Reduction of Acute Renal Failure and/or Hyperkaliemia Adverse Drug Events in Older Inpatients by Incorporating Specific Rules Into a Computerized Support System and Dedicated Procedures: a Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 783
- 试验地点
- 1
- 主要终点
- Number of adverse drug events such as acute renal failure and/or hyperkalemia in older hospitalized patients.
研究概览
简要总结
Current evidence shows that computerized decision support systems (CDSS) have shown to be insufficiently effective to prevent adverse drug reactions (ADRs) at large scale (e.g. whole hospital). Several barriers for successful implementation of CDSS have been identified: over-alerting, lack of specificity of rules, and physician interruption during prescription. The effectiveness of CDSS could be increased in two ways. Firstly, by creating rules that are more specific to a given adverse drug reaction: the current study focuses on acute renal failure and hyperkalemia (two serious and frequent ADR in older hospitalized patients). Secondly, by involving the pharmacist in the review of the alerts so that he/she can transmit, if deemed necessary, a pharmaceutical recommendation to the clinician. This procedure will reduce over-alerting and prevent task interruption.
The hypothesis is that the use of specific rules created by a multidisciplinary team and implemented in a CDSS, combined with a strategy for managing and transmitting alerts, can reduce specific ADRs such as hyperkalemia and acute renal failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- •Hospitalized for 3 days or more in an MCO (medicine surgery obstetrics) department participating in the study
- •Patient who gave oral consent to participate in the study
- •Socially insured patient
排除标准
- •Patient discharged or died before D3 of hospitalization
- •Patient in palliative care or end of life on entry to the service
- •Person under legal protection (curatorship)
- •Lack of coverage by the social security system, Failure to obtain oral consent to participate in the study
结局指标
主要结局
Number of adverse drug events such as acute renal failure and/or hyperkalemia in older hospitalized patients.
时间窗: through study completion, an average of 20 days
次要结局
- Number of pharmaceutical interventions accepted(through study completion, an average of 20 days)
- Presence of an adverse event related to the intervention provided ("change of prescription", "discontinuation of drug")(through study completion, an average of 20 days)
- Therapeutic adaptations implemented in case of acute renal failure (ARF) or hyperkalemia upon hospital admission(through study completion, an average of 15 days)
- Relevance of CDSS alerts(through study completion, an average of 20 days)
- Changes in ADEs (Adverse Drug Event) prevention/management work process induced by the introduction of alerts(Through study completion, an average of 20 days)
- Cost-effectiveness of the pharmaceutical intervention(through study completion, an average of 20 days)