Drug-Related Side Effects and Adverse ReactionAldigoNCT07008144
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
A study testing Digoxin alarm in people with Drug-Related Side Effects and Adverse Reaction and Digoxin Overdose, run by Consorci Sanitari de l'Alt Penedès i Garraf at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
- What is being tested?
- Digoxin alarm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,954 participants
- Where
- 2 sitesSpain
- Study dates
- 31 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women over 64 years of age.
- Hospitalized in inpatient wards of the study centers during the study period.
Who cannot join
- Pacients under 64 years old
- Patients without complete data available
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Consorci Sanitari Alt Penedès-Garraf Hospital Sant Camil
Barcelona, Spain, 08810
Consorci Sanitari Alt Penedès-Garraf-Hospital de Vilafranca
Vilafranca del Penedès, Barcelona, 08720
About this study
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.
Read the 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.
- Being tested
- Digoxin alarm
- Keywords
- digoxin, deprescription, Beers, computerized alerts, geriatrics, Elderly Hospitalized Patients
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digoxin alarmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Digoxin alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to hospital discharge, as much 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start31 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Related Side Effects and Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5,954 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Rodríguez Molinero, Study director, Consorci Sanitari de l'Alt Penedès i Garraf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008144
- Sponsor's protocol ID
- CSAPG-73
- Acronym
- Aldigo
- Status last verified
- Oct 2026
- First submitted
- 26 May 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
- ClinicalTrials.gov ID
- NCT07008144
- Acronym / sponsor ID
- Aldigo / CSAPG-73
- Keywords
- digoxin, deprescription, Beers, computerized alerts, geriatrics, Elderly Hospitalized Patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,954 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before intervention | No intervention | –In this group, the outcome will be measured before the intervention is implemented at the center |
| Post intervention | Experimental | Other: Digoxin alarmIn this group, the outcome will be measured after the intervention is implemented at the center |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women over 64 years of age.
- Hospitalized in inpatient wards of the study centers during the study period.
Key exclusion criteria (2 listed)
- Pacients under 64 years old
- Patients without complete data available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digoxin alarmA 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. | Other | Post intervention |
Primary outcome
Proportion of elderly inpatients receiving inappropriate digoxin doses
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Rodríguez Molinero study director
Consorci Sanitari de l'Alt Penedès i Garraf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digoxin alarm in people with Drug-Related Side Effects and Adverse Reaction and Digoxin Overdose, run by Consorci Sanitari de l'Alt Penedès i Garraf at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of elderly inpatients receiving inappropriate digoxin doses (time frame: From baseline to hospital discharge, as much 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.