Outcomes management as we know it today arrived after the failure of efforts during the 1980s, such as utilization review and medical audits, to provide adequate answers to questions of healthcare quality.1,2 The progression of outcomes management in recent times is in direct response to increased healthcare costs and the need for comparative databases to provide results of effectiveness in healthcare treatment protocols, evaluations of health-related quality of life, and cost containment measures. Outcomes research refers to the application of outcomes management data by all levels of healthcare providers.
Following the work of Earnest A. Codman,1 Donabedian, generally credited as being the father of outcomes management, used the term "outcome" as part of his paradigm for quality assessment composed of structure, process, and outcome.2 It was his belief that the ultimate validation of medical care resided in the measurement of these outcomes. Since Donabedian's early work, the confluence of social, medical, and financial pressures has led to the current concept of outcomes management. Thus, outcomes management can be thought of as a direct response to the question, "What is the best evidence that supports clinical practice?"
Evidence of Quality
The quality and performance level of healthcare services are assessed from three perspectives: (1) structure, the physical and structural setting in which healthcare is delivered; (2) process, what is done for patients; and (3) outcome, the end result in healthcare.2 Structure, process, and outcomes together provide evidence that the best strategy of healthcare was delivered.
Evidence of structure has been in place for decades. For example, structure elements, such as laboratory standards and grouping of in-hospital patients by similar pathologies, are ways of arranging resources in the physical and organizational settings of healthcare. The number of laboratory and diagnostic tests that are ordered is an example of process evidence. Outcomes represent the third "evidence" of healthcare quality, but they alone cannot directly measure quality of healthcare performance because structure, process, and outcomes vary from patient to patient, creating an almost uncountable number of treatment possibilities. Outcomes based on one patient are insufficient for inferences related to the quality of healthcare performance; this realization has led to the development of large national medical databases, such as the Northern New England Cardiovascular Disease Study Group, the Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database, and the National Registry of Myocardial Infarction.
Outcomes From One National Database
The STS National Adult Cardiac Surgery Database was begun in 1990 as an initiative for quality improvement and patient safety, with the corollary potential to be a powerful tool for clinical management. More than 500 participating sites have entered data from more than 1.6 million patients, which makes the STS Database the largest cardiothoracic surgery database in the world. Traditionally, members of the STS Database were hospitals, but membership now includes many surgeons' practices. Data collected by participating surgeons and institutions are housed at the Duke Clinical Research Institute (DCRI) at Duke University, Durham, North Carolina.
Data are collected and analyzed for coronary bypass procedures, valve procedures, and valve/coronary procedures. Adult cardiac surgery risk stratification models (ie, adjustments for differences in case mix) have been developed not only for operative mortality but also for measures of operative morbidity and length of stay. Every 6 months, each database participant contributing data receives an outcome report that has been risk adjusted. Examples of complications reported in the data set include perioperative myocardial infarction, atrial fibrillation, readmission within 30 days, and reoperation for bleeding. Participants also receive data on several processes of care, such as the frequency of use of the internal mammary artery, minimally invasive and off-pump approaches; types of valves; and cardiopulmonary bypass and ischemic times. Data are presented in graphics and tables that compare our institution to regional and to national benchmarks.
Program Exemplar: Inova Heart Institute
The Inova Heart Institute's (IHI) medical staff includes more than 140 cardiologists and 10 cardiac surgeons supported by hundreds of healthcare providers, such as advanced practice nurses, RNs, physician assistants, and skilled technicians. Each year these specialists treat 1000 patients who have experienced heart attack, conduct more than 10,000 invasive cardiology procedures, and perform 1200 cardiac operations. The IHI is one of only 25 heart programs in the United States and the only one in the metropolitan Washington, DC, area to provide complete heart care services for both adults and pediatric patients.
Cardiovascular Surgery Outcomes at Inova Heart Institute
The IHI collects four specific medical outcomes characteristics: market, measurements of efficacy, clinical effectiveness, and respect and caring. Market characteristics consist of patient demographics and IHI patient volume. Efficiency, effectiveness, and respect and caring are part of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) dimensions of performance.
Efficiency characteristics include length of stay (LOS), LOS variance, and cost. Effectiveness indicators for the IHI CV Surgery program focus on six primary postoperative complications (reoperation for bleeding, sternal dehiscence, mediastinal wound infection, superficial wound infection, stroke, and mortality) that target both surgeon and caregiver performance. Other calculated clinical effectiveness characteristics include risk-adjusted mortality, readmission rates, and quality of life. Respect and caring are measured with an 18-item patient satisfaction scale designed for use across all hospital patient populations. All clinical indicators, with the exception of patient satisfaction, are collected within the framework of the STS data collection tool.
Functional Status
The IHI assesses postoperative quality of life using the short form general health survey (SF-20) developed by the Medical Outcomes Study (MOS), a standardized, validated questionnaire.3 The SF-20 measures six domains of functional health: physical, limitation in physical activities; role, limitations in daily activities such as housework, work, or school; social, extent to which health interferes with routine social activities; mental health, general mood or affect in the past month; health perception, overall current health in general; pain, bodily pain in the past month; and overall, an average of all six domain scores. Scales are measured as continuous variables measured from 0 (worst) to 100 (best).
Patients complete the questionnaire preoperatively (0 months). The questionnaires also are mailed to patients at 6 months and 12 months after surgery, and annually thereafter. The IHI currently maintains longitudinal SF-20 assessment data for as long as 5 years.
The Clinical Practice Nurse Specialist (CPNS) serves as a critical link in the care of the cardiac patient at Inova Fairfax Hospital. The IHI uses four CPNSs, two of whom are master's prepared, across four cardiac service lines that approach 11,000 cases annually: cardiac surgery, electrophysiology studies, noninvasive cardiology, and invasive cardiology. The CPNS manages outcome data across these patient populations. Outcomes reports, generated quarterly, analyze trends in chosen indicators across 3 years and are reported at multidisciplinary performance improvement meetings. Cost data are merged with outcomes data and presented in multiple ways to different groups, including administration.
The CPNS also prepares individualized, blinded, and coded cardiac surgeon profiles. These profiles allow an individual surgeon to compare his or her performance to others for all agreed on clinical indicators, such as mediastinitis, reoperation for bleeding, and mortality.
Performance Improvement
Performance improvement and quality initiatives are an ongoing process at the IHI. Two examples are the Rapid After Bypass Back Into Telemetry (RABBIT) and the guided imagery programs.4 In 1993, the IHI began the RABBIT program to decrease the costs of cardiac surgery and maintain high quality. Patients in the RABBIT program are transferred to the telemetry unit from the ICU on the same day as their cardiac surgery. Costs were reduced by decreasing time to extubation and shortening both LOS in the ICU and the total LOS in the hospital. The cost savings were achieved without compromising the quality of care, which was assessed by measuring rates of readmission to the ICU and to the hospital and by surveying patients about their level of satisfaction with the RABBIT program.
The performance improvement team continues to monitor quarterly RABBIT data. Despite capacity issues, the institution's long-term goal is to have 30% of cardiac surgery patients transferred to the telemetry unit on the day of surgery. The team continues to explore creative solutions to capacity issues, such as advancing patients into the RABBIT program in the ICU when telemetry beds are unavailable. Because performance improvement is a continuous process, comparisons of LOS and other performance indicators will be made between patients transferred to the telemetry unit and those in the ICU RABBIT program to compare outcomes.
A second more recent example is IHI's success with guided imagery.5 Guided imagery is a simple form of relaxation that can reduce preoperative anxiety and postoperative pain among patients undergoing surgical procedures.6 In 1998, the cardiac surgery team implemented a guided imagery program to compare cardiac surgical outcomes between two groups of patients: with and without guided imagery. Data from the hospital financial cost/accounting database and patient satisfaction data were collected and matched to the two groups of patients. A questionnaire was developed to assess the benefits of the guided imagery program to those who elected to participate in it.
Patients who completed the guided imagery program had a shorter average LOS, a decrease in average direct pharmacy costs, and a decrease in average direct pain medication costs. Patients reported high overall patient satisfaction with the care and treatment provided. Guided imagery is now considered a complementary means to reduce anxiety, pain, and LOS among IHI's patients who undergo cardiac surgery.5
Summary
Accrediting organizations and payers are demanding valid and reliable data that demonstrate the value of services. Federal agencies, healthcare industry groups, and healthcare watchdog groups are increasing the demand for public access to outcomes data. A new and growing outcomes dynamic is the information requested by prospective patients in an increasingly consumer-oriented business. Patients demand outcomes, and resources are developing to meet these demands.
Physicians are increasingly confronted with requests for information about their mortality and morbidity rates, malpractice suits, and disciplinary actions received. For example, in Virginia, prospective patients have access to data provided by the nonprofit group Virginia Health Information.7 After numerous resolutions by the Virginia Senate since 1999, the prospective Virginia medical consumer now has access to several annual publications: Virginia Hospitals: A Consumer's Guide, 1999 Annual Report and Strategic Plan Update, and the 1999 Industry Report: Virginia Hospitals and Nursing Facilities. Consumers have access to cardiac outcomes data stratified by hospital, gender, and cardiac service line (cardiac surgery, noninvasive cardiology, and invasive cardiology). This is particularly relevant to IHI because Virginia Health Information specifically targets cardiac care.
IHI has a sizable investment in cardiovascular outcomes and has found outcomes measurement and research are key to providing quality care. IHI's goal is to move from an outcomes management model to a disease management model.8 The hope is to incorporate all aspects of the patient's continuum of care, from preoperative and diagnostic services through cardiac interventions to postoperative rehabilitation. Furthermore, every step along the way will be supported with functional status and quality of life assessments. Although these goals are ambitious and expensive, the return on investment is high.
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