NCT07008144

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,954

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Dec 2025Nov 2026

First Submitted

Initial submission to the registry

May 26, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

May 26, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

digoxindeprescriptionBeerscomputerized alertsgeriatricsElderly Hospitalized Patients

Outcome Measures

Primary Outcomes (1)

  • Proportion of elderly inpatients receiving inappropriate digoxin doses

    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).

    From baseline to hospital discharge, as much 3 months

Study Arms (2)

Before intervention

NO INTERVENTION

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

Post intervention

EXPERIMENTAL

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

Other: Digoxin alarm

Interventions

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.

Post intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women over 64 years of age.
  • Hospitalized in inpatient wards of the study centers during the study period.

You may not qualify if:

  • Pacients under 64 years old
  • Patients without complete data available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil

Barcelona, Spain, 08810, Spain

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Alejandro Rodríguez Molinero

    Consorci Sanitari de l'Alt Penedès i Garraf

    STUDY DIRECTOR

Central Study Contacts

Beatriz P Ortiz Naranjo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 6, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).

Shared Documents
STUDY PROTOCOL
Time Frame
After publication of main results of the study.
Access Criteria
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations