以群组为单位的控制干预试验，旨在改善养老院的处方行为。

Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes Study.

机构信息

KU Leuven, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.

UC Louvain, Louvain Drug Research Institute, Clinical Pharmacy Research Group, Brussels, Belgium.

出版信息

J Am Med Dir Assoc. 2019 Nov;20(11):1404-1411. doi: 10.1016/j.jamda.2019.06.006. Epub 2019 Aug 8.

DOI:10.1016/j.jamda.2019.06.006

PMID:31402136

Abstract

OBJECTIVES

To investigate the impact of a complex multifaceted intervention on the appropriateness of prescribing for Belgian nursing home (NH) residents.

DESIGN

A multicenter, nonblinded, cluster-randomized controlled trial, with randomization at the NH level, was set up [Cluster-Controlled Trial of an Intervention to Improve Prescribing in Nursing Homes (COME-ON) Study]. The complex intervention consisted of repeated interdisciplinary case conferences (ICCs) involving the general practitioner, pharmacist, and nurse, aimed at performing a medication review for each NH resident included. The ICCs were supported by a blended training program and local interdisciplinary meetings (discussion of the appropriate use of specific medication classes at the NH level). Control NHs delivered usual care. (isrctn.com: ISRCTN66138978).

SETTING AND PARTICIPANTS

Belgian NHs with at least 35 NH residents were eligible to participate. Eligible residents were those aged 65 years or over, not receiving palliative care, and being treated by a participating general practitioner.

MEASURES

The primary outcome measure related to appropriateness of prescribing at resident level and was considered successful when at least 1 potentially inappropriate medication (PIM) or potential prescribing omission (PPO) present at baseline had been solved at the end of study and when there were no new PIMs or PPOs at the end of study compared with baseline. Secondary outcomes included clinical outcomes, medication use, criterion-specific prevalence of PIMs and PPOs, and ICC outcomes.

RESULTS

In total, 54 NHs (24 intervention; 30 control) and 1804 NH residents (847 intervention; 957 control) participated. Using a 3-level mixed-effects model accounting for data clustering, a significant effect in favor of the intervention was observed (odds ratio 1.479 [95% confidence interval 1.062-2.059, P = .021]). There was no significant difference between groups for most clinical outcomes. The median number of medications did not change over time in either group.

CONCLUSIONS AND IMPLICATIONS

The complex multifaceted intervention tested in the COME-ON study successfully improved appropriateness of prescribing in NHs.

摘要

目的

研究一项复杂的多方面干预措施对改善比利时护理院（NH）居民处方适宜性的影响。

设计

采用多中心、非盲、整群随机对照试验，在 NH 层面进行随机分组[干预改善护理院处方适宜性的集群对照试验（COME-ON 研究）]。该复杂干预措施包括反复进行涉及全科医生、药剂师和护士的跨学科病例会议（ICCs），旨在对每位纳入的 NH 居民进行药物评估。ICCs 得到了混合培训计划和当地跨学科会议的支持（在 NH 层面讨论特定药物类别的合理使用）。对照组 NH 提供常规护理。（isrctn.com：ISRCTN66138978）。

地点和参与者

有至少 35 名 NH 居民的比利时 NH 有资格参与。合格的居民为年龄在 65 岁或以上、不接受姑息治疗且由参与的全科医生治疗的居民。

测量

主要结局指标与居民层面的处方适宜性相关，当基线时至少存在 1 种潜在不适当药物（PIM）或潜在处方遗漏（PPO）得到解决，且与基线相比，研究结束时无新的 PIM 或 PPO 时，认为干预成功。次要结局包括临床结局、药物使用、特定标准的 PIM 和 PPO 流行率以及 ICC 结局。

结果

共有 54 家 NH（24 家干预；30 家对照）和 1804 名 NH 居民（847 家干预；957 家对照）参与。使用考虑到数据聚类的 3 水平混合效应模型，观察到干预效果显著（优势比 1.479 [95%置信区间 1.062-2.059，P=0.021]）。两组之间大多数临床结局均无显著差异。两组的药物数量中位数在任何时间都没有变化。