University of Wuppertal, Wuppertal, Germany.
University of Applied Sciences Saarbrücken, Saarbrücken, Germany.
Trials. 2020 May 18;21(1):411. doi: 10.1186/s13063-020-04325-y.
The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated.
The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model.
A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment.
German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.
养老院（NH）居民人数的增加和他们日益复杂的治疗需求给德国的医疗保健系统带来了挑战。在德国，没有专门针对 NH 居民的老年医学护理。护理人员和全科医生（GP）尤其需要弥补这一额外的需求，而这又受到组织和结构障碍的影响。因此，会出现不必要的紧急呼叫和住院治疗。在 SaarPHIR 项目（Saarländische PflegeHeimversorgung Integriert Regelhaft）中，一个专注于医疗保健概念的复杂干预措施，通过参与式实践为基础的方法进行开发，涉及 NH 代表和 GP。该复杂干预措施旨在解决护士和 GP 之间的合作问题，并帮助重组和优化现有的日常护理常规。预计这将改善 NH 中老年患者的医疗护理，并减少紧张和昂贵的住院治疗。该干预措施在项目的前 12 个月进行了试点测试。在本研究中，将评估其有效性、成本效益和安全性。
本研究是一项集群随机对照试验，将干预组与对照组进行比较。干预措施包括跨专业合作的概念，其中 GP 组成区域性合作团队。鼓励团队与 NH 工作人员更紧密地合作，提供值班时间表、周末前访问、联合团队会议、联合记录和改善药物安全性。德国萨尔州至少有 32 家 NH（每家至少有 50 名居民）将被纳入并监测 12 个月。主要终点是住院治疗。次要终点是生活质量、护理质量和药物安全性。对照组接受常规治疗。该研究还包括过程评估和健康经济评估。数据集包含德国法定健康保险公司的索赔数据和主要数据。分析将使用广义线性混合模型进行。
预计 NH 居民的住院人数将减少，次要终点也将发生变化。反过来，这将对经济评估产生积极影响。
德国临床试验注册中心：DRKS00017129。于 2019 年 4 月 23 日注册。https://www.drks.de/drks_web/setLocale_EN.do。
