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临床试验/NCT02906657
NCT02906657已完成不适用

Development of Medication Reconciliation Using Electronic Pharmaceutical Record: a National Multicenter, Cluster-randomized, Two-period Crossover Study in Elderly Hospitalized in Geriatrics, Internal Medicine and Orthopedic Surgery

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,000
试验地点
2
主要终点
Proportion of patients with at least one ADE within the first 30 days of hospital stay.

研究概览

简要总结

Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from discrepancies between patient's current medications and the drugs prescribed at admission (omission,, dosing errors....).

Consequences of these discrepancies may be mild (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes. Medication reconciliation is a process of creating the most accurate list of patient's current medication in order to decrease discrepancies and eventually ADEs.

Information technology and electronic health records are of great interest in this process. In France, medications dispensed in community pharmacies during the past 4 months are registered in a patient's electronic pharmaceutical record. The impact of this record, together with pharmacist medication reconciliation, will be tested in the CONCIPAGE study.

Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period cross-over study. It will estimate the impact of medication reconciliation, made by a pharmacist, using the patient pharmaceutical record, on the occurrence of ADEs during the hospitalization of patients aged 65 years and over.

详细描述

Context Adverse drug events (ADEs) may occur in community or hospitalized patients. A review of the literature reports an incidence of ADEs varying from 0.1 to 61.4 %. This wide range may be explained by different designs and case-mix in the studies. For instance, the incidence of ADEs is higher in surgical wards or in the elderly, and increases with the number of prescribed drugs. In the elderly, the risk of ADE has been reported as 2-fold higher than that of a younger population. Some ADEs may not have been prevented, for example when the event was associated with an intended or known effect (e.g. neutropenia after cytotoxic drugs administration). However, some other ADEs might have been prevented whenever they were related to medications errors (omission, commission, dosing errors, prescription despite known allergies...). The proportion of preventable ADEs has been reported to range from 25% to 43% of total ADEs.

ADE can lead to extra monitoring because of biological abnormalities but also in more serious cases, to temporary or permanent harms, and even to death.

Prolonged hospitalizations are also attributed to ADE. Gastrointestinal tract events are the most common type of ADEs, followed by electrolyte and renal events, hemorrhages, metabolic and endocrine events. Drugs involved are cardiovascular drugs, followed by analgesics, antibiotics and anticoagulants.

Discrepancies between patient's current medication and the drugs prescribed at hospital admission hospital are frequent (27 to 54%) and have been reported in numerous studies. Potential consequences of such discrepancies have been extensively studied but data dealing with clinical outcomes are sparse.

Medication reconciliation is a process aiming at the creation of the most appropriate list of patient's medications, thus decreasing medication discrepancies and eventually ADE. Medication reconciliation can be performed by physicians, nurses, pharmacists. Usual sources of information for medication reconciliation are patient's prescriptions from the attending physician, patient's interview, hospital records... Additionally, information technology and electronic health records are of great help in this process. In France, drugs dispensed to a patient in community pharmacies during the 4 past months are registered in his/her electronic pharmaceutical record which is available to any pharmacist nationwide. This database is protected and can be consulted after recognition of the patient's healthcare card. To date, the contribution of this record to medication reconciliation has not been studied. The CONCIPAGE study will estimate the impact of a medication reconciliation using patient pharmaceutical record, on the occurrence of ADEs during the hospitalization of patients aged 65 years and over.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Proportion of patients with at least one ADE within the first 30 days of hospital stay.

时间窗: 30 days after admission

次要结局

  • Proportion of preventable adverse drug events(30 days after admission)
  • Distribution of the severity of adverse drug events(30 days after admission)
  • Proportion of patients with discrepancy(ies) between pre- and post-reconciliation prescriptions(30 days after admission)
  • 30-day mortality rate(30 days after admission)
  • Incremental hospital costs per ADE avoided(30 days after admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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