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BMC Psychiatry
Published in: BMC Psychiatry 1/2013

Open Access 01-12-2013 | Study protocol

Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial

Authors: Claudia HW Smeets, Martin Smalbrugge, Debby L Gerritsen, Marjorie HJMG Nelissen-Vrancken, Roland B Wetzels, Klaas van der Spek, Sytse U Zuidema, Raymond TCM Koopmans

Published in: BMC Psychiatry | Issue 1/2013

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Abstract

Background

Neuropsychiatric symptoms are highly prevalent in nursing home patients with dementia. Despite modest effectiveness and considerable side effects, psychotropic drugs are frequently prescribed for these neuropsychiatric symptoms. This raises questions whether psychotropic drugs are appropriately prescribed. The aim of the PROPER (PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) II study is to investigate the efficacy of an intervention for improving the appropriateness of psychotropic drug prescription in nursing home patients with dementia.

Methods/design

The PROPER II study is a multi-center cluster randomized controlled, pragmatic trial using parallel groups. It has a duration of eighteen months and four six-monthly assessments. Six nursing homes will participate in the intervention and six will continue care as usual. The nursing homes will be located throughout the Netherlands, each participating with two dementia special care units with an average of fifteen patients per unit, resulting in 360 patients. The intervention consists of a structured and repeated multidisciplinary medication review supported by education and continuous evaluation. It is conducted by pharmacists, physicians, and nurses and consists of three components: 1) preparation and education, 2) conduct, and 3) evaluation/guidance. The primary outcome is the proportion of patients with appropriate psychotropic drug use. Secondary outcomes are the overall frequency of psychotropic drug use, neuropsychiatric symptoms, quality of life, activities of daily living, psychotropic drug side effects and adverse events (including cognition, comorbidity, and mortality). Besides, a process analysis on the intervention will be carried out.

Discussion

This study is expected to improve the appropriateness of psychotropic drug prescription for neuropsychiatric symptoms in nursing home patients with dementia by introducing a structured and repeated multidisciplinary medication review supported by education and continuous evaluation.

Trial registration

Netherlands Trial Registry (NTR): NTR3569.
Appendix
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Metadata
Title
Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial
Authors
Claudia HW Smeets
Martin Smalbrugge
Debby L Gerritsen
Marjorie HJMG Nelissen-Vrancken
Roland B Wetzels
Klaas van der Spek
Sytse U Zuidema
Raymond TCM Koopmans
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2013
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-13-280

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