Prevention of Adverse Drug Events (ADEs) in Hospitalised Older Patients Using STOPP/START Criteria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 1
- 主要终点
- Number of patients with probable and definite adverse drug events in hospital
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 United 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.
Recent research data indicate a cause-and-effect relationship between inappropriate prescription medicines and serious ADEs in older people in hospital. To date, Beers' criteria have been the dominant set of criteria for defining potentially inappropriate medicines (PIMs) in late life. Research data collected by this group show that the recently validated STOPP/START criteria (Screening Tool of Older Persons' Prescriptions and Screening Tool to Alert doctors to Right Treatment) identify ADEs that are causal or contributory to acute hospital admission in older people 2.7 times more frequently than Beers' criteria. Based on these findings, our hypothesis is that STOPP/START criteria have the potential to be used as a regular intervention for the purpose of ADE prevention in older people. A recent single centre randomised control trial (RCT) undertaken at Cork University Hospital showed that prospective application of STOPP/START criteria led to a highly significant improvement in medication appropriateness in older hospitalised patients compared with standard inpatient pharmaceutical care. Significantly, the improvement in medication appropriateness was maintained to the end of the study follow-up i.e. 6 months post-discharge. However, the ability of STOPP/START criteria to significantly reduce ADEs in a prospective RCT has yet to be demonstrated.
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
- 否
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 or surgical team.
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.
结局指标
主要结局
Number of patients with probable and definite adverse drug events in hospital
时间窗: Up to Day 14 of hospital admission
次要结局
- drug ingredient cost at hospital discharge(Up to day 14)
- Composite health resource utilization including hospital readmissions and primary care consultations(At 3 months post discharge from hospital)
研究者
Denis O'Mahony
Senior Lecturer, Department of Medicine
University College Cork