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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,158
Medication Review + Person-centered Care
Medication Review only
Universität Witten/Herdecke
Witten Herdecke, North Rhine-Westphalia, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
University of Luebeck
Lübeck, Schleswig-Holstein, Germany
Proportion of residents receiving at least one antipsychotic medication after 12 months
Time frame: 12 months
Residents' quality of life
Will be measured with the QoL-AD
Time frame: 12 months
Behavioural and psychological symptoms of dementia
Will be measured with the CMAI
Time frame: 12 months
Costs within trial period
Cost parameters will be collected alongside the trial on intervention-related components as well as outcome-related components. Costs which are explicitly trial-associated will not be taken into account for cost analysis.
Time frame: 12 months
Falls and fall-related medical attention
Time frame: 12 months
Physical restraints within study period
Physical restraints will be assessed retrospectively by data extraction from residents' records- The following devices will be assessed: bilateral bedrails, belts, fixed tables, and other measures limiting free body movement.
Time frame: 12 months
Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
Time frame: 12 months
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