跳至主要内容
临床试验/NCT01906710
NCT01906710Unknown不适用

The Effect of Patient Centered Medication Reconciliation, Medication Review and Discharge Counseling With Information Transfer in Hospitalized Patients on Clinical and Economic Parameters: a Multicentre, Before-after Study.

Clementine CM Stuijt PharmD, MSc6 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
6
主要终点
number of rehospitalizations

研究概览

简要总结

The purpose of this study is to determine whether a hospital pharmacy team (pharmacy technicians and pharmacists) together with (recently admitted) patients are able to diminish the number of drug related problems including adverse drug events, made before, during and after admissions resulting in reductions of re-hospitalizations and costs.

详细描述

In its 2006 report "Preventing Medication Errors," the Institute of Medicine (IOM) estimated that more than 1.5 million adverse drug events (ADEs) occur annually in the United States. On average, every hospital patient is subjected to at least one medication error every day. Medication errors are a frequent cause of ADEs.

ADEs are usually defined as 'any injury due to medication use, including omission'. This may occur as an unavoidable result of the pharmacological action (better known as side effect or adverse drug reaction (ADR)) or by the manner the drug is applied (medication error or preventable ADE). ADEs can be regarded as the top of the iceberg containing all problems associated with drug therapy also known as Drug-Related Problems (DRPs). This means that besides ADEs, DRPs include other medication related problems like ADRs, medication errors, non-adherence and inadequate use of the medication by the patient. All these events can result in harm for the patient.

The wide variation of prevalence of ADEs found in the literature can be explained by differences in study setting, study population, outcome (ADRs, ADEs or both) and data collection method. Anticipating who will suffer an ADE, when, and from what medication is difficult. Research has not yet identified any valid predictors of the event. Patient characteristics currently are no useful predictors of an ADE because patients who have suffered ADEs are a non homogeneous group. Although older age, severity of illness, intensity of treatment, and poly-pharmacy have been associated with ADEs, no cause and effect relationship is known to exist between patients who suffer ADEs and age, comorbidity, or number of drugs received.

Around the time of hospitalization 15 to 72% of harmful events is attributed to ADEs and medication errors. ADEs are associated with substantial morbidity, increased mortality and longer length of stay in hospital and other direct costs. Nearly 1% (0,946) of patients who died during admission on an internal medicine department, were associated with the use of one or more drugs during this admission. Furthermore, a recent investigation among 21 Dutch hospitals by Hoonhout et al. revealed an excess length of stay of 6,2 days (95% CI 3.6,8.8) as a result of medication related adverse events. This figure is comparable to that of the American situation. Patients suffering from less severe ADEs (those that required a change in therapy or a longer hospital stay) had an average stay of 13 days, and patients who did not suffer an ADE had an average stay of 5 days.

As a result, common reasons for admission include avoidable ADEs. Gillespie et al. investigated the effect of a ward based pharmacist on hospital admissions amongst 80 year old patients and over. After 12 months the risk on medication related readmissions had been reduced in the intervention group with 80% OR 0.20 (95% CI 0.10, 0.41). However, the total number of readmission (including medication related) showed a very balanced outcome in both intervention and control group. Generally spoken, very few studies have shown a statistical significant impact of pharmacist intervention(s) on hospital readmission. Factors influencing (re) hospitalization are complex and comprise at least medical conditions and age. The pharmacist has shown to be very effective in reducing the number of DRPs and ADEs but only few studies have established an effect on healthcare utilization so far. A recent Cochrane review on discharge planning revealed that a structured discharge plan tailored to the individual patient probably brings about small reductions in hospital length of stay and readmission rates for older people admitted to hospital. This is in line with the results of the Institute for Healthcare Improvement survey: a multi faceted program comprising close coordination of care in the post-acute period, early post-discharge follow-up, enhanced patient education and self-management training, reduced the number of rehospitalizations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • > three prescribed systemic drugs intended for chronic use at admission and discharge
  • an expected length of stay of 48 hours or longer
  • insured with the Dutch insurance company Agis/Achmea
  • patients or their carers are able to express themselves in Dutch or English

排除标准

  • scheduled chemotherapy
  • radiation therapy
  • transplantation
  • transfer from another hospital
  • transfer from another non-eligible ward within the same hospital
  • no informed consent has been signed
  • a live expectancy less than 6 months
  • deceased during admission
  • inability to be counselled (e.g. cognitive dysfunction, language constraints)
  • discharge to a nursing home (presuming dependence on medication administration).
  • Patients will only be included once.

结局指标

主要结局

number of rehospitalizations

时间窗: 42 days

this objective will be measured in three different ways: by National data extraction from hospitals (including ED visits and re-hospitalizations) as well as supporting insurance company, and by patient diaries.

次要结局

  • numbers of ADEs(14 days after discharge)
  • numbers of DRPs(on admission at discharge)
  • cost per prevented re-hospitalization(6 months)
  • general health care use(6 months)

研究者

发起方
Clementine CM Stuijt PharmD, MSc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Clementine CM Stuijt PharmD, MSc

PharmD MSc

Dutch Society of Outpatient Pharmacies

研究点 (6)

Loading locations...

相似试验