Principal Investigator: Betty A. Chewning, Ph.D., M.S.
Grant Number: HS07773
Project Period: March 1993-February 1998
Overview
The purpose of this project was to look at the patient's perspective on the process and outcomes of arthritis drug regimen decisions. It considered:
The project has revealed interesting findings related to the patient's role in decisionmaking and in providing information useful to ongoing treatment planning. The research suggests that the patient's role may be particularly important for diseases such as arthritis where patient-reported symptoms are a primary determinant of regimen (as opposed to blood sampling or blood pressure tests for diseases such as diabetes or hypertension). Analysis of project results are not yet complete and additional information about this finding as well as others will be forthcoming.
Impact on Further Research (Level I)
Information generated by this project has been presented at numerous meetings of national and international organizations, including events sponsored by the American Association of Pharmaceutical Scientists, the American Pharmaceutical Association, the American College of Clinical Pharmacy, the American Association of Colleges of Pharmacy, and the American Public Health Association.
Tools for Patient Management
Role of Patient in Medication Management: The study found a high level of prescription and over-the-counter (OTC) medications taken as needed (PRN, according to patient judgement). "Approximately 37 percent of the rheumatoid arthritis patients and 43 percent of the osteoarthritis patients had a regiment that included a prescription or OTC drug to be taken PR.... While health care is conceptualized typically as prescribed by a provider or as self-care, these data help to describe a more complex medication management role of patients. Especially for patients who have symptoms (such as pain) which they can monitor personally, PRN medication judgements become part of their daily care. The PRN category is interesting not only for what it implies about patient arthritis medication management roles, but equally important for what it suggests about physicians' roles in relation to patients, acknowledging that patients are partners in deciding when certain medications are needed."71
In addition, the study found a high degree of change in medication regimens, including re-calibration of doses, changes in brand, and changes in drug. "Nearly half of the rheumatoid arthritis patients had their regimens change along the four dimensions across one year...more than half of the osteoarthritis patients showed changes in their regimens." This, along with the importance of patient-reported symptoms and patient assessment, suggests the need for paying greater attention to preparing patients as partners in decisionmaking. This also suggests a focus on developing tools and approaches to prepare, facilitate, and cue patients to provide the right information and data. The development of new techniques to facilitate patient documentation of drug side effects and other symptoms can be important to other diseases as well, such as cancer.71,72
Principal Investigator: Richard Platt, M.D., M.S.
Grant Number: HS07821
Project Period: August 1993-July 1998
Overview
By use of a new microelectronic technology, the project aimed to achieve four objectives with reference to hypertension medication compliance:
Impact on Further Research (Level I)
This study has led to AHRQ funded research in other related areas.
Tools for Patient Management
Monitoring Patient Compliance with Drug Regimens: The study found that there is considerable overlap of monitored adherence across levels of patient-reported adherence. Nonetheless, patient-reported forgetfulness of doses was qualitatively informative and predictive of adherence to dose number and timing. Patient-reported non-adherence when coupled with measures of drug effect or levels may be useful in guiding therapeutic decisions.
Factors associated with adherence included: younger age, increased number of children in household, lower vitality on the Medical Outcomes Study Short Form (SF-36), tendency to forget, and side effects of medication. To varying degrees these factors may be modifiable or addressable. Adherence is lower for timing than for number of doses; where dose timing is important, electronic monitoring should be considered. The relationship between adherence and outcomes (e.g., blood pressure) needs to factor in minimum thresholds for effect, and long- versus short-acting nature of treatment.73,74
Principal Investigator: Albert W. Wu, M.D., M.P.H.
Grant Number: HS07824
Project Period: September 1993-August 1995
Overview
As the first study in developing and using a health status measure in a clinical trial of an AIDS-related complication, this project was designed to demonstrate the reliability, validity, and usefulness of such a brief health status measure for acute Pneumocystis carinii pneumonia (PCP). Unlike traditional methodology studies in the field, this project added two new dimensions, namely, responsiveness and clinical utility, in the evaluation of health status measurement. By doing so, the project has enhanced the traditional validation approach that was based exclusively on reliability and validity of the instrument and set a new model for future studies in the field.
Impact on Further Research (Level I)
In addition to the application of new dimensions to health status measurement for this AIDS-related complication, this project influenced related publications that provide guidelines to researchers in understanding and selecting among quality-of-life measurement tools for different research purposes.
Treatment Effectiveness
Principal Investigator: Joseph T. Hanlon, Pharm.D.
Grant Number: HS07819
Project Period: March 1993-May 1995
Overview
Built on a series of secondary data analyses using the longitudinal data from a representative sample of community-dwelling elderly, this project evaluated the relationship between cognitive status and medication use. Focused on two classes of commonly used medications in the elderly, the study demonstrated, in a dose-response fashion, that current benzodiazepine use is associated with memory impairment while nonsteroidal antiinflammatory drug (NSAID) use is not. The study also provided nonsteroidal antiinflammatory drug some clues to the pattern of medication use after the elderly develop cognitive impairment. In general, those elderly were less likely to use over-the-counter medications and analgesics than cognitively intact community-dwelling elderly.
Impact on Further Research (Level I)
This project provided information that can inform treatment planning for the elderly. In addition, it addressed issues that can be incorporated into educational programs for clinicians regarding the special needs of the elderly who are cognitively impaired, and those who are African American.
Special Needs of Target Populations
Public Health and Prevention, Chronic and Persistent Diseases and Conditions
Cognitive Impairment in the Elderly: This study sought to determine whether medication use differs by cognitive status among community-dwelling elderly. This is of concern because medication is a common risk factor for cognitive impairment, and cognitive individuals may be over- or under-medicated, with each possibility having potential adverse outcomes. Given these issues and the growing number of drugs under investigation for treatment of dementia, documentation of the prescribing and self-medication patterns of cognitively impaired elderly is needed to guide health policy and future clinical research.
Cognitively impaired individuals were less likely to be users of prescription or over-the-counter medications than those who were cognitively intact. Those who were cognitively impaired were less likely to take analgesic medications, specifically NSAIDs, than those who were cognitively intact, but more likely to take central nervous system (CNS) medications. High use of CNS medications may reflect appropriate use of psychotropics, although comparative clinical trials have shown greater efficacy with selected alternative medicines as compared to benzodiazopine. Also, higher use of CNS medications may cause or exacerbate cognitive impairment.77
In a related study of the medication use patterns among demented, cognitively impaired and cognitively intact community-dwelling elderly people, researchers found an increasing level of cognitive dysfunction was associated with decreased use of OTC, cardiovascular and analgesic medications, and the use of fewer prescription medications.78
Principal Investigator: Alan Garber, M.D.
Grant Number: HS07818
Project Period: March 1993-August 1996
Overview
The underlying economic principles for the preference assessment, which serves as the foundation for quality-of-life (QOL) measurement, are somewhat complicated. Aimed at increasing a subject's understanding of the preference assessment instrument and detecting inconsistencies in response, this project developed a computer-based multimedia presentation of health states and preference elicitation to provide support for the preference assessment process. The project demonstrated the validity, reliability, and usefulness of this multimedia presentation. In addition, the project also found that when a subject assigns a preference to a health state, that preference appears to be affected by the subject's current health state.
Impact on Further Research (Level I)
Tools for Patient Management
Multi-media Presentation to Assess Patient Preference: This study found that a multimedia (MM) presentation of multi-attribute health states helped respondents provide quality-adjustment weights for cost-utility analysis better than paper-based text presentations. "The results suggest that: 1) MM presentation results in better recall and recognition, indicating better transfer of information; 2) MM presentation appears to result in better definition of preferences (a smaller preference interval) and 3) recall and recognition testing of a health state description can identify material in the description that has an unintended impact on the respondents. In order to perform rating tasks on a health state, subjects must first have an accurate understanding of the health state being presented." The study found that multimedia presentation leads to greater recall and recognition memory of the health state than does a text-only presentation.79
Another article describes the software construction of IMPACT (Interactive Multimedia Preference Assessment Construction Tool). "Validation studies show that preference assessments performed using IMPACT have high test-retest reliability. Future work with IMPACT will focus on additional validation of the preference elicitation procedures implemented in the program. We are developing methods to assess the internal consistency of valuations across different methods and within a given method of preference assessment [as well as] developing interface designs that will allow us to apply these tests in an interactive fashion during computer interviews."80
Patient Cost-utility and Preference Analysis: Although cost-utility analyses were designed to provide a common metric to compare competing health care interventions, the method of eliciting utilities and the population surveyed may so influence utility estimates that they make it difficult or impossible to compare the results of different studies. "We have shown that preferences depend on both the method of elicitation and the population surveyed." Further, this work suggests that future cost-utility analyses which attempt to elicit preferences for hypothetical health states from the general population should consider subjective rating of a respondent's own health status in determining representative population groups.81
A related article described the effort to determine whether different procedures for establishing preferences for health states among various scaling models produced different results, and whether repeated testing led to a convergence of utility values towards a single true estimation: Do the effects of search procedures diminish with repeated testing or do they persist indefinitely? This project sought to ascertain numerical, patient-derived quality weights ("utility values") using:
The project found that "the search procedure (using either the TTO or the SG method) can influence utility values as much as does the rating task. The search procedure effects were surprisingly large. While it is well known that different scaling methods yield different results, our results suggest that the exact implementation of the utility-elicitation task is as important as the underlying conceptual valuation framework." There was no difference in utility values between VAS and SG. "The fact that subtle differences in procedures for utility elicitation result in large differences in estimated preferences suggests that estimated utility values, like other preferences, are constructed during the process of elicitation."82
Principal Investigator: Laura B. Gardner, M.D., Ph.D., M.P.H.
Grant Number: HS08217
Project Period: September 1993-August 1996
Overview
The purpose of this study was to describe and analyze pharmaceutical and medical care utilization and costs for a group of older Americans over a period of time during which the patient's share of the cost of a prescription increased and changed several times. Whereas initially in 1988 enrollees were responsible for $5.00 of the charge of each prescription, this was increased to $8.00 for generics and $10.00 for brand name drugs in 1989, and again to $10.00 for generics and $15.00 for brand name in 1993. Then in 1994, the structure of the pharmaceutical benefit was radically modified so that the patient's co-payment became 50 percent of the allowed prescription charge, and capped at $50.00 per prescription. The study database was a group of 19,350 retirees of the Oregon Public Employees Retirement System (PERS) who were demographically representative of the general Medicare population. The database maximized its epidemiological potential by linking with Medicare claims data of those PERS individuals.
Impact on Policies (Level II)
This study had a direct impact on the Oregon Public Employees Retirement System (PERS) in demonstrating that the 50 percent co-pay was both a feasible and meaningful co-payment system. PERS has maintained this co-payment structure, in part because the study showed that it creates sufficient incentive for enrollees to consider generic drugs.
In addition, the study demonstrated the potential value of a database that links claims and clinical information. PERS has expanded the database so that International Classification of Disease (ICD-9) codes for visits can be linked to the drugs that are prescribed. This has allowed PERS to look at specific disease categories (e.g., osteoporosis) and the potential impact of concomitant and unrelated prescriptions.
Impact on Further Research (Level I)
The study is important in the context of policy discussions about a Medicare Prescription Drug benefit because it provides a case description of the relationship between utilization and a co-payment structure for a representative population.
Cost and Economics
Research Tools and Translating Research for Clinical Care
Principal Investigator: Marcia Anne Testa, Ph.D.
Grant Number: HS07767
Project Period: March 1993-February 1997
Overview
In this project the investigators:
Impact on Further Research (Level I)
This project illustrated through demonstration projects on key clinical conditions how quality-of-life data can provide substantive additional information that may alter treatment choices of individuals.
Treatment Effectiveness
Sensitivity of Quality-of-life Measures: "General measures of quality of life may be too crude and insensitive to capture the important gains in health outcomes due to new therapeutic interventions and programs in diabetes. Quality-of-life evaluations for diabetes are at risk of favoring inferior programs with lower costs simply because gains or losses in health outcomes go undetected."
Specifically, this study demonstrated that current health state levels influence how patients value decrements and improvements in health. The health states rating clearly revealed that losses in function at relatively asymptomatic states have a greater negative utility than do losses at more severe states. It further notes that "our health states analysis demonstrated that people with mild-to-moderate diabetes substantially value smaller health improvements." The study makes the following recommendations: (1) enhance sensitivity of generic instruments rather than using disease-specific QOL instruments; (2) a QOL outcome measure must incorporate the subjective nature of preference by providing a comprehensive evaluation that focuses on patient self-perceptions of symptoms and health.87
Tools for Patient Management
Research Tools and Translating Research for Clinical Care
Principal Investigator: Morris Weinberger, Ph.D.
Grant Number: HS09083
Project Period: June 1996-May 2000
Overview
The purpose of this study is to develop algorithms to facilitate pharmaceutical care for the treatment of asthma. A randomized controlled trial, with 460 patients in a pharmacy intervention group and two control groups, will be undertaken. The pharmacy intervention group will be provided with patient-specific clinical information displayed on their computer workstations when filling prescriptions. This study will take advantage of Indiana University's long-standing project to develop an electronic medical record. Patient records will be available to the pharmacist from six hospitals and 234 free-standing clinics. Pharmacy records will also be made available to these linked providers.
Findings and publications related to this study are forthcoming.
Principal Investigator: Frank M. Ahern, Ph.D.
Grant Number: HS09075
Project Period: August 1996-July 2000
Overview
The purpose of this study is to compare two different models of outpatient prospective drug utilization review (ProDUR) programs in the state of Pennsylvania, one of which allows active participation by a pharmacist in the process while the other does not. The study aims to:
The investigators will use data from the Program of All Inclusive Care for the Elderly (PACE) and Medicaid. Outcomes to be studied include hospitalization and utilization of other health-related resources.
Findings and publications related to this study are forthcoming.