Dementia Clinical Trial
Official title:
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Background: Up to 90% 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 seem to be prescribed as first line
treatment of neuropsychiatric symptoms in persons with dementia. A huge number is prescribed
for inappropriate reasons and too long without regular review. The use of antipsychotics is
associated with adverse events like increased risk of falling, stroke, and mortality. This
study aims to investigate whether a person-centered care approach developed in the United
Kingdom can be adapted and implemented in German nursing homes. The aim of the investigators
trial is to achieve a clinically relevant reduction of the proportion of residents with alt
least one antipsychotic drug prescription.
Methods/Design: Cluster-randomised controlled trial comparing an intervention group (two-day
initial skill training on person-centred care and on-going training and support programme)
with a control group receiving optimised usual care. Both study groups will receive a
medication review by an experienced psychiatrist with feedback to the prescribing physician.
Overall, 36 nursing homes from East, North and West Germany will be included and randomised.
The primary outcome is defined as the proportion of residents receiving at least one
antipsychotic medication at 12 months. Secondary outcomes are residents' quality of life,
behavioural and psychological symptoms of dementia as well as safety parameters like falls
and fall-related medical attention. Cost parameters will be collected and process evaluation
will be performed alongside the trial.
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