title: Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Netherlands Trial Registry (NTR): NTR3569.
authors.affiliation: Department of Primary and Community Care, Centre for Family Medicine, Geriatric Care and Public Health, Radboud university medical center, Code 117 ELG, P,O, Box 9101, 6500, HB Nijmegen, the Netherlands. claudia.smeets@radboudumc.nl.
authors.forename: Claudia H W
authors.initials: CH
authors.lastname: Smeets
authors.forename: Martin
authors.initials: M
authors.lastname: Smalbrugge
authors.forename: Debby L
authors.initials: DL
authors.lastname: Gerritsen
authors.forename: Marjorie H J M G
authors.initials: MH
authors.lastname: Nelissen-Vrancken
authors.forename: Roland B
authors.initials: RB
authors.lastname: Wetzels
authors.forename: Klaas
authors.initials: K
authors.lastname: van der Spek
authors.forename: Sytse U
authors.initials: SU
authors.lastname: Zuidema
authors.forename: Raymond T C M
authors.initials: RT
authors.lastname: Koopmans
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease; D002985:Clinical Protocols; D003704:Dementia / Q000188:drug therapy* / Q000523:psychology; D011307:Drug Prescriptions; D006801:Humans; D009426:Netherlands; D009735:Nursing Homes; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design
chemical_list: D011619:Psychotropic Drugs