Dr. Steven Belle: (412)624-1620
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COGNITIVE ENHANCEMENT MEDICATION UTILIZATION AMONG PERSONS WITH ALZHEIMER’S DISEASE WHO HAVE A FAMILY CAREGIVER: RESULTS FROM THE RESOURCES FOR ENHANCING ALZHEIMER’S CAREGIVER HEALTH (REACH) PROJECT
S. H. Belle1, S. Zhang1, S.J. Czaja2, R. Burns3, R. Schulz4
1 Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA 15261
2 Department of Psychiatry, University of Miami School of Medicine, Miami, FL 33136
3 Department of Preventive Medicine, University of Tennessee, and Regional Medical Center
Memphis, TN 38104
4 Department of Psychiatry and University Center for Social and Urban Research, University of Pittsburgh, Pittsburgh PA, 15261
Previous Presentation: . Annual Meeting of the Gerontological Society of America. Boston, MA. November 22-26, 2002.
REPRINT REQUESTS TO: Steven Belle, PhD. Department of Epidemiology. Graduate School of Public Health. University of Pittsburgh. 504 Parran Hall. 130 DeSoto St. Pittsburgh, PA 15261.
ACKNOWLEDGEMENTS: This research was supported through the Resources for Enhancing Alzheimer’s Caregiver Health (REACH) project, which is supported by the National Institute
on Aging and the National Institute of Nursing Research (Grants: U01-NR13269, U01-AG13313, U01-AG13297, U01-AG13289, U01-AG13265, U01-AG13255, U01-AG13305). Support was also provided by Eisai/Pfizer.
Keywords: Medication utilization
Dementia
Caregiving
uu
Cognitive impairment Cognitive enhancementDementia
Caregiving
COGNITIVE ENHANCEMENT MEDICATION UTILIZATION AMONG PERSONS WITH ALZHEIMER’S DISEASE WHO HAVE A FAMILY CAREGIVER: RESULTS FROM THE RESOURCES FOR ENHANCING ALZHEIMER’S CAREGIVER HEALTH (REACH) PROJECT
S. H. Belle1, S. Zhang1, S.J. Czaja2, R. Burns3, R. Schulz4
1 Department of Epidemiology Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA 15261
2 Department of Psychiatry, University of Miami School of Medicine, Miami, FL 33136
3 Department of Preventive Medicine, University of Tennessee, and Regional Medical Center
Memphis, TN 38104
4 Department of Psychiatry and University Center for Social and Urban Research, University of Pittsburgh, Pittsburgh PA, 15261
Abstract:
Objective: An agingAn aging population has has an increaseding prevalence of cognitive impairment and dementia. With evidence thatRecent efficacy studies report on prescription medications and herbal medicines preparations that affect cognitive function, but the prevalence and correlates of cognitive enhancement (CE) medication utilization among community-dwelling people elderswith dementia is not well studied. We examinedwas studied to determine the frequency and appropriateness of use, and whether use was appropriate, the importance of a family caregiver in decisions about medications taken by people with dementia, and whether there was differential access to medical care.
Method: REACH was a multi-site, multi-intervention feasibility study of several approaches to reduce negative impacts of caregiving on caregivers living with a family member with dementia. Medication use by care-recipients was collected at baseline and one year later.
Results: At baseline, 31% of 1222 care-recipients (CR) were using a cognitive enhancement (CE) medication. Independent fFactors independently related to greater CE use among CR at baseline were younger care recipientage, education, functional status ands, higher care recipient education level, fewer deficits in activities of daily living in care-recipients, and less caregiver vigilance. Within 1 year, 14% of CR started, and 30% quit, taking CE. Care-recipients more likely to be starters than never users had spouse caregivers, higher education, and fewer baseline ADL impairments than those who never took CE. Compared to those who continued taking CE, CR more likely to quitters had more ADL deficits at baseline, and became less able to perform ADL during followup.
Conclusions: CEognitive enhancement medication use among demented people with Alzheimer’s Disease who have a family caregiver is relatively common, though there is substantial geographic variability. in the United States. Our findings are mixed with respect to appropriate use of CE medications suggesting areas for improving physician education. Our data indicate the importance of the caregiver in CE medication use and they also suggest that there Relationships with education may beindicate disparities in access to health care among people with cognitive impairment. , whereas relationships with care-recipient functional status indicate appropriate use. However, the proportion of severely impaired people taking CE medications indicates an area for improving physician education.
Introduction
As the number of elderly people in the United Statespopulations increases, so does the burden on public health and on both medical and social services caused by age-related diseases and disabilities. In particular, the incidence of cognitive impairment and dementing disorders increase dramatically with age [1] [1]. Dementia is characterized by cognitive impairment, but affected individuals often experience behavioral and psychological symptoms such as agitation, wandering, sleep disturbance, depression, and anxiety [2] [2]. These manifestations may require medical or social services for many patients who are cared for at home and can eventually lead to institutionalization [2] [2].
Recent reports demonstrate the efficacy of a number of medications for treating mild to moderate Alzheimer’s Disease. These cognitive enhancement (CE) medications include cholinesterase inhibitors (e.g., tacrine [Cognex], galantamine [Reminyl], physostigmine, donezepil [Aricept], rivastigmine [Exelon]) and an N-methyl-aspartate (NDA)-receptor antagonist (memantine) [3-5]. [3-5][4,5]{Trinh NH, Hoblyn J, et al. 2003 TRINHNH2003 /id}.Other medications either under investigation or under consideration include nonsteroidal anti-inflammatory drugs, estrogen, antioxidants, and chelation therapy [6] [6]. Additionally, hHerbal medications including ginkgo biloba and ginseng have also been reported toto have cognitive or concentration enhancing properties [7][7]{Ernst E 2002 ERNSTE2002 /id}[8]{Ernst E 2002 ERNSTE2002 /id}{van Dongen MC, van Rossum E, et al. 2000 VANDONGENMCVANR2000 /id}.
[7,8].
To date, studies of CE medication use in this population have primarily focused on treatment efficacy. Relatively little is known about the prevalence of CE use in community-residing populations. The purpose of this paper is to examine the prevalence of use of CE medications and herbal products with putative cognitive enhancement properties in a well-characterized cohort of people with Alzheimer’s Disease. Since caregivers play a central role in managing patients’ medications, it is important to identify both caregiver and care-recipient characteristics associated with using these medications and herbal products. Moreover, thisThe availability of longitudinal datastudy also enabled us to examine changes in utilization patterns, of use.
Utilization data are also important for helping to answer questions about appropriate use of medications. For example, cholinesterase inhibitors are beneficial for community-living patients with mild to moderate dementia [5] [5], though they may soon be considered for people with more severe dementia [4][4]. Thus, at present, one may characterize use of cognitive enhancement medications by people with moderate to severe dementia asto be inappropriate, based on research current when data were being collected for this study. Characteristics of users compared to non-users can also help to identify disparities in access to potentially costly medical treatments. Finally, knowing characteristics of medication users can inform recruitment design and analytical strategies for randomized or observational efficacy studies.
Methods
The sample was enrolled in the Resources Enhancing Alzheimer’s Caregiver Health (REACH) project, a 6-site study with a central Coordinating Center funded jointly by the National Institute on Aging and the National Institute for Nursing Research. REACH was designed to investigate the feasibility of various interventions in alleviating the burden of family caregivers with Alzheimer’s Disease or a related disorder. Recruitment strategies and sources varied by site with the latter includingSite-specific recruitment sites included community, health, and social agenciesy settings,. with sSpecial attention to was given to enrolling ethnically and racially diverse participants. Details about recruitment strategies and the interventions at each site can be found in Wisniewski, Belle, Coon et al [8] [9].
Briefly, after obtaining informed consent as required by Institutional Review Boards (IRB) at each site, eligible caregiver/care-recipient dyads were randomly assigned to either a control condition or one of either one or two active treatment groups that varied by site. To be eligible, care-recipients had to have a diagnosis of Alzheimer’s Disease or a related dementia, and at least one limitation in basic activities of daily living (ADL; [9] [10]) or two dependencies in Instrumental Activities of Daily Living (IADL;[10] [11]).
Medication utilization was recorded by trained personnel during study visits (baseline and 6 months, 12 months, and 18 months following randomization) after examining containers of all medications being taken by care-recipients and by caregivers. Medications were initially classified using the Instant Drug Index [12]{Instant Drug Index 2001 ANON2001 /id}]. Those classified as Psychiatric, and all herbals, were examined by the study pharmacist to determine whether they were cognitive enhancement (CE) medications.
Measures
Caregiver: Baseline CE use was examined by site, caregiver relationship to care recipient, and by demographics (age, sex, race, educational level and family income). Additional caregiver factors studied were burden (Revised Memory and Behavior Problems Checklist; [13] [13]), depression (CES-D;, [14] [14]), a measure of the positive aspects of caregiving, anxiety [15] [15], self-rated health and health behavitors (adapted from [16,17]), health behaviors and vigilance {Gómez-Rubio, Porres, et al. 1990 GÓMEZRUBIO1990 /id}].[18]. Changes in medication use were examined by the baseline characteristics andas well as by changes in these characteristics.
Care-recipient characteristics included demographics, functional abilities (ADL, IADL) and cognitive status (MMSE; [19]). Changes in medication use were examined by the baseline characteristics and by changes in both ADL and IADL. Change in MMSE was not examined because of the relatively large amount of missing data at follow-up assessment times.
Analytical methods
The prevalence of CE use at baseline by caregiver and care-recipient characteristics was assessed. Chi-square tests for differences in proportions were performed to identify statistically significant differences in prevalence for the categorical factors. A p-value less than 0.05 was used to determine statistical significance for all tests. A simple generalized linear model with log link and binomial error was used for continuous factors [19] [20]. From this model, we obtained relative risk estimates. Multiple regression models were fit to identify caregiver and care recipient demographic characteristics, and other measures, that were independently associated with CE-use. Stepwise selection was used to determine which explanatory variables to keep in the fitted models.
To characterize changes in CE medication use over time, four groups were created: never users did not use CE at baseline or at the 12-months follow-up, starters did not use CE at baseline but did at 12-months, quitters used CE at baseline but not at 12-months and maintainers used CE at both baseline and 12-months. To examine factors associated with changes in medication use, starters were compared to never users (the two groups of baseline non-users) and quitters were compared to maintainers (the two groups of baseline users). Proportions of care-recipients changing (starting or quitting) use were calculated by caregiver and care-recipient characteristics. The chi-square test for differences in proportions were performed to identify statistically significant differences in the proportions changing pattern of use for the categorical factors Two sets of regression models (as described above) were used to identify caregiver and care-recipient factors associated with starting (vs. never using) and quitting (vs. maintaining), respectively. These models were built in a stepwise manner with probabilities of 0.05 required for keeping a variable in the model. Relative risks of the change in patterns of use (i.e., starting vs. never using, quitting vs. maintaining) are reported.
Results
The six REACH sites randomized 1222 care-recipient/caregiver dyads between October, 1996 and May, 2001. The caregivers averaged 62.3 (SD = 13.6) years of age, ranging from 22 to 95 years old. Reflecting the intent to recruit a sizeable number of minority caregivers, the sample of caregivers was racially and ethnically diverse, 24.2% were African-American/Black and 19.0% were Hispanic/Latino. Over 80% of the caregivers were female with approximately three-quarters of the caregivers being either wives (35.7%) or daughters or daughters-in-law (39.0%) of the care-recipients. The care-recipients averaged 79.1 (SD = 8.2) years of age (range 44-101 years), 72.3% were at least 75 years old and the majority was female (55.6%). Mini-Mental State Examination (MMSE;[11]) scores ranged from 0-29 with an average of 12.6. On average, care-recipients had 3.3 (out of 6) ADL deficits and needed assistance with 7.3 (out of 8) IADL
Cognitive Enhancement Medication Utilization at Baseline
Cognitive enhancement medications were used by 382 (31%) of the care-recipients at baseline. The most common CE medication was Aricept (Donepezil), used by 320 of the care-recipients who were using any CE (84%). Ginkgo biloba or ginseng was used by 80 care-recipients, 36 of whom were also using Aricept (Table 1).
In unadjusted analysis, baseline CE medication use differed (p<.05) by site, CG/CR relationship and caregiver demographic factors (age, sex, education, and income). Over half of the care-recipients at Miami used CE compared to only 11.7% at Palo Alto. Utilization ranged between 22.0% and 36.4% at the other 4 sites. Care recipients who were married to their caregiver were more likely to be CE users than care-recipients who had another relationship (usually parent) to their caregiver. CE use at baseline was higher if the caregiver was older, male, better educated, or had a higher income. The care-recipients of caregivers reporting higher levels of positive aspects of caregiving, fewer hours doing things for the care-recipient, or fewer hours being “on duty” were also more likely to use CE at baseline. Care-recipient characteristics associated with increased baseline CE use were age (use was highest among care-recieipientss of 70 to 84 years old), more education, less cognitive impairment and less functional impairment.
Multiple regression models were used to identify which of the baseline factors were independently associated with CE use (Table 2). Relative risks greater than one, indicating more CE use, were found for higher educated care recipients, those requiring assistance with fewer ADLs, and those whose caregivers spent less time “on duty”. CE utilization increased with care-recipient age up to 74 years of age, declining for older care-recipients. CE use was also significantly lower in Palo Alto than at the other five sites. There were no statistically significant interaction terms.
Change in Cognitive Enhancement Medication Utilization
Due to care-recipient death (n=130), placement (n=135), a missed visit (n=154), dropout (n=119) or a missing form (n=3), care-recipient medication utilization was available at 12 months for 681 participants (56% of the baseline cohort). These care-recipients included 467 who did not use CE at baseline (56% of non-users) and 214 who did use CE at baseline (56% of users). There were 67 starters (14% of baseline non-users) and 64 quitters (30% of baseline users).