BackgroundPhysical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomised controlled trial, the efficacy and safety of a guideline-based multicomponent intervention programme has been proven. The present study aims to evaluate the effectiveness of two different versions of the original intervention in nursing home residents in four different regions throughout Germany.Methods/DesignThe study is a pragmatic cluster-randomised controlled trial comparing two intervention groups, i.e. (1) the updated original multicomponent intervention programme and (2) the concise version of the updated programme, with a control group receiving optimised usual care. The first intervention group receives an educational programme for all nurses, additional training and structured support for nominated key nurses, printed study material and other supportive material. In the second intervention group, nurses do not receive education as part of the intervention, but may be trained by nominated key nurses who have received a short train-the-trainer module. All other components are similar to the first intervention group. The control group receives the printed study material only. Overall, 120 nursing homes including approximately 10,800 residents will be recruited and randomly assigned to one of the three groups. The primary outcome is defined as the proportion of residents with at least one physical restraint after 12 months follow-up. The use of physical restraints will be assessed by direct observation. Secondary outcomes are the residents’ quality of life and safety parameters, e.g. falls and fall-related fractures. In addition, comprehensive process and economic evaluations will be performed.ConclusionsWe expect a clinically relevant reduction in the proportion of residents with physical restraints. It is also expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme.Trial registrationClinicalTrials.gov: NCT02341898

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Intensive care patients that are weaned from mechanical ventilation are facing substantial physical and psychical stress. Due to the breathing tube, they often cannot voice their basic needs adequately. Possible consequences, amongst other complications, are a prolonged healing process and a delirium. To address this issue and support patient communication in intensive care, we provide a solution tailored to patients that are dealing with limited cognitive and physiological abilities, hindering them to use traditional devices efficiently. For this purpose, we develop a novel interaction device tailored to the special situation of in-bed interaction. In this paper, we present key requirements for the device, which are relevant to the interaction itself as well as possible interaction gestures that may be performed with the device. The basis for this is a human-centered design process consisting of a comprehensive user and context analysis, as well as a requirements analysis. As a result, we identified three categories relevant for the interaction, namely look and feel, sensors, and actuators. The results of the requirement analysis were precise enough to start the actual development process of the device.

ZusammenfassungDer Veränderungsdruck im Gesundheitswesen macht auch vor kleineren Krankenhäusern nicht Halt. Am Beispiel eines Krankenhauses der Grund-und Regelversorgung wird gezeigt, wie ein umfassender Reorganisationsprozess im zentralen Bereich der Patientenversorgung durch Ärzte und Pflegende in einem mehrere Jahre andauernden Prozess konzipiert, realisiert und weiterentwickelt wird. Die Begleitforschung steht vor der Herausforderung, gleichzeitig mit Hilfe prozessbegleitend gewonnener Kenngrößen eine formative Evaluation zu leisten und weiterhin auch Qualitäts-, Kosten-und Humanitätseffekte der Interventionen festzustellen.

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