Fleischer Steffen, Roling Gudrun, Beutner Katrin, Hanns Stephanie, Behrens Johann, Luck Tobias, Kuske Bettina, Angermeyer Matthias C, Riedel-Heller Steffi G, Heinrich Sven, König Hans-H, Lautenschläger Christine
Institute of Nursing and Health Science, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Germany.
BMC Public Health. 2008 May 28;8:185. doi: 10.1186/1471-2458-8-185.
Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future. It is not only an individual's interest but also of public concern to avoid a nursing home admission. Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits. As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany. Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention in Germany by a randomized controlled trial.
The trial is designed as a prospective multi-center randomized controlled trial in the cities of Halle and Leipzig. The trial includes an intervention and a control group. The control group receives usual care. The intervention group receives three additional home visits by non-physician health professionals (1) geriatric assessment, (2) consultation, (3) booster session. The nursing home admission rate after 18 months will be defined as the primary outcome. An absolute risk reduction from a 20% in the control-group to a 7% admission rate in the intervention group including an assumed drop out rate of 30% resulted in a required sample size of N = 320 (n = 160 vs. n = 160). Parallel to the clinical outcome measurement the intervention will be evaluated economically. The economic evaluation will be performed from a society perspective.
To the authors' knowledge for the first time a trial will investigate the effectiveness and cost-effectiveness of preventive home visits for people aged 80 and over in Germany using the design of a randomized controlled trial. Thus, the trial will contribute to the existing evidence on preventive home visits especially in Germany.
鉴于德国的人口结构变化,可以预计在不久的将来,老年人数量以及由此产生的长期护理需求将会增加。避免入住养老院不仅关乎个人利益,也是公众关注的问题。目前的证据表明,预防性家访可能是降低入住率的有效方式,从而使老年人能够比没有家访的情况下更长时间地居家生活。由于预防性家访的有效性和成本效益在很大程度上取决于社会和卫生系统现有的服务,现有的国际研究结果不能简单地照搬到德国。因此,有必要通过一项随机对照试验来研究这种干预措施在德国的有效性和成本效益。
该试验设计为在哈雷和莱比锡市进行的前瞻性多中心随机对照试验。试验包括一个干预组和一个对照组。对照组接受常规护理。干预组由非医生健康专业人员额外进行三次家访,分别是:(1)老年评估,(2)咨询,(3)强化课程。18个月后的养老院入住率将被定义为主要结局指标。从对照组20%的入住率降至干预组7%的入住率,假设失访率为30%,计算得出所需样本量为N = 320(n = 160对n = 160)。在测量临床结局的同时,将对干预措施进行经济学评估。经济学评估将从社会角度进行。
据作者所知,这是首次采用随机对照试验设计来研究德国80岁及以上人群预防性家访的有效性和成本效益。因此,该试验将为现有的预防性家访证据做出贡献,尤其是在德国。