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临床试验/NCT07008144
NCT07008144尚未招募不适用

Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults

Consorci Sanitari de l'Alt Penedès i Garraf4 个研究点 分布在 1 个国家目标入组 5,954 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,954
试验地点
4
主要终点
Proportion of elderly inpatients receiving inappropriate digoxin doses

研究概览

简要总结

The intervention consists of introducing computerized alerts into the electronic medical record of the CSAPG (MIRA software), which are triggered when a physician prescribes digoxin at a dose higher than the recommended amount (more than 0.125 mg/day).

The main objective of this study is to evaluate the effectiveness of a visible computerized alert aimed at physicians responsible for hospitalized elderly patients who have been prescribed digoxin at a dose higher than 0.125 mg/day (the recommended dose), in reducing the number of patients receiving inappropriate digoxin doses.

详细描述

Intervention This quasi-experimental pre-post intervention study evaluates the effectiveness of computerized alerts integrated into the CSAPG electronic health record system (MIRA software). These alerts are triggered when a physician prescribes digoxin at a dose higher than the recommended 0.125 mg/day for elderly patients.

Study Objective The main goal is to assess whether these alerts reduce the number of elderly hospitalized patients receiving inappropriate digoxin dosages.

Study Design and Duration The study will last 18 months in total, with a 12-month data collection period at each site (6 months before and 6 months after the intervention).

Sample Size and Population To detect a 25% reduction in inappropriate digoxin prescriptions with 80% power and a 0.05 alpha risk, the study requires 2,977 patients in both the pre- and post-intervention groups. Inclusion criteria include hospitalized men and women aged 65 and older. No patient exclusions are anticipated.

Statistical Analysis The primary analysis will compare the proportion of patients receiving digoxin doses above the recommended level before and after the intervention using the Chi-square test.

研究设计

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

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

  • •Men and women over 64 years of age.
  • •Hospitalized in inpatient wards of the study centers during the study period.

排除标准

  • •Pacients under 64 years old
  • •Patients without complete data available

研究组 & 干预措施

Before intervention

No Intervention

In this group, the outcome will be measured before the intervention is implemented at the center

Post intervention

Experimental

In this group, the outcome will be measured after the intervention is implemented at the center

干预措施: Digoxin alarm (Other)

结局指标

主要结局

Proportion of elderly inpatients receiving inappropriate digoxin doses

时间窗: From baseline to hospital discharge, as much 3 months

Proportion of patients aged 65 and older who are prescribed digoxin at a dose higher than 0.125 mg/day during hospitalization. The outcome compares this proportion between the pre-intervention and post-intervention periods to evaluate the effectiveness of a computerized alert integrated into the electronic medical record system (MIRA).

次要结局

未报告次要终点

研究者

发起方
Consorci Sanitari de l'Alt Penedès i Garraf
申办方类型
Other
责任方
Sponsor

研究点 (4)

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