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Background: Fragility fractures are one of the leading causes of disability in older adults. Yet, evidence for effectiveness and cost-effectiveness of preventive approaches combining bone health and fall prevention is rare. Objective: To conduct a health-economic evaluation of the German osteoporotic fracture prevention program in rural areas (OFRA). Design: Secondary cluster–randomized intervention study based on routine data. Participants: All districts in five federal states in Germany were cluster-randomized as intervention or control districts. OFRA was offered to community-living (a) women aged 75–79 years or (b) women and men aged 70–84 years with a prior fragility fracture in the intervention districts. Individuals who meet these criteria in the control districts were assigned to the control group. Intervention: OFRA comprised mobility and falls prevention classes, examination of bone health by bone density measurement, and consultation on safety in the home living environment. Main Measures: We measured health-care costs and effectiveness in terms of time to fragility fracture or death within 1 year after initial contact, based on health insurance claims data. Implementation costs were recorded by the intervention performers. We calculated an incremental cost-effectiveness ratio (ICER) and employed the net-benefit approach to construct a cost-effectiveness acceptability curve (CEAC). Key Results: There were 9408 individuals in the intervention group and 27,318 in the control group. Mean time to fragility fracture or death (difference: 0.82 days) and health-care costs (difference: 111.73€, p <.01) were reduced, but mean intervention costs (difference: 260.10€) increased total costs (difference: 148.37€, p <.001) in the intervention group. The ICER per fracture-free year of survival was 66,094.63€. The CEAC showed no acceptable probability of cost-effectiveness at a reasonable willingness to pay. Conclusion: OFRA showed reduced rates of fragility fractures, but had high implementation costs, resulting in an unfavorable ICER. The cost-effectiveness of OFRA may improve with a longer follow-up. [ABSTRACT FROM AUTHOR]

Background: Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about "safety in the living environment." The aim of this study was to evaluate this complex preventive intervention in a routine health care setting.Methods: This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70-85 years with prior fragility fractures and (b) all community-living women aged 75-80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days).Results: Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase "safety in the living environment." The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80-1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59-0.99). Mortality and nursing home admission did not differ between the intervention and the control group.Conclusions: A comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance.Trial Registration: German Clinical Trials Register DRKS-ID: 00009000. [ABSTRACT FROM AUTHOR]

Abstract Objectives Hip fractures are common consequences of falls in older adults and, among other negative health outcomes, often lead to care dependence in the long term. Until 2016, the German long-term care insurance classified care recipients according to a standardized classification system consisting of 3 care levels. It was based on required assistance in performing activities of daily living and assessed by a qualified physician or nurse. Thus, care level reflects the degree of care dependence. The aim of this study was to determine relevant patient characteristics, which are related to the likelihood of increasing care dependence in terms of worsening care level after hip fracture. Design Retrospective cohort study. Setting and participants Statutory health insurance claims data including 122,922 insured individuals living in Germany and aged 65 years or older, who sustained a hip fracture from 2009 through 2011. Measures The association of patient characteristics with worsening care level in the quarterly period after hip fracture was investigated by means of multinomial logit regression analysis. Death constitutes a competing risk and was modeled as additional nominal outcome. Results Among all patients, crude rates were 30.9% for worsening care level, 54.8% for unchanged care level, and 14.4% for death after hip fracture. The multivariate analysis revealed that patient factors male sex, increasing age, increasing comorbidity, increasing inpatient length of stay, and a lack of inpatient rehabilitation were significantly associated with a worsening care level. Conclusions/Implications This study uses the German standardized measurement of care dependence in terms of worsening care level after hip fracture and finds various related patient characteristics. Knowledge of these characteristics helps to identify possible risk groups for care dependence after hip fracture, for which special attention can be provided regarding treatment and prevention of hip fractures. [ABSTRACT FROM AUTHOR]