Medication Errors and Other Product Use Errors and IssuesNCT04598139
Safer Use of Medication in Pediatric Patients at Home
An observational study of Medication Errors and Other Product Use Errors and Issues, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
This study aims: to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients. to assess de user satisfaction and perceived usefulness of the system. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Errors and Other Product Use Errors and Issues
- What is being tested?
- Study group
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents or caregivers of children aged from 0 to 14 years.
Who may be able to join
- To care children aged under 14 years who have required drug treatment in the last two months
- To have an Internet connection
- To agree to participate in the study.
- To be registered in the study web-based notification system
- Age > 17 years
Who cannot join
- To be health provider
- To care children in residence for minors.
- To care children with a life expectancy of less than 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website
This study aims:
- to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients.
- to assess de user satisfaction and perceived usefulness of the system.
Participants:
Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study.
Sample size: 62 participants
Main outcome variable: overall satisfaction
- Being tested
- Study group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupOther
The study group uses a web-based medication error notification system
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Other: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the web-based medication error notification system
Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire
Measured: At one month after use of the website
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start5 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Errors and Other Product Use Errors and IssuesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercedes Guilabert Mora, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598139
- Sponsor's protocol ID
- PI18/00739
- Status last verified
- May 2022
- First submitted
- 8 Oct 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website
- ClinicalTrials.gov ID
- NCT04598139
- Acronym / sponsor ID
- PI18/00739
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Oct 2020 (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.
This study aims:
- to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients.
- to assess de user satisfaction and perceived usefulness of the system.
Participants:
Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study.
Sample size: 62 participants
Main outcome variable: overall satisfaction
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Study group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents or caregivers of children aged from 0 to 14 years.
Key inclusion criteria (5 listed)
- To care children aged under 14 years who have required drug treatment in the last two months
- To have an Internet connection
- To agree to participate in the study.
- To be registered in the study web-based notification system
- Age > 17 years
Key exclusion criteria (3 listed)
- To be health provider
- To care children in residence for minors.
- To care children with a life expectancy of less than 2 years.
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 |
|---|---|---|
| Study groupThe study group uses a web-based medication error notification system | Other | Study group |
Primary outcome
Satisfaction with the web-based medication error notification system
Time frame: At one month after use of the website
Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Errors and Other Product Use Errors and Issues, run by Universidad Miguel Hernandez de Elche at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Satisfaction with the web-based medication error notification system (time frame: At one month after use of the website). 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 18 May 2022.