Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-rand
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STUDY PROTOCOL
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Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial Christin Richter1*, Almuth Berg1, Steffen Fleischer1, Sascha Köpke2, Katrin Balzer2, Eva-Maria Fick2, Andreas Sönnichsen3, Susanne Löscher3, Horst Christian Vollmar3,4, Burkhard Haastert5, Andrea Icks6, Charalabos-Markos Dintsios6, Eva Mann7, Ursula Wolf1,8 and Gabriele Meyer1
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/design: 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. Discussion: To improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected. Trial registration: ClinicalTrials.gov: NCT02295462 Keywords: Implementation research, Nursing homes, Dementia, Antipsychotic agents, Person-centred care, Behavioural and psychological symptoms of dementia
* Correspondence: [email protected] 1 Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany Full list of author information is available at the end of the article © 2015 Richter et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/li
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