Context Despite unambiguous legal regulation and evidence for lack of effectiveness and safety, physical restraints are still frequently administered in nursing homes.Objective To reduce physical restraint prevalence in nursing homes using a guideline-and theory-based multicomponent intervention. Design, Setting, and ParticipantsCluster randomized controlled trial of 6 months' duration conducted in 2 German cities between February 2009 and April 2010. Nursing homes were eligible if they had 20% or more residents with physical restraints. Using external concealed randomization, 18 nursing home clusters were included in the intervention group (2283 residents) and 18 in the control group (2166 residents).Intervention The intervention was based on a specifically developed evidencebased guideline and applied the theory of planned behavior. Components were group sessions for all nursing staff; additional training for nominated key nurses; and supportive material for nurses, residents, relatives, and legal guardians. Control group clusters received standard information. Main Outcomes MeasuresPrimary outcome was percentage of residents with physical restraints (bilateral bed rails, belts, fixed tables, and other measures limiting free body movement) at 6 months, assessed through direct unannounced observation by blinded investigators on 3 occasions during 1 day. Secondary outcomes included restraint use at 3 months, falls, fall-related fractures, and psychotropic medication prescriptions. ResultsAll nursing homes completed the study and all residents were included in the analysis. At baseline, 30.6% of control group residents had physical restraints vs 31.5% of intervention group residents. At 6 months, rates were 29.1% vs 22.6%, respectively, a difference of 6.5% (95% CI, 0.6% to 12.4%; cluster-adjusted odds ratio, 0.71; 95% CI, 0.52 to 0.97; P=.03). All physical restraint measures were used less frequently in the intervention group. Rates were stable from 3 to 6 months. There were no statistically significant differences in falls, fall-related fractures, and psychotropic medication prescriptions. ConclusionA guideline-and theory-based multicomponent intervention compared with standard information reduced physical restraint use in nursing homes.

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BackgroundPhysical 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/DesignCluster-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.DiscussionIf 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.Trial registrationISRCTN34974819

The role of Breast Care Nurses (BCNs) has been discussed since Breast Centres have been opened in Germany. This article introduces the concept of the Breast Care Nurses on a national and an international level in the context of Advanced Nursing Practice (ANP). Within a descriptive study, graduates of a German BCN-education programme were interrogated regarding their current work, their main activities as a BCN, about general conditions in their work environment, experienced barriers, and supporting factors. 122 questionnaires were evaluated. The return rate was 71 % (n = 171). Results showed that 58.1 % (n = 71) of the graduates were employed as a Breast Care Nurse, however only 28.1 % (n = 20) in a full-time and 35.2 % (n = 25) in a part-time position. This first German study about BCN-services showed a lack of basic work conditions, for example regarding a consultation room, access to literature, or templates for documentation. In the discussion part, the situation of the BCNs is reviewed in the German context and in relation to ANP concepts as well as regarding future demands for the position of a BCN.

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