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J Am Coll Cardiol, 2007; 50:1400-1433, doi:10.1016/j.jacc.2007.04.033
(Published online 20 September 2007). © 2007 by the American College of Cardiology Foundation |
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Table of contents |
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Preamble |
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Occasionally, the evidence supporting a particular structural aspect or process of care is so strong that failure to perform such actions reduces the likelihood that optimal patient outcomes will occur. Creating a mechanism for quantifying these opportunities to improve the outcomes of care is an important and pressing challenge. In the next phase of its quality improvement efforts, the ACC and the AHA created the ACC/AHA Task Force on Performance Measures in February 2000 to spearhead the development of performance measures that allow the quality of cardiovascular care to be assessed and improved. Three nominees from each organization were charged with the task of assembling teams of clinical and methodological experts, both from within the sponsoring organizations and from other organizations dedicated to the care of patients covered by the performance measurement set. These writing committees were given careful guidance with respect to the necessary attributes of good performance measures and the process of identifying, constructing, and refining these measures so that they can accurately achieve their desired goals (1).
The role of performance measurement writing committees is not to perform a primary evaluation of the medical literature; this is undertaken by ACC/AHA guidelines committees. However, performance measurement writing committees work collaboratively with guidelines committees so that the guideline recommendations are written with a degree of specificity that supports performance measurement and so that new knowledge can be rapidly incorporated into performance measurement. Development of ACC/AHA guidelines includes a detailed review of and ranking of the evidence available for the diagnosis and treatment of specific disease areas. Published guideline recommendations employ the ACC/AHA classification system I, IIa, IIb, and III (Table 1).
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The ACC/AHA Performance Measurement Sets are to be applied in the inpatient and/or outpatient setting depending upon the topic. Although inpatient measures have traditionally been captured by retrospective data collection, the increased use of electronic medical records allows for prospective collection in the inpatient and outpatient settings. Prospective data collection is itself a continuous quality improvement process. The performance measures quantify explicit actions performed in carefully specified patients for whom adherence should be advocated in all but the most unusual circumstances. In addition, the measures are constructed with the intent to facilitate both retrospective and prospective data collection using explicit administrative and/or easily documented clinical criteria. Furthermore, the data elements required to construct the performance measures are identified and linked to existing ACC/AHA Clinical Data Standards to encourage the standardization of cardiovascular measurement.
While the focus of the performance measures writing committees is to develop measures for internal quality improvement, it is appreciated that other organizations may use these measures for external reporting of provider performance. Therefore, it is within the scope of the writing committee's task to comment on the strengths and limitations of externally reporting potential performance measures. Specifically, this was done in the "Challenges to Implementation" sections in each of the performance measures when appropriate (see Appendixes A and B).
All the measures contained in this set have limitations and challenges to implementation that could result in unintended consequences when used for accountability purposes. The implementation of these measures for purposes other than quality improvement (QI) require field testing to address issues related to, but not limited to, sample size, reasonable frequency of use for an intervention, comparability, and audit requirements. The way in which these issues are addressed will be highly dependent on the type of accountability system developed, including data collection method, assignment of patients to physicians for measurement purposes, baseline measure setting, incentive system, and public reporting method among others. The ACC/AHA encourages those interested in working on implementation of these measures for purposes beyond QI to work with the ACC/AHA to understand these complex issues in pilot testing projects that can measure the impact of any limitations and provide guidance on possible refinements of the measures that would make them more suitable for additional purposes.
In the process of facilitating the measurement of cardiovascular health care quality, the ACC/AHA Performance Measurement Sets can serve as a vehicle for more rapidly translating the strongest clinical evidence into practice. These documents are intended to provide practitioners with "tools" for measuring the quality of care and for identifying opportunities to improve. Because the target audience and unit of analysis for these measures is the practitioner, they were constructed from the provider's perspective and were not intended to characterize "good" or "bad" practice but to be part of a system with which to assess and improve health care quality. It is our hope that an application of these performance measures within a system of QI will provide a mechanism through which the quality of medical care can be measured and improved.
Robert O. Bonow, MD, FACC, FAHA Chair, ACC/AHA Task Force on Performance Measures
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I. Introduction |
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To formalize performance measures for CR services, the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR)/American College of Cardiology (ACC)/American Heart Association (AHA) Cardiac Rehabilitation/Secondary Prevention Performance Measures Writing Committee was convened in November 2005. The Writing Committee was given the charge of developing performance measures that cover 2 specific aspects of CR services: 1) referral of eligible patients to a CR program and 2) delivery of CR services through multidisciplinary CR programs.
The ultimate purpose of these performance measure sets is to help improve the delivery of CR in order to reduce cardiovascular mortality and morbidity and optimize health in persons with CVD, including acute myocardial infarction (MI) or status-post coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI), and heart transplant or heart valve surgery. Using the previously published methodology of the ACC and the AHA (1,19), performance measures for the referral of eligible patients to a CR program, and the delivery of CR services through multidisciplinary CR programs were developed, focusing on processes of care that have been documented to help improve patient outcomes (using the ACC/AHA system for classification of recommendations and level of evidence for guidelines and clinical recommendations shown in Table 1). Both inpatient and outpatient settings of cardiovascular care were considered, resulting in performance measures being created for 3 specific settings: 1) hospitals, 2) office practices, and 3) CR programs.
A. Rationale for Cardiac Rehabilitation/Secondary Prevention Performance Measures. The rationale for developing and implementing performance measure sets for referral to and delivery of CR services is based on several key factors:
Clearly there is a need and also a prime opportunity to reduce the gap in delivery of CR services to persons with CVD. Such an improvement in CR delivery will require better approaches in the referral to, enrollment in, and completion of programs in CR. It is anticipated that the implementation of CR performance measure sets will stimulate changes in the clinical practice of preventive and rehabilitative care for persons with CVD.
B. Writing Committee Structure and Members. To formalize performance measures for CR services, the AACVPR/ACC/AHA Cardiac Rehabilitation/Secondary Prevention Performance Measures Writing Committee was convened in November 2005. The Writing Committee was composed of nominated representatives from the AACVPR, the ACC, and the AHA, including past and current representatives of the ACC Task Force on Performance Measures, past and current presidents of AACVPR, and clinicians with expertise in general clinical cardiology, heart failure, CVD, and CR. An initial committee meeting was held in Kansas City, Missouri, on January 23 and 24, 2006. Committee meetings were otherwise held by teleconference, generally at weekly intervals.
C. Relationships With Industry. Committee members volunteered their time to participate in the Writing Committee and acknowledged any potential conflicts of interest (Appendix D). The cost of the initial committee meeting in January 2006 and the cost of conference calls were supported by the AACVPR, the ACC, and the AHA. No commercial support was provided for any aspect of the Committee's work.
D. Review and Endorsement. A public comment period was held for this document from December 11, 2006, until January 11, 2007. Reviewers were asked to provide comments on the document on the basis of the rating form and guide shown in Appendix C. Reviewer comments were considered and incorporated into a revised version of the document. Review and final approval of the final version of the paper was obtained through the governing bodies from the AACVPR, the ACC, and the AHA. Endorsement of the final paper was sought from key partnering organizations.
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II. Methodology |
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The definition for CR in general use today is based on a modification from the original World Health Organization 1964 definition of CR (30). This definition reinforced the observation that CR is an integral component in the overall management of patients with CVD, that the patient plays a significant role in the successful outcome of CR, and that CR is an important source of services aimed at the secondary prevention of CVD events (2,4,12).
Building on this original definition, a number of other complementary definitions of CR have been promulgated by various organizations including the U.S. Public Health Service, the AHA, the AACVPR, and the Canadian Association of Cardiac Rehabilitation (4,18). These updated definitions emphasize the integral role of CR in the secondary prevention of CVD.
The definition used by the U.S. Public Health Service and by the Cardiac Rehabilitation/Secondary Prevention Performance Measures Writing Committee is as follows:
"Cardiac rehabilitation services are comprehensive, long-term programs involving medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counselling. These programs are designed to limit the physiologic and psychological effects of cardiac illness, reduce the risk for sudden death or re-infarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients" (4).
Cardiac rehabilitation/secondary prevention programs are generally divided into 3 main phases:
The main focus of this position paper is on the referral to and delivery of early outpatient CR services principally because it is the component of CR that has been most widely documented to help reduce the risk of CVD mortality among its participants.
B. Definition of Appropriate Patients for Cardiac Rehabilitation/Secondary Prevention. Patients who are considered eligible for CR include those who have experienced 1 or more of the following conditions as a primary diagnosis sometime within the previous year:
The thrust of this document is focused on the management of persons with coronary artery disease-related conditions (noted in the list above with an *), but CR services are considered appropriate and beneficial for persons: 1) after heart valve surgical repair or replacement, and 2) after heart or heart/lung transplantation (as previously listed) (31–34). Furthermore, growing evidence from published studies supports a benefit of CR for persons with chronic heart failure or peripheral arterial disease (35,36). However, formal recommendations by health care organizations to approve and/or cover CR services in these patient populations will depend upon policy decision-makers and, particularly in the case of chronic heart failure, the results of ongoing research studies.
Persons who are potentially eligible for CR may, in fact, have barriers that limit their participation in CR. Such barriers include those that are patient-oriented (e.g., patient refusal), others that are provider-oriented (e.g., provider deems the patient ineligible for CR due to a high-risk medical condition and/or an absolute contraindication to exercise), and still others that are related to the health care system and/or societal barriers (e.g., lack of a CR program, lack of insurance coverage, etc.) (17). Patients with such barriers may be excluded from the number of patients who are considered to be eligible for CR referral (Appendix A, under "Numerator" criteria for assessing the percentage of eligible patients who have been referred to a CR program). It should be noted, however, that even though some persons may have significant patient- or provider-oriented barriers to CR referral, nearly all patients with CVD can benefit from at least some components of a comprehensive, secondary prevention CR program.
C. Overview of Performance Measures Created. Both structure-based and process-based performance measures are included in the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Sets. While important and related, specific measures focused on clinical outcomes are not included. The performance measures that are included are designed to help health care groups identify potentially correctable and actionable "upstream" sources of suboptimal clinical care, such as structure- and process-based gaps in CR services. Details for the dimensions of care included in the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Sets are outlined as follows:
It should also be noted that the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Sets have been designed for 3 different geographical settings of care: 1) the hospital, 2) the physician office, and 3) the CR program settings. Staff members within each of these areas who help provide care to persons with CVD are held accountable for the various aspects of CR services (referral to, enrollment in, and delivery of CR services).
D. Literature Review and Evidence Base. There is substantial evidence to conclude that CR is reasonable and necessary following MI, CABG surgery, stable angina, heart valve repair or replacement, PCI, and heart or heart/lung transplant (12). Outpatient, medically supervised CR, as described by the U.S. Public Health Service, is a comprehensive, long-term intervention including medical evaluation, prescribed exercise, cardiac risk-factor modification, education, and counseling typically initiated 1 to 3 weeks after hospital discharge and typically including electrocardiographic monitoring of patients (see Section II.A.) (4).
Meta-analyses and systematic reviews (2,3,5–11) provide and summarize the extensive evidence that has been generated from published randomized clinical trials demonstrating that exercise-based CR services are beneficial for patients with established CVD. These benefits include improved processes of care and risk-factor profiles that are closely linked to subsequent mortality and morbidity. Pooled data from randomized clinical trials of CR demonstrate a mortality benefit of approximately 20% to 25% (2,3,5–11) and a trend towards reduction in nonfatal recurrent MI over a median follow-up of 12 months (10).
E. Definition and Selection of Measures. The Cardiac Rehabilitation/Secondary Prevention Performance Measure Writing Committee initially identified 39 factors from various practice guidelines and other reports that were considered potential performance measures for the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Sets (see Table 1 for standard guidelines that were used to rate the classification of recommendations and level of evidence for assessing these factors). The group evaluated these 39 factors according to guidelines established by the ACC/AHA Task Force on Performance Measures (1). Those measures that were deemed to be most evidence-based, interpretable, actionable, clinically meaningful, valid, reliable, and feasible were included in the final performance measurement sets. Once these measures were identified, the Writing Committee then discussed and refined, over a series of months, the definition, content, and other details of each of the selected measures.
While most performance measures are designed for a specific condition and phase of a particular disease, CR referral is applicable and appropriate for a number of different conditions and phases of CVD. Accordingly, the Writing Committee created 2 sets of performance measures, one related to the appropriate referral of patients to a CR program and another set related to optimal performance of a CR program itself. In creating the first set, the Writing Committee sought to create a measure that would be appropriate for insertion into other performance measurement sets for which CR referral would be appropriate (e.g., performance measurement sets for care of patients following MI, PCI, or CABG). Figure 1 outlines the overall organization of these 2 types of measures and their intended applications.
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III. Measures Related to Early Outpatient CR Referral |
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A. Populations, Care Period, and Responsible Parties. Patients who are appropriate for referral to an early outpatient CR program include those patients who, in the previous 12 months, have had any of the diagnoses listed in Section II.B. The CR services are generally most beneficial when delivered soon after the index hospitalization. However, there are often clinical, social, and logistical reasons which delay enrollment in CR. For this reason, many third-party payers allow CR services to begin up to 6 to 12 months following a cardiac event. Because patients can be referred to CR at varying times following a CVD event, parties responsible for the referral of patients to CR include hospitals and health care systems as well as physician practices and other health care settings with primary responsibility for the care of patients after a CVD event.
B. Brief Summary of the Measures. The Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set A (Appendix A) is based on 2 criteria for the appropriate referral of patients to an early outpatient CR program:
It should be noted that the health care system and its providers who care for patients during and/or after CVD events are accountable for these performance measures. Physicians or other health care providers who see patients with CVD but who do not have a primary role in managing their CVD are not accountable for meeting these criteria. For example, an ophthalmologist who is performing an annual retinal exam on a diabetic patient in the year after their MI would not be responsible for referring the patient to a CR program. Additional details regarding this performance measurement set are included in Appendix A.
C. Data Collection Instruments. Examples of tools that may be of help in applying the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set A (Appendix A) into practice are included in Figures 2 and 3. In Figure 2 , an example is shown of a standardized CR referral tool that health care systems could potentially use in the inpatient setting, whereas Figure 3 shows an example of a potential CR referral tool for outpatient practice settings. Figure 4 shows an example of a performance measure tracking tool that can be used by health care systems following an MI, with the performance measure of CR referral included in the performance measurement tool. These tools are given as examples and not as endorsed instruments. Health care systems and providers are encouraged to develop and implement systematic tools that are most appropriate and most effective for their particular setting and patient population groups.
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IV. Measures to Define Quality Early Outpatient CR Programs |
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A. Populations, Care Period, and Responsible Parties. Patients who are appropriate for entry into a CR program include persons 18 years of age or older who, during the previous year, have had 1 or more of the qualifying diagnoses listed in Section II.B. Patients who are considered ineligible for CR services, by patient-oriented or provider-oriented criteria (see Section II.B.), may still be appropriate candidates for enrollment in modified CR programs that adapt their services to a given patient's limitations, geographic or otherwise. The period of care for early outpatient CR typically begins 1 to 3 weeks after the index CVD event and lasts up to 3 to 6 months.
The unit of analysis for the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set B is the health care system's CR program(s). Therefore, the responsible parties for the performance of early outpatient CR services include members of the CR program staff—the medical director, nurses, exercise specialists, cardiovascular administrators, and other members of the CR team.
B. Brief Summary of the Outpatient CR Program Measurement Set. The Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set B for the delivery of CR services includes those measures that were considered by the Writing Committee to have the highest level of evidence and consensus support among the Committee members.
The measures selected include both structure- and process-based measures that assess for the use of the following policies and procedures by CR programs:
Structural measures (Appendix B : Performance Measure B-1)
A plan to assess completion of the prescribed course of CR A standardized plan to reassess patient outcomes at the completion of CR C. Data Collection Instruments. The Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set B is intended to be used prospectively to review a program's internal procedures with the ultimate goal of enhancing the quality improvement process. To aid in data compilation, ideally collected prospectively, a data collection tool or flow sheet is recommended. An example of such a collection tool is shown in Table 2. Health care systems and practices are encouraged to develop and/or use a tool that conforms to local practice patterns and standards.
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V. Discussion |
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The Writing Committee focused its attention on two general performance measurement sets: 1) referral of eligible patients to an outpatient CR program, and 2) delivery of appropriate CR services by CR programs. The first performance measure is designed to be used as a plug-in component to other performance measurement sets for which CR referral is deemed appropriate (e.g., post-MI, post-CABG, post-PCI). The second performance measurement set is designed to clarify structure- and process-based performance measures that serve as a standard for CR programs as they work to continually improve the quality of care provided to their patients with CVD and thereby optimize their patients' health-related outcomes.
The Writing Committee did not include performance measures for all patient groups that may benefit from CR services, but focused on those groups of patients with the most current scientific evidence and other supporting evidence for benefits from CR. Other patient groups, including those patients who have undergone heart valve surgery or who have received heart or heart/lung transplantation, are also appropriate for CR referral. In addition, there is growing evidence for the benefits of CR in persons with other cardiovascular conditions, including heart failure and peripheral vascular disease. As more evidence becomes available for the benefits of CR in these patient groups, they will be included in future iterations of the Cardiac Rehabilitation/Secondary Prevention Performance Measurement Sets.
To be effective, the recommendations of the Writing Committee will need to be adapted, adopted, and implemented by health care systems, health care providers, health insurance carriers, chronic disease management organizations, and other groups in the health care field that have responsibility for the delivery of care to persons with CVD. Such strategies should be part of an overall systems-based approach to minimize inappropriate gaps and variation in patient care, optimize delivery of health-promoting services, and improve patient-centered health outcomes.
Special Thanks: Costas Lambrew, MD, FACC, Tilithia McBride, Joseph Allen, Abigail Lynn, Marie Bass, and Megan Dunn.
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Staff |
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John C. Lewin, MD, Chief Executive Officer
Thomas E. Arend, Jr., Esq., Chief Operating Officer
Tilithia McBride, Associate Director, Data Standards and Performance Measures
Erin A. Barrett, Senior Specialist, Clinical Policy and Documents
American Heart Association
M. Cass Wheeler, Chief Executive Officer
Rose Marie Robertson, MD, FACC, FAHA, Chief Science Officer
Kathryn A. Taubert, PhD, FAHA, Senior Science Advisor
American Association of Cardiovascular and Pulmonary Rehabilitation
Marie A. Bass, MS, CAE, Executive Director
Abigail Lynn, Senior Associate, National Office
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Appendix A. Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set A |
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Appendix B. Cardiac Rehabilitation/Secondary Prevention Performance Measurement Set B |
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Appendix C. Sample Rating Form and Rating Form Guide |
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Appendix D. Author Relationships With Industry—AACVPR/ACC/AHA Cardiac Rehabilitation/Secondary Prevention Performance Measures |
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Footnotes |
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This article has been copublished in the October 2, 2007, issue of Circulation and the September/October issue of the Journal of Cardiopulmonary Rehabilitation and Prevention.
Copies: This document is available on the World Wide Web sites of the American Association of Cardiovascular and Pulmonary Rehabilitation (www.aacvpr.org), American College of Cardiology (www.acc.org), and American Heart Association (www.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail reprints{at}elsevier.com
Permissions: Modification, alteration, enhancement and/or distribution of this document are not permitted without the express permission of the American Association of Cardiovascular and Pulmonary Rehabilitation, American College of Cardiology, or American Heart Association. Please contact the American Heart Association: Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml?identifier=4431. A link to the "Permission Request Form" appears on the right side of the page.
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References |
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Table of contents
Preamble
