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协作药学服务对医院出院用药错误发生率的影响:一项阶梯式楔形整群随机试验。

The impact of collaborative pharmaceutical care on hospital discharge medication error prevalence: A stepped-wedge cluster randomised trial.

作者信息

Kirwan Gráinne, Allen Ann, Deasy Evelyn, Delaney Tim, Hayde Jennifer, McManamly Ciara, Wall Catherine, O'Byrne John, Grimes Tamasine

机构信息

School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.

Pharmacy Department, Tallaght University Hospital, Dublin, Ireland.

出版信息

Explor Res Clin Soc Pharm. 2025 Jul 31;20:100638. doi: 10.1016/j.rcsop.2025.100638. eCollection 2025 Dec.

Abstract

OBJECTIVES

The benefits of a collaborative approach to medication management between pharmacists and clinicians in secondary care on patient safety has been demonstrated in clinical trials. However, less is known about the benefit of such collaboration in real-world settings. This study assessed the effectiveness of a collaborative model of pharmaceutical care including pharmacist collaborative prescribing, on discharge medication error, and explored the intervention fidelity.

METHODS

This stepped wedge cluster-randomised controlled trial was undertaken at a university hospital in Dublin, Ireland. A cluster was one or more medical or surgical specialty, or part thereof, delivering acute care. Adult patients, using five plus regular medicines pre-admission, receiving care from a participating cluster, and discharged alive from that cluster were eligible for inclusion. Patients previously admitted during the study period and enrolled were excluded. The intervention saw a pharmacist aligned to a specialty, delivering collaborative services to patients: medication history taking, admission medication reconciliation, inpatient medication optimisation, discharge medication reconciliation and collaborative prescribing. The comparator was ward-based pharmacist care. Sample size accounting for study design, attrition and effect size in discharge medication error was calculated as 430 participants. The primary analysis was undertaken by the intention-to-treat (ITT) principle and multilevel logistic regression through the Generalised Linear Mixed Model (GLMM) procedure, was used to account for the effect of clustering and adjust for confounders.

RESULTS

Eighty-six of 432 (19.9 %) assessable patients experienced a clinically significant discharge medication error, 37 (43 %) of whom were intervention group patients. Intention-to-treat analysis suggested no difference in the likelihood of experiencing this primary outcome between study groups (adjusted odds ratio 1.24, 95 % confidence interval 0.53-2.88). This finding was consistent in the extreme sensitivity and per protocol analyses. Intervention fidelity was poor with six (2.4 %) intervention patients receiving discharge medication reconciliation.

CONCLUSION

Under real-world conditions, this collaborative model of pharmaceutical care including medication reconciliation and collaborative prescribing was equivalent to standard care in protecting against clinically significant discharge medication error. Future research should employ an implementation science framework to better understand how pharmaceutical care at discharge can be spread.

摘要

目的

在二级医疗中,药剂师与临床医生采用协作方式进行药物管理对患者安全的益处已在临床试验中得到证实。然而,对于这种协作在现实环境中的益处了解较少。本研究评估了包括药剂师协作开方在内的药物治疗协作模式对出院用药错误的有效性,并探讨了干预的保真度。

方法

本阶梯式楔形整群随机对照试验在爱尔兰都柏林的一家大学医院进行。一个整群是一个或多个提供急性护理的内科或外科专科,或其一部分。成年患者在入院前使用五种及以上常规药物,从参与的整群接受护理,并从该整群存活出院,符合纳入条件。排除在研究期间曾入院并已入组的患者。干预措施是一名与专科对口的药剂师为患者提供协作服务:用药史采集、入院用药核对、住院期间用药优化、出院用药核对和协作开方。对照措施是基于病房的药剂师护理。考虑到研究设计、损耗和出院用药错误的效应大小,计算得出样本量为430名参与者。主要分析采用意向性分析(ITT)原则,并通过广义线性混合模型(GLMM)程序进行多水平逻辑回归,以考虑整群效应并对混杂因素进行调整。

结果

432名可评估患者中有86名(19.9%)出现了具有临床意义的出院用药错误,其中37名(43%)是干预组患者。意向性分析表明,研究组之间出现这一主要结局的可能性没有差异(调整后的优势比为1.24,95%置信区间为0.53 - 2.88)。这一发现在极端敏感性分析和符合方案分析中是一致的。干预保真度较差,有6名(2.4%)干预组患者接受了出院用药核对。

结论

在现实条件下,这种包括用药核对和协作开方在内的药物治疗协作模式在预防具有临床意义的出院用药错误方面与标准护理相当。未来的研究应采用实施科学框架,以更好地了解出院时的药物治疗如何得以推广。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4d4/12354959/b26f638daca3/gr1.jpg

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