title: Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial.
abstract: BACKGROUND
  The majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.
  
  
  METHODS
  The study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.
  
  
  CONCLUSIONS
  To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02295462.
authors.affiliation: Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. christin.richter@medizin.uni-halle.de.
authors.forename: Christin
authors.initials: C
authors.lastname: Richter
authors.affiliation: Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. almuth.berg@medizin.uni-halle.de.
authors.forename: Almuth
authors.initials: A
authors.lastname: Berg
authors.affiliation: Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. steffen.fleischer@medizin.uni-halle.de.
authors.forename: Steffen
authors.initials: S
authors.lastname: Fleischer
authors.affiliation: Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany. sascha.koepke@uksh.de.
authors.forename: Sascha
authors.initials: S
authors.lastname: Köpke
authors.affiliation: Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany. katrin.balzer@uksh.de.
authors.forename: Katrin
authors.initials: K
authors.lastname: Balzer
authors.affiliation: Institute of Social Medicine and Epidemiology, University of Lübeck, Lübeck, Germany. eva-maria.fick@uksh.de.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Fick
authors.affiliation: Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. andreas.soennichsen@uni-wh.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Sönnichsen
authors.affiliation: Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. susanne.loescher@uni-wh.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Löscher
authors.affiliation: Institute of General Practice and Family Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. horst.vollmar@med.uni-duesseldorf.de.|Institute of General Practice, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. horst.vollmar@med.uni-duesseldorf.de.
authors.forename: Horst Christian
authors.initials: HC
authors.lastname: Vollmar
authors.affiliation: mediStatistica, Neuenrade, Germany. haastert@medistatistica.de.
authors.forename: Burkhard
authors.initials: B
authors.lastname: Haastert
authors.affiliation: Department of Public Health, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. andrea.icks@uni-duesseldorf.de.
authors.forename: Andrea
authors.initials: A
authors.lastname: Icks
authors.affiliation: Department of Public Health, Medical Faculty, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany. dintsios@hhu.de.
authors.forename: Charalabos-Markos
authors.initials: CM
authors.lastname: Dintsios
authors.affiliation: Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria. evamann@vol.at.
authors.forename: Eva
authors.initials: E
authors.lastname: Mann
authors.affiliation: Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. ursula.wolf-jacobs@uk-halle.de.|University Hospital of the Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. ursula.wolf-jacobs@uk-halle.de.
authors.forename: Ursula
authors.initials: U
authors.lastname: Wolf
authors.affiliation: Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. gabriele.meyer@medizin.uni-halle.de.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Meyer
mesh_terms: D000058:Accidental Falls / Q000706:statistics & numerical data; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D003365:Costs and Cost Analysis; D003704:Dementia / Q000150:complications; D004363:Drug Utilization; D005858:Germany; D006707:Homes for the Aged / Q000458:organization & administration*; D006801:Humans; D007318:Inservice Training; D001523:Mental Disorders / Q000209:etiology / Q000628:therapy*; D009735:Nursing Homes / Q000458:organization & administration*; D018802:Patient-Centered Care / Q000458:organization & administration*; D011595:Psychomotor Agitation / Q000209:etiology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design
chemical_list: D014150:Antipsychotic Agents