Clinical trial NCT07008144: Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Official title: Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug-Related Side Effects and Adverse Reaction
Digoxin Overdose
Keywords: digoxin
deprescription
Beers
computerized alerts
geriatrics
Elderly Hospitalized Patients
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 5954
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of elderly inpatients receiving inappropriate digoxin doses
timeFrame: From baseline to hospital discharge, as much 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vilafranca del Penedès
country: Spain
facility: Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca
state: Barcelona
city: Barcelona
country: Spain
facility: Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil
Study officials:
affiliation: Consorci Sanitari de l'Alt Penedès i Garraf
name: Alejandro Rodríguez Molinero
role: STUDY_DIRECTOR
References: