University of Witten/Herdecke, Faculty for Medicine, Institute of Nursing Science, Stockumer Str. 12, 58453 Witten, Germany.
BMC Geriatr. 2009 Sep 7;9:42. doi: 10.1186/1471-2318-9-42.
Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations.
METHODS/DESIGN: Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures.
If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial.
ISRCTN34974819.
在德国的养老院中，经常会使用身体约束。然而，其使用频率在各个中心之间存在很大差异。尽管没有证据表明身体约束具有有益效果，但观察性研究和病例报告表明其存在各种不良影响。我们针对这一主题制定了基于证据的指南。本研究评估了一项基于该指南的干预计划的临床疗效和安全性，该计划旨在减少身体约束并最大限度地减少中心之间的差异。
方法/设计：采用整群随机对照试验，将养老院随机分为干预组或对照组，对照组给予标准信息。干预措施包括为护理人员提供结构化的信息方案、为法定监护人及居民亲属提供信息材料以及为指定护士举办为期一天的培训研讨会。总共将招募 36 个养老院集群，每个集群至少包含 3000 名居民，且必须满足基线时身体约束患病率至少为 20%的纳入标准。主要终点是在 6 个月时至少有 1 名居民使用身体约束的人数。次要结局指标为跌倒和跌倒相关骨折的数量。
如果干预成功，应该在全德国范围内实施。如果干预不成功，在随机试验之后，将在对照组中进行为期三个月的预-后研究，并实施优化后的干预计划。
ISRCTN34974819。
