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Fiscal Year 2003: Research on Health Care Costs, Quality and Outcomes (HCQO)
Purpose and Method of Operation
Support Improvements in Health Outcomes
Strengthen Quality Measurement and Improvement
Identify Strategies to Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures
AHRQ's Commitment to Improved Health for Priority Populations
Activities that Support All Goals
Rationale for AHRQ's FY 2003 Request
Priority 1: Department of Commerce's Current Population Survey
Priority 2: Secretarial Initiative to Improve Patient Safety
Priority 3: Research Management
Priority 5: Non-Patient Safety Research and Training Grants
Priority 6: Non-Patient Safety Contracts
Purpose and Method of Operation
The purpose of the Research on Health Care Costs, Quality and Outcomes (HCQO) activity is to support and conduct research that improves the outcomes, quality, cost, use and accessibility of health care. Accordingly, the Agency has identified three strategic plan goals that feed into this budget activity:
- Supporting improvements in health outcomes.
- Strengthening quality measurement and improvement.
- Identifying strategies to improve access, foster appropriate use, and reduce unnecessary expenditures.
The key themes throughout all three goals are to fund new research and to translate research into practice. Lastly, AHRQ has enhanced specific activities that support all of our strategic goals.
The Agency has made important strides toward meeting its strategic goals. This section on HCQO Research reviews specific achievements in the Agency's core programs as well as activities initiated in response to the increase in the Agency's budget in FY 2002.
The first section, Support Improvements in Health Outcomes, reviews the Agency's progress in specific research areas:
The second section, Strengthen Quality Measurement and Improvement, provides updates on activities in the following areas:
The third section, Identify Strategies to Improve Access, Foster Appropriate Use, and Reduce Unnecessary Expenditures, encompasses critical sources of data and information for policymakers:
The fourth section, AHRQ's Commitment to Improved Health for Priority Populations, outlines AHRQ's efforts and findings on the following issues:
The final section, Activities that Support All Goals, includes a discussion of our enhanced training and dissemination activities.
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Support Improvements in Health Outcomes
One of the most important priorities of AHRQ is to translate and disseminate the findings of research supported by the Agency into tools and information that can be used by its customers to make good health care decisions and to improve the outcomes of care. The research supported by AHRQ has historically concentrated on conditions that are common, costly, and for which there is substantial variation in practice. This research includes many of the conditions that represent major expenditures for Medicare and Medicaid.
AHRQ's research attempts to reduce inappropriate variation and provide health care decisionmakers with information on:
- What care is appropriate.
- Which clinical services work best in what circumstances and for which patients.
- How much is enough.
- What resources are used to provide it.
Outcomes research also helps decisionmakers understand the implications of structural and financing changes in the health care system on the outcomes of care delivered in the system.
Investigator-initiated Research—Centering Health Care Around the Patient
It is widely acknowledged that patients, more educated than ever about their health care, should be as active as they wish in decisionmaking regarding their care. For this to occur, both technical care and interpersonal interactions must be centered around the needs and preferences of individual patients—and research has shown that this approach yields better outcomes. As a result, health services research should be able to do more to identify and disseminate widely information about the factors that create an ideal environment for patient-centered care. As the recent Institute of Medicine (IOM) report, Crossing the Quality Chasm, stated, we must "modify the care to respond to the person, not the person to the care."
In FY 2001 and 2002, AHRQ has requested applications that focus on the factors that create an ideal environment for patient-centered care. The focus of this Program Announcement (PA), which was cosponsored by the National Institute of Mental Health, is on design and evaluation of care processes that empower patients, improve patient-provider interaction, help patients and clinicians navigate through complicated health care systems, and improve access, quality, and outcomes. Examples of relevant research topics include shared decisionmaking programs, electronic patient-provider communication, and patient self-management programs, particularly for chronic conditions.
Investigator-initiated Outcomes Research
A majority of the existing outcomes research grants come from investigator-initiated research. Outcomes and effectiveness research seeks to understand the end results of particular health care practices and interventions. End results include effects that people experience and care about, such as change in the ability to function. In particular, for individuals with chronic conditions—where cure is not always possible—end results include quality of life as well as mortality. By linking the care people get to the outcomes they experience, outcomes research has become the key to developing better ways to monitor and improve the quality of care. Supporting improvements in health outcomes is a strategic goal of the Agency for Healthcare Research and Quality.
In FY 2001, AHRQ's outcomes research portfolio focused on a range of projects, including, comparative effectiveness of interventions for chronic conditions in adults (e.g. diabetes and chronic heart disease) and children (e.g., asthma and attention deficit hyperactivity disorder) improvements in research methodology, and research to reduce inappropriate racial disparities. In FY 2002, AHRQ called for additional studies on patient-centered care.
Recent accomplishments: AHRQ's prostate Patient Outcomes Research Team (PORT) findings have been used by the Memphis Veterans Administration Medical Center to develop a "Patient Pointer" on the pros and cons of prostate-specific antigen (PSA) testing. This one-page, illustrated sheet was mailed to 15,000 veterans enrolled in its primary care clinics. Follow-up found that when the patients were properly informed about testing, there was substantially more appropriate use of PSA testing.
Several States have incorporated the recommendations of the schizophrenia PORT into their statewide treatment guidelines. The State of New York, in addition to establishing guidelines, has used the recommendations to develop quality indicators for their residency and rehabilitation programs as well as their clinics and hospitals. They also have developed automated pharmacy databases where the clinician's actual practices will be compared with the recommended regimes.
Seven States have implemented the recommendations or portions of them. By developing the recommendations, AHRQ has given the field the first comprehensive, evidence-based review of all treatments for schizophrenia.
Building on our research, the National Institute of Mental Health is funding the current effort to update the recommendations so that their usefulness will continue, especially in light of the ever-changing field of psychopharmacology. It is reasonable to assume that more States and others will adopt the recommendations through time, exposure, and the effort to keep abreast of changing therapeutics.
Investigator-initiated Outcomes Research
Maine Lumbar Spine Study, Maine Medical Assessment Foundation. This study is focused on the long-term outcomes of surgical and nonsurgical treatment of two common lumbar spine conditions: herniated intervertebral disc and degenerative spinal stenosis. The study will continue the followup of nearly 500 currently enrolled patients to 10 years from initial enrollment. For patients with disc herniation and sciatica, there will be a focus on work-related outcomes including disability compensation and work status. Analyses also will determine if surgical outcomes and nonsurgical treatment begin to merge as the only other long-term study indicated.
Research Finding. Lower respiratory infection is one of the most common causes of death and hospitalization among nursing home residents. While hospitalization can be lifesaving for the sickest patients, for those who are less ill there is considerable risk of incurring avoidable expense and harm from needless hospitalization.
Investigators from the University of Missouri studies nursing home residents with lower respiratory infection in 36 nursing homes, and developed a strategy to predict which patients are at highest risk of hospitalization and which could be more effectively treated in the nursing home.
Their findings demonstrate that up to 52 percent of nursing home residents with lower respiratory infection are at low risk of mortality and may not require hospital admission. (Mehr D, Binder E, et al. Predicting mortality in nursing home residents with lower respiratory infection. The Missouri LRI study. JAMA 2001; 286: 2427-2437.)
Centers for Education and Research on Therapeutics (CERTs)
Neither patients nor their caregivers should have to guess which therapies are the best or live in fear that a mistake will be made in treatment. This is the basis of AHRQ's Centers for Education and Research on Therapeutics (CERTs) program.
AHRQ was given authority to support the CERTS initiative under the Food and Drug Modernization Act of 1997. Between 1999 and 2000, AHRQ established seven centers under the CERTS program, each of which focuses on therapies used in a particular population or therapeutic area. The CERTs conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products. In FY 2001 AHRQ supported these seven CERTs with an investment of approximately $4.9 million.
Select for the CERTs Fact Sheet.
While drugs, medical devices, and biological products improve health for thousands of people, side effects, misuse, and overuse of products can seriously impair the health of many others. Many patients potentially could benefit from a therapy but do not receive it; this may be through lack of information, oversight, or in the mistaken belief that the therapy will do them harm. In addition, studies may not test medical products in combination with other therapies often used by the same patients.
Further, once approved, drugs and devices often are used for purposes other than those for which they were approved—sometimes these uses are supported by studies, but not always.
Finally, some side effects of medical products emerge only after they have been approved for sale, when large numbers of people begin to use them.
The CERTs program aims to fill these information gaps by answering important questions that have not been addressed and strive to develop educational interventions for current and future caregivers. Besides AHRQ, the participants in the CERTs include academic organizations, managed care organizations, drug and device companies, practitioners, commercial research groups, and consumer groups. The following are a few examples of how the CERTs seek to improve health through the best use of medical therapies.
Why aren't patients with certain types of heart disease taking medicines that may save their lives? Aspirin is inexpensive and available over-the-counter, and it greatly reduces the risk of heart attack, stroke, and related death in people with coronary artery disease (CAD; blockage of the blood vessels that supply blood to the heart). Similarly, another class of drugs, beta-blockers, has been shown to help people with congestive heart failure (CHF). Data collected by the Duke University CERT confirmed that 13 percent of people with CAD were not taking aspirin, and 55 percent of people with CHF were not taking a beta-blocker. More importantly, the people with CAD who were not taking aspirin were almost twice as likely to die within 1 year as those who were.
The news was only slightly better for people with CHF who were not taking a beta-blocker; they had 1.5 times the risk of dying compared with people who were taking the medicine. The Duke CERT is now investigating ways to get the right life-saving medicines to the right people. Once more is understood about why people may not be taking these medicines, programs to overcome these barriers and save lives can be designed.
Monitoring anti-HIV drug levels. The ability of drugs to help women and children with HIV can be affected by the way they take the drugs and how their bodies handle the medicine. The University of North Carolina CERT developed a screening test to measure the levels of anti-HIV drugs called protease inhibitors in the bloodstream. The test will determine whether the level of drugs is too high or too low as a result of a problem in the way the drug was taken or absorbed.
Research involving the test had an unexpected, important finding: giving anti-HIV drugs to babies with water can speed the passage of the drugs through babies' systems before they have a chance to work. Giving drugs with infant formula greatly improves results. In another case, the test showed high levels of protease inhibitor in a child whose parent had readjusted the dose of the drug without telling anyone. Some patients were not getting their drugs at all. In one case, a child's mother was too ill herself to medicate her child, but only through the screening test could the problem be uncovered.
The test demonstrated that there might be a big difference between what a doctor prescribes and what is at work in the body. Providing this test to HIV-infected individuals can go a long way in ensuring that people are getting the level of drugs they need. The test also may help reduce the incidence of drug-resistant viruses and the cost of caring for patients with HIV.
Rethinking antibiotics before dental treatment. Many people are prescribed antibiotics before they go to the dentist in the belief that it will reduce the risk of endocarditis (infection of the heart lining and valves). Because conventional wisdom suggests that patients with heart problems are at risk, this preventive measure has been recommended for more than 45 years. The University of Pennsylvania CERT conducted a study to evaluate and quantify the risk of such infection. They found that the incidence of infection remained the same even after the introduction of widespread antibiotic prophylaxis, and that neither dental work in general, nor any individual procedures, were associated with infective endocarditis, with the possible exception of tooth extraction. The study also determined that flossing daily slightly reduced the risk of infection. Efforts are under way by the researchers to have these findings incorporated into American Heart Association guidelines.
Focus of the CERTs:
- Duke University: Approved drugs and therapeutic devices in cardiovascular medicine.
- Georgetown University: Reduction of drug interactions, particularly in women.
- University of North Carolina: Rational use of therapeutics in pediatric populations.
- Vanderbilt University: Prescription medication use in the Medicaid managed care population.
- HMO Research Network: Use of large managed care databases to study prescribing patterns, dosing outcomes, and policy input.
- University of Pennsylvania: Antibiotic drug resistance, drug use, and intervention studies.
- University of Alabama: Therapeutics for musculoskeletal disorders.
Pharmaceuticals Research Finding. AHRQ's outcomes research program, including the Centers for Education and Research on Therapeutics, supports research to improve the safe and effective use of medications. In one such study researchers evaluated an intervention to educate clinicians on the use of acetaminophen, a safer alternative to non steroidal anti-inflammatory drugs (NSAIDs) in patients with osteoarthritis.
This Intervention could potentially minimize side effects of these medications, such as internal bleeding. The investigators were able to show, that in nursing homes, they were able to significantly reduce usage. Further study is needed to determine the clinical significance of using such an intervention. Since 59 percent of Medicare beneficiaries report having arthritis, the potential impact of this intervention could be substantial.
Rickets in North Carolina. The Center at the University of North Carolina hypothesized that rickets might be on the rise in the North Carolina African-American population as an unintended consequence of breast-feeding in that population. Breast milk is generally deficient in Vitamin D, and living conditions may create a situation in which sun exposure, the body's way of manufacturing its own Vitamin D, is disrupted for African-American infants. In the initial work, researchers found 30 cases of nutritional rickets among pediatric patients of the two centers between 1990 and 1999, with over half of them presenting in 1998 and 1999. All of these cases were cases of African-American children who were breast fed and who had not had Vitamin D supplementation.
The investigators published these findings in the August 2000 Journal of Pediatrics, accompanied by an editorial vigorously recommending that Vitamin D supplementation for breast fed children become a part of the standard of pediatric practice. The researchers shared both their findings and the results of the NC pediatricians study with the State of North Carolina. The State has taken swift action: it has already begun making free Vitamin D available to all breast fed children in the State, not just African American children. The vitamins are being distributed through the WIC program, and to date 744 children have already received their vitamins. We expect this work on rickets to result in a change in the American Academy of Pediatrics' standard of care for breast fed infants.
Select for Rickets Fact Sheet.
Health of the Elderly
It is estimated that by the year 2020, 16 percent of the U.S. population will be age 65 or older. With the aging of America comes a greater need for information on how people can live healthier lives. In FY 2001, AHRQ's portfolio includes approximately 60 studies on aging, as well as research related to the health care conditions that, because of their severity or frequency, are the most costly to the Medicare program, including heart disease, pneumonia, and diabetes.
Recent accomplishment: A collaborative research study between AHRQ and CMS found that chronic conditions such as arthritis and urinary incontinence, often suboptimally managed in clinical practice, contribute significantly to poor physical function among women age 65 and older enrolled in Medicare+Choice. Low income and minority women had worse functional status, as a result of differences in chronic disease prevalence suggesting that improved management of these common chronic conditions can improve functional health outcomes, and prevent disability for all older women while making progress toward eliminating health disparities.
Components of this work has been published in the Health Care Financing Review, Journal of the American Women's Medical Association, and Health Services Research, and it has been presented at national and international meetings. The Geriatric Measurement Advisory Panel of NCQA has developed a new quality indicator for Medicare+Choice plans for Urinary Incontinence, using the Medicare Health Outcomes Survey, and is exploring the feasibility of developing an indicator aimed at improving arthritis care. These findings will be shared with CMS's Quality Improvement Organizations (QIOs) for their initiatives on disparities.
The results of a recent study at New York's Mount Sinai Hospital, published in the June 6, 2001 issue of the Journal of the American Medical Association, can help acute and post-acute care medical staff improve the outcomes of the approximately 350,000 hip fractures that occur annually in the United States by focusing efforts on reducing the risks that often leave patients unable to walk or lead to death from complications. Currently, 4 of every 10 patients are unable to walk without total assistance by six months after the fracture occurs and a quarter of patients die within a year. In addition to its human toll, hip fracture and its consequences have a large economic impact, with hospital charges alone totaling roughly $6 billion a year. The challenge has been to identify characteristics that put patients at higher risk for these adverse outcomes.
AHRQ-funded researchers identified risk factors that accurately predicted the loss of locomotion and/or death. While previous studies have identified patient factors related to either the recovery of hip fracture patients or to death, most looked at function or mortality independently, and none reported on how risk-adjusted outcomes could be obtained to assess the effectiveness or quality of care in a hospital or post-acute care setting. Currently, each group involved in the care of a hip fracture patient tends to view only their small section of the overall condition. This means that aspects of care that need to be followed often slip through the cracks. The results of this study provide the evidence that close scrutiny and observation are critical to developing effective means of managing the care of hip fracture patients.
Long-term care is not just nursing home care. Rather, it is a continuum of services beginning with respite care for the caregiver and home health care. With the "graying" of the American population, the spread of AIDS, and the growing awareness of the needs of non-elderly disabled people, more long-term care and service options will be needed.
The U.S. long-term care system has developed in a piecemeal manner, resulting in inefficiency and problems with access, quality, and financing. Public funding of long-term care is directed heavily toward institutionalization, especially nursing home care, which accounts for about 12 percent of public health care spending. AHRQ's research also is directed toward assessing and projecting service use and costs, studying alternative care settings, and finding more cost-effective ways of improving the delivery and quality of long-term care.
Recent accomplishments: A major goal of AHRQ's long-term care agenda is to measure and improve quality and cost in all long-term care settings. The Agency is funding and conducting research as well as developing data to ensure the Department will be able to monitor change in quality and cost in all segments of the long-term care market, including the fastest growing segments: assisted living and sub-acute care.
The Medical Expenditure Panel Survey is a valuable source of long-term care information from household data. Plans to increase the size of the disabled population will increase its importance. When the editing of the 1996 and 1997 data is complete, AHRQ staff and others will be able to study long-term care users and their caregivers. These data are unique in being able to study the expenditures and caregivers of non-elderly disabled persons. To enhance other long term care data, the agency is collaborating with the National Center for Health Statistics and the Assistant Secretary for Planning and Evaluation to develop a frame for residential long-term care facilities.
In prior years, about three-quarters of AHRQ's grants for long-term care research focused on nursing home quality. These grants included studies of inappropriate hospitalizations, pain management, racial differences in quality, appropriate antibiotic use and care for urinary incontinence. In FY 2001, the majority of new long-term care grants are in the areas of patient safety and the impact of healthcare working conditions on quality. Patient safety grants include both nursing home and home health care studies. About one-fourth of new health care working condition grants concern long-term care. They focus on working conditions of nurses and aides in both nursing home and home care. In addition, AHRQ is supporting conferences that help bring together researchers, providers, and policymakers interested in long-term care as well as holding health services research conferences focused on long-term care topics for State policymakers as part of the User Liaison Program.
AHRQ published a program announcement demonstrating an interest in the impact of payment and organization on cost, quality, and equity which includes an express interest in funding long-term care research in these areas in FY 2002. Through AHRQ's intramural program, we are conducting studies of nursing home acquired pneumonia, hospitalization of nursing home residents with pneumonia, inappropriate drug use, falls and fractures, incontinence, changing nursing home staffing, and changing home care expenditures. Other studies are focusing on the non-elderly disabled and include studies of factors affecting functional change across all settings of care. We are also funding the development of quality indicators in assisted living, and health care expenditures of assisted living residents.
Recent publications include studies of minimum nursing standards for nursing homes, the relationship between cost and quality in nursing homes, the increasing competition in long-term care markets, and evidence that pressure ulcer care quality is improving. Intramural staff also are collaborating with CMS to develop long-term care quality measures to be included in the National Quality Report mandated by Congress, and to develop a consumer assessment of nursing home care based on the Consumer Assessment of Health Plans Survey (CAHPS®) model that was developed by AHRQ.
Evidence-based Practice Centers (EPCs)
While outcomes research is developing new knowledge on what works in health care, for whom, and under what conditions to improve practice in the years ahead, the Evidence-based Practice Centers (EPCs) program synthesizes the existing literature to inform practice improvements today. AHRQ's 12 EPCs develop evidence reports and technology assessments on therapies and technologies that are common, expensive, and/or significant for the Medicare and Medicaid populations. The EPCs systematically review and analyze the published scientific literature to develop the reports.
Since 1997, the EPCs have conducted more than 80 systematic reviews and analyses of the literature on a wide spectrum of topics, and they have incorporated the results and conclusions into evidence reports and technology assessments. Some of these reviews are ongoing, and others have been published.
Select for Evidence Reports and Technology Assessments.
Users of these reports and assessments include doctors, medical and professional associations, health system managers, researchers, consumers organizations, and policymakers. These public- and private-sector organizations use the reports as the basis for developing their own clinical guidelines, performance measures, and other quality improvement tools and strategies. The reports and assessments often are used in formulating reimbursement and coverage policies. All EPCs collaborate with other medical and research organizations so that a broad range of experts can be included in the development process.
Nominations of topics are solicited routinely through notices in the Federal Register and are accepted on an ongoing basis. Professional organizations, health plans, providers, and others who nominate topics are considered partners and agree to use the evidence reports when they are completed. AHRQ invites comments from interested parties about the EPC program with respect to what has worked well, what has not worked well, and what changes and improvements could be made. We also are interested in suggestions about new opportunities, such as what steps the agency can take to encourage more health care organizations and other relevant groups to translate EPC reports into clinical practice guidelines and related products.
AHRQ funded 28 new evidence topics in FY 2001, 8 of which were nominated by outside organizations, 2 that are part of AHRQ's patient safety initiative, and 1 that was funded in collaboration with another Federal agency.
AHRQ's evidence reports are being used by professional associations to create clinical practice guidelines, as well as Federal agencies, academic institutions, patient groups and health systems. Examples include:
The AAP has released a second guideline on the management of this disorder, also based on an AHRQ-sponsored evidence report, prior to launching a 3-year, multi-faceted campaign to promote the implementation of these guidelines in practice. The program will include a variety of media events; development of physician tool kits, patient materials, and educational curricula and conferences; all designed to facilitate improvements in clinical practice and patient behavior consistent with the scientific evidence outlined in the EPC evidence reports.
Other recent studies that demonstrate the use of EPC expertise to help policymakers, researchers, and patients are:
- One EPC found that bone density measured at the hip by dual energy X-ray absorptiometry (DXA) is the best predictor of hip fracture, and that repeating the bone density tests within the first year of treatment is not recommended. This finding is particularly important to the estimated 14 million American women over age 50 who are affected by low bone density at the hip. Another EPC found that a synthetic hormone developed to replace a natural hormone was effective in reducing the need for transfusions in cancer patients with anemia resulting from chemotherapy.
- A Research Triangle Institute/University of North Carolina report completed in May 2001, Systems to Rate Strength of Scientific Evidence, that will be used to disseminate guidance on rating quality of evidence. AHRQ will develop and disseminate short summaries customized to the needs of several major audiences. These will help, for instance: busy clinicians who need to know quickly what to look for in the many journal articles on research findings; policymakers who rely on clinical studies in their decisionmaking role, whether for making coverage decisions or for implementing protocols in a clinical setting; the media who need to accurately report on, and not overstate, clinical research findings; and patients who need straightforward information in order to talk with their providers.
- A study currently being conducted by the RAND EPC, Utilization of Physician's Services, in response to the Balanced Budget Refinement Act of 1999. RAND is analyzing:
- Various methods for accurately estimating economic impact on expenditures for physician services from:
- Improvements in medical capabilities.
- Advances in scientific technology.
- Changes in the composition of enrollment of beneficiaries under the fee-for-service Medicare Program.
- Geographic changes in locations where Medicare beneficiaries receive benefits.
- Rate of usage of physicians' services.
- Other factors that may be reliable predictors of beneficiary utilization under the Medicare fee-for-service program.
FY 2001 AHRQ-funded EPCs and Technology Assessments
- Effect of seasonal allergies on working populations.
- Management of venous thrombosis.
- Use of glycohemoglobin and microalbuminuria in diagnosis and monitoring of diabetes mellitus.
- Neonatal hyperbilirubinemia.
- Hyperbaric oxygen therapy for brain injury and stroke.
- Vaginal birth following c-section.
- Effect of patient safety on health care working conditions.
- Management of bronchiolitis.
- Management of coronary heart disease in women.
- Making health care safer: Critical analysis of patient safety practices.
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