Hong, Yuling MD, MSc, PhD*; LaBresh, Kenneth A. MD†
Despite recent advances in scientific knowledge about and improvement of treatment and prevention (primary and secondary) for heart disease and stroke, these conditions remain the number one and 3 causes of death in the United States.1 Every year, there are nearly 500,000 deaths from coronary heart disease and over 160,000 from stroke in the country. An estimated 700,000 Americans have new coronary heart disease (CHD) every year and an additional 500,000 have recurrent CHD events. The corresponding numbers for stroke are 500,000 and 200,000. The burden of heart failure in the society is also substantial. Deaths attributable to heart failure as the primary or secondary cause total 265,000 per year. In addition, there are one million annual heart failure discharges from hospitals. The combined annual direct and indirect cost for CHD, stroke, and heart failure exceeds $225 billion.1
This enormous burden of disease is also associated with numerous data collection efforts in hospitals to assess the quality of care delivered in coronary artery disease (CAD), heart failure, and stroke. These include the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) ORYX and the Centers for Medicare & Medicaid Services (CMS) measure sets for acute myocardial infarction and heart failure,2–4 the National Registry of Myocardial Infraction,5 GRACE for acute coronary syndromes,6 The Paul Coverdell National Acute Stroke Registry,7 and ADHERE for heart failure.8 Table 1 presents data from several of these sources that demonstrate, despite wide dissemination of these guidelines, recommended interventions are frequently not initiated during hospitalization for acute cardiac events, heart failure, and stroke.4,6–8
Barriers to the Use of Guidelines
Barriers to the routine use of evidence-based care fall into 3 general categories: knowledge, attitudes, and behavior9 (Table 2). Knowledge barriers include absence of knowledge of new or updated guidelines or, if known, insufficient familiarity with the guidelines to be willing or able to use them. For example, one hospital seeking to extend CAD prevention measure use to patients with peripheral vascular disease engaged vascular surgeons to initiate lipid and angiotensin-converting enzyme (ACE) inhibitor therapies before hospital discharge. Resistance to the plan was substantial until a medical consultant offered to select and initiate these therapies in appropriate patients. On further discussion, the initial unwillingness to participate centered on unfamiliarity with specific agents and doses. Guidelines and evidence may be known but not adhered to because of a lack of belief in the concept of evidenced medicine or lack of belief that the benefits seen in clinical trials really occur in the “real world.” These attitudinal barriers may mask knowledge barriers as illustrated presently or may represent concerns about autonomy and control.
The final category, behavioral factors related to patients, guidelines, and the organizational environment. Patient preferences may not be consistent with guideline recommendations. Guidelines from multiple organizations may be contradictory causing confusion. The most common issues relate to the environment such as organizational constraints in culture, priorities, resources, and systems. Even if physicians know, believe, and intend to use the guidelines every time, this may not result in higher treatment rates. Davis and colleagues have demonstrated that typical didactic presentations may improve knowledge but do not produce increased use of evidence-based therapies.10 In a chart review of primary care practices, selected as practices that were high prescribers of statins, knowledge of the National Cholesterol Education Program (NCEP) guidelines for lipid treatment and the intention of practitioners to use these guidelines were assessed. Although 95% of the physicians could demonstrate complete and accurate knowledge of the guidelines and 65% stated that they used the guidelines most or all of the time, only 18% of their CAD population had low-density lipoprotein (LDL) cholesterol levels of <100 mg/dL and this was only in their patients who were on treatment.11
The use of a team approach can help to address patient factors and support patient self-management after discharge. Environmental issues are usually addressed by changes in the underlying culture and systems of care delivery. W. Edwards Demming has said that most problems are 10% about the people and 90% about the systems.12 Systems always produce exactly the result they were designed to produce (Burwick DM, personal communication). It then follows that “trying harder” with the same system will not change practice. This then explains the dichotomy between physicians with knowledge and intention, cited previously, and yet poor performance of the system to deliver care.
In the hospital setting where the highest-risk patients, those with acute cardiovascular events or stroke, are treated, there is a unique opportunity to redesign systems of care. Hospitals have professionals from a number of disciplines that participate in the care of these patients. System changes such as the use of preprinted order sets reduce the reliance on memory that often fails us when there are more urgent, acute treatments to occupy our attention. For this reason, preprocedure orders for cardiac catheterization and revascularization procedures are common. Using similar systems for admission orders and a discharge checklist can be helpful in insuring that key evaluations such as LDL cholesterol measurement, A1C measurement in patients with diabetes, and routine, evidence-based therapies are given for all patients unless there is a specific contraindication. The participation of multidisciplinary teams in the development and implementation of these systems can also lead to the use of all members of the care team to catch the inadvertent omissions that too often characterize secondary prevention.
The American Heart Association's (AHA) Get With the Guidelines (GWTG) is a program designed to assist hospitals in redesigning these systems of care. GWTG currently offers quality improvement modules for 3 disease states. The coronary artery disease module (GWTG-CAD) was launched nationally in April 2001 and is currently being implemented in almost every state. The stroke module (GWTG-Stroke) and the heart failure module (GWTG-HF) were launched in May 2004 and March 2005, respectively.
Elements of the program include organizational stakeholder and opinion leader meetings, hospital recruitment, collaborative learning sessions, hospital tool kits, local clinical champions, multidisciplinary teams, and hospital recognition.13 Data collection, decision support, and hospital data feedback through multiple on-demand reports of performance on all key measures are done with an Internet-based Patient Management Tool (PMT).
This program uses a collaborative model to bring together teams from many hospitals in a region to work together to address barriers to care (Fig. 1). Learning from each other, hospitals can successfully adapt the successful approaches used by others for their own unique environment. This approach significantly speeds up the improvement process and helps to engage hospital leadership, an important ingredient in producing permanent change, by creating a sense of community. Workshops include didactic presentation of clinical trial evidence and the AHA/American College of Cardiology (ACC), American Stroke Association (ASA) guidelines for acute care and secondary prevention for CHD, stroke, or heart failure followed by examples of successful hospital implementation. Observing the successes of other hospitals creates the sense that improvement is achievable. Standardized quality improvement methodology based on the Model for Improvement is presented at each session.14,15
Hospital teams learn to clearly state their goals for each measure and select a pilot population and location to begin the process. By initially focusing on an area in the hospital where success is most likely, hospital teams can develop positive momentum as they expand to other areas and patient populations. They also learn to use plan-do-study-act cycles (PDSA) to test their ideas for change. These tests are designed to answer 2 questions. The first is: “How will we know that the change is an improvement?” This question is designed to provide a framework to quickly evaluate new and creative solutions to defects in their system of care. These change ideas are brought back from GWTG sessions; learned from calls, e-mail lists, and GWTG materials; and developed by the teams themselves.16 Change concepts may be very successful in some environments but not in others. Even well-developed critical pathways, preprinted orders, and reminders often require adaptation to a specific hospital environment; some may not work at all. Thus, after a small test is planned (a few patients on 1 or 2 days using a single physician and care team), done, and the resulting data studied, teams act by adopting or adapting the change and doing further tests on a larger scale or abandoning the idea and moving on to another. The small scale of these initial tests gives teams the ability to try new and innovative ideas not previously considered, sorting through many to find the few highly effective concepts that substantially improve performance. There appears to be relationship to the number of tests run and success in improvement.14,15
The second question is: “What change can we make that will result in improvement?” This question is the basis of implementing the successful changes previously tested with the emphasis on what we can implement. Large-scale implementation requires widespread communication and support. These strategies need to become part of the standard system of care. Here, there is no room for failure. New systems need to be monitored and adjusted by the ongoing collection of key performance measures, and they need to be adapted as needed over time.
Implementation requires acceptance of doing things in a new way. What predicts the successful adoption of change by a diverse group? Everett Rogers17 describes 5 criteria that predict the success adoption of change. The demonstration of relative advantage implies that the change is better than the system that is being replaced. Because the process of changing routines is difficult, the new system must perform better than the old system to make the effort worthwhile. Successful change should not be overly complex and its advantage should be observable. Trialability implies that the innovation should have the capacity for testing on a small scale before full-scale implementation. Successfully adopted innovation needs to be compatible with individual or institutional values, priorities, and resources. The ability to test a system change and customize it is one way to help address this issue. If stroke is not an important part of a hospital's strategic priorities, it is much less likely that a system change to improve stroke care will be successfully adopted. A system change that uses emergency department physicians to administer alteplase (rtPA) for an acute stroke without the onsite evaluation of a neurologist may be successful in some hospital environments but not feasible in others.
Simultaneous, facilitated breakout sessions, a key part of the GWTG workshops, allow multidisciplinary teams from 6 to 8 hospitals each to discuss barriers and potential solutions, share tools and pathways each has developed, and share results of their small tests of change. The hallmark of these sessions is “Share openly and steal shamelessly (with attribution).” Each team then develops a plan for testing a new change. Hospitals teams present their plans including the PDSA cycle they will “do by next Tuesday.” These brief presentations create a sense of purpose, urgency, and accountability to each other and the program. Between workshops, hospital interactions are continued by conference calls and e-mail exchanges. Results of PDSA cycles are shared by many of the participants. These exchanges provide an opportunity for coaching on cycle design and execution by both faculty and peers. Guest speaker presentations are also included in the calls to communicate new science and guidelines.
One example of a successful systems-based approach is the creation of a practitioner order system that defaults to evidence-based treatment in all patients with cardiovascular disease. When this occurs, all patients are treated unless they have a specific contraindication to that therapy. Thus, the physician need manage only these exceptions. Such an approach can significantly reduce the burden of remembering every appropriate therapy for every patient every time. The role of the GWTG program in addressing each of the categories of barriers is illustrated in Table 2.
Additional sharing and quality improvement skills are provided in subsequent workshops. These face-to-face meetings provide an important vehicle to exchange specific information on how changes were accomplished and lessons learned.18 Momentum is maintained and more reluctant participants become motivated by the success of others and the desire not to be left behind.17,19 Teams also learn new skills to maintain the progress they have made and spread success to other areas and with additional patient groups.14,15
An important tool for the program is the Internet-based PMT that is used to collect data and provide decision support at the point of care.16 This tool provides measure definitions, including inclusion and exclusion criteria and decision support with references to the content of the guidelines and references for each measure. Clinical staff at the point of care can do the data collection. Electronic systems with these elements have been shown to significantly reduce medication errors.20 Reminders in the PMT can help to provide a safety net for the discharge measures by providing feedback before the patients leaves the care setting, thus proving the opportunity to correct any unintended omissions.16 Customized patient education materials from the AHA/ASA can be printed for patients along with a treatment summary letter to support patient self-management after discharge, a key element in improving chronic management.21,22 A summary letter can also be prepared within the system and faxed to the patient's physician at the time of discharge to support the transition of care to the office setting.
The performance measures assessed in the GWTG-CAD program are indicated in Table 3. Indicator-specific inclusion and exclusion criteria were applied so that only eligible patients without contraindications or documented intolerance for that specific indicator remained in the denominators (ideal patients). Measure definitions for early and late aspirin, early and late beta-blockers, and smoking cessation counseling use the JCAHO and CMS specifications2,3; in addition, ACE or angiotensin receptor blocker (ARB) use is collected for all patients with acute myocardial infarction at all levels of left ventricular function. Two lipid indicators are used: the percent of all patients discharged on lipid therapy, LipidRX, and LDL100Rx, defined as the percent of patients who have an LDL cholesterol >100 mg/dL or who enter the hospital on lipid-lowering agents. Measurement of LDL cholesterol for all patients within the first 24 hours of admission is also tracked. The blood pressure measure assesses the percent of patients with the last recorded hospital blood pressure <140/90 mm Hg. The final measure is the percentage of patients referred for cardiac rehabilitation or given formal exercise recommendation by the time of discharge.
Performance measures for the GWTG-Stroke program (Table 4) include acute, subacute, and prevention measures and exclude patients with contraindications to the measure. Acute measures are the percent of patients with acute ischemic stroke who present to the hospital within 2 hours of the onset of symptoms and receive rtPA within 60 minutes and the percent of patients with ischemic stroke or transient ischemic attack (TIA) who receive antithrombotic therapy within the first 48 hours of admission. The subacute measure is the use of deep vein thrombophlebitis prophylaxis for nonambulatory patients. The prevention measures, applicable for patients with ischemic stroke or TIA, include antithrombotic therapy at discharge, anticoagulation for patients with atrial fibrillation, lipid-lowering therapy for LDL >100 mg/dL or on therapy on admission, and smoking cessation counseling for all patients who have smoked within 12 months of admission.
Performance measures for GWTG-HF are the 4 CMS/JCAHO measures: heart failure discharge instructions, measurement of left ventricular function, ACE inhibitor and/or ARB at discharge for patients with left ventricular ejection fraction (LVEF) ≤0.40, in the absence of documented contraindications or intolerance to both agents2,3 plus an additional measure, beta blocker use at discharge for patients with LVEF ≤0.40 in the absence of documented contraindications or intolerance (Table 5).
Each GWTG module offers recognition awards. The first level designates participating hospitals as those that have a multidisciplinary team, a physician champion, orders or protocols that include the GWTG measures, and submission of baseline data from at least 30 consecutive patients. The Performance Achievement Award recognizes the attainment of 85% performance for each of the modules of performance measures (Tables 3–5). Sustained achievement at 85% for each of the performance measures is also recognized on an annual basis for consecutive years of achievement.
Recognition awards have been used as a nonfinancial incentive to engage hospital leadership, governance, and the hospital's community in support of the team's efforts. They have played an important role in incorporating the goals of the GWTG modules into the organization's strategic plan and help to mobilize resources to maintain the program over time.
In Hawaii, AHA recognition milestones were incorporated into the pay for quality initiative of the state's largest commercial payer, resulting in near universal participation in the CAD program.23
Get With the Guidelines Results
There are more than 600 hospitals in the GWTG-CAD program. The GWTG collaborative approach was demonstrated to produce significant improvement in several measures in the initial 24-hospital pilot by the fourth quarter of intervention24 (Fig. 2). Significant increases of 10% to 20% compared with baseline in many of the essential acute treatment and secondary prevention measures in less than a year of implementation have been seen in the larger national cohort with improvement continuing through 2 years in the program.25
GWTG-Stroke has grown even more rapidly with more 500 hospitals joining in less than 18 months. The early results from the GWTG-Stroke has indicated nearly a 5-fold increase in the use of rtPA with no increase in rates of complication and even larger increases from lower baseline performance in the prevention measures than seen in the CAD module.26,27 There has been rapid adoption of the heart failure module as well with nearly 200 hospitals participating within the first 6 months of the program.
Challenge and Opportunities
The increasing emphasis on data collection by a number of organizations, as discussed previously, creates great pressure on hospital resources that may detract from the ability to use the data to improve care. Although CMS provides process improvement assistance through the quality improvement program, most of these efforts provide data feedback only. The design of some of these data collection systems, necessitating retrospective chart review well after care has been delivered, eliminates the possibility of using that feedback to correct “near misses” in the omission of care. Data collection programs without robust process change support also tend to document poor care, but may not support rapid improvement in that care. Although data feedback is a necessary part of care improvement, excessive time spent collecting data not related to quality measures may divert resources from improvement activities, particularly in smaller hospitals.
Public reporting of data, emphasis on culture change, and the adoption of Health Information Technology along with process improvement support are key strategies to transform the health care system.28 Coupled with potential change in reimbursement system to reward the investment in quality, these emerging trends will play an important role in enhancing the care of patients with CAD, stroke, and heat failure. GWTG engages medical and administrative leadership, promotes team approaches to care and improvement, and uses electronic technology that can be used during the care process to produce process and cultural change in participating hospitals. Nonfinancial incentives such as AHA/ASA recognition awards also encourage leadership and community support of high-performing systems of care. Expanded participation in such programs, catalyzed by campaigns such as the Institute for Healthcare Improvement's 100,000 lives campaign,29 are encouraging progress to the goal of providing the right care for every patient every time.
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