Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digoxin alarm.
- Who it may be relevant to
- Registry conditions: Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Digoxin alarm
A computerized alert will be integrated into the CSAPG electronic health record system (MIRA software). These alerts will be triggered when a physician prescribes digoxin at a dose higher than the recommended 0.125 mg/day for elderly patients.
Primary outcome measures
- Proportion of elderly inpatients receiving inappropriate digoxin doses [Time frame: From baseline to hospital discharge, as much 3 months]
Eligibility criteria
Inclusion criteria
- Men and women over 64 years of age.
- Hospitalized in inpatient wards of the study centers during the study period.
Exclusion criteria
- Pacients under 64 years old
- Patients without complete data available
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 2 centers
- Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca — Vilafranca del Penedès
- Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil — Barcelona
Identifiers
NCT: NCT07008144 · CSAPG-73