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临床试验/NCT01467128
NCT01467128已完成4 期

Title of Study: Adverse Drug Event (ADE) Incidence in Older Patients Following Hospital Admission and Pharmacist Review to Older Persons' Prescriptions and Its' Effect on ADE Reduction in Hospital: a Randomised Controlled Trial

University College Cork1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
720
试验地点
1
主要终点
Number of patients with definite and possible adverse drug events during their hospital admission

研究概览

简要总结

The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.

A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.

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
Single (Participant)

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

  • All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical team will be eligible for the study.

排除标准

  • Age less than 65 years.
  • Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
  • Terminally ill patient attended by palliative care team.
  • Critically ill patient e.g. admitted to Intensive Care Unit.
  • Patients who do not wish to participate in the study.
  • Patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ADE prevention is not yet demonstrated.

结局指标

主要结局

Number of patients with definite and possible adverse drug events during their hospital admission

时间窗: From point of randomization to Day 14

次要结局

  • Drug ingredient cost at hospital discharge(Up to Day 14)
  • Medication Appropriateness Index score(measured at Day 14 and again at three months post hospital discharge.)
  • Composite health resource utilization including hospital admissions and primary care consultations(Measured at 3 months post hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis O'Mahony

Senior Lecturer, Dept. of Medicine

University College Cork

研究点 (1)

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