Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Information source: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia
Intervention: Person-centered Care (Other); Optimised Treatment (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Martin-Luther-Universität Halle-Wittenberg Official(s) and/or principal investigator(s): Gabriele Meyer, Prof. Dr., Principal Investigator, Affiliation: Martin-Luther-Universität Halle-Wittenberg
Overall contact: Gabriele Meyer, Prof. Dr., Phone: +49345, Ext: 5574498, Email: gabriele.meyer@medizin.uni-halle.de
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.
Clinical Details
Official title: Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Proportion of residents receiving at least one antipsychotic medication after 12 months
Secondary outcome: Residents' quality of lifeBehavioural and psychological symptoms of dementia Costs within trial period Falls and fall-related medical attention Physical restraints within study period Median daily dose of antipsychotics in chlorpromazine equivalents within study period
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gabriele Meyer, Prof. Dr., Phone: +49345, Ext: 5574498, Email: gabriele.meyer@medizin.uni-halle.de
Universität Witten/Herdecke, Witten Herdecke, Nordrhein-Westfalen 58448, Germany; Not yet recruiting Andreas Sönnichsen, Prof. Dr., Phone: +49 2302926741, Email: andreas.soennichsen@uni-wh.de Susanne Löscher, MSc, Phone: +49 2302926784, Email: susanne.loescher@uni-wh.de Horst C Vollmar, PD Dr., Sub-Investigator
University of Luebeck, Lübeck, Schleswig-Holstein 23562, Germany; Not yet recruiting Sascha Köpke, Prof. Dr., Phone: +49 4515005467, Email: sascha.koepke@uksh.de Eva-Maria Fick, Dr., Phone: +49 4515005918, Email: eva-maria.fick@uksh.de
Additional Information
Starting date: December 2014
Last updated: December 2, 2014
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