Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial (EPCentCare)
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|ClinicalTrials.gov Identifier: NCT02295462|
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Other: Person-centered Care Other: Optimised Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: Person-centered Care
Medication Review + Person-centered Care
Other: Person-centered Care
Medication Review + Person-centered CareOther: Optimised Treatment
Medication Review only
Active Comparator: Optimised Treatment
Other: Optimised Treatment
Medication Review only
- Proportion of residents receiving at least one antipsychotic medication after 12 months [ Time Frame: 12 months ]
- Residents' quality of life [ Time Frame: 12 months ]Will be measured with the QoL-AD
- Behavioural and psychological symptoms of dementia [ Time Frame: 12 months ]Will be measured with the CMAI
- Costs within trial period [ Time Frame: 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.
- Falls and fall-related medical attention [ Time Frame: 12 months ]
- Physical restraints within study period [ Time Frame: 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 [ Time Frame: 12 months ]Each resident's daily dose of antipsychotic drugs will be translated into chlorpromazine daily equivalents.
- Process evaluation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295462
|Witten Herdecke, Nordrhein-Westfalen, Germany, 58448|
|Halle (Saale), Sachsen-Anhalt, Germany, 06110|
|University of Luebeck|
|Lübeck, Schleswig-Holstein, Germany, 23562|
|Principal Investigator:||Gabriele Meyer, Prof. Dr.||Martin-Luther-Universität Halle-Wittenberg|