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

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Person-centered Care; Other: Optimised Treatment

• Registration Number: NCT02295462
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Study Start: 2014-12
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1158

Inclusion Criteria

• nursing homes with at least 50 residents

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Person-centered Care	Optimised Treatment	Medication Review + Person-centered Care
Person-centered Care	Person-centered Care	Medication Review + Person-centered Care
Optimised Treatment	Optimised Treatment	Medication Review

Primary Outcome Measures

Name	Time	Method
Proportion of residents receiving at least one antipsychotic medication after 12 months	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Universität Witten/Herdecke; 🇩🇪 Witten Herdecke, Nordrhein-Westfalen, Germany

Martin-Luther-Universität Halle-Wittenberg; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

University of Luebeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany