Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults

NCT ID: NCT07008144

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5954 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Drug-Related Side Effects and Adverse Reaction Digoxin Overdose

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Before intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Post intervention

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

Group Type EXPERIMENTAL

Digoxin alarm

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Rodríguez Molinero

Role: STUDY_DIRECTOR

Consorci Sanitari de l'Alt Penedès i Garraf

Locations

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Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca

Vilafranca del Penedès, Barcelona, Spain

Site Status

Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil

Barcelona, Spain, Spain

Site Status

Countries

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Spain

Central Contacts

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Beatriz P Ortiz Naranjo

Role: CONTACT

+34606820268

Facility Contacts

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Beatriz Ortiz, MD

Role: primary

0034606820268

Noemí Casaponsa

Role: backup

0034938960025 ext. 43197

Alejandro Rodríguez, Ph.D.

Role: primary

0034938960025

Noemí Casaponsa

Role: backup

0034938960025 ext. 43197

Other Identifiers

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CSAPG-73

Identifier Type: -

Identifier Source: org_study_id

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