1. Optimization of psychotropic drug prescription in nursing home patients with dementia: the PROPER study (PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia) Claudia H.W. Smeets 1 MSc, Klaas van der Spek MSc 1, Roland Wetzels MD 1, Debby L. Gerritsen PhD 1, Martin Smalbrugge MD PhD 2, Marjorie Nelissen-Vrancken PhD 3, Sytse U. Zuidema MD PhD 1, Raymond T.C.M. Koopmans MD PhD 1 1 Department of Primary and Community Care, Centre for Family Medicine, Geriatric Care and Public Health, Radboud University Nijmegen Medical Centre, C.Smeets@elg.umcn.nl 2 Department of Nursing Home Medicine, EMGO Institute for Health and Care Research, VU University Medical Center, 3 Dutch Institute for Rational Use of Medicine (all in the Netherlands) Background Nursing home patients with dementia use psychotropic medication more frequently and longer than appropriate according to guidelines (1). Moreover, there is a large variance in psychotropic drug use between different nursing homes. The knowledge about factors related to appropriate prescription of psychotropic drugs is scarce, whereas the need to optimize psychotropic drug prescription is high. Conclusion The PROPER study is expected to provide further insight in the factors related to the appropriate prescription of psychotropic drugs, and to investigate a method for increasing the quality of prescription in nursing home patients with dementia. Conclusion The PROPER study is expected to provide further insight in the factors related to the appropriate prescription of psychotropic drugs, and to investigate a method for increasing the quality of prescription in nursing home patients with dementia. Design & methods For the first objective, a cross-sectional observational study will be conducted. Dependent variables in this study are the frequency and appropriateness of psychotropic drug prescription. Appropriateness is assessed using a newly developed ‘Quality of psychotropic drugs prescription instrument’, see box 1. Both patients’ and environmental correlates are studied, see box 2. Quantitative as well as qualitative research methods are used. For the second objective, a subsequent 18-month cluster-randomized controlled pragmatic trial with 6-monthly measurements will be conducted. Randomization is on the level of nursing home, with equal distribution to either intervention or control group. The intervention group receives 4 education and training sessions, carried out by the Dutch Institute for Rational Use of Medication, and will conduct a structured 3-monthly repeated medication review by the physician, pharmacist and nurse. The control group provides care as usual. Primary outcome is the frequency of appropriate psychotropic drug prescription. For secondary outcomes, see box 2. Data will be analyzed using multilevel regression analysis. A process analysis is carried out for facilitators and barriers regarding introduction of the medication review. Box 1. Quality of psychotropic drugs prescription instrument This instrument consists of the 7 items shown below and is based on the 10-item Medication Appropriateness Index (2). Each item is scored with 0, 1, or 2, resulting in a total score of 0 to 14 per drug, with lower score indicating more appropriate prescription. 1.Indication 2.Evaluation of effect 3.Dosing 4.Clinically relevant interactions 5.Clinically relevant contraindications 6.Unnecessary (pseudo-)duplications 7.Duration Scoring is individually described for those psychotropic drugs prescribed in Dutch practice, based on the guideline for problem behavior in dementia of the Dutch Association of Elderly Care Physicians and Social Geriatricians (Verenso) (3), the Drug database of the Royal Dutch Association for the Advancement of Pharmacy (4), and the ‘Farmacotherapeutisch kompas‘ (5). Box 1. Quality of psychotropic drugs prescription instrument This instrument consists of the 7 items shown below and is based on the 10-item Medication Appropriateness Index (2). Each item is scored with 0, 1, or 2, resulting in a total score of 0 to 14 per drug, with lower score indicating more appropriate prescription. 1.Indication 2.Evaluation of effect 3.Dosing 4.Clinically relevant interactions 5.Clinically relevant contraindications 6.Unnecessary (pseudo-)duplications 7.Duration Scoring is individually described for those psychotropic drugs prescribed in Dutch practice, based on the guideline for problem behavior in dementia of the Dutch Association of Elderly Care Physicians and Social Geriatricians (Verenso) (3), the Drug database of the Royal Dutch Association for the Advancement of Pharmacy (4), and the ‘Farmacotherapeutisch kompas‘ (5). Objectives (1)To study the quality of prescription and to identify factors related to the prescription of psychotropic drugs in nursing home patients with dementia (2)To study the effect of a multidisciplinary structured repeated medication review on the appropriateness of this prescription Objectives (1)To study the quality of prescription and to identify factors related to the prescription of psychotropic drugs in nursing home patients with dementia (2)To study the effect of a multidisciplinary structured repeated medication review on the appropriateness of this prescription Study population Subjects will be recruited from nursing homes selected for high, average, or low psychotropic drug prescription rates. Figures on prescription rates are derived from a preceding pilot study. (1)For the first objective, from 18 nursing homes: 540 nursing home patients with dementia 40 to 60 nurses, and ±40 physicians (2)For the second objective, from 12 of the 18 nursing homes: 360 nursing home patients with dementia 24 to 36 nurses, and ±24 physicians References 1.Wetzels, RB, Zuidema SU, et al: Prescribing pattern of psychotropic drugs in nursing home residents with dementia. Int Psychogeriatr. 2011 Jun 20:1-11. 2.Samsa GP, Hanlon JT, et al: A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994 Aug; 47(8):891-6. 3.Smalbrugge M, Boersma F, et al: Guideline problem behavior, NVVA, 2008 4.www.kennisbank.knmp.nl 5.www.fk.cvz.nl Box 2. Hypothesized factors related to psychotropic drug prescription. In blue: included in observational study as correlates. In green: included as secondary parameters or correlates in interventional trial. In black: included in both studies as either correlate or parameter. Environment-related Nursing home Physical environment Nurses Psychosocial environment Organizational culture Workload Job satisfaction Characteristics (age, educational level, work experience, etc.) Number of staff per unit Absence rate Physicians Characteristics (age, work experience, tenure on unit, etc.) Patient-related Patients Demographics Neuropsychiatric symptoms Number of falls Use of restraints Use of psychosocial interventions Use of other drugs Quality of life Cognition Activities of daily living Motor symptoms Adverse events Co-morbidity Hospital admission Mortality