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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Person-centered Care

Medication Review + Person-centered Care

Group Type EXPERIMENTAL

Person-centered Care

Intervention Type OTHER

Medication Review + Person-centered Care

Optimised Treatment

Intervention Type OTHER

Medication Review only

Optimised Treatment

Medication Review

Group Type ACTIVE_COMPARATOR

Optimised Treatment

Intervention Type OTHER

Medication Review only

Interventions

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Person-centered Care

Medication Review + Person-centered Care

Intervention Type OTHER

Optimised Treatment

Medication Review only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* nursing homes with at least 50 residents

* all residents within a cluster are eligible to participate in the study

Exclusion Criteria

* other ongoing trial in the institution

On individual level

* diagnoses of schizophrenia, schizoaffective psychosis, or other forms of primary psychosis
* respite care

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No