, nurses, dieticians, physical therapists, and clinical pharmacists evaluated the guideline compliance in the control group and developed interventions to assure guideline compliance at the time of discharge. A subsequent study group of 50 patients was then assessed prospectively to measure the guideline compliance after institution of intervention programs. The multidisciplinary team agreed on predefined acceptable compliance limits as follows: (1) ⬎80% of patients receive ACE inhibitors at discharge, (2) 100% of patients receive betablockers, aspirin, and lipid-lowering agents at discharge, and (3) 100% of patients receive lifestyle modification counseling at discharge. Compliance with guidelines was defined as documentation in the medical record of provision of medications and lifestyle counseling at the time of discharge. Results. In the control group, the rate of guideline compliance was surprisingly low. Rates of compliance with guidelines increased significantly after the multidisciplinary interventions were undertaken. Conclusions. We conclude that compliance with guidelines known to improve long-term outcome is suboptimal after CABG. A multidisciplinary intervention program can improve compliance with currently accepted guidelines and quality indicators in patients following CABG. (Surgery 2006;140:541-52.) From the Department of Pharmacy Services, Kentucky Chandler Medical Center;a Division of Pharmacy Practice & Science, College of Pharmacy;b and Department of Surgery, College of Medicine,c University of Kentucky
Presented at the 63rd Annual Meeting of the Central Surgical Association, Louisville, Kentucky, March 9-11, 2006. Accepted for publication May 18, 2006. Reprint requests: Victor A. Ferraris, MD, PhD, University of Kentucky, C-208 Chandler Medical Center, 900 South Limestone, Suite 320, Lexington, KY 40536. E-mail: [email protected] or [email protected]. 0039-6060/$ - see front matter © 2006 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2006.05.014
INTRODUCTION Secondary prevention is imperative among patients undergoing invasive coronary procedures such as coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA).1 Evidence suggests, however, that there are significant gaps in implementation of secondary prevention these patients receive despite the strong body of evidence that describes optimum medical care and best practice.2-8 The American Heart Association (AHA) initiated a program entitled “Get With the Guidelines” (GTWG) for patients with coronary artery disease (CAD) to identify and implement secondary preSURGERY 541
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vention measures in appropriate patients to improve the quality of care and outcomes following revascularization. These quality indicators are identified in the latest AHA/American College of Cardiology (ACC) guidelines for preventing heart attack and death in patients with known atherosclerotic cardiovascular disease (http://circ.ahajournals. org/cgi/content/full/104/13/1577#TBL1). The hospitalization following an invasive revascularization procedure provides a “teachable moment” during which secondary prevention measures can be effectively implemented.9 Within these guidelines, the AHA/ACC emphasizes specific drug therapies as key quality indicators for secondary prevention. Unless contraindications exist, medications at discharge should include aspirin or clopidogrel, beta-blockers,8,10 HMG-CoA reductase inhibitors,11-13 and angiotensin-converting enzyme (ACE) inhibitors.14-16 The GWTG program also emphasizes the importance of lifestyle modification in improving outcomes in patients with significant CAD. Patient counseling on lifestyle modification issues such as diet, exercise, and smoking cessation are an important part of secondary prevention and should be included in discharge planning in all patients undergoing CABG.17 During the past year, we evaluated adherence to these 7 areas of secondary prevention in CABG patients at our institution. We found that there were several areas for potential improvement. We hypothesized that the establishment of a multidisciplinary intervention program would assure guideline compliance and secondary prevention goals. METHODS Study population. Two groups of patients undergoing CABG at the University of Kentucky Chandler Medical Center were studied. For the control group, a retrospective chart review of 50 consecutive CABG patients was conducted to determine the percentage of AHA/ACC guideline compliance. For the intervention group, 50 consecutive patients who agreed to participate in the study were subjected to various interventions to promote guideline compliance. Only data from the first 50 patients who consented to participate in the study were included in the intervention group. Institutional review and approval were obtained before beginning the study. Program and guideline description. The AHA/ ACC guidelines for prevention of CAD were applied to patients in the treatment group.9 Patients undergoing CABG have significant CAD and are ideal candidates for application of guideline-related interventions to prevent long-term risks of
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CAD. Seven AHA/ACC guideline–recommended interventions were applied to the treatment group of 50 patients. Compliance with these same guideline interventions was assessed by chart review of 50 consecutive patients in the control group. A multidisciplinary team was formed to conduct this quality improvement program. The team consisted of thoracic surgeons, clinical pharmacists, dieticians, physical therapists, and nurse coordinators. The initial task of the team was to develop a comprehensive chart documentation form that was included in the patient’s medical record. This form included a section for surgeons, pharmacists, discharge nurse coordinators, dieticians, and physical therapists (Appendix). The form served as documentation of the implementation of guideline-driven medications, clarification of medication purpose and duration, and counseling for diet, exercise, and smoking cessation. Relevant drug monitoring and appropriate laboratory values also were documented on this form. The pharmacist member of the multidisciplinary team made recommendations for optimizing drug therapy to the surgeon staff in charge of the patient’s hospital care. At discharge, each patient’s medication regimen was reconciled and evaluated for safety and compliance with established guidelines for secondary prevention of CAD, as described earlier. An emphasis was placed on using each healthcare professional’s unique expertise to provide education that was goal-specific and directed at maximizing patient outcomes. Physicians provided initial education on the risk and benefits of CABG surgery. Following surgery, the pharmacist provided drug therapy and smoking cessation counseling. Dieticians were involved immediately following surgery to maximize nutritional status and prior to discharge to discuss the importance of maintaining a heart-healthy diet. Physical therapists were consulted to address exercise needs and to promote increased levels of physical activity (Fig 1). This process was facilitated through the utilization of standard order sets in a computerized physician order entry (CPOE) system, The clinical pharmacist on the cardiovascular service at our facility served as the director of this program given their unique position to communicate with all members of the multidisciplinary team and provide counseling on 5 of the 7 primary guideline components. In addition to ensuring AHA/ACC CABG guideline compliance, patients received educational materials, provided through the institution’s patient education resources department to assist in their understanding of heart disease and the importance of appropriate medication use and healthy living.
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Surgeon: The surgeon is responsible for total care of patient. Nurse: The nurse is responsible for providing nursing care and documenting daily patient activities and vital signs. The nurse also has a vital role in communicating patient needs to the team. Physical therapist: The physical therapist monitors the patient’s physical activity and documents progress and sets goals. Dietician: The dietician counsels the patient on lifestyle changes and dietary goals. Discharge planner: The discharge planner will ensure that follow-up appointments are coordinated with the healthcare team and primary care surgeon. Pharmacist: The pharmacist is responsible for obtaining a detailed medication history upon patient admission, for ensuring that the patient is initiated on all appropriate medication, and for monitoring therapy for any possible drug-drug interactions or adverse drug reactions. The pharmacist also provides medication, smoking cessation counseling, and discharge planning.
Fig 1. Multidisciplinary group members.
Table I. Criteria for ACE inhibitor initiation (angiotensin receptor blockers were considered in patients intolerant to ACE inhibitors) Indications
Contraindications
Post-MI CHF; EF ⬍40 Patients with vascular disease
Allergy or intolerance SBP ⬍100 mmHg at discharge Renal artery stenosis
ACE, Angiotensin-converting enzyme inhibitor; MI, myocardial infarction; CHF, chronic heart failure; EF, ejection fraction; SBP, systolic blood pressure.
The patients had these manuals throughout their hospital stay, and healthcare providers used the manuals to assist in patient counseling and teaching. At discharge, the manuals were used to organize patient education material and discharge instructions provided to the patient. Study endpoints. The primary outcome measured was compliance with 7 recognized interventions to reduce long-term events in patients with known CAD (secondary prevention).9 Seven evidence-based interventions were studied after CABG: (1) institution of beta-blocker therapy, (2) institution of ACE inhibitor therapy, (3) institution of aspirin therapy, (4) institution of lipid-lowering therapy, (5) smoking cessation intervention, (6) heart-healthy diet therapy, and (7) physical activity recommendations. Compliance with medication guidelines was defined as documentation of medication administration or of specific contraindications in the intervention group compared with the control group. All patients requiring CABG surgery were considered to have at least 1 criterion for the initiation of ACE inhibitor therapy. Patients requiring CABG were assumed to have vascular disease and were thus eligible for ACE inhibitors on this basis alone (Table I). Patients who were intolerant of ACE inhibitors were eligible to receive angiotensin receptor blockers (ARBs), and documentation of contraindications would be considered compliant with the guidelines.
Table II. Baseline subject characteristics Control (n ⫽ 50) Male (%) Mean age (y) Mean LOS (d) Meds at admission (d) Meds at discharge (d) Mean EF (%) Mean EF (%) ⬍40 Mean # of grafts Diabetes (%) History of MI (%)
92 64 ⫾ 9.7 7.6 ⫾ 4.6 6.6 ⫾ 2.7 8.3 ⫾ 2.7 50 ⫾ 13.5 26 3 38 42
Intervention (n ⫽ 50)* 61 8.7 6.6 8.6 46
70 ⫾ 11.4 ⫾ 3.9 ⫾ 3.8 ⫾ 3.3 ⫾ 15 32 3 44 38
LOS, Length of stay; Meds, mean number of medications; EF, ejection fraction; MI, myocardial infarction. *No significant differences were identified between groups (P ⬎ 0.05).
Data and statistical analysis. An estimated sample size of 100 patients (50 per group) was required to detect a 20% difference in ACE inhibitor initiation with 80% power using a 2-sided test and a priori level of significance set at 0.05. Between group differences were evaluated using the Student t test for continuous data and the Fisher exact test for dichotomous variables. RESULTS Demographics. Demographics data for the intervention and control arms of the study are shown in Table II. The intervention and control groups did not significantly differ in age, number of medications at admission and discharge, length of stay, mean ejection fraction, or mean number of grafts. Both control and intervention groups had a significant number of patients with diabetes and a history of myocardial infarction (MI), but no between-group differences were detected. There was also no significant difference in the utilization of guideline-recommended medications upon admission (Fig 2). Effect of intervention. ACE inhibitor initiation at discharge increased from 40% in the control group to 84% in the intervention group (P ⫽ 0.00001). A total of 8 patients did not receive ACE inhibitors at discharge with 6 of those a result of legitimate contraindications, resulting in 96% compliance with the guidelines (Table III). Compliance with HMG-CoA reductase inhibitor and aspirin initiation were also significantly increased as compared to the control group (Table III). There was also a non-significant increase in the use of beta-blockers. Compliance with lifestyle modification indicators including dietary, physical activity, and smoking cessation were also significantly improved as compared to control. No documenta-
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Table III. Guideline compliance rates
100 90 80 70 60 50 40 30 20 10 0
Percent compliance
ACE
B-blocker
ASA Medications
Statin Control
Clopidogrel Intervention
Fig 2. Medications on admission in intervention (n ⫽ 50) and control group (n ⫽ 50). All groups were not statistically different (P ⬎ 0.05). ACE, angiotensin-converting enzyme; B-blocker, beta-blocker; ASA, aspirin.
tion for smoking cessation counseling was found in the medical records of patients in the control group. DISCUSSION Patients with CAD, cerebral vascular disease, and peripheral atherosclerosis are at high risk for vascular events and cardiac death.1 Combination medication therapy targeting the underlying disease process can markedly improve clinical outcomes in patients following CABG surgery, whereas failure to employ these therapies can increase patient morbidity and mortality.4,7,18,19 Compliance and treatment utilization can be enhanced by employing secondary prevention measures prior to hospital discharge.5 The AHA encourages providers to take advantage of the “teachable moment” in the patient’s care process. The importance of lifestyle intervention is often overlooked in the acute setting and deferred to the patient’s primary care provider. Our retrospective review identified inconsistencies in documentation and provision of these basic services. Through a coordination of efforts between the physician, pharmacist, dietician, and physical therapist, we were able to standardize this process and incorporate it into the care plan of all patients’ post-CABG and prior to discharge. We believe that patients should not be discharged from the hospital without initiation of definitive treatment, with the exception of existing contraindications that are documented in the medical chart. Our study suggests that guideline-recommended therapies are not given to all patients following CABG. This observation reinforces the findings of others. ACE inhibitors, beta-blockers, HMG-CoA reductase inhibitors, and antiplatelet therapy have all been proven to reduce cardiovascular events and mortality in patients with CAD, other vascular
Guideline
Control (n ⫽ 50)
Intervention (n ⫽ 50)
ACE inhibitor Lipid-lowering Aspirin Beta-blocker Dietary counseling Active lifestyle refresher Smoking cessation
42% 76% 92% 95% 49% 54% 0%
84% (P ⬍0.001) 96% (P ⫽ 0.006) 100% (P ⫽ 0.04) 100% (P ⫽ n.s.) 91% (P ⬍0.001) 87% (P ⬍0.001) 100% (P ⬍0.001)
disease, and diabetes.4,7,18,19 Although current guidelines by the AHA/ACC recommend that all patients with CAD, vascular disease, and/or diabetes be treated with all 4 medications, unless contraindications exist or treatment is not tolerated, compliance continues to be suboptimal.5,6 Fonarow et al demonstrated these shortcomings in 2 separate studies that showed compliance rates for ACE inhibitors, aspirin, and HMG-CoA reductase inhibitors were 16%, 68%, and 32%, respectively in patients with known CAD. A retrospective, medication-use evaluation at our institution revealed similar suboptimal guideline compliance rates in our population and prompted the development of a multidisciplinary program to improve compliance. Multidisciplinary teams are essential in providing comprehensive and optimal medical care. Our success with obtaining guideline compliance in 7 key areas reinforces the value of a multidisciplinary team. We obtained significant increases in compliance with all of the relevant guidelines studied. In addition to increasing the rate of ACE inhibitor initiation at discharge, we showed a significant increase in HMG-CoA reductase inhibitor, aspirin, and a nonsignificant increase in beta-blocker initiation at discharge. Lifestyle modification counseling also increased when compared with the control group. Previous studies in this area have shown that pharmacist intervention did not increase ACE inhibitor initiation in patients with CAD at discharge when compared with “usual care” without a pharmacist (68% vs 62%, respectively, P ⫽ 0.85).20 This study, by Chapman et al,20 suggested that convincing physicians of adding ACE inhibitors was difficult due to physician misconception that ACE inhibitors would benefit patients without heart failure or diabetes. In our study, we demonstrated that a pharmacist could have a significant impact in directing multidisciplinary care and improving guideline compliance.
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Our ability to increase ACE inhibitor utilization and other quality indicators in this population underscores the collaborative relationship that clinical pharmacists can develop with surgeons and other healthcare providers and the resultant impact on the provision of quality patient care. This relationship was instrumental in forming a multidisciplinary team and coordinating care for CABG patients, which illustrates the importance of collaborative care and standardized approaches to postoperative management of patients. Furthermore, the Centers of Medicaid and Medicare Services (CMS) proposed the use of quality indicators that will require hospitals to document care provided to receive reimbursement for specific diagnoses. Additionally, the American Society of Health System Pharmacists (ASHP) 2015 Initiative has called for increased pharmacist involvement in ensuring medication therapy reflects current evidence-based practices. These initiatives identify collaborative, multidisciplinary relationships as an essential component of advanced practice and quality patient care. The multidisciplinary team approach to disease management will likely be an important component of so-called “pay for performance.” Despite evidence supporting the use of ACE inhibitors in patients with stable CAD, not all clinicians may be convinced of the benefits in patients without left ventricular dysfunction or comorbidities, such as diabetes. In the HOPE trial, Yusef et al14 demonstrated that patients with stable CAD randomized to receive ramipril had significant reductions in the rate of MI, stroke, and death. A significant number of patients were considered at high risk and included 38% diabetics, 52% with history of MI, and 26% having received CABG intervention.14 This study helped extend the benefits of ACE inhibitors to patients without left ventricular dysfunction or diabetes. More recently, however, the PEACE trial, conducted by Braunwald et al,21 which included a majority of patients on “current standard” cardiovascular treatment regimens who were randomized to trandolapril vs placebo, did not show a reduction in mortality from cardiovascular causes, myocardial infarction, or coronary revascularization. This seemingly contradicts the benefit of ACE inhibitors in patients without left ventricular dysfunction or diabetes. However, it is important to note that the study by Braunwald et al was conducted in patients with “current standard” cardiovascular treatment regimens, which included increased utilization of more potent antiplatelet agents, more aggressive use of HMG-CoA reductase inhibitors, and beta-blockers. Patients in the PEACE trial also had lower rates of
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cardiovascular events when compared with previous trials. As such, the HOPE population14 appears to be more reflective of post-CABG patients and our population in general. In our CABG population, we had a significant number of patients with diabetes (44%) and ejection fraction (EF) ⬍40% (38%), as well as 38% of patients with a history of MI. This further validates the appropriateness of ACE inhibitor use in this population. HMG-CoA reductase inhibitor initiation and titration of doses to reach target low-density lipoproteins (LDL) goals was imperative in our population. All patients in the intervention group were evaluated to receive HMG-CoA reductase therapy, representing 100% compliance with guidelines. Goals for therapy were communicated to the patient and their primary healthcare provider through a combination of verbal and written communication with instructions to titrate LDL to a goal of less than 70 mg/dL. The two patients who did not receive HMG-CoA reductase inhibitors therapy had a documented intolerance, one with a history of rhabdomyolysis and the other with documented liver toxicity. These patients were referred to their primary care provider for alternative LDL-lowering therapies. A significant increase in clopidogrel utilization at discharge also was seen in our intervention population. This likely reflects increasing evidence that clopidogrel can be used safely and effectively in combination with aspirin to reduce secondary cardiovascular events such as non-fatal MI, death, or stroke.22-24 Current CHEST guidelines recommend the use of combination antiplatelet activity in patients who undergo CABG for non-ST–segment elevation acute coronary syndrome for a period of 9 to 12 months following the procedure.23,25 Although long-term outcome data are not available, there is also an increasing trend of dual antiplatelet therapy in off-pump CABG patients.23,26 Although our protocol involved the inclusion of dietary and physical therapy consults for all patients postoperatively, the introduction of CPOE at our hospital resulted in miscommunication of orders for such services during 2 months of the intervention period. Initially, orders that were placed did not appear on the electronic worksheets of the dieticians or physical therapists. As such, that may explain our less then 100% compliance with achieving these quality indicators. When these orders were rectified, 100% of patients postoperatively received both dietary and physical therapy counseling concerning their postoperative cardiac care. Current AHA/ACC guidelines also recommend that all patients receive smoking cessation counsel-
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ing.9 A recent study by Ong et al,27 showed that hospital smoking-cessation counseling of patients was an independent predictor in maintenance of smoking cessation 2 months following discharge. In response, the pharmacist provided smoking cessation counseling to all patients with a history of smoking prior to discharge through verbal counseling, educational literature, and a smoking cessation video developed by the AHA. This included the discussion of nicotine replacement, medication options, and available support groups. Our quality improvement project included limitations that were due to multiple factors inherent in academic medical centers. A pharmacist, who was also the primary investigator, was actively involved in both the control and intervention groups, which has the possibility of introducing selection bias in patients who received selected therapy. Additionally, long-term follow-up for these patients is often difficult to assess due to the nature of a tertiary, referral center and the size of the area to which care is provided. Because our main objective was to improve outcomes through compliance, the ability to measure patient safety, response rates, and compliance to therapy would have increased the validity of our study. Further studies to evaluate the effectiveness of such programs in improving patient outcomes are needed. Currently, we have plans to follow our intervention group after discharge to ensure the communication of important medical information reaches the patients’ primary care providers. Our goal is to establish a relationship with each patient’s primary care provider to facilitate the transition from acute to ambulatory care. This will be done in the form of a consultative letter sent from the attending surgeon on behalf of the multidisciplinary team to the primary care provider. The letter will list patientspecific goals and describe optimal secondary prevention therapy for patients following CABG surgery. STUDY SHORTCOMINGS The short-term nature of this study is a shortcoming. Although the data suggest significant improvement in guideline compliance, there is limited follow-up information about long-term benefit. A secondary phase of the study will include follow-up with referring physicians and assessment of continued compliance with guideline interventions. This part of the study may eventually become very important as “pay for performance” quality interventions are introduced into the reimbursement picture by both governmental and nongovernmental payors.28 First, a clear-cut link needs to be es-
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tablished between intervention programs to assure guideline compliance and long-term benefit. Multiple threads of evidence suggest survival and eventfree survival benefit from guidelines recommended interventions in controlled randomized trials.9 It remains to be shown that active intervention programs such as ours provide additional benefit to normal physician-directed recommendations for guideline adherence. Further studies are required to close this loop. The rate of guideline compliance is relatively low in the control group, especially for nondrugrelated guidelines. One possible explanation for this low rate is that interventions were missed in the retrospective review of the control group charts. The possibility of false-negative guideline compliance was excluded by the multidisciplinary team at the beginning of the study. All of the team members were very aware of how CABG patients were treated up to the point of the prospective study intervention. For example, it was recognized that no patient received formal smoking cessation counseling before the study interventions were initiated. Likewise, physical therapy intervention in CABG patients was “hit or miss” in the control group because of the lack of a standard orders in the CPOE template. Similar considerations existed in the control group for dietary interventions. It was only after standard multidisciplinary interventions, including CPOE templates, were introduced that guideline compliance increased. Because of the familiarity of the multidisciplinary team with the daily patient interventions, it is highly unlikely that there was a significant false-negative rate of control group guideline compliance. CONCLUSION An organized method of postoperative acute care is necessary to provide comprehensive medical care to patients following coronary revascularization. The quality of that care can be maximized through using the specific skill sets of each healthcare provider to maximize patient education and self-understanding of their disease state management. CABG patients in particular are at high risk for secondary coronary events and so treatment should be optimized to reflect current guidelines. In particular, institutions that perform these procedures must take advantage of the “teachable moment” provided by this acute event. REFERENCES 1. Charlson ME, Isom OW. Clinical practice. Care after coronary-artery bypass surgery. N Engl J Med 2003;348(15): 1456-63.
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2. Krumholz HM, Radford MJ, Wang Y, Chen J, Marciniak TA. Early beta-blocker therapy for acute myocardial infarction in elderly patients. Ann Intern Med 1999;131:648-54. 3. Barron HV, Michaels AD, Maynard C, Every NR. Use of angiotensin-converting enzyme inhibitors at discharge in patients with acute myocardial infarction in the United States: data from the National Registry of Myocardial Infarction 2. J Am Coll Cardiol 1998;32:360-7. 4. Ellerbeck EF, Jencks SF, Radford MJ, Kresowik TF, Craig AS, Gold JS, et al. Quality of care for Medicare patients with acute myocardial infarction. A four-state pilot study from the Cooperative Cardiovascular Project. JAMA 1995;273: 1509-14. 5. Fonarow GC, Gawlinski A, Moughrabi S, Tillisch JH. Improved treatment of coronary heart disease by implementation of a Cardiac Hospitalization Atherosclerosis Management Program (CHAMP). Am J Cardiol 2001;87:819-22. 6. Fonarow GC, Ballantyne CM. In-hospital initiation of lipidlowering therapy for patients with coronary heart disease: the time is now. Circulation 2001;103:2768-70. 7. Gottlieb SS, McCarter RJ, Vogel RA. Effect of beta-blockade on mortality among high-risk and low-risk patients after myocardial infarction. N Engl J Med 1998;339:489-97. 8. Krumholz HM, Radford MJ, Ellerbeck EF, Hennen J, Meehan TP, Petrillo M, et al. Aspirin for secondary prevention after acute myocardial infarction in the elderly: prescribed use and outcomes. Ann Intern Med 1996;124: 292-8. 9. Smith SC Jr, Blair SN, Bonow RO, Brass LM, Cerquiera MD, Drakup K, et al. AHA/ACC guidelines for preventing heart attack and death in patients with atherosclerotic cardiovascular disease: 2001 update. A statement for healthcare professionals from the American Heart Association and the American College of Cardiology. J Am Coll Cardiol 2001;38:1581-3. 10. Chen J, Radford MJ, Wang Y, Marciniak TA, Krumholz HM. Are beta-blockers effective in elderly patients who undergo coronary revascularization after acute myocardial infarction? Arch Intern Med 2000;160:947-52. 11. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. The post coronary artery bypass graft trial investigators. N Engl J Med 1997;336:153-62. 12. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med 2004;350:1495-504. 13. Heart Protection Study Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22. 14. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000;342:145-53. 15. Fox KM, Henderson JR, Bertrand ME, Ferrari R, Remme WJ, Simoons ML. The European trial on reduction of cardiac events with perindopril in stable coronary artery disease (EUROPA). Eur Heart J 1998;19(Suppl J):J52-5. 16. Eagle KA, Guyton RA, Davidoff R, Edwards FH, Ewy GA, Gardner TJ, et al. ACC/AHA 2004 guideline update for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association
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Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery). Circulation 2004;110:e340-437. Denton TA, Fonarow GC, LaBresh KA, Trento A. Secondary prevention after coronary bypass: the American Heart Association “Get with the Guidelines” program. Ann Thorac Surg 2003;75:758-60. Goldman S, Copeland J, Moritz T, Henderson W, Zadina K, Ovitt T, et al. Long-term graft patency (3 years) after coronary artery surgery. Effects of aspirin: results of a VA cooperative study. Circulation 1994;89:1138-43. Ivancan V, Husedzinovic I, Nikic N, Baudoin Z. [Hemodynamic effects of captopril, an ACE inhibitor, in patients after aortocoronary bypass]. Lijec Vjesn 1995;117(Suppl 2): 103-4. Chapman NR, Fotis MA, Yarnold PR, Gheorghiade M. Pharmacist interventions to improve the management of coronary artery disease. Am J Health Syst Pharm 2004;61: 2672-8. Braunwald E, Domanski MJ, Fowler SE, Geller NL, Gersh BJ, Hsia J, et al. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med 2004; 351:2058-68. Stein PD, Schunemann HJ, Dalen JE, Gutterman D. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(3 Suppl):600S-8S. Shennib H, Endo M, Benhameid O. A feasibility study of the safety and efficacy of a combined clopidogrel and aspirin regimen following off-pump coronary artery bypass grafting. Heart Surg Forum 2003;6:288-91. Mehta SR, Yusuf S. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial programme; rationale, design and baseline characteristics including a metaanalysis of the effects of thienopyridines in vascular disease. Eur Heart J 2000;21:2033-41. Fox KA, Mehta SR, Peters R, Zhao F, Lakkis N, Gersh BJ, et al. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-ST-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) Trial. Circulation 2004;110:1202-8. D’Ancona G, Donias HW, Karamanoukian RL, Bergsland J, Karamanoukian HL. OPCAB therapy survey: off-pump clopidogrel, aspirin or both therapy survey. Heart Surg Forum 2001;4:354-8. Ong KC, Cheong GN, Prabhakaran L, Earnest A. Predictors of success in smoking cessation among hospitalized patients. Respirology 2005;10:63-9. Bufalino V, Peterson ED, Burke GL, LaBresh KA, Jones DW, Faxon DP, et al. Payment for quality: guiding principles and recommendations: principles and recommendations from the American Heart Association’s Reimbursement, Coverage, and Access Policy Development Workgroup. Circulation 2006;113:1151-4.
DISCUSSION Dr Peter K. Henke (Ann Arbor, Mich): Compliance with those medications probably makes a much bigger difference in long-term outcomes than any surgical interventions that we do for the most part. Have you determined what the long-
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term compliance rate is? I would be interested in your plans for long term follow-up. Dr Charles Yowler (Cleveland, Ohio): One of the problems with ACE inhibitors is that many of these patients are elderly. We have noticed that our cardiologists have put patients on ACE inhibitors only to have their geriatric physicians discontinue them because of complaints of dizziness and low blood pressure. Did you ever look to see if some of the patients who were not discharged on ACE inhibitors had relative contraindications to their use? Dr Jonathan M. Saxe (Dayton, Ohio): You are making a basic assumption that the statins are completely necessary in every patient. How do you know that is actually true? Dr Jeremy D. Flynn: We have looked into longterm medication use. We are in the process of developing some type of continuous quality improvement database so that we can see these patients in the future. With a large tertiary referral center with a very wide area of practice, many times those patients are lost to follow-up, at least to our practice, after the 2- to 3-week postop follow-up. One of our main goals is to really improve communication with community cardiologists and internal
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medicine physicians so that we can follow-up and discuss with them what our goals were and what our intended outcomes were. As for appropriateness of therapy, protocol compliance was documented if there was a confirmed contraindication, of which there were several instances. Several patients had been on statins in the past with documented lipid abnormalities but had had either myalgias or had LFT increases and had been taken off, so those patients were not put back on. So each patient was evaluated for appropriateness by the physician as well as the pharmacist. As far as the elderly and ACE inhibitors, we were hesitant to initiate therapy for any patients at discharge if they had any significant renal dysfunction in the hospital, if they had problems with ACE inhibitors in the past, or if their blood pressure at the time of discharge was not back to their baseline blood pressure, which happens quite often. In those cases, we documented that in the patient’s medical record and tried to communicate with their internal medicine physician or their cardiologist so that, in the future, they could begin therapy.
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APPENDIX Multidisciplinary discharge form to document guidelines adherence.
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