Implementation of a multicomponent intervention to prevent physical restraints in nursing home residents (IMPRINT): study protocol for a cluster-randomised controlled trial

Abstract

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

Physical restraints and associations with neuropsychiatric symptoms and personal characteristics in residential care: a cross‐sectional study

“…Our observations that restraints were used for the most vulnerable and disabled persons with poor ADL functioning are supported by others (Karlsson et al ., ; Hamers and Huizing, ; Saarnio et al ., ). It can be discussed, how much this practice is a matter of nursing traditions and routines, because nurses have a decisive role in the application of physical restraints for fall prevention (Evans et al ., ; Möhler and Meyer, ) and to control NPS (Hamers and Huizing, ; Meyer et al ., ; Abraham et al ., ). No typical organizational variables are associated with restraint use (Hofmann et al ., ), but routines, ignorance of alternatives and even requests by the family may increase their use (Gastmans and Milisen, ).…”

“…The use of physical restraints has also been related to direct injuries through fatal entrapments as well as to reduced psychological well‐being (Evans et al ., ; Castle and Engberg, ; Scherder et al ., ). Moreover, restraints apparently do not reduce falls or fall‐related injuries, nor do they control NPS (Evans et al ., ; Köpke et al ., ; Möhler et al ., ; Abraham et al ., ), but in opposite, increase further risks for restrained persons (Hofmann and Hahn, ). The use of restraints may impact negatively on a person's dignity, autonomy and integrity, and cause a traumatic experience (Gallinagh et al ., , Gastmans and Milisen, ).…”

Implementation of a complex intervention to improve participation in older people with joint contractures living in nursing homes: A process evaluation of a cluster-randomised pilot trial

“…The applied facilitation approach is a proven strategy for implementing interventions in nursing homes and for supporting changes in the daily nursing routine [40][41][42][43]. A successful implementation of knowledge into practice depends on the quality and type of the evidence, existing speci c nursing home characteristics and the modalities of facilitation [21].…”

Development methods of guidelines and documents with recommendations on physical restraint reduction in nursing homes: a systematic review

“…This was confirmed by our own study, which revealed that the implementation of the German evidence-based guideline in nursing homes was effective in reducing PR without increasing adverse effects like falls or fall-related injuries [ 5 ]. Currently, the effectiveness and safety of a large-scale implementation of the updated German evidence-based guideline is being investigated in a pragmatic trial [ 28 ]. This indicated that the PR use can be reduced by offering recommendations for nursing staff, based on the best available evidence.…”