Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial (EPCentCare)
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nordrhein-Westfalen
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Witten Herdecke、Nordrhein-Westfalen、ドイツ、58448
- Universität Witten/Herdecke
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Sachsen-Anhalt
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Halle (Saale)、Sachsen-Anhalt、ドイツ、06110
- Martin-Luther-Universität Halle-Wittenberg
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Schleswig-Holstein
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Lübeck、Schleswig-Holstein、ドイツ、23562
- University of Luebeck
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Person-centered Care
Medication Review + Person-centered Care
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Medication Review + Person-centered Care
Medication Review only
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アクティブコンパレータ:Optimised Treatment
Medication Review
|
Medication Review only
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Proportion of residents receiving at least one antipsychotic medication after 12 months
時間枠:12 months
|
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Residents' quality of life
時間枠:12 months
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Will be measured with the QoL-AD
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12 months
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Behavioural and psychological symptoms of dementia
時間枠:12 months
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Will be measured with the CMAI
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12 months
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Costs within trial period
時間枠: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.
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12 months
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Falls and fall-related medical attention
時間枠:12 months
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12 months
|
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Physical restraints within study period
時間枠:12 months
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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.
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12 months
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Median daily dose of antipsychotics in chlorpromazine equivalents within study period
時間枠:12 months
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Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
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12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Process evaluation
時間枠: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.
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12 months
|
協力者と研究者
捜査官
- 主任研究者:Gabriele Meyer, Prof. Dr.、Martin-Luther-Universität Halle-Wittenberg
出版物と役立つリンク
一般刊行物
- Richter C, Fleischer S, Langner H, Meyer G, Balzer K, Kopke S, Sonnichsen A, Loscher S, Berg A. Factors influencing the implementation of person-centred care in nursing homes by practice development champions: a qualitative process evaluation of a cluster-randomised controlled trial (EPCentCare) using Normalization Process Theory. BMC Nurs. 2022 Jul 8;21(1):182. doi: 10.1186/s12912-022-00963-6.
- Richter C, Berg A, Langner H, Meyer G, Kopke S, Balzer K, Wolschon EM, Silies K, Sonnichsen A, Loscher S, Haastert B, Icks A, Wolf U, Fleischer S. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial. Age Ageing. 2019 May 1;48(3):419-425. doi: 10.1093/ageing/afz016.
- Dichter MN, Wolschon EM, Schwab CGG, Meyer G, Kopke S. Item distribution and inter-rater reliability of the German version of the quality of life in Alzheimer's disease scale (QoL-AD) proxy for people with dementia living in nursing homes. BMC Geriatr. 2018 Jun 19;18(1):145. doi: 10.1186/s12877-018-0834-z.
- Richter C, Berg A, Fleischer S, Kopke S, Balzer K, Fick EM, Sonnichsen A, Loscher S, Vollmar HC, Haastert B, Icks A, Dintsios CM, Mann E, Wolf U, Meyer G. Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): study protocol for a cluster-randomised controlled trial. Implement Sci. 2015 Jun 4;10:82. doi: 10.1186/s13012-015-0268-3.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- EPCentCare
- 01GY1335A (その他の助成金/資金番号:German Federal Ministry of Education and Research)
- 01GY1335B (その他の助成金/資金番号:German Federal Ministry of Education and Research)
- 01GY1335C (その他の助成金/資金番号:German Federal Ministry of Education and Research)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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