Abstract
INTRODUCTION
The prevalence of people with dementia (PWD) is increasing worldwide. In Germany, approximately 1.5 million people are affected by dementia and this number is estimated to double by 2050 [1]. This development presents a major challenge for the current health care system. It is essential to ensure that the needs of people affected are properly met and that future needs are anticipated as best as possible. This is especially necessary for health care planning on the individual and the societal level. Planning requires information beyond the prevalence of people diagnosed with dementia. Comprehensive data will help policy makers to identify capacities and gaps in the health care system for people affected. It will also provide a better opportunity to compare between different settings and countries.
In Germany, all citizens are mandatory insured by statutory health (SHI) and care insurance (SCI). From a certain amount of earning, they can choose to receive private insurance. Citizens who get social welfare are insured by the statutory health insurance as well. Primary care is defined as patient’s main source for regular medical care, ideally provided continuity and integration several health care services. In Germany, this is typically done by the general practitioner (GP), doctors who are members of the statutory health care system. They coordinate further outpatient treatments conducted by specialists and can prescribe drugs, outpatient therapies (like physical, occupational, and speech therapies) and medical aids. Furthermore, the GP can initiate in-hospital treatment and rehabilitation. All of these treatments are covered by the SHI. Within the SCI, all participants who are in need of care are entitled to formal care, like ambulatory care, day- and night care, long-term care, and other support programs. In this insurance, further payments for informal care could be provided.
In Germany, a number of studies have estimated the prevalence and incidence of dementia and described people affected by dementia in some detail. The Leipzig Longitudinal Study of the Aged (LEILA 75+; [2, 3]), a large populations-based prospective cohort study of older adults in Leipzig, examined risk factors for developing dementia. However, since PWD at baseline were excluded, a cross-sectional, population-based description was not possible. While the study delivers important results for risk factors, its use for describing PWD in primary care is limited. In the German Study on Ageing, Cognition and Dementia in primary care patients (AgeCoDe) [4, 5] participants were randomly drawn from registries of general physicians and repeatedly examined longitudinally. A diagnosis of dementia was an exclusion criteria, so that this study delivers a description of people in primary care without a formal diagnosis. While it is well known that dementia is underdiagnosed or recognized too late in primary care [6–8], excluding people with a formal diagnosis does not provide a valid picture of people affected by dementia in primary care. The presence or absence of a formal diagnosis is of importance in PWD; however, it constitutes a selection bias in health care oriented research. Thus, despite the rapid development in population-based dementia research, there is still a lack of knowledge about the population of PWD in primary care.
The benefit of indepth knowledge of PWD in specific settings has been shown before. For example, analyses of dementia networks in Germany have proven that these structures are beneficial to improving care for PWD by increasing utilization rates of specialized physicians, implying an improved treatment [9]. Cross-sectional analyses have shown that people served by these dementia networks show higher rates of formal diagnoses, receive antidementia drug treatment and non-pharmacological therapies more often, and show increased utilization of medical aids [10, 11]. The study of the population of PWD served by dementia networks allows stakeholders to tailor dementia networks to the needs of the people using them. Therefore the establishment of dementia networks is a focus area of the German dementia strategy as laid out in the “national alliance for people with dementia” [12].
Recent reviews describe key areas for PWD in primary care both nationally and internationally [13, 14] and illustrate the complexity associated with treatment and care of PWD. They underline the need for a comprehensive analysis of the population of PWD in primary care—simultaneously focusing on all variables and analyzing associations between them. By nature, analyses of PWD in primary care in Germany are specific to the health care system. However, a comprehensive analysis of dementia care specific variables allows a comparison of the population with other countries and health care systems. Differences between countries can be described and could be indicative of advantages or disadvantages of the respective health care intervention under examination.
A comprehensive, multivariate description of people affected by dementia is needed. Thus, the objective of the current analysis is to comprehensively describe the population of community-dwelling PWD in primary care with respect to various dementia care specific variables.
MATERIALS AND METHODS
Study design
The analyses are based on the baseline data of the ongoing GP-based, randomized, controlled intervention trial DelpHi-MV (Dementia: life- and person-centered help in Mecklenburg-Western Pomerania). The details of this study trial are described elsewhere [15]. Patients were systematically screened for dementia by their GP during routine visits, when they are 70 years or older and live at home. Patients meeting theses eligibility criteria were screened for dementia in participating GP practices using the DemTect [16]. This personal interview-based instrument is widely used for dementia screening in general practices in Germany [17]. Patients who meet the inclusion criteria for DelpHi-MV (DemTect <9) were informed about the study by their GPs, invited to participate, and asked to provide written informed consent. If the patient named a caregiver, he or she was asked to participate in the DelpHi-study as well. When the patient was unable to give a written informed consent, his or her legal representative was asked to sign the consent form on his or her behalf (as approved by the Ethical Committee of the Chamber of Physicians of Mecklenburg-Western Pomerania, registry number BB 20/11). The study physicians received allowances for performing the screening test (10€ per patient) and study enrollment (100€ per patient). The study enrollment into the main study started on January 1, 2012 and ended on December 31, 2014. The participants and their caregivers were assigned to an intervention and a control group, depending on whether the treating GP practice was randomized to the control or intervention group. This cluster-randomization procedure was chosen for the best possible control of spill-over effects of the intervention in one practice. In both groups, identical, standardized, computer-assisted baseline assessments were conducted as computer-assisted face-to-face interviews at the participants’ homes. After the baseline assessment, the control group continued receiving “care as usual”, whereas the intervention group received the “DelpHi-Intervention” [18]. The DelpHi-Intervention aims to provide “optimum care” by integrating multi-professional and multimodal strategies to individualize and optimize treatment of dementia within the framework of the established health care and social service system. The intervention is conducted by Dementia Care Managers (DCM)—nurses with dementia-specific training—at the people’s homes. The intervention begins with a comprehensive assessment of the care situation, needs, and resources. The DCM develops and implements an intervention plan tailored to the individual conditions in close cooperation with the GP.
Study population
A total of 6,838 patients were screened for dementia in 125 participating GP practices. Of these, 1,167 patients (17.1%) were eligible for the DelpHi-MV trial and of these 634 patients (54.4%) agreed to participate in the study. One hundred and eighteen patients dropped out of the study before the baseline assessment due to withdrawal of informed consent (n = 85); death (n = 19); relocation (n = 5); or other reasons (n = 9). There were no statistically significant differences between patients included in and those who dropped-out regarding the variables DemTect score, age, and sex. A detailed description of the study population is provided according to the CONSORT reporting standard in Fig. 1. Due to the comprehensive and demanding baseline assessment, not all variables could be assessed in all subjects. Therefore, descriptive statistics provide the respective number of participants for each assessment tool.
Procedures and instruments
For the present analysis of PWD in primary care, we assessed variables concerning age, sex, living situation (alone/not alone), cognitive status, functional status, level of impairment, comorbidities, formal diagnosis of dementia, depression, neuropsychiatric symptoms, quality of life, utilization of medical support, and pharmacological therapy.
Cognitive status was assessed using the German version of the Mini-Mental State Examination (MMSE) [19]. The MMSE provides a total score as well as a categorization that indicates “no indication or mild” (score, 20–30), “moderate” (score, 10–19), and “severe cognitive impairment” (score, 0–9). The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL) [20, 21], which yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment. Level of impairment was defined according to the “care level (Pflegestufe)” used by the care insurance for long-term care. Each person is assigned to either none or a specific grade of care. If a care level is assigned, each patient is categorized into one of four levels ranging from 0–3, with people in three needing the highest and in zero the lowest level of care. For all patients who had provided the respective informed consent, all formal medical diagnoses were retrieved from the medical records in their GPs’ practice. For a formal diagnosis of dementia, we analyze the ICD-10 codes: F00, F01, F02, F03, G30, and G31. Depression was operationalized using the Geriatric Depression Scale (GDS) [22, 23] as dichotomized variable (“no depression”: score, 0–5; “depression”: score, 6–15).
Neuropsychiatric symptoms were assessed using the German version of the Neuropsychiatric Inventory (NPI), an internationally widely used and validated, comprehensive assessment of psychopathology in PWD [24]. A total NPI-score can be calculated. A NPI-score of 5 and greater is considered to indicate clinically relevant symptoms. Based on this cut-off-score neuropsychiatric symptoms were dichotomized into “not clinically relevant” and “clinically relevant”.
The utilization of medical support was assessed by items asking whether in the preceding12 months the PWD has visited a neurologist/psychiatrist (yes/no). The utilization of health services was assessed whether the person with dementia had used one or more of the services during the preceding 12 month (yes/no). Services asked for were physiotherapy, occupational therapy, short term care, outpatient care, nursing home care, day and night care, acute hospital stay, and planned hospital stay. To ensure the validity of the responses, the caregivers were asked to indicate utilization.
Quality of life was assessed using the QoL–AD, a measure designed specifically to obtain a rating of the patient’s quality of life from both the patient and the caregiver. Each item is rated on a four-point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all items, range from 13 to 52.
Pharmacological therapy data was collected using a computer-based home medication review [25]. This review encompasses all medications used by the study participants and includes questions about compliance, adverse effects, and drug administration. The primary medication data in the context of the home medication review includes both prescription drugs and over-the-counter drugs. Data was then integrated using a pharmaceutical index of the statutory health insurance. To describe pharmaceutical treatment, we used the Anatomical Therapeutic Chemical (ATC) classification system [26]. For describing treatment with antidementia drugs, these chemical substances and their combinations were considered: donepezil (N06DA02), rivastigmine (N06DA03), galantamine (N06DA04), memantine (N06DX01), and donepezil and memantine (N06DA52). To describe treatment with antidepressant drugs, we used chemical substances of pharmacological subgroup N06A. To describe treatment with antipsychotic drugs, we used chemical substances of pharmacological subgroup N05A.
Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as “a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition” [27]. The PIM were identified using the Priscus list [28], which contains 83 drugs from 18 different drug classes.
Statistical analyses
We summarized the variables that describe the population using descriptive statistics. To test whether there was a bias in assignment to intervention and control, we analyzed both groups and tested for statistically significant differences between them using Fisher’s exact test and Welch’s t-test depending on the variable under examination. We chose a level of statistical significance of α <0.05. Even though assignment to either group was randomized, we could not rule out that GP practices changed their recruiting behavior after realizing what group they were assigned to. To evaluate a possible selection bias regarding the people with dementia, we conducted an analysis for people who dropped out before baseline assessment based on variables available at this point in time (age, sex, screening score). Statistical analyses were performed by STATA/SE [29].
RESULTS
The sample of people screened positive for dementia in primary care is on average 80.0 years old and in 59.5% female. About 49.1% indicated not to live alone, and 31.2% indicated that there was no caregiver available for them at that time of recruitment. The majority of subjects was married (42.1%) or widowed (45.2%), while just a few were single (5.7%) or divorced (7.0%). About 89.7% indicated that they had children. The people under examination rated their quality of life as average or rather good (mean = 2.8 on a scale from 1–4). There was no statistically significant difference between the intervention and the control group in most variables. There was a statistically significant difference in quality of life with people in the intervention group indicating slightly lower quality of life (2.76 versus 2.82). The detailed statistics are given in Table 1. A selection bias due to drop out could not be found, there was no difference between people who dropped out and people who provided baseline data with respect to age, sex, and cognitive impairment. The detailed analysis is given in Table 3.
Concerning clinical-, dementia-, and health-related variables, the sample under examination was on average mildly cognitively impaired with an average MMSE score of m = 22.2. Also, functional impairment was low (m = 3.7 on a scale from 0–10 with the lower the score the less impaired). An impairment grade was assigned in 38.0% of the population (n = 196) and among those impairment grade 1 was the most frequent (25.4%). Depression was identified in 15.4% of the people and other frequent comorbidities were high blood pressure (83.3%), diabetes mellitus type 1 and 2 (51.7%), coronary heart diseases (37.1%), and cerebrovascular diseases (22.3%). In 48.6%, neuropsychiatric symptoms were present in a clinically relevant severity. Pharmacological treatment with antidementia medication was received by 25.8%, antidepressant medication by 14.0%, and antipsychotic medication by 10.6% of PWD. The majority did not receive potentially inadequate medication according to Priscus criteria (78.5%), however 19.3% identified one PIM, 2.3% two PIM, and 0.2% three PIM. There was no statistically significant difference between intervention and control group in any of the variables. The detailed statistics are given in Table 2.
Examining the utilization of health care professionals during the last 12 months, 25.5% indicated to have visited a neurologists/ psychiatrist and 23.7% used ambulatory care. Considering hospital stays, 9.4% had a planned hospital stay and 21.8% an acute hospital stay. 10.2% of the sample used any kind of ambulatory care and 28.4% used any professional care (including ambulatory and in-patient). The frequency of non-medical therapies was low, with 21.7% having visited a physiotherapist, 3.3% an occupational therapist, and 1.2% a speech therapist. There was a statistically significant difference between intervention and control group in utilization of specialist service by neurologists/ psychiatrists; ambulatory care and acute hospital stay (people in the intervention group showed higher frequencies). This is probably an effect of the cluster-randomizing procedure. The detailed statistics are given in Table 2.
DISCUSSION
To the best of our knowledge, this is the first comprehensive analysis of community dwelling people screened positive for dementia in primary care in Germany. The results fit well into the international literature [1, 30–32]. Dementia, as an age-associated illness, is prevalent among the elderly; around 17% of the elderly (70+) were identified by screening. Prevalence figures across Europe range from 5.7% to 21.9% [32]. Two-thirds of people affected are female. Half of the PWD are widowed, the others are married; PWD being single or divorced are a minority. Nearly all have children and quality of life on average is moderate. This information does not give adequate information about informal care in community-dwelling PWD. Here more indepth analyses are necessary like those that have been published by Michalowsky et al. [33].
The sample under examination is representative of the people in primary care. More than 50% of people screened positive agreed to participate in this demanding study, which leaves some room for a selection bias that might affect the results toward over- or under-estimation. However, this is comparable to other intervention studies in the field, and there was no selection bias found between the participants and the non-participants as well as between the persons who dropped out during the study versus those who stayed on. However, we cannot rule out that our results are somewhat biased due to our recruitment by GP-practices. We are not able to statistically analyze whether there is a selection bias for participating versus non-participating practices. A survey we conducted in the area, however, indicates that participating practices did not differ at least in their attitude toward dementia treatment [34].
Community dwelling people screened positive for dementia in primary care are underdiagnosed and in their majority mildly to moderately affected. The average cognitive as well as functional impairment is moderate. Treatment and utilization of services is low, which can be interpreted in different ways. This might be a sign of inadequate treatment or unavailability or limited access to specialized care. On the other hand, treatment could not be indicated in the early stages of the disease. The data assessed does not allow a judgment about adequacy of treatment or non-treatment. Illnesses associated with dementia, like depression, were as frequent as expected (approximately 15%). In depression, pharmacological treatment was nearly as frequent as the occurrence of clinically relevant depressive symptoms. But, clinically relevant neuropsychiatric symptoms as consequence of dementia were present in almost half of the people in our sample. Every tenth person received treatment with antipsychotic drugs. This treatment rate is low compared to findings of a study that reported a treatment rate of 18% for community dwelling PWD with formal diagnosis of dementia in German primary care facilities [35]. Internationally, studies have determined rates of antipsychotic drug treatment that range from 7% in the United Kingdom [36] to 22% in Finland [37] and 27% in the United States [38]. However, three of these studies analyzed data from health insurance claims which are prone to a selection bias as stated previously [35, 38]. Specialist medical treatment by neurologists/psychiatrists seems to be frequent. The utilization of other health services including occupational therapy or the utilization of dementia-specific, evidence-based services is generally low. The utilization of physiotherapy is high, however, considering the multimorbidity of the sample, we do not know what the indication for this respective therapy is. Very little is known about the naturalistic course of utilization during the course of the disease. Since the study is a prospective trial, these data will become available as a result of the monitoring of the control group over time.
PWD in primary care need to be considered not only as suffering from dementia, but as general geriatric patients as well. Apart from dementia and dementia-related variables, other chronic diseases are frequent among PWD. This fits in the picture of the elderly being a population with high prevalence of multimorbidity. PWD are no exception to this and thus treatment and intervention needs to be multimodal and aiming at the other conditions as well.
In general, PWD screened positive for dementia in primary care constitute a complex and unique population of patients. The present analysis has shown a comprehensive, multivariate description leaving room for more in depth analyses. For example, there is a need to study the relations, associations, and interactions between different variables in more detail. The study completely leaves out people with dementia in nursing homes where similar analyses could be worthwhile. However, the purpose of this analysis was a descriptive analysis of the medical, social, and subjective properties of “the” community-dwelling PWD and initiate and generate more research. The overarching goal is to provide knowledge to develop health care/ treatment strategies that have the best impact on people with dementia in primary care.
ACKNOWLEDGMENTS
The assessment of data was conducted as part of the DelpHi-Trial. We thank the experienced field study team and research group, namely (in alphabetical order): Kerstin Albuerne, Aniela Angelow, Grit Assmann, Vaska Böhmann, Georgia Böwing, Kathleen Dittmer, Thomas Fiss, Sarah Gardzella, Jana Hubert, Ulrike Kempe, Viktoriya Kim, Saskia Moll, Andrea Pooch, Steffen Richter, Christiane Schnick, Christine Winckler.
Authors’ disclosures available online (http://j-alz.com/manuscript-disclosures/15-1076r1).