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Randomized Controlled Trial
. 2015 Jul 21:15:86.
doi: 10.1186/s12877-015-0086-0.

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

Jens Abraham  1 , Ralph Möhler  2   3 , Adrienne Henkel  4 , Ramona Kupfer  5   6 , Andrea Icks  7 , Charalabos-Markos Dintsios  8 , Burkhard Haastert  9 , Gabriele Meyer  10 , Sascha Köpke  11
Affiliations
Randomized Controlled Trial

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

Jens Abraham et al. BMC Geriatr. .

Abstract

Background: Physical 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/design: The 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.

Conclusions: We 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 registration: ClinicalTrials.gov: NCT02341898.

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Figures

Fig. 1
Fig. 1
Flowchart for the cluster-randomised controlled trial
See this image and copyright information in PMC

References

    1. Köpke S, Mühlhauser I, Gerlach A, Haut A, Haastert B, Möhler R, Meyer G. Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial. JAMA. 2012;307:2177–84. doi: 10.1001/jama.2012.4517. - DOI - PubMed
    1. Möhler R, Richter T, Köpke S, Meyer G. Interventions for preventing and reducing the use of physical restraints in long-term geriatric care - a Cochrane review. J Clin Nurs. 2012;21:3070–81. doi: 10.1111/j.1365-2702.2012.04153.x. - DOI - PubMed
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    1. Meyer G, Köpke S, Haastert B, Mühlhauser I. Restraint use among nursing home residents: cross-sectional study and prospective cohort study. J Clin Nurs. 2009;18:981–90. doi: 10.1111/j.1365-2702.2008.02460.x. - DOI - PubMed

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