Dementia
Conditions
Keywords
nursing homes, person-centered care, inappropriate prescriptions, cluster-randomised controlled trial, antipsychotic drugs
Brief summary
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.
Interventions
OTHERPerson-centered Care
Medication Review + Person-centered Care
OTHEROptimised Treatment
Medication Review only
Sponsors
University of Luebeck
University of Witten/Herdecke
Martin-Luther-Universität Halle-Wittenberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of residents receiving at least one antipsychotic medication after 12 months | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioural and psychological symptoms of dementia | 12 months | Will be measured with the CMAI |
| Residents' quality of life | 12 months | Will be measured with the QoL-AD |
| Costs within trial period | 12 months | 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. |
| Physical restraints within study period | 12 months | 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. |
| Median daily dose of antipsychotics in chlorpromazine equivalents within study period | 12 months | Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents. |
| Falls and fall-related medical attention | 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process evaluation | 12 months | Different methods will be used for data collection: investigators documentation, questionnaires on staff knowledge and self-efficacy, structured interviews and in depth-interviews with staff. |
Countries
Germany
Outcome results
None listed