Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults (Aldigo)

Consorci Sanitari de l'Alt Penedès i Garraf

Status: Not yet enrolling

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

Treatments: Other: Digoxin alarm

Study type: Interventional

Funder types: Other

Identifiers

NCT07008144

CSAPG-73

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,954 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,954 participants in 2 patient groups

Before intervention

No Intervention group

Description:

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

Post intervention

Experimental group

Description:

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

Treatment:

Other: Digoxin alarm