title: Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial.
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
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02341898.
authors.affiliation: Martin Luther University Halle-Wittenberg, Medical Faculty, Institute of Health and Nursing Science, Magdeburger Str. 8, 06112, Halle (Saale), Germany. jens.abraham@medizin.uni-halle.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Abraham
authors.affiliation: Martin Luther University Halle-Wittenberg, Medical Faculty, Institute of Health and Nursing Science, Magdeburger Str. 8, 06112, Halle (Saale), Germany. ralph.moehler@uni-wh.de.|Witten/Herdecke University, Faculty of Health, School of Nursing Science, Stockumer Str. 12, 58453, Witten, Germany. ralph.moehler@uni-wh.de.
authors.forename: Ralph
authors.initials: R
authors.lastname: Möhler
authors.affiliation: University of Lübeck, Institute of Social Medicine, Nursing Research Unit, Ratzeburger Allee 160, 23538, Lübeck, Germany. adrienne.henkel@uksh.de.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Henkel
authors.affiliation: University of Lübeck, Institute of Social Medicine, Nursing Research Unit, Ratzeburger Allee 160, 23538, Lübeck, Germany. ramona.kupfer@uksh.de.|University of Hamburg, MIN Faculty, Health Sciences, Martin-Luther-King-Platz 6, 20146, Hamburg, Germany. ramona.kupfer@uksh.de.
authors.forename: Ramona
authors.initials: R
authors.lastname: Kupfer
authors.affiliation: Heinrich-Heine-University Düsseldorf, Medical Faculty, Department of Public Health, Moorenstraße 5, 40225, Düsseldorf, Germany. andrea.icks@uni-duesseldorf.de.
authors.forename: Andrea
authors.initials: A
authors.lastname: Icks
authors.affiliation: Heinrich-Heine-University Düsseldorf, Medical Faculty, Department of Public Health, Moorenstraße 5, 40225, Düsseldorf, Germany. chmdintsios@aol.com.
authors.forename: Charalabos-Markos
authors.initials: CM
authors.lastname: Dintsios
authors.affiliation: mediStatistica, Lambertusweg 1b, 58809, Neuenrade, Germany. haastert@medistatistica.de.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Haastert
authors.affiliation: Martin Luther University Halle-Wittenberg, Medical Faculty, Institute of Health and Nursing Science, Magdeburger Str. 8, 06112, Halle (Saale), Germany. gabriele.meyer@medizin.uni-halle.de.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Meyer
authors.affiliation: University of Lübeck, Institute of Social Medicine, Nursing Research Unit, Ratzeburger Allee 160, 23538, Lübeck, Germany. sascha.koepke@uksh.de.
authors.forename: Sascha
authors.initials: S
authors.lastname: Köpke
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000328:Adult; D016000:Cluster Analysis; D005260:Female; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel / Q000193:education / Q000523:psychology; D006707:Homes for the Aged; D006801:Humans; D008297:Male; D009735:Nursing Homes; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D012107:Research Design; D012149:Restraint, Physical / Q000009:adverse effects / Q000379:methods / Q000523:psychology; D013192:Staff Development / Q000379:methods*; D013664:Teaching Materials