Healthcare Needs Patterns and Pattern-Predicting Factors in Dementia: Results of the Comprehensive, Computerized Unmet Needs Assessment from the Randomized, Controlled Interventional Trial InDePendent.

Background: Determining unmet need patterns and associated factors in primary care can potentially specify assessment batteries and tailor interventions in dementia more efficiently. Objective: To identify latent unmet healthcare need patterns and associated sociodemographic and clinical factors. Methods: This Latent Class Analysis (LCA) includes n = 417 community-dwelling people living with dementia. Subjects completed a comprehensive, computer-assisted face-to-face interview to identify unmet needs. One-hundred-fifteen predefined unmet medical, medication, nursing, psychosocial, and social care needs were available. LCA and multivariate logistic regressions were performed to identify unmet needs patterns and patient characteristics belonging to a specific pattern, respectively. Results: Four profiles were identified: [1] "few needs without any psychosocial need" (n = 44 (11%); mean: 7.4 needs), [2] "some medical and nursing care needs only" (n = 135 (32%); 9.7 needs), [3] "some needs in all areas" (n = 139 (33%); 14.3 needs), and [4] "many medical and nursing needs" (n = 99 (24%); 19.1 needs). Whereas the first class with the lowest number of needs comprised younger, less cognitively impaired patients without depressive symptoms, the fourth class had the highest number of unmet needs, containing patients with lower health status, less social support and higher comorbidity and depressive symptoms. Better access to social care services and higher social support reduced unmet needs, distinguishing the second from the third class (9.7 versus 14.3 needs). Conclusions: Access to the social care system, social support and depressive symptoms should be assessed, and the patient's health status and comorbidities monitored to more comprehensively identify unmet needs patterns and more efficiently guide tailored interventions.

Sociodemographic and Clinical Characteristics of People Living with Dementia and Their Associations with Unmet Healthcare Needs: Insights from the Baseline Assessment of the InDePendent Study.

Background: The healthcare needs of People living with Dementia (PlwD) (such as Alzheimer's disease) are often unmet. Information about the needs of community-dwelling PlwD and their association with sociodemographic and clinical characteristics is needed to fill the knowledge gap regarding factors influencing unmet needs among PlwD and to conduct a comprehensive needs assessment to develop tailored interventions. Objective: To describe sociodemographic and clinical characteristics of the InDePendent study population with particular reference to determinants of unmet needs. Methods: We analyzed baseline data of the multi-centre cluster-randomized controlled trial (InDePendent) using descriptive statistics to describe patients' sociodemographic and clinical characteristics and Poisson regression models to predict unmet needs, separated by sex. Data were collected personally via face-to-face interviews. Results: Most of the n = 417 participating PlwD were mild to moderately cognitively impaired, were not depressed, had an average of 10.8 diagnoses, took 6.7 medications, and had, on average, 2.4 unmet needs (62% of PlwD had at least one unmet need) measured by the Camberwell Assessment of Need for the Elderly (CANE). Low social support, a high body-mass-index, a lower education, functional impairment, and worse health status were associated with more unmet needs, regardless of sex. In women, higher unmet needs were associated with more depressive symptoms, a poor financial situation, living alone and not being recently treated by a general practitioner. In males, unmet needs increased with the number of medications taken. Conclusions: PlwD had a broad array of unmet healthcare needs, indicating primary healthcare provision improvement potentials. The results underscore the significance of early assessment of patient's clinical characteristics and unmet needs as a basis for individualized gender-sensible intervention strategies.∥ClinicalTrials.gov Identifier: NCT04741932, Registered on February 5, 2021.

Fluctuations of health states in dementia diseases and their impact on the assessment of health today using the EQ-5D-5L: Protocol of a mixed-methods study.

Introduction: The EQ-5D is a widely used health-related quality of life (HRQoL) instrument. The recall period "today" may miss out on recurrent health fluctuations often observed in people with dementia (PlwD). Thus, this study aims to assess the frequency of health fluctuations, affected HRQoL dimensions and the impact of the health fluctuations on the assessment of health today using the EQ-5D-5L. Methods and analysis: This mixed-methods study will base on n=50 patient and caregiver dyads and four main study phases: (1) Baseline assessment of patients' socio-demographic and clinical characteristics; (2) caregivers self-completion of a daily diary for 14 days, documenting patient's today's health compared to yesterday, the affected HRQoL dimensions, and events that could have caused the fluctuations; (3) administration of the EQ-5D-5L as self- and proxy-rating at baseline, day seven and day 14; (4) interviewing caregivers on patient's health fluctuation, the consideration of past fluctuations in the assessment of health today using the EQ-5D-5L, and the appropriateness of recall periods to capture health fluctuations on day 14. Qualitative semi-structured interview data will be analyzed thematically. Quantitative analyses will be used to describe the frequency and intensity of health fluctuations, affected dimensions, and the association between health fluctuation and its consideration in the assessment of health today. Discussion: This study aims to reveal insights into the health fluctuation in dementia, the affected dimensions, and underlying health events, as well as whether individuals adhere to the recall period of health today using the EQ-5D-5L. This study will also provide information about more appropriate recall periods that could better capture health fluctuations. Trial registration: This study is registered in the German Clinical Trials Register (DRKS00027956).

Impact of low-value medications on quality of life, hospitalization and costs - A longitudinal analysis of patients living with dementia.

INTRODUCTION: This study aimed to analyze the impact of low-value medications (Lvm), that is, medications unlikely to benefit patients but to cause harm, on patient-centered outcomes over 24 months. METHODS: This longitudinal analysis was based on baseline, 12 and 24 months follow-up data of 352 patients with dementia. The impact of Lvm on health-related quality of life (HRQoL), hospitalizations, and health care costs were assessed using multiple panel-specific regression models. RESULTS: Over 24 months, 182 patients (52%) received Lvm at least once and 56 (16%) continuously. Lvm significantly increased the risk of hospitalization by 49% (odds ratio, confidence interval [CI] 95% 1.06-2.09; p = 0.022), increased health care costs by €6810 (CI 95% -707€-14,27€; p = 0.076), and reduced patients' HRQoL (b = -1.55; CI 95% -2.76 to -0.35; p = 0.011). DISCUSSION: More than every second patient received Lvm, negatively impacting patient-reported HRQoL, hospitalizations, and costs. Innovative approaches are needed to encourage prescribers to avoid and replace Lvm in dementia care. HIGHLIGHTS: Over 24 months, more than every second patient received low-value medications (Lvm). Lvm negatively impact physical, psychological, and financial outcomes. Appropriate measures are needed to change prescription behaviors.

Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial.

BACKGROUND: A redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD). Especially in rural areas with limited access to primary care physicians and specialists, these models might improve PwD's quality of life and well-being. However, such care models are not available in Germany in regular healthcare. This study examines the acceptance, safety, efficacy, and health economic efficiency of an advanced nursing practice model for PwD in the primary care setting in Germany. METHODS: InDePendent is a two-arm, multi-center, cluster-randomized controlled intervention study. Inclusion criteria are age ≥70 years, cognitively impaired (DemTect ≤8) or formally diagnosed with dementia, and living in the own home. Patients will be recruited by general practitioners or specialists. Randomization is carried out at the physicians' level in a ratio of 1:2 (intervention vs. waiting-control group). After study inclusion, all participants will receive a baseline assessment and a follow-up assessment after 6 months. Patients of the intervention group will receive advanced dementia care management for 6 months, carried out by specialized nurses, who will conduct certain tasks, usually carried out by primary care physicians. This includes a standardized assessment of the patients' unmet needs, the generation and implementation of an individualized care plan to address the patients' needs in close coordination with the GP. PwD in the waiting-control group will receive routine care for 6 months and subsequently become part of the intervention group. The primary outcome is the number of unmet needs after 6 months measured by the Camberwell Assessment of Need for the Elderly (CANE). The primary analysis after 6 months is carried out using multilevel models and will be based on the intention-to-treat principle. Secondary outcomes are quality of life, caregiver burden, acceptance, and cost-effectiveness. In total, n=465 participants are needed to assess significant differences in the number of unmet needs between the intervention and control groups. DISCUSSION: The study will provide evidence about the acceptance, efficacy, and cost-effectiveness of an innovative interprofessional concept based on advanced nursing care. Results will contribute to the implementation of such models in the German healthcare system. The goal is to improve the current treatment and care situation for PwD and their caregivers and to expand nursing roles. TRIAL REGISTRATION: ClinicalTrials.gov NCT04741932 . Registered on 2 February 2021.

Associations Between Low-Value Medication in Dementia and Healthcare Costs.

BACKGROUND: Low-value medications (Lvm) provide little or no benefit to patients, may be harmful, and waste healthcare resources and costs. Although evidence from the literature indicates that Lvm is highly prevalent in dementia, evidence about the financial consequences of Lvm in dementia is limited. This study analyzed the association between receiving Lvm and healthcare costs from a public payers' perspective. METHODS: This analysis is based on data of 516 community-dwelling people living with dementia (PwD). Fourteen Lvm were extracted from dementia-specific guidelines, the German equivalent of the Choosing Wisely campaign, and the PRISCUS list. Healthcare utilization was retrospectively assessed via face-to-face interviews with caregivers and monetarized by standardized unit costs. Associations between Lvm and healthcare costs were analyzed using multiple linear regression models. RESULTS: Every third patient (n = 159, 31%) received Lvm. Low-value antiphlogistics, analgesics, anti-dementia drugs, sedatives and hypnotics, and antidepressants alone accounted for 77% of prescribed Lvm. PwD who received Lvm were significantly less cognitively impaired than those not receiving Lvm. Receiving Lvm was associated with higher medical care costs (b = 2959 €; 95% CI 1136-4783; p = 0.001), particularly due to higher hospitalization (b = 1911 €; 95% CI 376-3443; p = 0.015) and medication costs (b = 905 €; 95% CI 454-1357; p < 0.001). CONCLUSION: Lvm were prevalent, more likely occurring in the early stages of dementia, and cause financial harm for payers due to higher direct medical care costs. Further research is required to derive measures to prevent cost-driving Lvm in primary care, that is, implementing deprescribing interventions and moving health expenditures towards higher value resource use.

Prevalence of Low-Value Care and Its Associations with Patient-Centered Outcomes in Dementia.

BACKGROUND: Low-value care (LvC) is defined as care unlikely to provide a benefit to the patient regarding the patient's preferences, potential harms, costs, or available alternatives. Avoiding LvC and promoting recommended evidence-based treatments, referred to as high-value care (HvC), could improve patient-reported outcomes for people living with dementia (PwD). OBJECTIVE: This study aims to determine the prevalence of LvC and HvC in dementia and the associations of LvC and HvC with patients' quality of life and hospitalization. METHODS: The analysis was based on data of the DelpHi trial and included 516 PwD. Dementia-specific guidelines, the "Choosing Wisely" campaign and the PRISCUS list were used to indicate LvC and HvC treatments, resulting in 347 LvC and HvC related recommendations. Of these, 77 recommendations (51 for LvC, 26 for HvC) were measured within the DelpHi-trial and finally used for this analysis. The association of LvC and HvC treatments with PwD health-related quality of life (HRQoL) and hospitalization was assessed using multiple regression models. RESULTS: LvC was highly prevalent in PwD (31%). PwD receiving LvC had a significantly lower quality of life (b = -0.07; 95% CI -0.14 - -0.01) and were significantly more likely to be hospitalized (OR = 2.06; 95% CI 1.26-3.39). Different HvC treatments were associated with both positive and negative changes in HRQoL. CONCLUSION: LvC could cause adverse outcomes and should be identified as early as possible and tried to be replaced. Future research should examine innovative models of care or treatment pathways supporting the identification and replacement of LvC in dementia.

Who Benefits Most from Collaborative Dementia Care from a Patient and Payer Perspective? A Subgroup Cost-Effectiveness Analysis.

BACKGROUND: Dementia care management (DCM) aims to provide optimal treatment for people with dementia (PwD). Treatment and care needs are dependent on patients' sociodemographic and clinical characteristics and thus, economic outcomes could depend on such characteristics. OBJECTIVE: To detect important subgroups that benefit most from DCM and for which a significant effect on cost, QALY, and the individual cost-effectiveness could be achieved. METHODS: The analysis was based on 444 participants of the DelpHi-trial. For each subgroup, the probability of DCM being cost-effective was calculated and visualized using cost-effectiveness acceptability curves. The impact of DCM on individual costs and QALYs was assessed by using multivariate regression models with interaction terms. RESULTS: The probability of DCM being cost-effective at a willingness-to-pay of 40,000€ /QALY was higher in females (96% versus 16% for males), in those living alone (96% versus 26% for those living not alone), in those being moderately to severely cognitively (100% versus 3% for patients without cognitive impairment) and functionally impaired (97% versus 16% for patients without functional impairment), and in PwD having a high comorbidity (96% versus 26% for patients with a low comorbidity). Multivariate analyses revealed that females (b = -10,873; SE = 4,775, p = 0.023) who received the intervention had significantly lower healthcare cost. DCM significantly improved QALY for PwD with mild and moderate cognitive (b = +0.232, SE = 0.105) and functional deficits (b = +0.200, SE = 0.095). CONCLUSION: Patients characteristics significantly affect the cost-effectiveness. Females, patients living alone, patients with a high comorbidity, and those being moderately cognitively and functionally impaired benefit most from DCM. For those subgroups, healthcare payers could gain the highest cost savings and the highest effects on QALYs when DCM will be implemented.

Drug-Related Problems Increase Healthcare Costs for People Living with Dementia.

BACKGROUND: Drug-related problems (DRP) are common in the elderly population, especially in people living with dementia (PwD). DRP are associated with adverse outcomes that could result in increased costs. OBJECTIVE: The objective of the study was to analyze the association between DRP and healthcare costs in PwD. METHODS: The analysis was based on the cross-sectional data of 424 PwD. Compliance, adverse effects, and drug administration of prescribed and over-the-counter drugs taken were assessed. DRP were identified and classified by pharmacists using an adapted German version of "PIE-Doc®". Healthcare utilization was assessed retrospectively used to calculated costs from a public payer perspective using standardized unit costs. The associations between DRP and healthcare costs were analyzed using multiple linear regression models. RESULTS: 394 PwD (93%) had at least one DRP. An inappropriate drug choice was significantly associated with increased total costs (b = 2,718€; CI95% 1,448-3,988) due to significantly higher costs for hospitalization (b = 1,936€; 670-3,202) and for medications (b = 417€; 68-765). Problems with medication dosage and drug interactions were significantly associated with higher medication costs (b = 679€; 31-1,328; and b = 630€; 259-1,001, respectively). CONCLUSIONS: DRP could significantly lead to adverse outcomes for PwD and healthcare payers, reflected by a higher hospitalization and costs, respectively. Further research is needed to clarify on interventions and approaches efficiently avoiding DRP and on the effect on patient-reported and economic outcomes.