Kormelinck Claudia M Groot, Gerritsen Debby L, van Teunenbroek Charlotte F, de Boer Michiel R, Smalbrugge Martin, Zuidema Sytse U
Department of Primary and Long-term Care, University of Groningen, University Medical Centre Groningen, PO Box 196, Groningen, 9700 AD, FA21, the Netherlands.
Alzheimer Centre Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
BMC Geriatr. 2025 Aug 2;25(1):581. doi: 10.1186/s12877-025-06206-y.
BACKGROUND: Psychotropic drugs are modestly effective and may cause adverse effects. Efforts to reduce inappropriateness and increase usage of psychosocial interventions often suffer from suboptimal implementation. The purpose of this study was to evaluate effectiveness of an innovative study using implementation promoting elements in nursing home residents with dementia and neuropsychiatric symptoms. METHODS: A multicenter cluster randomized controlled trial with a special case of a stepped-wedge design with two arms and one stap was designed. The intervention comprised participatory action research, tailored information provision and external coaching, leading to the implementation of tailored action and implementation plans. The primary outcome was inappropriateness of psychotropic drug use (Appropriate Psychotropic Drug Use in Dementia [APID] index) and the secondary outcome was percentage of psychotropic drug use at baseline, 8 months, and 16 months. Homes were allocated to start with usual care or the intervention. After 8 months, the control group crossed over to receive the intervention. The other homes continued the intervention to 16 months. Patients were eligible if they were diagnosed with dementia, had a life expectancy of at least 3 months, and resided in psychogeriatric units. RESULTS: An adjusted multilevel model revealed no effect on the APID index sum score at 8 months (0.564; 95% confidence interval [CI], -2.449-3.577; p = 0.71) or 16 months (2.165; 95% CI, -1.113-5.443; p = 0.20). An adjusted generalized estimation equation (GEE) model showed an effect at 16 months for percentage of use (OR 0.654; 95% CI, 0.481-0.889; p = 0.007). Adjusted GEE models showed an effect especially at 16 months for anxiolytics (OR 0.573; 95% CI, 0.382-0.859; p = 0.007) and antidepressants (OR 0.678; 95% CI, 0.475-0.968; p = 0.033). CONCLUSIONS: No reduction of inappropriateness was found although overall usage was reduced. Professionals focused on implementing alternatives to compensate for usage, rather than prescribing quality. Future studies may focus on changing physicians' prescribing behaviors in combination with multicomponent and multidisciplinary psychosocial alternatives. TRIAL REGISTRATION: Netherlands Trial Registry (NTR5872) on 27/05/2016, https://onderzoekmetmensen.nl/nl/node/26060/pdf .
背景：精神药物疗效一般且可能会产生不良反应。减少用药不当并增加心理社会干预措施使用的努力往往因实施效果欠佳而受阻。本研究旨在评估一项创新性研究的效果，该研究在患有痴呆症和神经精神症状的养老院居民中使用了促进实施的要素。 方法：设计了一项多中心整群随机对照试验，采用特殊的阶梯楔形设计，有两个组和一个阶段。干预措施包括参与式行动研究、量身定制的信息提供和外部指导，从而实施量身定制的行动和实施计划。主要结局是精神药物使用不当情况（痴呆症患者精神药物合理使用[APID]指数），次要结局是基线、8个月和16个月时精神药物使用的百分比。养老院被分配为开始接受常规护理或干预措施。8个月后，对照组转而接受干预措施。其他养老院继续干预措施至16个月。如果患者被诊断患有痴呆症、预期寿命至少3个月且居住在老年精神科病房，则符合入选条件。 结果：调整后的多水平模型显示，在8个月（0.564；95%置信区间[CI]，-2.449 - 3.577；p = 0.71）或16个月（2.165；95%CI，-1.113 - 5.443；p = 0.20）时，对APID指数总分无影响。调整后的广义估计方程（GEE）模型显示，在16个月时，使用百分比有影响（比值比[OR]0.654；95%CI，0.481 - 0.889；p = 0.007）。调整后的GEE模型显示，尤其是在16个月时，对苯二氮䓬类药物（OR 0.573；95%CI，0.382 - 0.859；p = 0.007）和抗抑郁药（OR 0.678；95%CI，0.475 - 0.968；p = 0.033）有影响。 结论：尽管总体用药量有所减少，但未发现用药不当情况有所减少。专业人员专注于实施替代方案以补偿用药量，而非处方质量。未来的研究可能侧重于结合多成分和多学科心理社会替代方案来改变医生的处方行为。 试验注册：荷兰试验注册中心（NTR5872），2016年5月27日，https://onderzoekmetmensen.nl/nl/node/26060/pdf 。
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