METHODS: A cluster-randomized trial will be conducted in which local pharmacy-general practice teams in the Netherlands will be randomized to conducting clinical medication reviews with patients as usual (control) or after receiving the CO-DEPRESCRIBE training program (intervention). People of 75 years and older using specific cardiometabolic medication (diabetes drugs, antihypertensives, statins) and eligible for a medication review will be included. The CO-DEPRESCRIBE intervention is based on previous work and applies models for patient-centered communication and shared decision making. It consists of 5 training modules with supportive tools. The primary outcome is the percentage of patients with at least 1 cardiometabolic medication deintensified. Secondary outcomes include patient involvement in decision making, healthcare provider communication skills, health/medication-related outcomes, attitudes towards deprescribing, medication regimen complexity and health-related quality of life. Additional safety and cost parameters will be collected. It is estimated that 167 patients per study arm are needed in the final intention-to-treat analysis using a mixed effects model. Taking loss to follow-up into account, 40 teams are asked to recruit 10 patients each. A baseline and 6-months follow-up assessment, a process evaluation, and a cost-effectiveness analysis will be conducted.
CONCLUSIONS: The hypothesis is that the training program will lead to more proactive and patient-centered deprescribing of cardiometabolic medication. By a comprehensive evaluation, an increase in knowledge needed for sustainable implementation of deprescribing in primary care is expected.
BACKGROUND: The study is registered at ClinicalTrials.gov (identifier: NCT05507177).
方法:将进行一项整群随机试验,在该试验中,荷兰当地的药学-普通实践团队将被随机分配到与患者照常(对照)或在接受CO-DEPRESCRIBE培训计划(干预)后进行临床药物审查。75岁及以上的人使用特定的心脏代谢药物(糖尿病药物,抗高血压药,他汀类药物),并有资格进行药物审查。共同描述干预基于先前的工作,并将模型应用于以患者为中心的沟通和共享决策。它由5个培训模块和支持工具组成。主要结果是至少有1种心脏代谢药物恶化的患者百分比。次要结果包括患者参与决策,医疗保健提供者沟通技巧,健康/药物相关结果,对开药的态度,药物治疗方案的复杂性和健康相关的生活质量。将收集额外的安全和成本参数。据估计,在使用混合效应模型的最终意向治疗分析中,每个研究臂需要167名患者。考虑到后续损失,40个团队被要求招募每个10名患者。基线和6个月随访评估,过程评估,并进行成本效益分析。
结论:假设是培训计划将导致更主动和以患者为中心的心脏代谢药物处方。通过综合评价,预计初级保健中可持续实施去处方所需的知识将会增加.
背景:该研究已在ClinicalTrials.gov注册(标识符:NCT05507177)。