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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. [ABSTRACT FROM AUTHOR]

Background: Psychotropic drugs are often prescribed to treat neuropsychiatric symptoms in nursing home residents with dementia, despite having limited efficacy and considerable side effects. To reduce the inappropriate prescribing of these psychotropic drugs, various non-pharmacological, psychosocial, person-centered, or multidisciplinary interventions are advocated. However, existing multidisciplinary interventions have shown variable effects, with limited effectiveness often resulting from suboptimal implementation. We hypothesize that an effective intervention needs to fit the local situation of a nursing home and that support should be offered during implementation. Methods: We will embed participatory action research within a stepped-wedge cluster randomized controlled trial to study the effects of a tailored intervention and implementation plan to reduce inappropriate psychotropic drug prescribing. Nursing homes will be provided with tailored information about the perceived problems of managing neuropsychiatric symptoms and we will offer coaching support throughout. Alongside the participatory action research, we will perform a process evaluation to examine the quality of the study, the intervention, and the implementation. Our aim is to recruit 600 residents from 16 nursing homes throughout the Netherlands, with measurements taken at baseline, 8 months, and 16 months. Nursing homes will be randomly allocated to an intervention or a deferred intervention group. During each intervention stage, we will provide information about inappropriate psychotropic drug prescribing, neuropsychiatric symptoms, and difficulties in managing neuropsychiatric symptoms through collaboration with each nursing home. After this, a tailored intervention and implementation plan will be written and implemented, guided by a coach. The primary outcome will be the reduction of inappropriate prescribing, as measured by the Appropriate Psychotropic drug use In Dementia index. Secondary outcomes will be the frequency of psychotropic drug use and neuropsychiatric symptoms, plus quality of life. A mixed methods design will be used for the process evaluation. Effects will be assessed using multilevel analyses. The project leader of the nursing home and the coach will complete questionnaires and in-depth interviews. Discussion: We anticipate that the proposed tailored intervention with coaching will reduce inappropriate psychotropic drug prescribing for nursing home residents with neuropsychiatric symptoms. This study should also provide insights into the barriers to, and facilitators of, implementation. Trial registration: NTR5872, registered on July 2, 2016. [ABSTRACT FROM AUTHOR]