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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 life

Behavioural 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

Page last updated: August 23, 2015

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