Development and implementation of a treatment pathway to reduce coronary angiograms - lessons from a failure.

BACKGROUND: The rates of coronary angiograms (CA) and related procedures (percutaneous intervention [PCI]) are significantly higher in Germany than in other Organisation for Economic Co-ordination and Development (OECD) countries. The current guidelines recommend non-invasive diagnosis of coronary heart disease (CHD); CA should only have a limited role in choosing the appropriate revascularisation procedure. The aim of the present study was to explore whether improvements in guideline adherence can be achieved through the implementation of regional treatment pathways. We chose four regions of Germany with high utilisation of CAs for the study. Here we report the results of the concomitant qualitative study. METHODS: General practitioners and specialist physicians (cardiologists, hospital-based cardiologists, emergency physicians, radiologists and nuclear medicine specialists) caring for patients with suspected CHD were invited to develop regional treatment pathways. Four academic departments provided support for moderation, provision of materials, etc. The study team observed session discussions and took notes. After the development of the treatment pathways, 45 semi-structured interviews were conducted with the participating physicians. Interviews and field notes were transcribed verbatim and underwent qualitative content analysis. RESULTS: Pathway development received little support among the participants. Although consensus documents were produced, the results were unlikely to improve practice. The participants expressed very little commitment to change. Although this attempt clearly failed in all study regions, our experience provides relevant insights into the process of evidence appraisal and implementation. A lack of organisational skills, ignorance of current evidence and guidelines, and a lack of feedback regarding one's own clinical behaviour proved to be insurmountable. CA was still seen as the diagnostic gold standard by most interviewees. CONCLUSIONS: Oversupply and overutilisation can be assumed to be present in study regions but are not immediately perceived by clinicians. The problem is unlikely to be solved by regional collaborative initiatives; optimised resource planning within the health care system combined with appropriate economic incentives might best address these issues.

Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease­a Randomized Controlled Trial.

BACKGROUND: Supervised exercise programs are commonly used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic, multicenter, randomized and controlled trial (registration number NCT03496948), 1982 patients with symptomatic IC, insured by one of three German statutory health-insurance carriers, received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores 12 and 24 months after the start of the intervention (intention-to-treat analysis). The secondary outcomes were health-related quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine dependence. RESULTS: There was a significant difference between arms in favor of TeGeCoach in the WIQ (p<0.0001). Patients in the TeGeCoach arm had WIQ scores that were 6.30 points higher at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points higher at 24 months ([2.20; 6.91], d = 0.19). They also fared better in some of the secondary outcomes at 12 months, including physical health-related quality of life and patient activation, with at least small effect sizes (d > 0.20). The average daily step count was no higher in the TeGeCoach group. CONCLUSION: The observed reductions of symptom burden indicate the benefit of home-based exercise programs in the treatment of intermittent claudication. Such programs expand the opportunities for the guideline-oriented treatment of IC. Future studies should address the effect of home-based exercise programs on clinical variables, e.g., the 6-minute walk test.

Gender-specific association of loneliness and health care use in community-dwelling older adults.

BACKGROUND: Loneliness in older adults is common, particularly in women. In this article, gender differences in the association of loneliness and health care use are investigated in a large sample of community-dwelling older adults. METHODS: Data of 2525 persons (ages 55-85 years)-participants of the fourth follow- up (2011-2014) of the ESTHER study- were analyzed. Loneliness and health care use were assessed by study doctors in the course of a home visit. Gender-specific regression models with Gamma-distribution were performed using loneliness as independent variable to predict outpatient health care use, adjusted for demographic variables. RESULTS: In older women, lonely persons were shown to have significantly more visits to general practitioners and mental health care providers in a three-month period compared to less lonely persons (p = .005). The survey found that outpatient health care use was positively associated with loneliness, multimorbidity, and mental illness in older women but not in older men. Older men had significantly more contact with inpatient care in comparison to women (p = .02). CONCLUSIONS: It is important to consider gender when analyzing inpatient and outpatient health care use in older persons. In older women loneliness is associated with increased use of outpatient services.

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial.

BACKGROUND: Peripheral artery disease (PAD) is the third most prevalent atherosclerotic cardiovascular disease. In 2016, costs per patient associated with PAD exceeded even the health-economic burden of coronary heart disease. Although affecting over 200 million people worldwide, a clear consensus on the most beneficial components to be included in home-based exercise programs for patients with peripheral artery disease is lacking. The aim of the study was to examine the health care use and costs caused by the 12-month patient-centered 'Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease' (TeGeCoach) program in a randomized controlled trial. METHODS: This is a two-arm, parallel-group, open-label, pragmatic, randomized, controlled clinical trial (TeGeCoach) at three German statutory health insurance funds with follow-up assessments after 12 and 24-months. Study outcomes were medication use (daily defined doses), days in hospital, sick pay days and health care costs, from the health insurers' perspective. Claims data from the participating health insurers were used for analyses. The main analytic approach was an intention-to-treat (ITT) analysis. Other approaches (modified ITT, per protocol, and as treated) were executed additionally as sensitivity analysis. Random-effects regression models were calculated to determine difference-in-difference (DD) estimators for the first- and the second year of follow-up. Additionally, existing differences at baseline between both groups were treated with entropy balancing to check for the stability of the calculated estimators. RESULTS: One thousand six hundred eighty-five patients (Intervention group (IG) = 806; Control group (CG) = 879) were finally included in ITT analyses. The analyses showed non-significant effects of the intervention on savings (first year: - 352€; second year: - 215€). Sensitivity analyses confirmed primary results and showed even larger savings. CONCLUSION: Based on health insurance claims data, a significant reduction due to the home-based TeGeCoach program could not be found for health care use and costs in patients with PAD. Nevertheless, in all sensitivity analysis a tendency became apparent for a non-significant cost reducing effect. TRIAL REGISTRATION: NCT03496948 (www. CLINICALTRIALS: gov), initial release on 23 March 2018.

Low Tortuous, Highly Conductive, and High-Areal-Capacity Battery Electrodes Enabled by Through-thickness Aligned Carbon Fiber Framework.

Thick electrode with high-areal-capacity is a practical and promising strategy to increase the energy density of batteries, but development toward thick electrode is limited by the electrochemical performance, mechanical properties, and manufacturing approaches. In this work, we overcome these limitations and report an ultrathick electrode structure, called fiber-aligned thick or FAT electrode, which offers a novel electrode design and a scalable manufacturing strategy for high-areal-capacity battery electrodes. The FAT electrode uses aligned carbon fibers to construct a through-thickness fiber-aligned electrode structure with features of high electrode material loading, low tortuosity, high electrical and thermal conductivity, and good compression property. The low tortuosity of FAT electrode enables fast electrolyte infusion and rapid electron/ion transport, exhibiting a higher capacity retention and lower charge transfer resistance than conventional slurry-casted thick electrode design.

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

INTRODUCTION: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

A Comparison of Matching and Weighting Methods for Causal Inference Based on Routine Health Insurance Data, or: What to do If an RCT is Impossible.

Due to a multitude of reasons Randomized Control Trials on the basis of so-called "routine data" provided by insurance companies cannot be conducted. Therefore the estimation of "causal effects" for any kind of treatment is hampered since systematic bias due to specific selection processes must be suspected. The basic problem of counterfactual, which is to evaluate the difference between two potential outcomes for the same unit, is discussed. The focus lies on the comparison of the performance of different approaches to control for systematic differences between treatment and control group. These strategies are all based on propensity scores, namely matching or pruning, IPTW (inverse probability treatment weighting) and entropy balancing. Methods to evaluate these strategies are presented. A logit model is employed with 87 predictors to estimate the propensity score or to estimate the entropy balancing weights. All analyses are restricted to estimate the ATT (Average Treatment Effect for the Treated) Exemplary data come from a prospective controlled intervention-study with two measurement occasions. Data contain 35 857 chronically ill insurants with diabetes, congestive heart failure, arteriosclerosis, coronary heart disease or hypertension of one German sickness fund. The intervention group was offered an individual telephone coaching to improve health behavior and slow down disease progression while the control group received treatment as usual. Randomization took place before the insurants' consent to participate was obtained so assumptions of an RCT are violated. A weighted mixture model (difference-in-difference) as the causal model of interest is employed to estimate treatment effects in terms of costs distinguishing the categories outpatient costs, medication costs, and total costs. It is shown that entropy balancing performs best with respect to balancing treatment and control group at baseline for the first three moments of all 87 predictors. This will result in least biased estimates of the treatment effect.

eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA).

BACKGROUND: Panic disorder (PD), frequently occurring with agoraphobia (AG), and depression are common mental disorders in primary care and associated with considerable individual and societal costs. Early detection and effective treatment of depression and PD/AG are of major importance. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety and depressive symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual. METHODS/DESIGN: This is a two-arm cluster-randomized, controlled trial (cRCT). General practices represent the units of randomisation. General practitioners recruit adult patients with depression and PD ± AG according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. Practice teams and patients are supported by eHealth components. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after 6 months (T1), and at follow-up after 12 months (T2). The primary outcome is the mental health status of patients as measured by the Mental Health Index (MHI-5). Effect sizes of 0.2 standard deviation (SD) are regarded as relevant. Assuming a drop-out rate of 20% of practices and patients each, we aim at recruiting 1844 patients in 148 primary care practices. This corresponds to 12.5 patients on average per primary care practice. Secondary outcomes include depression and anxiety-related clinical parameters and health-economic costs. DISCUSSION: If the intervention is more effective than treatment as usual, the three-component (cognitive behaviour therapy, case-management, eHealth) primary care-based intervention for patients suffering from PD/AG or depression could be a valuable low-threshold option that benefits patients and primary care practice teams. TRIAL REGISTRATION: German clinical trials register, DRKS00016622. Registered on February 22nd, 2019.

Caring for the elderly: A person-centered segmentation approach for exploring the association between health care needs, mental health care use, and costs in Germany.

BACKGROUND: Person-centered care demands the evaluation of needs and preferences of the patients. In this study, we conducted a segmentation analysis of a large sample of older people based on their bio-psycho-social-needs and functioning. The aim of this study was to clarify differences in health care use and costs of the elderly in Germany. METHODS: Data was derived from the 8-year follow-up of the ESTHER study-a German epidemiological study of the elderly population. Trained medical doctors visited n = 3124 participants aged 57 to 84 years in their home. Bio-psycho-social health care needs were assessed using the INTERMED for the Elderly (IM-E) interview. Further information was measured using questionnaires or assessment scales (Barthel index, Patients Health Questionnaire (PHQ) etc.). The segmentation analysis applied a factor mixture model (FMM) that combined both a confirmatory factor analysis and a latent class analysis. RESULTS: In total, n = 3017 persons were included in the study. Results of the latent class analysis indicated that a five-cluster-model best fit the data. The largest cluster (48%) can be described as healthy, one cluster (13.9%) shows minor physical complaints and higher social support, while the third cluster (24.3%) includes persons with only a few physical and psychological difficulties ("minor physical and psychological complaints"). One of the profiles (10.5%) showed high and complex bio-psycho-social health care needs ("complex needs") while another profile (2.5%) can be labelled as "frail". Mean values of all psychosomatic variables-including the variable health care costs-gradually increased over the five clusters. Use of mental health care was comparatively low in the more burdened clusters. In the profiles "minor physical and psychological complaints" and "complex needs", only half of the persons suffering from a mental disorder were treated by a mental health professional; in the frail cluster, only a third of those with a depression or anxiety disorder received mental health care. CONCLUSIONS: The segmentation of the older people of this study sample led to five different clusters that vary profoundly regarding their bio-psycho-social needs. Results indicate that elderly persons with complex bio-psycho-social needs do not receive appropriate mental health care.

Longitudinal association between panic disorder and health care costs in older adults.

BACKGROUND: To analyze whether probable panic disorder (PD) is associated with health care costs in older age over time. METHODS: Data regarding individuals aged 65 and over were derived from two waves of the ESTHER cohort study (nt1 = 2,348, nt2 = 2,090). Probable PD was assessed using the panic screening module from the Patient Health Questionnaire. Health care costs were obtained through monetary valuation of self-reported health care use data. Fixed effects regressions analyzed the association between transitions in probable PD status and change in health care costs, while adjusting for potential confounders. RESULTS: On a descriptive level, study participants with a positive PD screening displayed higher three-month health care costs compared to those without (incremental costs: € 259 for t1 , € 1,544 for t2 ). Transitions in probable PD were associated with an approximate increase of 65% in outpatient health care costs (ß = 0.50, p < .05). There was no significant association between probable PD transition and change in any other cost category. CONCLUSIONS: Using longitudinal data, our results highlight the economic consequences of probable PD in older adults. Future research should address whether reducing PD in older adults may reduce the associated economic burden and analyze underlying mechanisms.

Prediction of Drug-Related Risks Using Clinical Context Information in Longitudinal Claims Data.

OBJECTIVES: To develop and internally validate prediction models for medication-related risks arising from overuse, misuse, and underuse that utilize clinical context information and are suitable for routine risk assessment in claims data (i.e., medication-based models predicting the risk for hospital admission apparent in routine claims data or MEDI-RADAR). METHODS: Based on nationwide claims from health-insured persons in Germany between 2010 and 2012, we drew a random sample of people aged ≥65 years (N = 22,500 randomly allocated to training set, N = 7500 to validation set). Individual duration of drug supply was estimated from prescription patterns to yield time-varying drug exposure windows. Together with concurrent medical conditions (ICD-10 diagnoses), exposure to the STOPP/START (screening tool of older persons' potentially inappropriate prescriptions/screening tool to alert doctors to the right treatment) criteria was derived. These were tested as time-dependent covariates together with time-constant covariates (patient demographics, baseline comorbidities) in regularized Cox regression models. RESULTS: STOPP/START variables were iteratively refined and selected by regularization to include 2 up to 11 START variables and 8 up to 31 STOPP variables in parsimonious and liberal selections in the prediction modeling. The models discriminated well between patients with and without all-cause hospitalizations, potentially drug-induced hospitalizations, and mortality (parsimonious model c-indices with 95% confidence intervals: 0.63 [0.62-0.64], 0.67 [0.65-0.68], and 0.78 [0.76-0.80]). CONCLUSIONS: The STOPP/START criteria proved to efficiently predict medication-related risk in models possessing good performance. Timely detection of such risks by routine monitoring in claims data can support tailored interventions targeting these modifiable risk factors. Their impact on older peoples' medication safety and effectiveness can now be explored in future implementation studies.

The impact of potentially inappropriate medication on the development of health care costs and its moderation by the number of prescribed substances. Results of a retrospective matched cohort study.

BACKGROUND: In the growing population of the elderly, drug-related problems are considered an important health care safety issue. One aspect of this is the prescription of potentially inappropriate medication (PIM) which is considered to increase health care costs. OBJECTIVE: Using data from the Health Economics of Potentially Inappropriate Medication (HEPIME) study, we aimed to analyze how the number of prescribed substances moderates the association of PIM use as defined by the German PRISCUS list and health care costs applying a longitudinal perspective. METHODS: An initial number of 6,849,622 insurants aged 65+ of a large German health insurance company were included in a retrospective matched cohort study. Based on longitudinal claims data from the four separate quarters of a 12-month pre-period, 3,860,842 individuals with no exposure to PIM in 2011 were matched to 508,212 exposed individuals. Exposure effects of PIM use on health care costs and the number of prescribed substances were measured based on longitudinal claims data from the four separate quarters of the 12-month post-period. RESULTS: After successful balancing for the development of numerous matching variables during the four quarters of the pre-period, exposed individuals consumed 2.1 additional prescribed substances and had higher total health care costs of 1,237 € when compared to non-exposed individuals in the 1st quarter of the post-period. Controlling for the number of prescribed substances, the difference in total health care costs between both study groups was 401 €. The average effect of one additionally prescribed substance (other than PIM) on total health care costs was increased by an amount of 137 € for those being exposed to a PIM. In quarters 2-4 of the post-period, the differences between both study groups tended to decrease sequentially. CONCLUSIONS: PIM use has an increasing effect on the development of health care costs. This cost-increasing effect of PIM use is moderated by the number of prescribed substances.

Frailty and healthcare costs-longitudinal results of a prospective cohort study.

Objective: to investigate how frailty and frailty symptoms affect healthcare costs in older age longitudinally. Methods: data were gathered from a prospective cohort study in Saarland, Germany (two waves with 3-year interval, n = 1,636 aged 57-84 years at baseline). Frailty was assessed by the five Fried frailty criteria. Frailty was defined as having at least three criteria, the presence of 1-2 criteria as 'pre-frail'. Healthcare costs were quantified based on self-reported healthcare use in the sectors of inpatient treatment, outpatient treatment, professional nursing care and informal care as well as the provision of pharmaceuticals, medical supplies and dental prostheses. Results: while the onset of pre-frailty did not increase (log) total healthcare costs after adjusting for potential confounders including comorbidity, progression from non-frailty to frailty was associated with an increase in total healthcare costs (for example, costs increased by ~54 and 101% if 3 and 4 or 5 symptoms were present, respectively). This association of frailty onset with increased healthcare costs was in particular observed in the inpatient sector and for informal nursing care. Among the frailty symptoms, the onset of exhaustion was associated with an increase in total healthcare costs, whereas changes in slowness, weakness, weight loss and low-physical activity were not significantly associated with an increase in total healthcare costs. Conclusions: our data stress the economic relevance of frailty in late life. Postponing or reducing frailty might be fruitful in order to reduce healthcare costs.

Health Service Use, Costs, and Adverse Events Associated with Potentially Inappropriate Medication in Old Age in Germany: Retrospective Matched Cohort Study.

BACKGROUND: Drug-related problems are an important healthcare safety concern in the growing population of older people. Prescription of potentially inappropriate medication (PIM) is one aspect of this concern that is considered to increase the risk of adverse health outcomes. OBJECTIVE: The aim of the Health Economics of Potentially Inappropriate Medication (HEPIME) study was to analyze the association between the prescription of PIMs according to the German PRISCUS list and healthcare utilization, healthcare costs, and the occurrence of adverse events in old age. METHODS: Insurants of a large German health insurance company aged 65+ years were included in a retrospective matched cohort study. A total of 3,953,423 individuals with no exposure to PIM in 2011 were matched to 521,644 exposed individuals and compared in terms of outpatient healthcare utilization, healthcare costs, and the occurrence of adverse events in outpatient, hospital, and rehabilitation sectors during a 12-month follow-up. RESULTS: On average, individuals in the exposed group had additional 143 [95% confidence interval (CI) 140-146] daily defined doses of pharmaceuticals and 4.5 (95% CI 4.4-4.6) days in hospital. Mean annual total healthcare costs per individual in the exposed group exceeded those in the non-exposed group by €2321 (95% CI 2269-2372), resulting mainly from differences in hospitalization costs of €1718 (95% CI 1678-1759). Odds ratios for the occurrence of adverse events in the exposed group were 1.32 (95% CI 1.32-1.34) in the outpatient sector, 1.76 (95% CI 1.73-1.79) in the hospital sector, and 1.82 (95% CI 1.76-1.89) in the rehabilitation sector. CONCLUSIONS: Increased healthcare utilization and costs as well as an increased probability for adverse events in individuals exposed to PIM demonstrate the health economic relevance of PIM prescriptions. Whether avoiding PIM listed on the PRISCUS list may potentially improve the quality and efficiency of healthcare is currently unknown.

A Longitudinal Investigation of Willingness to Pay for Health Insurance in Germany.

OBJECTIVE: To investigate factors affecting willingness to pay (WTP) for health insurance of older adults in a longitudinal setting in Germany. DATA SOURCES: Survey data from a cohort study in Saarland, Germany, from 2008-2010 and 2011-2014 (n1  = 3,124; n2  = 2,761) were used. STUDY DESIGN: Panel data were taken at two points from an observational, prospective cohort study. DATA COLLECTION: WTP estimates were derived using a contingent valuation method with a payment card. Participants provided data on sociodemographics, lifestyle factors, morbidity, and health care utilization. PRINCIPAL FINDINGS: Fixed effects regression models showed higher individual health care costs to increase WTP, which in particular could be found for members of private health insurance. Changes in income and morbidity did not affect WTP among members of social health insurance, whereas these predictors affected WTP among members of private health insurance. CONCLUSIONS: The fact that individual health care costs affected WTP positively might indicate that demanding (expensive) health care services raises the awareness of the benefits of health insurance. Thus, measures to increase WTP in old age should target at improving transparency of the value of health insurances at the moment when individual health care utilization and corresponding costs are still relatively low.

Investigating the Additive Interaction of QT-Prolonging Drugs in Older People Using Claims Data.

INTRODUCTION: Drugs that potentially prolong the QT interval carry the risk of life-threatening Torsades de pointes (TdP) ventricular arrhythmia. OBJECTIVE: The objective of this study was to investigate the potential additive risk for ventricular arrhythmia with concomitant prescriptions of QT-prolonging drugs. METHODS: Claims data for persons aged ≥65 years between 2010 and 2012 in Germany were analyzed and all cases hospitalized for ventricular arrhythmia were selected. In a case-crossover analysis, exposure with QT-prolonging drugs according to the Arizona Center for Education and Research on Therapeutics (AZCERT) classification of 'known,' 'conditional,' and 'possible' TdP risk was determined in respective event and control windows preceding hospitalization. Conditional logistic regression was applied to derive odds ratios (ORs). RESULTS: Among 6,849,622 health-insured persons, we identified 2572 patients newly hospitalized for ventricular arrhythmia. Drugs with 'known' risk were more frequently prescribed in the event window than in the control window (309 vs. 239; P < 0.001). The number of drugs with an attributed 'known' risk of TdP was significantly associated with hospitalization for ventricular arrhythmia (OR: 2.22; 95% confidence interval [1.51-3.25]; P < 0.001), while increased risk estimates were also obtained upon categorization into one and two or more drugs compared with no drugs for the combined group of drug with 'known' (1.52 [1.16-2.00]) and 'conditional' risk (2.20 [1.42-3.41]). Pairwise comparisons and trend tests based on these classification categories could not demonstrate a significantly increased risk of two or more drugs compared with one drug. CONCLUSION: Beyond suitable single-drug classifications for QT-associated risk estimation, the situation when there is co-prescription of several drugs appears to be complex and may not be extrapolated to all possible multi-drug combinations.

Effectiveness of Telephone-Based Health Coaching for Patients with Chronic Conditions: A Randomised Controlled Trial.

BACKGROUND: Chronic diseases, like diabetes mellitus, heart disease and cancer are leading causes of death and disability. These conditions are at least partially preventable or modifiable, e.g. by enhancing patients' self-management. We aimed to examine the effectiveness of telephone-based health coaching (TBHC) in chronically ill patients. METHODS AND FINDINGS: This prospective, pragmatic randomized controlled trial compares an intervention group (IG) of participants in TBHC to a control group (CG) without TBHC. Endpoints were assessed two years after enrolment. Three different groups of insurees with 1) multiple conditions (chronic campaign), 2) heart failure (heart failure campaign), or 3) chronic mental illness conditions (mental health campaign) were targeted. The telephone coaching included evidence-based information and was based on the concepts of motivational interviewing, shared decision-making, and collaborative goal setting. Patients received an average of 12.9 calls. Primary outcome was time from enrolment until hospital readmission within a two-year follow-up period. Secondary outcomes comprised the probability of hospital readmission, number of daily defined medication doses (DDD), frequency and duration of inability to work, and mortality within two years. All outcomes were collected from routine data provided by the statutory health insurance. As informed consent was obtained after randomization, propensity score matching (PSM) was used to minimize selection bias introduced by decliners. For the analysis of hospital readmission and mortality, we calculated Kaplan-Meier curves and estimated hazard ratios (HR). Probability of hospital readmission and probability of death were analysed by calculating odds ratios (OR). Quantity of health service use and inability to work were analysed by linear random effects regression models. PSM resulted in patient samples of 5,309 (IG: 2,713; CG: 2,596) in the chronic campaign, of 660 (IG: 338; CG: 322) in the heart failure campaign, and of 239 (IG: 101; KG: 138) in the mental health campaign. In none of the three campaigns, there were significant differences between IG and CG in time until hospital readmission. In the chronic campaign, the probability of hospital readmission was higher in the IG than in the CG (OR = 1.13; p = 0.045); no significant differences could be found for the other two campaigns. In the heart failure campaign, the IG showed a significantly reduced number of hospital admissions (-0.41; p = 0.012), although the corresponding reduction in the number of hospital days was not significant. In the chronic campaign, the IG showed significantly increased number of DDDs. Most striking, there were significant differences in mortality between IG and CG in the chronic campaign (OR = 0.64; p = 0.005) as well as in the heart failure campaign (OR = 0.44; p = 0.001). CONCLUSIONS: While TBHC seems to reduce hospitalization only in specific patient groups, it may reduce mortality in patients with chronic somatic conditions. Further research should examine intervention effects in various subgroups of patients, for example for different diagnostic groups within the chronic campaign, or duration of coaching. TRIAL REGISTRATION: German Clinical Trials Register DRKS00000584.

Comparative evaluation of methods approximating drug prescription durations in claims data: modeling, simulation, and application to real data.

PURPOSE: The purpose of this study was to compare the predictive accuracy of different methods suggested for approximation of drug prescription durations in claims data. METHODS: We expanded a well-established modeling and simulation framework to compare approximated drug prescription durations with 'true' (i.e., simulated) durations. Real claims data of persons aged ≥65 years insured by the German nationwide 'Statutory Health Insurance Fund' AOK between 2010 and 2012 provided empiric input parameters that were completed with missing information on actual dosing patterns from an observational cohort. The distinct approximation methods were based on crude measures (one tablet a day), population-averaged measures (defined daily doses), or individually-derived measures (longitudinal coverage approximation of the applied dose, COV). As a proof-of-principle, we assessed the methods' performance to predict the well-characterized bleeding risks of anticoagulant, antiplatelet, and/or non-steroidal anti-inflammatory drugs. RESULTS: When applied to modeling and simulation data sets, the closest, least biased, and thus most accurate approximation was observed using the COV approximation. In a real-data example, rather similar results to an external reference were obtained for all methods. However, some of the differences between methods were meaningful, and the most reasonable and consistent results were obtained with the COV approach. CONCLUSION: Based on theoretically most accurate approximations and practically reasonable estimates, the individual COV approach was preferable over the population-averaged defined daily dose technique, although the latter might be justified in certain situations. Advantages of the COV approach are expected to be even bigger for drug therapies with particularly large dosing heterogeneity. Copyright © 2016 John Wiley & Sons, Ltd.

Associations of frailty with health care costs--results of the ESTHER cohort study.

BACKGROUND: The concept of frailty is rapidly gaining attention as an independent syndrome with high prevalence in older adults. Thereby, frailty is often related to certain adverse outcomes like mortality or disability. Another adverse outcome discussed is increased health care utilization. However, only few studies examined the impact of frailty on health care utilization and corresponding costs. The aim of this study was therefore to investigate comprehensively the relationship between frailty, health care utilization and costs. METHODS: Cross sectional data from 2598 older participants (57-84 years) recruited in the Saarland, Germany, between 2008 and 2010 was used. Participants passed geriatric assessments that included Fried's five frailty criteria: weakness, slowness, exhaustion, unintentional weight loss, and physical inactivity. Health care utilization was recorded in the sectors of inpatient treatment, outpatient treatment, pharmaceuticals, and nursing care. RESULTS: Prevalence of frailty (≥3 symptoms) was 8.0%. Mean total 3-month costs of frail participants were €3659 (4 or 5 symptoms) and €1616 (3 symptoms) as compared to €642 of nonfrail participants (no symptom). Controlling for comorbidity and general socio-demographic characteristics in multiple regression models, the difference in total costs between frail and non-frail participants still amounted to €1917; p < .05 (4 or 5 symptoms) and €680; p < .05 (3 symptoms). Among the 5 symptoms of frailty, weight loss and exhaustion were significantly associated with total costs after controlling for comorbidity. CONCLUSIONS: The study provides evidence that frailty is associated with increased health care costs. The analyses furthermore indicate that frailty is an important factor for health care costs independent from pure age and comorbidity. Costs were rather attributable to frailty (and comorbidity) than to age. This stresses that the overlapping concepts of multimorbidity and frailty are both necessary to explain health care use and corresponding costs among older adults.