期刊论文详细信息
BMC Psychiatry
Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial
Raymond TCM Koopmans3  Sytse U Zuidema2  Klaas van der Spek3  Roland B Wetzels3  Marjorie HJMG Nelissen-Vrancken1  Debby L Gerritsen3  Martin Smalbrugge4  Claudia HW Smeets3 
[1] Dutch Institute for Rational Use of Medicine, P.O. Box 3089, 3502, GB Utrecht, the Netherlands;Department of General Practice, University of Groningen, University Medical Center Groningen, HPC FA21, P.O. Box 196, 9700, AD Groningen, the Netherlands;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;Department of General Practice and Elderly Care Medicine/EMGO + Institute for Health and Care Research, VU Medical Center, P.O Box 7057, 1007, MB Amsterdam, The Netherlands
关键词: Clinical trial;    Medication safety;    Nursing homes;    Psychotropic drugs;    Dementia;   
Others  :  1123915
DOI  :  10.1186/1471-244X-13-280
 received in 2013-10-17, accepted in 2013-10-23,  发布年份 2013
PDF
【 摘 要 】

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.

【 授权许可】

   
2013 Smeets et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150216051301774.pdf 362KB PDF download
Figure 1. 78KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]Zuidema S, Koopmans R, Verhey F: Prevalence and predictors of neuropsychiatric symptoms in cognitively impaired nursing home patients. J Geriatr Psychiatry Neurol 2007, 20(1):41-49.
  • [2]Seitz D, Purandare N, Conn D: Prevalence of psychiatric disorders among older adults in long-term care homes: a systematic review. Int Psychogeriatr 2010, 22(7):1025-1039.
  • [3]Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT: Course of neuropsychiatric symptoms in residents with dementia in nursing homes over 2-year period. Am J Geriatr Psychiatry 2010, 18(12):1054-1065.
  • [4]Ballard CG, Gauthier S, Cummings JL, Brodaty H, Grossberg GT, Robert P, Lyketsos CG: Management of agitation and aggression associated with Alzheimer disease. Nat Rev Neurol 2009, 5(5):245-255.
  • [5]van Iersel MB, Zuidema SU, Koopmans RT, Verhey FR, Olde Rikkert MG: Antipsychotics for behavioural and psychological problems in elderly people with dementia: a systematic review of adverse events. Drugs Aging 2005, 22(10):845-858.
  • [6]Schneider LS, Dagerman K, Insel PS: Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Am J Geriatr Psychiatry 2006, 14(3):191-210.
  • [7]Knol W, van Marum RJ, Jansen PA, Souverein PC, Schobben AF, Egberts AC: Antipsychotic drug use and risk of pneumonia in elderly people. J Am Geriatr Soc 2008, 56(4):661-666.
  • [8]Eggermont LH, de Vries K, Scherder EJ: Psychotropic medication use and cognition in institutionalized older adults with mild to moderate dementia. Int Psychogeriatr 2009, 21(2):286-294.
  • [9]Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT: Prescribing pattern of psychotropic drugs in nursing home residents with dementia. Int Psychogeriatr 2011, 23(8):1249-1259.
  • [10]Nijk RM, Zuidema SU, Koopmans RT: Prevalence and correlates of psychotropic drug use in dutch nursing-home patients with dementia. Int Psychogeriatr 2009, 21(3):485-493.
  • [11]Ballard C, Corbett A, Chitramohan R, Aarsland D: Management of agitation and aggression associated with Alzheimer’s disease: controversies and possible solutions. Curr Opin Psychiatry 2009, 22(6):532-540.
  • [12]van Dijk KN, de Vries CS, van den Berg PB, Brouwers JR, den de Jong-van Berg LT: Drug utilisation in dutch nursing homes. Eur J Clin Pharmacol 2000, 55(10):765-771.
  • [13]Kaur S, Mitchell G, Vitetta L, Roberts MS: Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging 2009, 26(12):1013-1028.
  • [14]Verrue CL, Petrovic M, Mehuys E, Remon JP, Vander Stichele R: Pharmacists’ interventions for optimization of medication use in nursing homes: a systematic review. Drugs Aging 2009, 26(1):37-49.
  • [15]Forsetlund L, Eike MC, Gjerberg E, Vist GE: Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr 2011, 11:16. BioMed Central Full Text
  • [16]Stuijt CC, Franssen EJ, Egberts AC, Hudson SA: Appropriateness of prescribing among elderly patients in a dutch residential home: observational study of outcomes after a pharmacist-led medication review. Drugs Aging 2008, 25(11):947-954.
  • [17]Patterson SM, Hughes CM, Crealey G, Cardwell C, Lapane KL: An evaluation of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in northern ireland (fleetwood northern ireland study). J Am Geriatr Soc 2010, 58(1):44-53.
  • [18]Child A, Clarke A, Fox C, Maidment I: A pharmacy led program to review anti-psychotic prescribing for people with dementia. BMC Psychiatry 2012, 12:155. BioMed Central Full Text
  • [19]Schols JM, Crebolder HF, van Weel C: Nursing home and nursing home physician: the dutch experience. J Am Med Dir Assoc 2004, 5(3):207-212.
  • [20]van der Spek K, Gerritsen D, Smalbrugge M, Nelissen-Vrancken M, Wetzels R, Smeets C, Zuidema S, Koopmans R: PROPER I: frequency and appropriateness of psychotropic drugs use in nursing home patients and its associations: a study protocol. BMC Psychiatry 2013., 13http://www.biomedcentral.com/1471-244X/13/307 webcite
  • [21]Instituut voor verantwoord medicijngebruik. http://www.medicijngebruik.nl/ webcite
  • [22]Smalbrugge M, Boersma F, Kleijer BC, Kok RM, Sival RC, Verburg D, Verheij FRJ, Zuidema SU, NVVA: Guideline problem behavior.. 2008.
  • [23]Nederlands huisartsen genootschap - multidisciplinaire richtlijn polyfarmacie bij ouderen. https://www.nhg.org/themas/artikelen/mdr-polyfarmacie-bij-ouderen webcite
  • [24]Gallagher P, Ryan C, Byrne S, Kennedy J, O’Mahony D: STOPP (screening tool of older Person’s prescriptions) and START (screening tool to alert doctors to right treatment). Consensus validation. Int J Clin Pharmacol Ther 2008, 46(2):72-83.
  • [25]Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, Cohen HJ, Feussner JR: A method for assessing drug therapy appropriateness. J Clin Epidemiol 1992, 45(10):1045-1051.
  • [26]Van Gool WA, Hagemeijer A, Barkhof F, Brouwer KJ, Eefsting JA, Eikelenboom P, Jonker C, Olde Rikkert MGM, Sanders JB, Scheltens PH, Schmand BA, Sival RC, Stam CJ, Steenhoek A, Verhey FRJ, Wind AW, Nederlandse Vereniging voor Klinische Geriatrie: Richtlijn diagnostiek en medicamenteuze behandeling van dementie. Alphen aan den Rijn: Van Zuiden Communications; 2005. http://www.diliguide.nl/document/969/dementie.html webcite
  • [27]KNMP kennisbank. http://www.kennisbank.knmp.nl/index.asp webcite
  • [28]Farmacotherapeutisch Kompas. http://www.fk.cvz.nl/ webcite
  • [29]Nordic council on medicines: guidelines for ATC classification. Oslo: WHO Collaborating Center for Drugs Statistics Methodology; 1990. http://www.who.int/classifications/atcddd/en/ webcite
  • [30]Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST: Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci 2000, 12(2):233-239.
  • [31]Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J: The neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994, 44(12):2308-2314.
  • [32]de Jonghe JF, Kat MG, Kalisvaart CJ, Boelaarts L: Neuropsychiatric inventory questionnaire (NPI-Q): a validity study of the dutch form. Tijdschr Gerontol Geriatr 2003, 34(2):74-77.
  • [33]Cohen-Mansfield J, Marx MS, Rosenthal AS: A description of agitation in a nursing home. J Gerontol 1989, 44(3):M77-M84.
  • [34]de Jonghe JF, Kat MG: Factor structure and validity of the dutch version of the cohen-mansfield agitation inventory (CMAI-D). J Am Geriatr Soc 1996, 44(7):888-889.
  • [35]Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT: Agitation in dutch institutionalized patients with dementia: factor analysis of the dutch version of the cohen-mansfield agitation inventory. Dement Geriatr Cogn Disord 2007, 23(1):35-41.
  • [36]Zuidema SU, Buursema AL, Gerritsen MG, Oosterwal KC, Smits MM, Koopmans RT, de Jonghe JF: Assessing neuropsychiatric symptoms in nursing home patients with dementia: reliability and reliable change index of the neuropsychiatric inventory and the cohen-mansfield agitation inventory. Int J Geriatr Psychiatry 2011, 26(2):127-134.
  • [37]Leontjevas R, Gerritsen DL, Vernooij-Dassen MJ, Teerenstra S, Smalbrugge M, Koopmans RT: Nijmegen observer-rated depression scale for detection of depression in nursing home residents. Int J Geriatr Psychiatry 2012, 27(10):1036-1044.
  • [38]Morris JN, Hawes C, Fries BE, Phillips CD, Mor V, Katz S, Murphy K, Drugovich ML, Friedlob AS: Designing the national resident assessment instrument for nursing homes. Gerontologist 1990, 30(3):293-307.
  • [39]Burrows AB, Morris JN, Simon SE, Hirdes JP, Phillips C: Development of a minimum data set-based depression rating scale for use in nursing homes. Age Ageing 2000, 29(2):165-172.
  • [40]Gerritsen D, Ooms M, Steverink N, Frijters D, Bezemer D, Ribbe M: Three new observational scales for use in dutch nursing homes: scales from the resident assessment instrument for activities of daily living, cognition and depression. Tijdschr Gerontol Geriatr 2004, 35(2):55-64.
  • [41]Ettema TP, Droes RM, de Lange J, Mellenbergh GJ, Ribbe MW: QUALIDEM: development and evaluation of a dementia specific quality of life instrument–validation. Int J Geriatr Psychiatry 2007, 22(5):424-430.
  • [42]Ettema TP, Droes RM, de Lange J, Mellenbergh GJ, Ribbe MW: QUALIDEM: development and evaluation of a dementia specific quality of life instrument. Scalability, reliability and internal structure. Int J Geriatr Psychiatry 2007, 22(6):549-556.
  • [43]Reisberg B, Ferris SH, de Leon MJ, Crook T: The global deterioration scale for assessment of primary degenerative dementia. Am J Psychiatry 1982, 139(9):1136-1139.
  • [44]Gerritsen DL, Steverink N, Frijters DH, Hirdes JP, Ooms ME, Ribbe MW: A revised index for social engagement for long-term care. J Gerontol Nurs 2008, 34(4):40-48.
  • [45]Mor V, Branco K, Fleishman J, Hawes C, Phillips C, Morris J, Fries B: The structure of social engagement among nursing home residents. J Gerontol B Psychol Sci Soc Sci 1995, 50(1):P1-P8.
  • [46]Hirdes JP, Fries BE, Morris JN, Steel K, Mor V, Frijters D, LaBine S, Schalm C, Stones MJ, Teare G, et al.: Integrated health information systems based on the RAI/MDS series of instruments. Healthc Manage Forum 1999, 12(4):30-40.
  • [47]Morris JN, Fries BE, Morris SA: Scaling ADLs within the MDS. J Gerontol A Biol Sci Med Sci 1999, 54(11):M546-M553.
  • [48]Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K: The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl 1987, 334:1-100.
  • [49]Schmitt FA, Saxton JA, Xu Y, McRae T, Sun Y, Richardson S, Li H: A brief instrument to assess treatment response in the patient with advanced Alzheimer disease. Alzheimer Dis Assoc Disord 2009, 23(4):377-383.
  • [50]Saxton J, McGonigle-Gibson KL, Swihart AA, Miller VJ, Boller F: Assessment of the severely demented patient: description and validation of a new neuropsychological test battery. Psychol Assess A J Consult Clin Psychol 1990, 2:298-303.
  • [51]van Oostrom SH, Picavet HS, van Gelder BM, Lemmens LC, Hoeymans N, Verheij RA, Schellevis FG, Baan CA: Multimorbidity and comorbidity in the dutch population–data from general practices. Ned Tijdschr Geneeskd 2011, 155:A3193.
  • [52]Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT: Psychotropic drug prescription in nursing home patients with dementia: influence of environmental correlates and staff distress on physicians’ prescription behavior. Int Psychogeriatr 2011, 23(10):1632-1639.
  • [53]Java applets for power and sample size. http://homepage.stat.uiowa.edu/~rlenth/Power/ webcite
  • [54]Twisk JWR: Applied multilevel analysis. USA: Cambridge University Press; 2006.
  • [55]WMA declaration of helsinki - ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/index.html webcite
  文献评价指标  
  下载次数:26次 浏览次数:14次