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Centers for Education and Research on Therapeutics
In fiscal year 1999, AHRQ announced funding of four Centers for Education and Research on Therapeutics (CERTs). As described earlier, the CERTS will disseminate information on therapeutics to health care providers and other decisionmakers. The Agency was given initial authority to support the CERTS initiative under the Food and Drug Modernization Act of 1997. In fiscal year 2000, AHRQ added three additional centers to expand the program and help researchers tackle the complicated and difficult issues involved in the safe and effective use of medical products.
The CERTs are:
- Duke University Clinical Research Institute Cardiovascular CERT. This center focuses on currently approved therapies in cardiovascular medicine, including special surveillance programs for cardiovascular devices, revascularization, new prosthetic valves, and coronary stents. In addition, the center conducts demonstration projects involving the treatment of congestive heart failure, chest pain, and abnormal heart rhythms.
- University of North Carolina CERT on Rational Therapeutics for the Pediatric Population. Improvement in child health is the focus of this center. Activities include innovative education and research on new drugs and devices used in pediatric care and new uses of existing drugs and devices. Potential study topics include therapeutic drug monitoring in HIV-infected children, drug metabolism, vitamin D deficiency (rickets), asthma care, attention deficit/hyperactivity disorder, and adverse drug reactions in children.
- Vanderbilt University CERT. The goal of this center is to improve use of prescription medicines in Medicaid managed care by addressing three specific threats to rational pharmacotherapy: inadequate knowledge of medications and their benefits and risks, inappropriate provider and patient behavior, and policies that lead to poor patient outcomes. A major focus of this project is the treatment of arthritis.
- Georgetown University CERT. This CERT focuses on reducing drug interactions, particularly in women, by improving prescribing practices. Objectives include identifying potential candidates for investigations of drug interactions and designing and implementing a comprehensive educational program on specific drug interactions aimed at physicians, pharmacists, and patients.
- Harvard Pilgrim Health Care CERT. This CERT is developing and testing the usefulness of large databases for studying the effectiveness and safety of antibiotic use in children, drugs for preventing congestive heart failure, and hypoglycemic medications in people with diabetes.
- University of Pennsylvania CERT. This CERT is studying ways to reduce resistance to antimicrobial drugs and carrying out other research, such as studies on drug use and subsequent intervention, research on medication safety, efficacy and effectiveness research, and methodology studies.
- University of Alabama at Birmingham CERT. This CERT is studying therapeutics used for rheumatoid arthritis, osteoporosis, and other musculoskeletal diseases, including their cost effectiveness and effects on health-related quality of life, as well as ways to minimize any adverse effects associated with their use.
Translating Research Into Practice (TRIP)
There have been significant advances in science in the last few years, yet not enough of this knowledge has been put to work in daily clinical practice. There is a gap between what we know and what we do. One consequence of this gap is the wide variation in the quality of care from one clinician to another and from one area of the country to another. Variations in health care can contribute to a higher mortality rate and billions of dollars in wasted spending.
As a nation, we need to step up our efforts to address this variation, particularly since it takes between 6 and 10 years for clinical practice to adopt new knowledge for most patients. AHRQ-supported research is working toward this goal. We have a growing agenda to accelerate the translation of research into clinical practice. AHRQ is committed to informing practitioners, patients, consumers, and other decisionmakers about needed changes in health care as revealed through research. A key challenge is to identify more effective strategies for change and facilitate the adoption and use of research findings.
In fiscal year 2000, AHRQ published a solicitation, known as TRIP II, to help accelerate the impact of research on practice. The goal was to stimulate research to improve our understanding of which quality improvement efforts work and in which situations, in what kind of systems, for which types of patients, and under which circumstances. The agency funded 13 new TRIP II grants in fiscal year 2000. Examples of funded projects include:
- An Internet intervention to increase chlamydia screening. This is a randomized trial in the offices of 220 primary care physicians to test Internet-based learning modules for physicians that are designed to increase screening of at-risk patients and decrease the incidence of pelvic inflammatory disease.
- Better use of ischemic stroke research. These researchers are assessing the use of evidence-based treatment guidelines for acute ischemic stroke in 24 urban and rural hospitals in Minnesota.
- Better pediatric outcomes through improved chronic care. The goal is to reduce costs by using affordable technology to improve asthma care for poor, inner city, minority children aged 5-18 who are enrolled in a community health center-based Medicaid managed care organization.
- Use of multimedia for educating vulnerable populations about diabetes. The researchers are comparing usual care with patient education through the use of an interactive, multimedia computer program to improve diabetes-related knowledge, attitudes, and compliance with self-care recommendations.
- Improved pain management in nursing homes. The goal is to develop educational materials, improve quality of pain assessment and management procedures, improve knowledge and attitudes toward pain, and assess the cost-effectiveness of the intervention to nursing homes.
- Improved quality with outpatient decision support. The researchers will test physician compliance with paper-based and electronic guidelines, reminders, and alerts for outpatient settings. The reminders and alerts will focus on disease and medication management and test ordering.
Integrated Delivery System Research Network
The Integrated Delivery System Research Network (IDSRN) is a new model of field-based research developed by AHRQ in fiscal year 2000 to link the Nation's top researchers with some of the largest health care systems to conduct fast-track research on cutting-edge issues in health care. The goal is to determine what works in terms of data and measurement systems, and identify organizational "best practices" related to care delivery and research diffusion. The IDSRN comprises a cadre of delivery-based researchers and sites to test ways to adapt and apply existing knowledge in real world settings.
Together, the members of the IDSRN provide health services in a wide variety of organizational care settings to over 34 million Americans. The populations served include privately insured individuals, Medicare and Medicaid patients, the uninsured, ethnic and racial minorities, and rural and inner-city residents. Each of the nine IDSRN partners has the following three attributes:
- Data availability. IDSRN partners collect and maintain administrative, claims, encounter, and other data on large populations that are clinically, demographically, and geographically diverse.
- Research expertise. IDSRN partners include some of the country's leading health services researchers, with proficiency in quantitative and qualitative research and expertise in emerging areas that have critical policy or managerial implications.
- Authority to implement a health care intervention. IDSRN partners are responsible for managing delivery systems and are in a position to implement financial and organizational strategies.
Ten research projects are underway, with total funding of approximately $2.4 million. Project timelines range from 9 to 30 months. IDSRN projects can be divided into two categories; data and measurement capacity and care delivery.
Three of the IDSRN projects involve data and measurement capacity and will:
- Build capacity to study racial/ethnic disparities in access, use, and outcomes.
- Validate the Agency's HCUP Quality Indicators, a software tool that can be used with hospital administrative data for hospital self-assessment.
- Evaluate the potential of private-sector data to augment public data for use in assessing the state of health care quality in the United States.
Seven IDSRN projects will collect, test, and apply evidence about how to structure health care delivery, as follows:
- Assess variations in quality of care for the management of cardiovascular disease and its risk factors, including those related to race, sex, or socioeconomic status.
- Assess the impact of organizational interventions on quality of care and efficiency.
- Advance understanding of which hospital policies and practices underlie the volume-outcomes association for certain complex procedures.
- Determine how and to what extent health plans include quality-related provisions in their contracts with hospitals and other providers.
- Track and evaluate how a clinical practice guideline is implemented by a health plan.
- Identify barriers to the use of information technology within delivery systems.
- Examine the delivery system's capacity for responding to public health threats, including those related to bioterrorism.
National Guideline Clearinghouse™
While developing the evidence-based foundation for improved health care is an important first step, a critical next step is to make the information available to the people who need it promptly and in an appropriate format. In January 1999, AHRQ debuted the National Guideline Clearinghouse™ (NGC), a comprehensive, publicly available online repository of evidence-based clinical practice guidelines and related materials. The NGC, developed in partnership with the American Medical Association and the American Association of Health Plans, includes standardized abstracts, full text (or links to full text) of guidelines, and comparisons between guidelines on similar topics. The guidelines included in the NGC must meet rigorous criteria. By the end of fiscal year 2000, the NGC included more than 850 hundred evidence-based guidelines.
Primary Care Research
AHRQ's Center for Primary Care Research (CPRC) is the only research entity in the Federal Government devoted to the study of primary care. CPCR conducts and supports studies of primary care and clinical, preventive, and public health policies and systems. Findings from this research shed light on the most common interaction patients have in the health care system—with their primary care physicians, nurses and other first-line providers. CPCR's research also provides the information and tools that help primary care clinicians provide high quality health care services. For example, primary care research supported by AHRQ has found:
- Recognizing and treating depression in primary care can prevent unnecessary hospitalizations and save money. More than 25 percent of primary care patients have a diagnosable mental health disorder (most often anxiety or depression), and in many cases, these conditions go undetected and untreated. Researchers at the University of Rochester School of Medicine found that patients of primary care physicians who diagnosed the greatest number of mental health disorders among their patients had 9 percent lower overall health care expenditures and 20 percent lower inpatient expenditures than patients of physicians who diagnosed the smallest number of such disorders. Primary care physicians who diagnose more mental health disorders in their patients may recognize when unexplained medical symptoms are due to emotional distress or a mental health problem. Thus, they are less likely to order unnecessary diagnostic tests, inappropriately refer patients to specialists, or admit them to the hospital when it is not necessary.
- Nine of every ten California patients in managed care plans say that they value having a primary care doctor provide their everyday care, and 89 percent say that they value having a primary care doctor coordinate their specialty care. But nearly a quarter of the patients studied had difficulty getting referrals to specialty care, which, according to the researchers, is a reason why some patients may lose trust and confidence in their primary care doctors.
Goal 2: Strengthen Quality Measurement and Improvement
AHRQ's second research goal is the centerpiece of the Agency's effort to develop the strategies and tools that will lead to improvements in the quality of health care. Under this goal, the Agency is developing and testing measures of quality and supporting research on the best ways to collect, compare, and communicate these data to the appropriate audiences.
To help ensure that this information is used in everyday health care practice, AHRQ will also focus on research that identifies the most effective ways to improve health care quality, including promoting the use of information on quality through a variety of strategies, such as information dissemination and assessing the impact on health care organization and financing.
The Agency funded 24 grants in fiscal year 1999 totaling over $8.8 million to develop new quality measures and identify strategies for measuring and improving the quality of health care. These grants included responses to three RFAs mentioned earlier:
- Translating Research into Practice (TRIP).
- Quality Measurement for Vulnerable Populations.
- Assessment of Quality Improvement Strategies in Health Care.
In fiscal year 1999, more than 90 million Americans began using AHRQ's CAHPS® to help them decide which health plan would best meet their health care needs. CAHPS® is an easy-to-use kit of survey and reporting tools that provides accurate and useful information to help consumers and purchasers assess and choose a health plan.
CAHPS® was used by more than 20 States in fiscal year 1999 and by corporations such as Daimler Chrysler, Ford, and GM; health plans; and employer groups around the country. The Health Care Financing Administration also began using CAHPS® to survey Medicare managed care enrollees. The U.S. Office of Personnel Management also fielded its first CAHPS® survey to report consumer assessments of their health plans to Federal employees for the fiscal year 2000 open season for choosing health benefits.
In fiscal year 1999, AHRQ released CONQUEST 2.0 (Computerized Needs-Oriented Quality Measurement Evaluation System). CONQUEST is a database that helps health care and quality improvement professionals quickly identify, understand, compare, evaluate, and select measures to assess and improve clinical performance in acute, ambulatory, long-term, and home health care settings. The measures cover children and adults and include many different common and costly diagnoses and conditions that are, in turn, linked with evidence-based treatment guidelines. The new 2.0 version includes more clinical performance measures and medical conditions than the previous version, as well as new information on how to select and apply the measures.
Research on Quality Improvement
In fiscal years 1999-2000, AHRQ-supported studies provided insight into the critical issues of health care quality. Examples of pertinent findings include:
- Quality reports, or physician profiles, for diabetes were unable to detect reliably true practice differences among doctors at three medical practices—a large, West Coast staff-model health maintenance organization, an urban medical school teaching clinic located in the Midwest, and a group of private-practice physicians in New England. Differences in how the physicians managed their patients' diabetes contributed only 4 percent at most to the overall variance in hospitalization rates, office visits, laboratory use, and blood glucose control rates. The difficulty in using these outcomes to evaluate physician performance was due, in large part, to the relatively small number of patients with diabetes managed by each doctor.
- According to five nursing home "stakeholder" groups—nursing home advocates, administrators, regulators, ombudsmen, and nursing service directors—quality of care is the most important yardstick for assessing nursing home quality, followed closely by the residents' quality of life, and then by residents' rights. Although the stakeholders agreed on the three most important categories for measuring quality, they differed in how they thought each should be ranked. Nursing home advocates and nursing directors tended to give quality of care the highest ranking, while administrators and State licensing and certification survey agency training coordinators were more likely to pick quality of life as the most important category. State nursing home ombudsmen generally chose residents' rights as the most important. The stakeholders saw the remaining 14 categories considered in this study as being much less important.
- Heart bypass surgery patients insured by private HMOs may get higher quality hospital care in some areas of the country, while patients in other areas of the country may get poorer quality care. HMO patients in California who underwent heart bypass surgery in 1994 were more likely to be directed to hospitals with lower-than-expected death rates for the operation than non-HMO patients undergoing the same surgery. California has long-established managed care markets that are dominated by large HMOs. But in Florida, a State in which managed care arrived more recently and where market areas tend to be smaller and not dominated by large HMOs, the researchers found that privately insured HMO patients were no less likely to use hospitals with average and high heart bypass surgery rates than non-HMO patients (those insured through indemnity and preferred provider organization [PPO] plans).
AHRQ Quality Indicators
In fiscal year 1999, AHRQ released a powerful software tool that can be applied to routinely available administrative data from hospitals. The Quality Indicators (QIs) are an outgrowth of the Agency's Healthcare Cost and Utilization Project (HCUP), a standardized multi-State database of hospital information developed by AHRQ in partnership with States and private-sector organizations. (Select for more information about HCUP).
The QIs can provide initial insight into quality of care, not only within the hospital but also in other health care sectors such as ambulatory care. QIs can be used to derive national and regional benchmarks against which individual providers, localities, and States can compare themselves. Also, with an understanding of the limitations of administrative data and with appropriate precautions, the QIs can form a preliminary basis for a quality improvement program.
For example, the Healthcare Association of New York State applied HCUP QIs to discharge data from over 200 of its member hospitals throughout the State. The association provided each hospital with a customized report on the quality of care in that facility, including an analysis of how it compared with other hospitals. The customized hospital analyses resulted in a number of quality initiatives, such as promoting a large health system to create a regional center of excellence for the care of patients with diabetes and a collaboration between the association and its partners to work to improve adult immunization rates.
The next generation of QIs is being developed and enhanced by the UCSF-Stanford Evidence-based Practice Center as follows:
- Add QIs to cover populations and conditions that are not well represented in the initial version, specifically pediatric conditions, chronic illnesses, and technological innovations.
- Provide for population-based denominators when appropriate.
- Develop a risk-adjustment method for the QIs to account for differences in case mix across institutions and communities.
AHRQ's Leadership in the QuIC
In fiscal years 1999-2000, AHRQ continued its work in coordinating the activities of the Federal Quality Interagency Coordination Task Force (QuIC). The QuIC was established in 1998 in response to the final report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry. The QuIC's goal is to ensure that all Federal agencies involved in purchasing, providing, researching, or regulating health care services are working in a coordinated way toward the common goal of improving quality of care.
The QuIC is co-chaired by the Secretary of Health and Human Services (HHS) and the Secretary of Labor (DoL). AHRQ Director John M. Eisenberg, M.D., serves as operating chair of the QuIC. In addition to HHS and DoL, the other Federal members of the QuIC are:
- The Departments of Defense, Veterans Affairs, and Commerce.
- The Office of Personnel Management.
- The Office of Management and Budget.
- The U.S. Coast Guard.
- The Federal Bureau of Prisons.
- The National Highway Transportation Safety Administration.
- The Federal Trade Commission.
Research on Patient Safety and Medical Errors
According to the Institute of Medicine, as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors. Even at the lower number, medical errors would be the eighth leading cause of death in this country, bypassing motor vehicle accidents, breast cancer, and AIDS. About 7,000 people each year die from medication errors alone, which is about 16 percent more deaths than can be attributed to work-related injuries.
Clearly, medical errors represent a serious problem. The good news is that medical errors can be prevented. Previous agency-supported research has demonstrated that errors result from system failures, which can be identified and prevented. In fiscal year 2000, AHRQ supported research designed to improve patient safety by identifying and preventing avoidable system errors. We consider this a down payment on our future investment in patient safety research—one that will have a measurable impact on the quality of care received by people in this country.
Examples of agency-sponsored patient safety research now in progress include:
- A study focused on the prevention of medical errors in emergency department triage and treatment of acute cardiac ischemia by assessing the probability that a patient has the condition.
- A project addressing the impact of electronic medical records and computerized medication prescribing on adverse drug events in outpatient clinics.
- A study looking at ways to improve detection of adverse drug events through the use of an automated monitor.
- A project that involves in-depth interviews with primary care patients and their providers to elicit their definitions of medical errors and their experiences with and opinions about such errors.
- A study using video and audio recordings to evaluate the procedure used in chest tube insertion and demonstrate how medical errors can occur through deviations in process. The goal is to produce a "best practices" training guideline to reduce complications from this procedure.
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