Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial

Conditions
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Dementia

Intervention / Treatment
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* Other: Person-centered Care
* Other: Optimised Treatment


Participation Criteria
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Eligibility Criteria
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On cluster level Inclusion Criteria: nursing homes with at least 50 residents Exclusion Criteria: other ongoing trial in the institution On individual level Inclusion Criteria: all residents within a cluster are eligible to participate in the study Exclusion Criteria: diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis respite care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Person-centered Care<br>Medication Review + Person-centered Care | Other: Person-centered Care<br>* Medication Review + Person-centered Care<br>Other: Optimised Treatment<br>* Medication Review only<br>|
| Active Comparator: Optimised Treatment<br>Medication Review | Other: Optimised Treatment<br>* Medication Review only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of residents receiving at least one antipsychotic medication after 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residents' quality of life | Will be measured with the QoL-AD | 12 months | 
| Behavioural and psychological symptoms of dementia | Will be measured with the CMAI | 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. | 12 months | 
| Falls and fall-related medical attention |  | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing homes, person-centered care, inappropriate prescriptions, cluster-randomised controlled trial, antipsychotic drugs