Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,158
- 试验地点
- 3
- 主要终点
- Proportion of residents receiving at least one antipsychotic medication after 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On cluster level
- •Inclusion Criteria:
- •nursing homes with at least 50 residents
排除标准
- •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
研究组 & 干预措施
Person-centered Care
Medication Review + Person-centered Care
干预措施: Optimised Treatment (Other)
Optimised Treatment
Medication Review
干预措施: Optimised Treatment (Other)
Person-centered Care
Medication Review + Person-centered Care
干预措施: Person-centered Care (Other)
结局指标
主要结局
Proportion of residents receiving at least one antipsychotic medication after 12 months
时间窗: 12 months
次要结局
- Residents' quality of life(12 months)
- Behavioural and psychological symptoms of dementia(12 months)
- Costs within trial period(12 months)
- Falls and fall-related medical attention(12 months)
- Physical restraints within study period(12 months)
- Median daily dose of antipsychotics in chlorpromazine equivalents within study period(12 months)
研究者
Gabriele Meyer
Prof. Dr.
Martin-Luther-Universität Halle-Wittenberg
