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临床试验/NCT03654963
NCT03654963已完成不适用

Parallel Group Randomized Controlled Trial to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes

Ente Ospedaliero Cantonale, Bellinzona4 个研究点 分布在 1 个国家目标入组 1,702 人开始时间: 2018年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,702
试验地点
4
主要终点
Composite post-discharge healthcare use variable

研究概览

简要总结

Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients. Internationally, the value of this procedure is mainly attributed to the reduction in the number of adverse drug events, which can cause drug-related morbidity and mortality, as well as unnecessary health care costs.

As part of the Progress! Pilot project Safe Pharmacotherapy at the interface points, promoted by the Federal Office of Public Health, coordinated by the Swiss Patients Safety Foundation and held in several Swiss hospitals, medication reconciliation at hospital admission was introduced at the regional hospital Beata Vergine in Mendrisio, from 2014 to 2016. During this pilot project it was shown that medication reconciliation after obtaining the best possible medication history by a pharmacist at hospital admission, in comparison with the standard medication history obtained by the physician at admission, reduced the number of clinically relevant drug discrepancies.

A structured, well-established and practicable procedure of medication reconciliation that improves patient safety assuring a better quality of care at hospital admission might provide evidence that medication reconciliation could be a valuable intervention to be applied systematically in all EOC hospitals at admission, as well as subsequently potentially at the other hospital interfaces.

The purpose of this study is to evaluate whether obtaining the best possible medication history and performing medication reconciliation at hospital admission results in improving some specific healthcare outcomes.

The study seeks primarily to determine if obtaining the best possible medication history and performing medication reconciliation, in comparison with the standard medication history, reduces the number of subsequent unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge). As secondary objectives, the study aims at assessing if best possible medication history with medication reconciliation, in comparison with the standard medication history, reduces the incidence of adverse drug reactions during hospital stay, shortens length of stay, leads to a reduction in the use of hospital resources, and/or is associated with a decreased number of deaths.

详细描述

Patients of the control group will not receive the best possible medication history with medication reconciliation at admission. The standard physician-acquired medication history will be performed as usual.

Eligible patients, randomized within the intervention arm, will receive medication reconciliation according to the following steps:

  1. The pharmacy assistant will obtain the best possible medication history by compiling a comprehensive list of the medications the patient is taking and details about how the drugs are taken. In order to confirm the accuracy of the history, the pharmacy assistant will use at least two sources of information, one of which being, when possible, the interview with the patient and/or family members, in addition to referral letters, prescriptions and drug lists from primary care centres, and other.
  2. The clinical pharmacist will reconcile best possible medication history with prescribed medicines and, to resolve unclear or ambiguous discrepancies between the two lists and/or to propose any adaptations of the pharmacotherapy, the clinical pharmacist will refer to the medical doctor.
  3. The medical doctor will decide potential changes in pharmacotherapy and communicate them to the patient providing complete information on medicines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Only pharmacy assistants and clinical pharmacists, who will obtain the best possible medication history and perform medication reconciliation, will know the assignment to either the intervention or the control group. Participants and outcomes assessor will be masked.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients admitted to the inpatient wards of the two regional hospitals Beata Vergine in Mendrisio and La Carità in Locarno, fulfilling one of the following inclusion criteria, will be eligible for the study:
  • patients aged ≥ 85 years
  • patients with > 10 drugs at admission
  • Patients with home care as well as patients from elderly homes, meeting the inclusion criteria, will be factored in the study population.
  • Eligible patients will be included one-time only.

排除标准

  • The presence of any of the following exclusion criteria will lead to patient exclusion:
  • patients admitted to intensive care unit who do not reach inpatient wards
  • patients who are planned to stay within inpatient wards for less than 48 hours
  • patients who have been admitted to any of the EOC hospital wards within the previous 3 months and have been discharged at home

结局指标

主要结局

Composite post-discharge healthcare use variable

时间窗: Within 30 days after initial discharge

Total number of unplanned all-cause hospital visits (readmissions and emergency department visits within 30 days after initial discharge).

次要结局

  • Incidence of ADRs during hospital stay(1 year)
  • Length of hospital stay(1 year)
  • Death during hospital stay(1 year)
  • Number of resources used during hospital stay(1 year)

研究者

发起方
Ente Ospedaliero Cantonale, Bellinzona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Ceschi

Medical and scientific director of the Istituto di Scienze Farmacologiche della Svizzera Italiana

Ente Ospedaliero Cantonale, Bellinzona

研究点 (4)

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