Department of Health Services Management at LMU (LMU-HSM), Munich, Germany.
Department of General, Trauma and Reconstructive Surgery, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.
BMC Geriatr. 2021 Jan 12;21(1):43. doi: 10.1186/s12877-020-01966-1.
The economic and public health burden of fragility fractures of the hip in Germany is high. The likelihood of requiring long-term care and the risk of suffering from a secondary fracture increases substantially after sustaining an initial fracture. Neither appropriate confirmatory diagnostics of the suspected underlying osteoporosis nor therapy, which are well-recognised approaches to reduce the burden of fragility fractures, are routinely initiated in the German healthcare system. Therefore, the aim of the study FLS-CARE is to evaluate whether a coordinated care programme can close the prevention gap for patients suffering from a fragility hip fracture through the implementation of systematic diagnostics, a falls prevention programme and guideline-adherent interventions based on the Fracture Liaison Services model.
The study is set up as a non-blinded, cluster-randomised, controlled trial with unequal cluster sizes. Allocation to intervention group (FLS-CARE) and control group (usual care) follows an allocation ratio of 1:1 using trauma centres as the unit of allocation. Sample size calculations resulted in a total of 1216 patients (608 patients per group distributed over 9 clusters) needed for the analysis. After informed consent, all participants are assessed directly at discharge, after 3 months, 12 months and 24 months. The primary outcome measure of the study is the secondary fracture rate 24 months after initial hip fracture. Secondary outcomes include differences in the number of falls, mortality, quality-adjusted life years, activities of daily living and mobility.
This study is the first to assess the effectiveness and cost-effectiveness/utility of FLS implementation in Germany. Findings of the process evaluation will also shed light on potential barriers to the implementation of FLS in the context of the German healthcare system. Challenges for the study include the successful integration of the outpatient sector as well as the future course of the coronavirus pandemic in 2020 and its influence on the intervention.
German Clinical Trial Register (DRKS) 00022237 , prospectively registered 2020-07-09.
德国髋部脆性骨折的经济和公共卫生负担很高。初次骨折后，患者需要长期护理的可能性以及再次发生骨折的风险会大幅增加。德国医疗体系中并未常规开展针对疑似潜在骨质疏松症的适当确诊诊断，也未开展有助于降低脆性骨折负担的治疗。因此，FLS-CARE 研究的目的是评估协调护理计划是否可以通过实施基于骨折联络服务模式的系统诊断、防跌倒计划和基于指南的干预措施来缩小髋部脆性骨折患者的预防差距。
该研究采用非盲、集群随机对照试验设计，且集群大小不等。干预组（FLS-CARE）和对照组（常规护理）采用创伤中心作为分组单位，按照 1:1 的分配比例进行分组。样本量计算结果表明，总共需要 1216 名患者（每组 608 名患者，分布在 9 个集群中）进行分析。在获得知情同意后，所有参与者在初次髋部骨折后直接进行评估，分别在出院后 3 个月、12 个月和 24 个月进行评估。该研究的主要结局指标是初次髋部骨折后 24 个月的继发性骨折发生率。次要结局指标包括跌倒次数、死亡率、质量调整生命年、日常生活活动和移动能力的差异。
该研究首次评估了 FLS 在德国的实施效果和成本效益/效用。过程评估的结果也将阐明 FLS 在德国医疗体系背景下实施的潜在障碍。该研究面临的挑战包括成功整合门诊部门以及 2020 年冠状病毒大流行的未来进程及其对干预措施的影响。
德国临床试验注册处（DRKS）00022237 ，前瞻性注册，2020 年 7 月 9 日。
