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

Martin-Luther-Universität Halle-Wittenberg

Status: Completed

Conditions: Dementia

Treatments: Other: Optimised Treatment; Other: Person-centered Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02295462

01GY1335C (Other Grant/Funding Number)

EPCentCare

01GY1335B (Other Grant/Funding Number)

01GY1335A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,158 participants in 2 patient groups

Person-centered Care

Experimental group

Description:

Medication Review + Person-centered Care

Treatment:

Other: Optimised Treatment

Other: Person-centered Care

Optimised Treatment

Active Comparator group

Description:

Medication Review

Treatment:

Other: Optimised Treatment