Design and implementation of the participatory German network for translational dementia care research (TaNDem): A mixed-method study on the perspectives of healthcare providers and dementia researchers in dementia care research.

BACKGROUND: Currently, there is a lack of interaction between research and healthcare practice. As a result, research findings reach healthcare practice only late, and topics relevant to practice are often not known in research. Involving people living with dementia (PlwD), their relatives and healthcare providers in dementia care research can accelerate this process. For inclusion, firm and reliable structures are needed, which are to be established with the help of the Translational Network for Dementia Care Research in Germany. However, there is only limited knowledge about the priorities, expectations and conditions of stakeholders (healthcare providers and dementia researchers) for such cooperation within a network. OBJECTIVES: The aim is to gather stakeholders' views on (i) future research topics to be addressed within the dementia care research network, (ii) the nature of collaboration within the network and (iii) the facilitating and hindering factors for establishing such a network. METHODS: Within an exploratory sequential mixed-method study, we interviewed 87 stakeholders within eleven semistructured focus group interviews. The interviews were transcribed, pseudonymized and analyzed using qualitative content analysis. The qualitative data were analyzed with MAXQDA. Based on the qualitative results found in the focus group interviews, a supplementary online questionnaire was developed to prioritise and rank these findings afterwards. RESULTS: Stakeholders prioritized a comprehensible transfer of research results into practice, increased involvement of PlwD and their relatives (additionally marginalized groups such as people with a migrant background) in research and exchange between researchers. Cooperation should preferably occur in a regional context with local contacts, and the latest research results should be made available via an online database. The stakeholders' time, finances and human resources should be considered. CONCLUSION: Stakeholders have partly similar preferences and goals for cooperation and involvement, emphasizing that such interaction in a network offers the possibility of long-term, effective collaboration and added value for practice and research. PATIENT OR PUBLIC CONTRIBUTION: For this study, dementia healthcare providers and dementia care researchers were asked about their perspectives. Their involvement is further elucidated in the manuscript text.

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.

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.

Clinical Outcomes and Cost-Effectiveness of Collaborative Dementia Care: A Secondary Analysis of a Cluster Randomized Clinical Trial.

Importance: Long-term evidence for the effectiveness and cost-effectiveness of collaborative dementia care management (CDCM) is lacking. Objective: To evaluate whether 6 months of CDCM is associated with improved patient clinical outcomes and caregiver burden and is cost-effective compared with usual care over 36 months. Design, Setting, and Participants: This was a prespecified secondary analysis of a general practitioner (GP)-based, cluster randomized, 2-arm clinical trial conducted in Germany from January 1, 2012, to December 31, 2014, with follow-up until March 31, 2018. Participants were aged 70 years or older, lived at home, and screened positive for dementia. Data were analyzed from March 2011 to March 2018. Intervention: The intervention group received CDCM, comprising a comprehensive needs assessment and individualized interventions by nurses specifically qualified for dementia care collaborating with GPs and health care stakeholders over 6 months. The control group received usual care. Main Outcomes and Measures: Main outcomes were neuropsychiatric symptoms (Neuropsychiatric Inventory [NPI]), caregiver burden (Berlin Inventory of Caregivers' Burden in Dementia [BIZA-D]), health-related quality of life (HRQOL, measured by the Quality of Life in Alzheimer Disease scale and 12-Item Short-Form Health Survey [SF-12]), antidementia drug treatment, potentially inappropriate medication, and cost-effectiveness (incremental cost per quality-adjusted life year [QALY]) over 36 months. Outcomes between groups were compared using multivariate regression models adjusted for baseline scores. Results: A total of 308 patients, of whom 221 (71.8%) received CDCM (mean [SD] age, 80.1 [5.3] years; 142 [64.3%] women) and 87 (28.2%) received usual care (mean [SD] age, 79.2 [4.5] years; 50 [57.5%] women), were included in the clinical effectiveness analyses, and 428 (303 [70.8%] CDCM, 125 [29.2%] usual care) were included in the cost-effectiveness analysis (which included 120 patients who had died). Participants receiving CDCM showed significantly fewer behavioral and psychological symptoms (adjusted mean difference [AMD] in NPI score, -10.26 [95% CI, -16.95 to -3.58]; P = .003; Cohen d, -0.78 [95% CI, -1.09 to -0.46]), better mental health (AMD in SF-12 Mental Component Summary score, 2.26 [95% CI, 0.31-4.21]; P = .02; Cohen d, 0.26 [95% CI, -0.11 to 0.51]), and lower caregiver burden (AMD in BIZA-D score, -0.59 [95% CI, -0.81 to -0.37]; P < .001; Cohen d, -0.71 [95% CI, -1.03 to -0.40]). There was no difference between the CDCM group and usual care group in use of antidementia drugs (adjusted odds ratio, 1.91 [95% CI, 0.96-3.77]; P = .07; Cramér V, 0.12) after 36 months. There was no association with overall HRQOL, physical health, or use of potentially inappropriate medication. The CDCM group gained QALYs (0.137 [95% CI, 0.000 to 0.274]; P = .049; Cohen d, 0.20 [95% CI, -0.09 to 0.40]) but had no significant increase in costs (437€ [-5438€ to 6313€] [US $476 (95% CI, -$5927 to $6881)]; P = .87; Cohen d, 0.07 [95% CI, -0.14 to 0.28]), resulting in a cost-effectiveness ratio of 3186€ (US $3472) per QALY. Cost-effectiveness was significantly better for patients living alone (CDCM dominated, with lower costs and more QALYs gained) than for those living with a caregiver (47 538€ [US $51 816] per QALY). Conclusions and Relevance: In this secondary analysis of a cluster randomized clinical trial, CDCM was associated with improved patient, caregiver, and health system-relevant outcomes over 36 months beyond the intervention period. Therefore, it should become a health policy priority to initiate translation of CDCM into routine care. Trial Registration: ClinicalTrials.gov Identifier: NCT01401582.

Discrepancies between self- and proxy-rated quality of life in people living with dementia.

INTRODUCTION: The aim of this study was to analyze discrepancies between self- and proxy-rated health-related quality of life (HRQoL), measured with the EuroQol 5 Dimension 5 Level survey (EQ-5D-5L), in people living with dementia (PlwD) and their caregivers on an individual response level. METHODS: EQ-5D-5L, sociodemographic and clinical data were obtained from baseline data of n = 174 dyads of a cluster-randomized, controlled intervention trial. Self- and proxy-rated EQ-5D-5L health profiles were evaluated in terms of response distribution and agreement (weighted Kappa), and discrepancies in individual dimension level were analyzed using the Paretian Classification of Health Change (PCHC) as well as the presence and degree of inconsistencies between ratings. RESULTS: PlwD had a mean age of 80.1, nearly the half were female and 82.3% were mildly to moderately cognitively impaired. PlwD reported a higher utility index than caregiver proxies (mean 0.75 vs. 0.68, 83% of PlwD > 0.5). According to the PCHC and inconsistency approach, 95% of PlwD rated their health differently compared to proxies; 66% with divergent responses in at least three EQ-5D-5L dimensions. Nine dyads (5%) showed identical ratings. Discrepancies of one higher or lower EQ-5D-5L response represented the most frequent discrepancy (35.4%). Caregivers were two times more likely to report "moderate problems," representing the middle of the 5-point Likert scale. Usual activities had the lowest agreement between ratings (weighted kappa = 0.23). In PlwD reporting no or some problems in EQ-5D-5L-dimensions, proxies were more likely to report more problems and vice versa, especially in the more observable dimension usual activities and less likely in the less observable domains pain/discomfort and anxiety/depression. DISCUSSION: The central tendency bias observed in proxy-ratings could be associated with assessment uncertainties, resulting in an underestimation (overestimation) in PlwD reporting better (worse) health. This diverging trend extends the knowledge from previous studies and underlines the need for more methodological research in this area. Highlights: People living with dementia (PlwD) rate their health differently than proxies.Proxy-ratings over- or underestimate PlwD health when self-ratings are low or high.Proxies indicate a possible central tendency bias.Further research is needed to understand influencing factors.

Do They Align? Congruence Between Patient Preferences of People Living with Cognitive Impairments and Physicians' Judgements for Person-Centered Care: An Analytic Hierarchy Process Study.

BACKGROUND: Person-centered care (PCC) requires knowledge about patient preferences. Among people living with cognitive impairments (PlwCI), evidence on quantitative, choice-based preferences, which allow to quantify, weigh, and rank care elements, is limited. Furthermore, data on the congruence of patient preferences with physicians' judgements for PCC are missing. Such information is expected to support the implementation of PCC; state-of-the-art medical care aligned with patients' preferences. OBJECTIVE: To elicit patient preferences and physicians' judgements for PCC and their congruence. METHODS: Data from the mixed-methods PreDemCare study, including a cross-sectional, paper-and-pencil, interviewer-assisted analytic hierarchy process (AHP) survey conducted with n = 50 community-dwelling PlwCI and n = 25 physicians. Individual AHP weights (preferences/judgements) were calculated with the principal eigenvector method and aggregated per group by aggregation of individual priorities mode. Individual consistency ratios (CRs) were calculated and aggregated per group. Group differences in preferences/judgements were investigated descriptively by means and standard deviations (SDs) of AHP weights, resulting ranks, and boxplots. Additionally, differences between groups were investigated with independent paired t-test/Mann Whitney U-test. Sensitivity of AHP results was tested by inclusion/exclusion of inconsistent respondents, with an accepted threshold at CR≤0.3 for patients, and CR≤0.2 for physicians, due to better cognitive fitness of the latter group. RESULTS: Patient preferences and physicians' judgements did not differ significantly, except for the criterion Memory Exercises (AHP weights (mean (SD)): 0.135 (0.066) versus 0.099 (0.068), p = 0.01). We did not see rank-reversals of criteria after exclusion of inconsistent participants. Mean CR for patients at the criteria level was 0.261, and 0.181 for physicians. CONCLUSION: Physicians' judgements in our setting aligned well with patients' preferences. Our findings may be used to guide the implementation of preference-based PCC.

Development of a Quantitative Preference Instrument for Person-Centered Dementia Care-Stage 2: Insights from a Formative Qualitative Study to Design and Pretest a Dementia-Friendly Analytic Hierarchy Process Survey.

Person-centered care (PCC) requires knowledge about patient preferences. An analytic hierarchy process (AHP) is one approach to quantify, weigh and rank patient preferences suitable for People living with Dementia (PlwD), due to simple pairwise comparisons of individual criteria from a complex decision problem. The objective of the present study was to design and pretest a dementia-friendly AHP survey. Methods: Two expert panels consisting of n = 4 Dementia Care Managers and n = 4 physicians to ensure content-validity, and "thinking-aloud" interviews with n = 11 PlwD and n = 3 family caregivers to ensure the face validity of the AHP survey. Following a semi-structured interview guide, PlwD were asked to assess appropriateness and comprehensibility. Data, field notes and partial interview transcripts were analyzed with a constant comparative approach, and feedback was incorporated continuously until PlwD had no further comments or struggles with survey completion. Consistency ratios (CRs) were calculated with Microsoft® Excel and ExpertChoice Comparion®. Results: Three main categories with sub-categories emerged: (1) Content: clear task introduction, (sub)criteria description, criteria homogeneity, (sub)criteria appropriateness, retest questions and sociodemography for heterogeneity; (2) Format: survey structure, pairwise comparison sequence, survey length, graphical design (incl. AHP scale), survey procedure explanation, survey assistance and response perspective; and (3) Layout: easy wording, short sentences and visual aids. Individual CRs ranged from 0.08 to 0.859, and the consolidated CR was 0.37 (0.038). Conclusions: Our formative qualitative study provides initial data for the design of a dementia-friendly AHP survey. Consideration of our findings may contribute to face and content validity in future quantitative preference research in dementia.

Translation of Collaborative Dementia Care Management into Different Healthcare Settings: Study Protocol for a Multicenter Implementation Trial (DCM:IMPact).

Background: Collaborative care models for people living with dementia (PwD) have been developed and evaluated, demonstrating safety, efficacy, and cost-effectiveness. However, these studies are based on heterogeneous study populations and primary care settings, limiting the generalizability of the results. Therefore, this study aims to implement and evaluate collaborative care across various healthcare settings and patient populations. Objective: To describe the study design of this multicenter implementation trial. Methods: This single-arm, multicenter, longitudinal implementation study will be conducted in five different healthcare settings, including 1) physicians' networks, 2) dementia networks, 3) counselling centers, 4) hospitals, and 5) ambulatory care services. Eligibility criteria are: having a formal dementia diagnosis or having been screened positive for dementia and living community-dwelling. The staff of each healthcare setting identifies patients, informs them about the study, and invites them to participate. Participants will receive a baseline assessment followed by collaborative individualized dementia care management, comprising proven safe, effective, and cost-effective modules. Over six months, specially-qualified nurses will assess patients' unmet needs, transfer them to individualized care plans, and address them, cooperating with various healthcare providers. A follow-up assessment is conducted six months after baseline. Approximately 60-100 PwD per setting per year are expected to participate. Differences across settings will be assessed regarding acceptability, demand, implementation success and barriers, efficacy, and cost-effectiveness. Results: We expect that acceptability, demand, implementation success and barriers, efficacy, and cost-effectiveness will vary by patients' sociodemographic and clinical characteristics and unmet needs in each setting. Conclusion: The results will provide evidence highlighting differences in the implementation of collaborative care in various healthcare settings and demonstrating the settings with the highest need, best conditions for a successful implementation, and highest (cost-)effectiveness, as well as the population group that benefits most from collaborative care. Trial registration: German Clinical Trials Register: DRKS00025074. Registered 16 April 2021-retrospectively registered.

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.

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.

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.