Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial.

Jens Abraham,Adrienne Henkel,Charalabos-Markos Dintsios,Gabriele Meyer,Ramona Kupfer,Ralph Möhler,Burkhard Haastert,Andrea Icks,Sascha Köpke

doi:10.1186/s12877-015-0086-0

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

Highlights

Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety
It is expected that the process outcomes of this trial will enrich the knowledge about facilitators and barriers for the implementation of the multicomponent intervention programme
Physical restraints (PR) such as bedrails and belts are commonly used in German nursing homes despite clear evidence showing their lack of effectiveness and safety [1,2,3]

Summary

Introduction

Physical restraints such as bedrails and belts are regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. Physical restraints (PR) such as bedrails and belts are commonly used in German nursing homes despite clear evidence showing their lack of effectiveness and safety [1,2,3]. More important are the marked differences in the prevalence of PR between nursing homes, as shown in our earlier studies [1, 5]. These differences cannot be explained by the residents’ case mix or objectively measurable centre characteristics such as staffing level or staff training [5]. The fact that there are nursing homes using very few or even no PR [5] indicate that adequate standard care in German nursing homes does not require the use of PR

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