Outcomes of Pharmaceutical Outcomes Research

Impact of Studies Funded: Final Report (continued)

Outcomes of Compliance with an Acute MI Guideline

Principal Investigator: Stephen B. Soumerai, M.D.
Grant Number: HS07631
Project Period: December 1993-November 1996

Overview

This project confirmed that beta-blocker therapy reduces mortality and cardiac hospitalizations of myocardial infarction (MI) patients over the age of 75, a group accounting for 80 percent of all heart attack deaths. The project resulted in the first of several peer-reviewed articles that provided real-world confirmation of clinical trial evidence for the benefit of these agents. It has contributed to changes in clinical practice and outcomes, as well as the implementation of related policies and procedures among key national organizations.

Impact on Clinical Practice and Outcomes (Levels III and IV)

There is evidence that both clinical practice and outcomes have changed as a result of this and related studies.²⁹

• A followup study of opinion leaders found that an intervention to improve quality of care for heart attack patients increased appropriate use of beta-blockers and aspirin by 31 percent.³⁶
• The Cooperative Cardiovascular Project (CCP) included the appropriate use of beta-blockers among its efforts to improve care of Medicare heart attack patients. Aspirin use, use of re-perfusion, and counseling for smoking cessation were also targeted. In its four-State pilot program, prescription of beta-blockers at discharge improved from 47 to 68 percent. Absolute mortality was 0.9 percent less in pilot States than in non-pilot States during the followup period.³⁷ The Health Care Financing Administration (HCFA) estimates that 200 deaths were prevented. If the national CCP effort produces comparable results, about 3,000 fewer Medicare patients hospitalized with heart attacks will die.

Impact on Policies (Level II)

This work is associated with the adoption of policies and programs by key change agents including the National Committee for Quality Assurance (NCQA), the American Medical Association (AMA), and major health maintenance organizations (HMOs).²⁹

• Based on the result of this study, NCQA amended its Health Plan Employer Data and Information Set (HEDIS) measures by requesting all HMOs nationwide report beta-blocker use among this age population after diagnosis of MI.

• United HealthCare has included this measure in a national profiling project of its 262,000 physicians.
• The AMA has identified appropriate use of this medication as an achievable aim for improved quality of care for older Americans.
• The AMA, in conjunction with the American Academy of Family Physicians, the American College of Cardiology, and the American College of Physicians-American Society of Internal Medicine, issued a Quality Care Alert regarding the benefits and underuse of beta-blockers post MI.

Impact on Further Research (Level I)

This study was covered extensively in the lay press, including AP, AP Worldstream, UPI, and the Boston Globe. A followup study demonstrated that beta-blockers are underutilized in frail and disabled elderly patients and that the benefits of beta-blockers extend to this population. The Soumerai study was also part of the basis for the General Accounting Office report, "Heart Attack Survivors Treated by Cardiologists More Likely to Take Recommended Drugs."²⁹ In addition, publications in leading journals, including The New England Journal of Medicine and the Journal of the American Medical Association, described the various findings of this research.

Treatment Effectiveness

• Calcium Channel Blockers and AMI: A retrospective cohort study which used linked New Jersey Medicare and Medicaid drug claims data found that the use of long-acting dihydropyridine calcium channel blockers after acute myocardial infarction (AMI) was associated with substantially lower rates of re-hospitalization and death compared with use of their short-acting counterparts.³⁸
• Beta-blockers and AMI: This study found that only 21 percent of eligible New Jersey Medicare beneficiaries who survived an acute myocardial infarction (AMI) receive beta-blocker therapy following the heart attack. Calcium channel blockers were used almost three times as often despite a lack of evidence that they decreased mortality. Those patients on beta-blockers were re-hospitalized 22 percent less often and their mortality rate was 43 percent lower than non-recipients. Eligible patients receiving calcium channel blockers instead of beta-blockers doubled their risk of death.³⁹

Special Needs of Target Populations

• Beta-blockers and Elderly That Have Had AMI: Although the beneficial effects of beta-blockers post-MI were found to extend to the elderly (not normally included in RCTs), rates of use were very low in a study of New Jersey Medicare enrollees.³⁹

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Outcomes of Pharmaceutical Therapy for HIV Disease

Principal Investigator: Richard D. Moore, M.D.
Grant Number: HS07809
Project Period: February 1993-January 1998

Overview

This project served the multiple purposes of:

1. Developing a comprehensive longitudinal database of human immunodeficiency virus (HIV)-infected individuals cared for in an urban setting.
2. Examining the effectiveness of antiretroviral and antimicrobial therapies in preventing progression of HIV disease and its complications.
3. Determining the association of surrogate laboratory markers with clinical outcomes.
4. Delineating the frequency and consistency of prescription drug use.
5. Identifying the sociodemographic and clinical patient characteristics associated with consistent use of and response to drug therapy.

The project has contributed to significant changes in treatment for HIV/AIDS patients. Further, project-related data and information have been used by a variety of clinical, policy, and regulatory organizations. The project has not only furthered research in the field through a broad range of studies, but it has established a powerful data resource to fuel ongoing research efforts.

Impact on Clinical Practice and Outcomes (Levels III and IV)

Most research associated with this project focused on clinical outcomes associated with different drug and other treatment regimens. A study conducted within this project, one of three studies in the field that were published around the same time, made the important finding that "combination therapy is superior to monotherapy with regard to measures of viral load and immune suppression."⁴⁰ This finding has resulted in major changes in treatment of the disease.

The dissemination of HIV/AIDS-related research, including research conducted under this project, has been amplified through the efforts of a variety of clinical and policy organizations (select policies). There has been rapid change in treatment protocols, and clinicians in the field may anticipate and monitor developments more regularly than in many other specialties. For this reason it may be particularly difficult to associate changes in treatment and outcome with specific research efforts.

Nevertheless, this project has addressed many key questions related to treatment issues for HIV/AIDS. Some examples are provided below.

• Pneumocystis Carnii Pneumonia (PCP): An assessment of the long-term safety of adjunctive corticosteroids in the treatment of PCP found that adjunctive corticosteroids do not increase mortality or the risk of most common HIV-associated complications.⁴¹
• Bacterial Infection and AIDS: This study provides evidence that neutropenia raises the risk of bacterial infections in patients with advanced immunodeficiency from HIV infection. "Neutropenia appears to be an independent risk factor for acquiring bacterial infection in patients with HIV infection." The study cites the need to assess the cost-effectiveness of interventions to prevent neutropenia in advanced HIV disease.⁴² Subsequent findings suggested that the associated risks were not great, suggesting that available high cost drug treatment was not necessarily optimal.⁴³
• Opportunistic Disease and HIV Infection: The study determined that the development of opportunistic disease is a risk factor for survival that is independent of cell count (CD4) and possibly viral load. This underscores the need for continued prophylaxis for opportunistic illness even if the CD4 count improves on new antiretroviral therapies. The study concludes that "these data support the hypothesis that opportunistic diseases enhance HIV pathogenesis and further underscore the importance of prophylaxis."⁴⁴

Impact on Policies (Level II)

Project-related data and findings have been presented and used by a wide variety of Federal, State, private and voluntary organizations, including the Food and Drug Administration (FDA), The Health Resources and Services Administration's HIV/AIDS Bureau (HRSA's HAB), the Health Care Financing Administration (HCFA), Maryland's Department of Health and Mental Hygiene, the Infectious Disease Society of America, the HIV Quality Care Association, and several pharmaceutical companies. Project-related publications have been among those reviewed by several groups involved in developing treatment guides for HIV/AIDS with respect to anti-retroviral use and the prevention and treatment of opportunistic disease.^43,45

The kinds of policies that project-related data have helped to address include those related to drug toxicity (FDA), those related to financing policy (Maryland Medicaid), those related to service delivery (HRSA and HAB), and those related to guideline development. For example:

• Pharmaceutical companies have followed project results. Findings by the project related to neutropenia (low white cell count) prevent over-utilization of a high cost drug.
• The Maryland Department of Health and Mental Hygiene reviewed project-related data in the development of its AIDS capitation program in 1996-97.
• HRSA followed data on cost implications related to the use of antiretroviral medication.

Impact on Further Research (Level I)

This project has a had similarly broad impact on research in multiple areas as described below.

Treatment Effectiveness

• HIV and Drug Therapy Adverse Events: This study found that adverse effects from antiretroviral drugs and PCP prophylaxis that interrupt therapy are relatively common, although serious events requiring hospitalization are rare; adverse event rates increase progressively with decline of CD4+ count; gender and race modify risk of adverse events for some drugs.⁴⁶
• Zidovudine (ZDV) Regimen for HIV: This study found no difference between ZDV-experienced and ZDV-naïve patients. Results suggest that earlier clinical studies demonstrating a diminished response to d4T in ZDV-experienced patients may not generalize to the current clinical practice setting. In contrast to previous trials, most patients in this study also received a protease inhibitor. The debate over sequencing of nucleoside reverse transcriptase inhibitors (NRTIs) may be less relevant when they are combined with protease inhibitors. Longer term followup data from ongoing clinical trials will help to clarify this issue further.⁴⁷
• Natural History of Opportunistic Disease in HIV Patients: This study documented trends in HIV disease important for resource and treatment planning. In patients studied, incidences of secondary PCP, cryptococcal meningitis and herpes zoster (all frequently complications of HIV infection) declined in the previous 5 years and occurred at more advanced immunosuppression than in the past. The study finds that continued efforts are needed to develop effective strategies for preventing opportunistic disease in very advanced HIV infection.⁴⁶

Cost and Economics

• Protease Inhibitors and the Cost of HIV: This study found that although protease inhibitor-containing antiretroviral regimens were being used by only about half of Maryland's Medicaid-insured patients with HIV infection, when they were used there were significantly lower hospital inpatient and community care costs, as well as lower costs associated with the treatment of opportunistic diseases. Even with the concurrent increase in their pharmacy costs, total health care costs were stable or slightly lower for these patients.⁴⁸ The costs savings benefit was primarily associated with patients with the most advanced disease.⁴³

• Incorporation of Cost in Project Database: The database associated with this project allows researchers to quantify the cost of clinical care provision for HIV infection. About 60 percent of patients in the database are insured by Medical Assistance. For these patients the project linked claims and clinical data which are extremely detailed and include both charges and payments for all individual inpatient, outpatient, home health, pharmacy and long-term care resources.

  "We have quantified how costs increase with advancing HIV disease. Among those with relatively early HIV disease, the cost is approximately $1,000 per month, but rises to $2,500 per month when CD4 counts decline below 50 cells/mm and becomes as high as $4,000 per month in the last six months before death. We have also modeled the cost-effectiveness of combination antiretroviral therapy with a protease inhibitor, finding a remarkably low rate of $10K per year of life saved when these drugs are used compared to monotherapy."⁴⁵

• Combination Therapy for HIV Infection: This study found that combination drug therapy, while costlier from a pharmaceutical perspective, yields increased lifespan of three years. Pharmaceutical costs are likely to be offset by savings in other health costs. Also, combination therapy is superior to monotherapy with regard to measures of viral load and immune suppression. The study calls for subsequent studies with longer term longitudinal clinical followup. It also references a change in the New Zealand government's drug subsidization agency's policy to approve funding for antiretroviral combination therapy.⁴⁰
• Cost to Medicaid of Immunosuppression in HIV: This study sought to determine the relative costs that a Medicaid program will likely incur in providing payment for an HIV-infected patient population. The average costs to Medicaid for treating this urban clinic's poor patients increase more than twofold as CD4+ count declines from greater than 500 cells/mm³ to less than 50 cells/mm³. The use of inpatient care has declined from as high as 80 percent of overall costs since estimates five years ago. "These data should provide a useful comparative benchmark of the cost of health care for Medicaid-insured HIV-infected patients as we enter a new era of treatment using combination antiretroviral therapies."⁴⁹
• Trends in Inpatient Costs for HIV: This study evaluates the evolution of patterns of inpatient hospital care in Maryland for HIV-infected individuals, and compares Maryland data with those of a national survey. It found that both the number and proportion of hospital discharges increased almost threefold between 1988 and 1992. It also noted the changing demography of HIV (an increasing proportion of hospitalized women). The study found significant decreases in lengths of stay and financial charges that are independent of demographic factors and clinical stage of disease.⁵⁰
• Prophylaxis and Resource Use in PCP: Patients who developed PCP despite prophylaxis had a better outcome and used fewer resources than patients not receiving preventive therapy. The study emphasizes the impact of PCP prophylaxis on the morbidity, mortality and economics of HIV health care. It found that, although the choice of prophylactic regimens is an important consideration, access to primary health care, early detection of HIV infection, and compliance with appropriate preventive therapy are ultimately as important or more important in decreasing morbidity, mortality, and costs associated with PCP and AIDS.⁵¹

Translating Research to Influence Practice

• HIV Infection and Dependency: This study corroborated findings that patients with dependencies in activities of daily living (ADLs) face higher mortality rates. The study indicated that further investigation is needed to determine how dependencies in ADLs and instrumental activities of daily living (IADLs) relate to survival: "Knowledge of the type of dependencies a patient has may assist in targeting interventions to address specific needs.... What is most interesting about our findings is the extent to which the dependencies reported in our population are those essential to independent living."⁵²

Special Needs of Target Populations

• Racial Differences in Drug Therapy for HIV: This study found racial disparities in the receipt of medication to prevent PCP among patients with HIV disease. It found that blacks were significantly less likely than non-Hispanic Caucasian Americans to receive antiretroviral drug therapy and prophylactic drug therapy against PCP.⁵³

• Factors Associated with HIV Disease: Among patients with HIV infection who received medical care from a single urban center, there were no differences in disease progression or survival associated with gender, race, injection drug use, or socioeconomic status. The study determined that clinical outcomes as measured by progression to AIDS and survival are similar in: a) whites and non-whites; and b) those of higher versus lower socioeconomic status if access to and receipt of care for HIV infection is similar. The study contradicts previous studies' findings of differences in disease progression based on demographics. Data suggest that access to medical care is a more important predictor of survival than differences between the sexes, racial or ethnic groups, or other groups (e.g., users/nonusers of injection drugs).

  "This was an important finding since some earlier studies had suggested that there were differences in clinical outcome by gender, by race, and by drug use behavior. Importantly, our analysis was able to adjust for a large number of clinical, demographic and economic variables."⁵⁴

Public Health and Prevention, Chronic and Persistent Diseases and Conditions

• Access to Care for HIV Patients: The goal of this study was to identify demographic, behavioral, and clinical features that correlate to failure to suppress viral load outside of clinical trial setting. The study found that unselected patients who begin highly active antiretroviral therapy (HAART) in a clinical setting achieve viral suppression substantially less frequently than do patients in controlled clinical trials. Missed clinic visits were the most important risk factor for failure to suppress HIV-1 RNA levels. Women and patients taking ritonavir were at increased risk for adverse drug interactions. Studies are needed to identify interventions that maximize the performance of HAART in inner-city clinics. Association between increased age and higher rates of viral suppression must be confirmed and its underlying factors must be further delineated in future studies. Differences between men and women in body mass, metabolic rates or hormonal effects may play a role and warrant study in future investigations of new antiretroviral agents. Future studies of antiretroviral agents should address sex differences of HAART in real-world practice, and should address sex differences in pharmacodynamics and adverse drug reactions.⁵⁵

• HIV in Injection Drug Users (IDUs): The goal of this study was to assess antiretroviral therapy (ART) in HIV-infected IDUs. The study findings support anecdotal evidence suggesting that HIV+ IDUs are not receiving optimal care, and make recommendations for expanding simultaneous treatment services for HIV infection and substance abuse (and other interventions, e.g., housing) to enhance response to ART.

  "If some of the identified barriers to care can be resolved, appropriate use of combination therapy could be expanded."⁵⁶

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Patient Outcomes Associated with Antidepressant Drugs

Principal Investigator: Judith M. Garrard, Ph.D.
Grant Number: HS07772
Project Period: March 1993-February 1998

Overview

This study looked at the association between different indicators for depression among community-dwelling elderly who were members of a managed care plan (Health Partners) in Minnesota between 1992 and 1994. Building on prior findings in the field about the under-detection of depression, this project yielded important insights into the diagnosis of depression among the elderly. In addition to contributing to further research in the field, the results of the project were used within the participating managed care plan to generate discussion among its clinicians about diagnosis and treatment patterns and potential obstacles to diagnosis among the elderly members of the plan.⁵⁷

Impact on Policies (Level II)

Information resulting from this project was shared with Health Partners' geriatric providers, and focus groups were conducted to explore issues related to diagnosis and treatment. The focus groups revealed interesting observations related to the study's findings that persons with "minor depression" experience significantly lower quality of life measures compared to those who are asymptomatic. Providers reported they are reluctant to share a minor diagnosis with the patient or put it in the medical record, because they feel the patient will feel stigmatized; often they will not conduct systematic testing, but will talk to the patient instead; words such as "depression" are considered to be particularly negative and "loaded" by the elderly and therefore physicians find it hard to communicate about this diagnosis.

Health plan staff reported a generally increased awareness among clinical staff about diagnosis and treatment of depression among the elderly. Plan administrators found it valuable to learn that minor depression has significant cost implications. This study also provided support for a related initiative to staff primary care clinics with mental health professionals. It also generated discussion about the most effective tools for patient screening.

In addition, Health Partner staff working with the Women's Health Task Force of the American Association of Health Plans, are involved in a related initiative to look at what health plans are doing programmatically related to the detection and treatment of depression.

Impact on Further Research (Level I)

The findings of studies associated with this project resulted in important information about different approaches to detecting depression, and about key issues in the diagnosis of depression in the elderly that could be used to influence practice.

Tools for Patient Management

• The Significance of Minor Depression: The project found that minor depression may play a stronger role in the health-related quality of life of community-dwelling elderly people than previously suspected. Controlling for other factors, elderly people living in the community who reported symptoms of either minor depression or serious depression had significantly worse health-related quality of life than those who were asymptomatic. Differences between the asymptomatic and minor depression groups were statistically significant on all eight health-related quality-of-life measures. In contrast, mean differences between those with minor versus serious depression were statistically significant on only three of the eight measures.⁵⁸
• Self-report versus Clinical Detection: This study found that:
  • Approximately half of the community-based elderly people with self-reported feelings of depression were not detected as possibly depressed by their health providers based on documentation in the health care records.
  • Physician detection of depression appears to increase with the severity of patients' self-reported indications of depression.
  • Elderly women tend to have higher rates of clinical detection of depression than men.
  • The two groups at highest risk for under-detection of depression were men between the ages of 65-74 and men 85 years and older.
  • Despite the increasing rates of clinical detection of depression by severity of the test score, approximately one fifth of women and over a third of the men with the most severe indications of self-reported depression were not recognized as possibly depressed by their physicians.⁵⁹
• The Effect of Depression on Self-rated Physical Health: This study tested whether the association between self-rated physical health and clinically defined illness differs for persons who are not depressed compared with persons with minor or serious depression. Self-rated physical health was associated with both minor and serious depression, independent of clinically defined illness; minor depression was no longer significant when self-reported pain and physical function were added to the model. A significant negative correlation between self-rated physical health and clinically defined illness was observed for minor and no depression, but no correlation was seen for serious depression. These results emphasize that for persons with serious depression, self-rated health provides a less accurate picture of clinically defined illness at both ends of the spectrum. Also, a diagnosis of minor depression should not forestall investigation of inconsistencies between patient report and clinical evidence.⁶⁰

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Patient Outcomes with Antibiotic Therapy for Lyme Disease

Principal Investigator: G. Thomas Strickland, M.D., Ph.D.
Grant Number: HS07813
Project Period: March 1993-February 1998

Overview

By prospectively following up with patients reported to the Maryland Lyme Disease Registry, the project was designed to address the comparative effectiveness of different antibiotic regimens in treating Lyme disease (LD). Delmarva Health Plan, which participated as a partner in the research, has used information from the study in educating health plan physicians about over-diagnosis and over-treatment of the disease. The project raised important questions about what definition of LD should be used in estimating impact on prevention and public health budgets, in contrast to definitions that may be appropriate for surveillance purposes. This information was of considerable interest to pharmaceutical companies marketing vaccines for the disease.

The project is of interest beyond the particular disease it addresses because it is a case example of a condition where clinical guidelines for testing and treatment conflict significantly with the fears and desires of patients, resulting in pressure on physicians to over-diagnose and over-treat, with potentially significant implications for excess costs.

Finally, although not yet published, the research has found significantly greater long-term morbidity among adults that have had LD compared with a matched comparison of those that did not have the disease. Analysis of project results is still in progress.⁶¹

Impact on Policies and Clinical Practice (Levels II and III)

Delmarva Health Plan has experienced declines in the use of expensive antibiotics and overtreatment of tick bites by health plan physicians during the period in which it provided educational materials and presentations to health plan physicians about the results of this research. Education consisted of announcements in the Delmarva Health Plan Provider Bulletin, and presentations (e.g., through Grand Rounds) at local hospitals by project researchers. The plan's May 2000 Provider Bulletin included a Lyme Disease Update, which among other things reported that:

"Management of tick bites has proven a source of confusion. In general, only a few percent of tick bites will result in infection in endemic areas, and there is ample evidence that prolonged attachment (more than a day at least) is necessary for infection, although rare exceptions exist. The recommendation for tick bite management is generally to carefully observe for signs and symptoms of infection although it may be prudent to consider prophylactic antibiotic therapy for those individuals in endemic areas who have had prolonged tick attachment. There is almost no place for serologic testing of patients with tick bites without symptoms of Lyme disease (emphasis added)."^62,63

Impact on Further Research (Level I)

Treatment Effectiveness

• Antibiotic Treatment of Lyme Disease (LD): This report provides an analysis of antibiotic therapy for LD in Maryland. It found that patients presenting with erythema migrans (EM) alone were more likely to receive one course of antibiotic than those with extracutaneous manifestations, with or without EM. It also established average length of treatment with different antibiotics. The study further found that, although "almost half of the patients did not meet the national surveillance case definition for LD, these patients were diagnosed and treated for LD by their primary care physicians." The article suggests including such cases in calculations of total cost of LD and cost-effectiveness of new LD vaccines.⁶⁴

  Another report from the study establishes that oral doxycycline, tetracycline and amoxicillin were the most frequently prescribed antibiotics in LD treatment. Most (71 percent) therapeutic courses lasted 2-3 weeks, and there is evidence of over-diagnosis of LD. This report notes that physicians are generally following choices, dosages and duration most frequently recommended in the literature. Given this and the over-diagnosis/treatment of patients with Lyme disease-like symptoms, this study "shows that efforts to educate physicians should be directed more towards the diagnosis rather than the treatment of Lyme disease."⁶⁴

  A related discussion of the study suggests the need to provide practicing physicians in the State with guidelines for ordering screening serologic tests and encouragement to obtain Western blot confirmation before treating serologically positive patients with atypical findings of LD.⁶⁴ The most important component of the project, the outcomes of patients with Lyme disease as influenced by their initial symptoms, antibiotic regimens and a host of other independent variables, has not been published yet.⁶⁵

Cost and Economics

• Antibiotic Therapy for Lyme Disease: The objective of the study was to assess the pattern of use of serologic testing and antibiotic therapy for tick bites and LD, and associated charges for management in the endemic area. Expert recommendations discourage the routine use of antibiotic therapy for prophylaxis of LD following tick bites, but the extent to which physicians in endemic areas have adopted these recommendations is not known. The study found that most patients consulting physicians for tick bites received prophylactic antibiotic therapy of unproven efficacy and underwent unnecessary, costly serologic testing. Despite almost universal use in this study, serologic testing for LD did not appear to influence treatment of patients diagnosed as having LD.⁶⁶
• Serologic Testing for Lyme Disease: This study analyzed testing on patients with Lyme disease (LD) reported to Maryland's Department of Health and Mental Hygiene from 1992 through 1995. The most commonly performed test, an enzyme immunoassay (EIA), lacks sensitivity in detecting (certain) antibodies in the earliest stages of the disease, and costs about $72 per test. The use of the Western immunoblot (WB) test, which costs about $106, constitutes 10 percent of the LD serologic tests performed on Maryland residents. The study found that the use of serologic tests in managing patients suspected of having LD or tick bite exposures in Maryland is increasing in both number and cost. "The 30,000 tests for LD performed annually on Maryland residents at a cost of over $2 million in direct medical costs must be added to the public health burden of LD in this State." Data from this study and other sources show that physicians in Maryland are using LD serology more often in patient management. They often used EIAs to follow patients after treatment, an inappropriate practice that provides misleading information, increases the proportion of positive EIAs, and increases the overall cost of testing for LD. Also, some physicians have used EIAs and WBs simultaneously while screening for LD. This increases the cost and reduces the proportion of positive WBs. Neither of these practices is considered a cost-effective use of serology in managing LD. The researchers found that, "it might be cost-effective to base clinical management decisions on results of EIA for patients who have characteristic clinical findings of LD (e.g., facial palsy, arthritis of the knee in children), using the second test only in patients with positive or equivocal EIA results and less typical manifestations of LD." Further, ."..we join the California investigators [the only other study of economic impact of LD serology] in urging primary care physicians to resist using LD serology in this inefficient manner."⁶⁷

Special Needs of Target Populations

• Rates of Lyme Disease Among African Americans: This study found that African Americans are not less likely to get Lyme disease than Caucasians. The rash (and thus the acute infection) is less frequently recognized in dark-skinned individuals. African Americans therefore have a higher risk for chronic manifestations of Lyme disease, e.g., Lyme arthritis.⁶⁸

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Pharmaceutical Care and Pediatric Asthma Outcomes

Principal Investigator: Andreas S. Stergachis, Ph.D.
Grant Number: HS07834
Project Period: March 1993-February 1997

Overview

This was a community-based, randomized controlled trial to demonstrate the effectiveness and cost-effectiveness of a pharmacist intervention program to enhance the outcomes of asthma care in children. While the final result failed to support the program's effectiveness, the study's findings provide information relevant to efforts to develop reimbursement to pharmacists for cognitive services.

Impact on Further Research (Level I)

Translating Research to Influence Practice

• Patient Counseling by Pharmacists: This pharmaceutical care evaluation of asthma in kids (PEAK) found no significant effect on health or health systems use outcomes of those using a pharmaceutical care intervention designed to be offered by pharmacists within the context of community-based practice. However, the study identified factors that should be addressed in future research in this area. For example, the report notes that the intervention may not have been powerful enough to significantly affect pharmacists' behaviors, the study measures may not have been sensitive to the assessment of the effects of interventions, and/or the pharmacists may have had low compliance with the study protocol due, in part, to patient- and practice-related barriers.

  In addition, study findings could have impact on the development of programs involving reimbursement to pharmacists for cognitive services under Medicaid, Medicare or other drug utilization review programs. Interviews with pharmacists identified the following patient- and pharmacy-centered barriers to the provision of pharmaceutical care.

  Patient-related barriers included:

  • Difficulty in scheduling appointments with patients was the main barrier.
  • Patients enrolled in the study were typically in school during the period of the day when pharmacists had time for appointments.
  • Patients frequently did not have access to transportation, or parents were unable to bring patients because of work schedule.
  • Patients and parents were skeptical of, or unfamiliar with pharmacists' role (relative to physicians).

  Pharmacy-related barriers included:

  • Prescription volume and lack of time to perform intervention.
  • Difficulty staffing and scheduling pharmacists to allow those participating in the PEAK program to prepare for and perform the intervention.

  Better management support and intervention was considered necessary to accommodate these factors.⁶⁹

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