LaBresh, Kenneth A. MD*; Fonarow, Gregg C. MD†; Smith, Sidney C. Jr MD‡; Bonow, Robert O. MD§; Smaha, Lynn C. MD¶; Tyler, Patricia A. RN∥; Hong, Yuling MD, PhD∥; Albright, Dawn MS*; Ellrodt, A Gray MD**; for the Get With The Guidelines Steering Committee
Cardiovascular disease remains the number 1 cause of death in the United States. Of an estimated 1.1 million myocardial infarctions each year, 450,000 occur in patients who have experienced a previous acute cardiovascular event.1 Guidelines from the American College of Cardiology/American Heart Association for treatment of acute myocardial infarction and for secondary prevention include evidence-based therapies that can significantly improve acute care outcomes and reduce recurrent events.2–4 Despite the wide dissemination of these guidelines, recommended interventions are frequently not initiated during hospitalization for acute cardiac events.5,6
Barriers cited for this gap between efficacy (demonstrated utility in clinical trials) and effectiveness (demonstrated utility in clinical practice) include lack of knowledge, lack of acceptance of the concept of guidelines, lack of systems for implementation, and lack of resources.7 Typical educational responses to this treatment gap include didactic presentations such as grand rounds, journal articles, and other efforts to disseminate the guidelines. Recognizing that knowledge and acceptance of guidelines, while necessary, do not significantly change guideline adherence,8 the American Heart Association launched Get With The Guidelines, an initiative focused on the redesign of hospital systems of care.
Get With The Guidelines is based on a collaborative model and an Internet-based Patient Management Tool, which were pilot tested in 24 Massachusetts hospitals by the American Heart Association and Masspro, the Massachusetts Quality Improvement Organization with the support of multiple organizations in the Commonwealth.9 The collaborative learning model10 includes interactive learning sessions, teleconference, and electronic communication between multidisciplinary teams from hospitals in a variety of settings to facilitate the transfer of the “how-to” necessary to produce system change.11 The Patient Management Tool aids in concurrent data collection and decision support, and also provides real-time online reporting features. Over a 1-year period, from July 2000 to June 2001, a diverse group of 24 Massachusetts hospitals produced statistically and clinically significant changes in smoking cessation counseling, lipid measurement and treatment, blood pressure treatment and control, and referral to cardiac rehabilitation and maintained high baseline levels of aspirin, β-blocker, and angiotensin-converting enzyme inhibitor use in a group of 1738 patients.12
The Get With The Guidelines pilot demonstrated the ability of a collaborative approach and an Internet tool to extend the significant improvement seen in secondary prevention measures in the previously reported Cardiovascular Hospitalization Atherosclerosis Management Program13 at a rapid pace in a variety of hospital settings and to 24 hospitals simultaneously in a single state. Data from 45,988 patients in the initial 92 participating hospitals in the Get With The Guidelines program were analyzed to evaluate the generalizeability of this experience in many states, small and large hospitals and systems, and with a large network of volunteers and staff to execute the program. This analysis evaluates the change in measures to assess early treatment of acute coronary syndrome, as well as secondary prevention, over a 1-year period of intervention.
The quality improvement collaborative sessions for the hospital teams were organized by 9 regional directors working in major metropolitan areas with a high concentration of cardiovascular discharges. The components of the program, previously described,10 include organizational stakeholder and opinion leader meetings, hospital recruitment, collaborative learning sessions, hospital tool kits, local clinical champions, and hospital recognition. Data collection, decision support, and hospital data feedback via multiple on-demand reports of performance on all key measures are done with the Internet-based Patient Management Tool.
Workshops include didactic presentation of clinical trial evidence and the American Heart Association/American College of Cardiology guidelines for secondary prevention of coronary artery disease, followed by examples of successful hospital implementation. Standardized quality improvement methodology, based on the Model for Improvement,14 is presented at each session. Simultaneous, facilitated breakout sessions, a key part of the Get With The Guidelines workshops, allow multidisciplinary teams from 6 to 8 hospitals to discuss barriers and potential solutions, share tools each has developed, and share results of their small tests of change. Each team then develops a plan for testing and implementation. Hospitals teams present their plans to other to create a sense of purpose, urgency, and accountability to this developing community of practice. Between workshops, hospital interactions are continued via conference calls and e-mail exchanges. Guest speaker presentations are also included in the calls to address emerging issues around new clinical data and guidelines.
Hospitals from across the country were invited to participate in Get With The Guidelines when collaborative workshops were held in their region. This study includes 45,988 patients from the initial 92 hospitals participating in the program that entered patient data utilizing the Patient Management Tool for at least 12 months after the initial baseline collection, prior to the quality improvement intervention. Get With The Guidelines includes teaching and nonteaching, rural and urban, large and small hospitals from all census regions of the United States. The patient population included all patients entered into the Patient Management Tool, with diagnoses of acute myocardial infarction, unstable angina, chronic stable angina, ischemic heart disease (International Classification of Diseases, Ninth Revision diagnoses 410–414), or peripheral vascular disease. Data were collected by participating hospitals without financial compensation as a nonprobabilistic sample. Case finding was based on clinical identification of patients with these diagnoses, rather than by retrospective diagnosis coding, to permit the concurrent use of the Patient Management Tool and other decision support tools adapted by hospitals in the program. Some hospitals, however, used retrospective Joint Commission ORYX core measure identification, with clinical verification for retrospective data abstraction. Data from a minimum of 30 patients per hospital entered in the Patient Management Tool prior to the start of system change interventions are defined as the baseline data for all analyses and were obtained by retrospective chart review. Patients with a primary diagnosis of heart failure were excluded from the analysis. Data were collected from July 2000 through December 2003. Actual starting dates for individual hospitals varied based on hospital entry into the program. Hospitals other than the initial 24 hospitals began data collection after September 2001.
Measures assessed in this quality improvement program are indicated in Table 1. 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 discharge aspirin, early and discharge β-blockers, and smoking cessation counseling used the Medicare specifications15; angiotensin-converting enzyme inhibitor use was evaluated for all patients with acute myocardial infarction at all levels of left ventricular function.2 Two lipid indicators were used: the percent of all patients discharged on lipid therapy, LipidRX, and a second measure, LDL100Rx, defined as the percent of patients who have a low-density-lipoprotein cholesterol >100 mg/dL or enter the hospital on lipid-lowering agents. Measurement of low-density-lipoprotein cholesterol for all patients within the first 24 hours of admission was also tracked. The blood pressure measure assessed the percent of patients with the last recorded hospital blood pressure <140/90 mm Hg. The final measure was the percentage of patients referred for cardiac rehabilitation or given formal exercise recommendation by the time of discharge.2 These additional measures were developed by an expert steering committee.
Data were systematically collected for each hospitalization, including patient demographics, medical history, symptoms on arrival, electrocardiographic examination, in-hospital treatment and events, discharge treatment and counseling, and disposition. The data abstraction tool used for Get With The Guidelines uses defined logic features for data verification (Outcome Inc., Cambridge, MA). Required fields include hard edits that require data entry before the form can be regarded as complete and the data entered into the database. Range check using dropdown reminders and hard edits were used for inconsistent or out-of-range data. All hospital personnel using the tool receive individual passwords to create an audit trail for data entered or changed. Training in the use of the tool is provided online for all users. The intuitive layout and embedded data definitions and data entry instructions available online as dropdown screens for each data element simplify training and support rapid assimilation into hospital data entry routines. This web-based system uses coding and transmission techniques that maintain patient confidentiality and embeds ORYX core measures. Hospital teams are able to enter data concurrently during hospitalization or may enter data after discharge. Reliability of Patient Management Tool data entry compared with chart abstraction has been verified at 94% (Outcome, Inc. unpublished data). Data collected by hospitals were not independently audited by external chart review.
All analyses were performed using SAS (SAS Institute, Research Triangle, NC). Data are presented as proportions. Changes in compliance rates for the measured outcomes over the study period were assessed using the Fisher exact test, with the Bonferroni method of Holm for multiple comparisons. All P values are 2-sided, with P < 0.05 considered statistically significant. The baseline quarter is defined as the calendar quarter in which the hospital's initial 30 records were submitted. Progress over the study period was further assessed at each calendar quarter subsequent to baseline, per hospital. When missing data elements were present for a specific measure, that patient was excluded for analysis for the measure.
Data from 45,988 patients from 92 hospitals were included in this analysis. The demographic distribution and clinical characteristics of the patient group are shown in Table 2. The population was predominately white (74.2%), with more men than women (59.6% versus 40.4%) and had a mean age of 67.7 ± 13.8 years. There was a high prevalence (61.8%) of hypertension in the past history and 27.0% of the population had smoked within the 12 months prior to admission. Acute coronary syndromes accounted for 74.5% of the admissions. Revascularization, including coronary bypass surgery, and percutaneous coronary intervention were done in 45.3% of the patients.
Baseline and quarterly data demonstrate a significant increase in 10 of 11 measures (Fig. 1; Table 3). The largest differences in performance were seen in smoking cessation counseling, 15.6% (P < 0.0001); early β-blocker use, 15.1% (P < 0.0001); exercise counseling or referral to cardiac rehabilitation, 12.6% (P < 0.0001); and early aspirin use, 11.6% (P < 0.0001). All measures demonstrated significant improvement at the P < 0.0001 level, except for aspirin use at discharge, which was the highest-performing measure at baseline at 89.9% and did not change, and blood pressure control prior to discharge (65.9% to 68%) was significant at P = 0.03.
While 10 of these measures improved significantly by the fourth quarter of participation in Get With The Guidelines, Table 3 demonstrates that improvement actually occurred much earlier. Seven of the 10 improving measures, early aspirin, early and late β-blocker, smoking cessation counseling, lipid treatment for all patients, angiotensin-converting enzyme inhibitor use for acute myocardial infarction patients, and referral to cardiac rehabilitation or exercise counseling, demonstrated significant improvement by the end of quarter 2.
Individual hospital performance was variable, even in the fourth quarter data, as shown in Figure 2 for early and discharge aspirin use, early and discharge β-blocker use, angiotensin-converting enzyme inhibitor use, and smoking cessation counseling. Variability was less in the high-performing measures such as early and discharge aspirin or β-blockers, where 34% of hospitals were below the mean performance level. More variability was present in the lower-performing measures, with below mean performance levels in 54% of hospitals for angiotensin-converting enzyme inhibitor use and 44% of hospitals for smoking cessation counseling.
Clinically and statistically significant improvement in hospital performance in 10 measures was demonstrated in a time frame that is much shorter than is conventionally believed to be required to produce change.16 Innovation in medical care, including the system changes needed to produce such significant change, typically is embraced by early adopters who embrace change early, before success has been fully demonstrated by others.17,18 These hospitals may therefore represent a group that both has higher baseline performance and is more likely to be successful in quality improvement programs. However, in Get With The Guidelines hospitals, the baseline levels for 3 of the 5 measures that are comparable to Medicare measures were lower than the adherence levels reported in a random national sample by independent chart abstraction,5 with early aspirin at 76.4% versus 85% in the Medicare study, early β-blockers at 64.4% versus 69% for Medicare, and discharge β-blockers at 75% versus 79% for Medicare. Further, in some states, participation rates of 40% to 90% of hospitals have been observed. This is much higher than the 16.4% prevalence of early adopter institutions predicted by the Everett Rogers Diffusion of Innovations model that might be expected to embrace change at an earlier a time and more rapid pace.17,18
The acute myocardial infarction quality measures in the American College of Cardiology Guidelines Applied in Practice project were similar to many of the Get With The Guidelines measures but had higher baseline levels. In 1 year using a tool kit and didactic lectures, but without a real-time decision support tool, smaller changes were seen, although high rates were present for many of the measures throughout the project. However, in the 25% of the patients in which the tool kit was used, significant improvement was seen.19 The greater changes seen in the larger and more geographically diverse group of Get With The Guidelines hospitals may be due to lower baseline treatment rates with more opportunity for improvement or the ongoing collaborative support and face-to-face meetings to transfer the tacit “how-to” knowledge needed to help implement change ideas.11 This level of change over a 13-month cycle has been demonstrated using the collaborative approach and the Model for Improvement in other disease states and settings.14 The Internet-based tool9 combines point-of-service data collection, reminders, and decision support with on-demand access for each hospital to its own performance data and benchmark comparisons to national or regional aggregate Get With The Guidelines data and may play an important complementary role in the improvement process. This analysis was obtained from patient-level data input into the Patient Management Tool, which insured that the quality improvement “tool kit” embedded in the tool was used for all of the patients. Thus, the results from Guidelines Applied in Practice and Get With The Guidelines are consistent and emphasize the value of tool use to produce positive changes in the output of care systems.
While many of the measures used in Get With The Guidelines have been used by Medicare and the Joint Commission, there are also new measures not previously used in large-scale quality improvement programs, including blood pressure control prior to discharge and referral to cardiac rehabilitation or specific physical activity recommendations. Blood pressure control is the only physiologic end point addressed in this hospital-based treatment and secondary prevention program. Despite very short lengths of stay, we were able to demonstrate a relatively high rate of blood pressure control to the Joint National Committee VII recommendations of less than 140/90 mm Hg,20 for 68.0% of patients prior to discharge compared with 65.9% in the Get With The Guidelines baseline data. Although hospital blood pressure may not be a true reflection of blood pressure control in the ambulatory arena, these data show a relatively high level of control in an inpatient population at high risk for subsequent coronary events and were identical to the level achieved in the smaller-scale New England Get With The Guidelines pilot data.12
The cardiac rehabilitation/physical activity recommendation measure is important because of the longstanding recommendation that patients with coronary artery disease events be given guidance to resume physical activity and, when available, referral to a supervised exercise program. Cardiac rehabilitation also provides reinforcement for the lifestyle recommendations made at discharge. The final rate of 71.6% represents a 12.6% increase from baseline, further demonstrating the importance of reminders and system change for the array of pharmacologic and nonpharmacologic intervention recommended in the guidelines.
Finally, Get With The Guidelines uses a bundled approach to pharmacologic secondary prevention at discharge in a system which includes items such as a preprinted discharge form, reminders embedded in the Patient Management Tool or other reminder systems for all of the 4 therapies recommended (aspirin, β-blocker, lipid lowering, angiotensin-converting enzyme inhibitor) and produces similar magnitude of change despite the variety of locations and care providers involved across a spectrum of cardiovascular diagnoses. In contrast, the early measures for acute myocardial infarction patients, aspirin, and β-blocker use showed nearly twice the rate of improvement. This may reflect the more homogeneous location, typically emergency department or coronary care unit, and care providers, as well as the acute nature of the events and the increased likelihood of improving short-term hospital outcomes.
This analysis used a before-and-after intervention design to assess a quality improvement program without randomization or a control group. Since input into the database is part of the intervention, it is not possible to assess the performance of hospitals who drop out of the program before completing 1 year. It is possible that such hospitals may already be high performers who do not choose to begin or continue in the program or are low performers and do not participate in quality improvement projects in general. The change observed here may represent general improvement in care in the hospital community as a whole. Data from the Medicare project5 comparing acute myocardial infarction measures between 1998–1999 to 2000–2001 showed improvements of 3% for early aspirin use, 2% for aspirin at discharge, 6% for the early use of β-blockers and 7% for use at discharge, 4% for angiotensin-converting enzyme inhibitor use, and 3% for smoking cessation counseling. These data are obtained from a random sample of all acute care hospitals whether or not they were participating in quality improvement initiatives and thus likely reflect the general secular trends that occurred over a period of 2–3 years and include the 2000–2001 timeframe of this analysis. In all cases, the changes noted in these 92 hospitals are larger and more rapid than the Medicare data would suggest as mere background trends. However, in the absence of a randomized concurrent control group of hospitals and patients, we cannot fully exclude secular trends and/or the impact of other efforts accounting for the quality improvement observed. Many other quality initiatives (eg, ORYX core measures, the Centers for Medicare and Medicaid Services acute myocardial infarction improvement project, and internal hospital quality improvement efforts) were operating simultaneously during this study period.
These data were not gathered as an epidemiologic sample with full retrospective case ascertainment. The purpose of data collection was to identify gaps in care not explained by individual patient characteristics that could be corrected with protocols, reminders, and other system change elements. Over time, hospitals broaden their target patient population to include more diverse diagnostic categories for which these acute treatment and secondary prevention strategies are appropriate. This phenomenon is described as spread17 and is an essential part of the Get With The Guidelines quality improvement model. Data from the Global Registry of Acute Coronary Events21 demonstrate that performance in the care of patient subgroups with ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina is quite comparable and thus, the spread in population in Get With The Guidelines is not likely to have substantially influenced the improvement in the measures reported here. In addition, most spread occurs 9 to 12 months after the quality improvement initiative has started, while significant improvement in this analysis occurred by quarter 2 in 7 of the measures.
Hospitals participating in the American Heart Association's Get With The Guidelines program had a rapid and significant improvement in the provision of 10 of 11 evidence-based acute care and secondary prevention interventions. The improvement may have been due to a number of factors, including multiple supportive systems and programs, including a collaborative learning environment and the Patient Management Tool, which facilitated concurrent feedback of guideline information at the point of care. The fact that not all Get With The Guidelines hospitals are able to achieve the high levels of performance despite these factors indicates that the process of changing hospital systems and culture is both complex and challenging. There remains much to learn about this process and more work to be done to achieve the goal of providing the right treatment for every cardiovascular patient every time.
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