Skip to main content
OpenTrials
Completed

NCT Number: NCT02295462

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Witten/Herdecke, Witten Herdecke, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Person-centered Care

Other

Medication Review + Person-centered Care

Optimised Treatment

Other

Medication Review only

Primary outcomes

  1. Proportion of residents receiving at least one antipsychotic medication after 12 months

    Time frame: 12 months

Secondary outcomes

  1. Residents' quality of life

    Time frame: 12 months

    Will be measured with the QoL-AD

  2. Behavioural and psychological symptoms of dementia

    Time frame: 12 months

    Will be measured with the CMAI

  3. 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.

  4. Falls and fall-related medical attention

    Time frame: 12 months

  5. 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.

  6. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Collaborators

  • University of Luebeck
  • University of Witten/Herdecke

Registry information

Acronym: EPCentCare

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.