Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults

Not Applicable

Not yet recruiting

• Conditions: Drug-Related Side Effects and Adverse Reaction; Digoxin Overdose

• Registration Number: NCT07008144
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

Brief Summary

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Study Start: 2025-08
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5954

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Proportion of elderly inpatients receiving inappropriate digoxin doses	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).

Trial Locations

Locations (2)

Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca; 🇪🇸 Vilafranca del Penedès, Barcelona, Spain

Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil; 🇪🇸 Barcelona, Spain