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Implementation Science
Published in: Implementation Science 1/2015

Open Access 01-12-2015 | Study protocol

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial

Authors: Christin Richter, Almuth Berg, Steffen Fleischer, Sascha Köpke, Katrin Balzer, Eva-Maria Fick, Andreas Sönnichsen, Susanne Löscher, Horst Christian Vollmar, Burkhard Haastert, Andrea Icks, Charalabos-Markos Dintsios, Eva Mann, Ursula Wolf, Gabriele Meyer

Published in: Implementation Science | Issue 1/2015

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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
Appendix
Available only for authorised users
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Metadata
Title
Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial
Authors
Christin Richter
Almuth Berg
Steffen Fleischer
Sascha Köpke
Katrin Balzer
Eva-Maria Fick
Andreas Sönnichsen
Susanne Löscher
Horst Christian Vollmar
Burkhard Haastert
Andrea Icks
Charalabos-Markos Dintsios
Eva Mann
Ursula Wolf
Gabriele Meyer
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-015-0268-3

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