Patient SafetySAFESTNCT05350345
Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST)
An observational study of Patient Safety, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
Patient safety is a priority in Europe. The World Health Organization's World Alliance for Patient Safety has included incident reporting systems as indispensable tools for patient safety. These systems are widespread in healthcare facilities throughout Europe. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety
- What is being tested?
- Root-cause analysis
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2022to 8 Nov 2023
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All students during their clinical internship can participate in this study.
Who may be able to join
- Students with Clinical Practices.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Patient safety is a priority in Europe. The World Health Organization's World Alliance for Patient Safety has included incident reporting systems as indispensable tools for patient safety. These systems are widespread in healthcare facilities throughout Europe. While in some countries trainees in healthcare disciplines are able to report incidents, in others they are unable to do so. In many cases, they do not have adequate information about the reporting systems, there is low motivation to report, or there is a fear that reporting may lead to problems in their studies.
Until now, there have been no interventions designed and validated to achieve the objective of promoting incident reporting among students of health disciplines. Nor there were tools for these students to participate in the analysis of the causes of these incidents and in the identification of barriers to prevent their recurrence.
Read more
Researchers currently have tools from the digital world (artificial intelligence and gamification) whose application in this area can be useful for improving patient safety.
In this context, the investigators have developed an incident notification system aimed at students and trainees in order to familiarize this group with the notification process and thus contribute to improving patient safety. Students will be encouraged to participate with the incentive of earning Miguel Hernández University nanocourse credits or direct prizes. Once the notification is made, their role will be to evaluate and give feedback to notifications made by other peers, so they will get points. After finishing, those students with the most points will be rewarded with the prizes mentioned above.
- Conditions
- Patient Safety
- Being tested
- Root-cause analysis
- Keywords
- Patient Safety, Safety Incident, Student, Report System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root-cause analysisOther
Also called Gamification
The first part of this study involves a report with a root-cause analysis done by the students. The second part is a gamification in which they have to evaluate each other and give feedback.
What is being measured
The primary outcome is the main question the study is designed to answer.
Root-cause analysis
An analysis of the causes of the problem will be carried out to try to prevent its recurrence in the future.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start9 Apr 2022
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Joaquín Mira Solves, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350345
- Sponsor's protocol ID
- UGP-21-215
- Acronym
- SAFEST
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donal, L. (2020). Patient Safety Incident Reporting and Learning Systems: Technical report and guidance. In World Health Organization.
Scott, C.M., Lubritz, R.R., Graham, G.F. (2016). Adverse Events. In: Abramovits, W., Graham, G., Har-Shai, Y., Strumia, R. (eds) Dermatological Cryosurgery and Cryotherapy. Springer, London. https://doi.org/10.1007/978-1-4471-6765-5_47
Gil-Hernandez E, Carrillo I, Guilabert M, Bohomol E, Serpa PC, Ribeiro Neves V, Maluenda Martinez M, Martin-Delgado J, Perez-Esteve C, Fernandez C, Mira JJ. Development and Implementation of a Safety Incident Report System for Health Care Discipline Students During Clinical Internships: Observational Study. JMIR Med Educ. 2024 Jul 18;10:e56879. doi: 10.2196/56879.
PubMed 39024005
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST)
- ClinicalTrials.gov ID
- NCT05350345
- Acronym / sponsor ID
- SAFEST / UGP-21-215
- Conditions
- Patient Safety
- Keywords
- Patient Safety, Safety Incident, Student, Report System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 28 Apr 2022 (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.
Patient safety is a priority in Europe. The World Health Organization's World Alliance for Patient Safety has included incident reporting systems as indispensable tools for patient safety. These systems are widespread in healthcare facilities throughout Europe. While in some countries trainees in healthcare disciplines are able to report incidents, in others they are unable to do so. In many cases, they do not have adequate information about the reporting systems, there is low motivation to report, or there is a fear that reporting may lead to problems in their studies.
Until now, there have been no interventions designed and validated to achieve the objective of promoting incident reporting among students of health disciplines. Nor there were tools for these students to participate in the analysis of the causes of these incidents and in the identification of barriers to prevent their recurrence.
Researchers currently have tools from the digital world (artificial intelligence and gamification) whose application in this area can be useful for improving patient safety.
In this context, the investigators have developed an incident notification system aimed at students and trainees in order to familiarize this group with the notification process and thus contribute to improving patient safety. Students will be encouraged to participate with the incentive of earning Miguel Hernández University nanocourse credits or direct prizes. Once the notification is made, their role will be to evaluate and give feedback to notifications made by other peers, so they will get points. After finishing, those students with the most points will be rewarded with the prizes mentioned above.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All students during their clinical internship can participate in this study.
Key inclusion criteria (1 listed)
- Students with Clinical Practices.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Root-cause analysisAlso: GamificationThe first part of this study involves a report with a root-cause analysis done by the students. The second part is a gamification in which they have to evaluate each other and give feedback. | Other | – |
Primary outcome
Root-cause analysis
Time frame: 5 months
An analysis of the causes of the problem will be carried out to try to prevent its recurrence in the future.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- BackgroundDonal, L. (2020). Patient Safety Incident Reporting and Learning Systems: Technical report and guidance. In World Health Organization.
- BackgroundScott, C.M., Lubritz, R.R., Graham, G.F. (2016). Adverse Events. In: Abramovits, W., Graham, G., Har-Shai, Y., Strumia, R. (eds) Dermatological Cryosurgery and Cryotherapy. Springer, London. https://doi.org/10.1007/978-1-4471-6765-5_47
- Derived from this study: PubMed 39024005Gil-Hernandez E, Carrillo I, Guilabert M, Bohomol E, Serpa PC, Ribeiro Neves V, Maluenda Martinez M, Martin-Delgado J, Perez-Esteve C, Fernandez C, Mira JJ. Development and Implementation of a Safety Incident Report System for Health Care Discipline Students During Clinical Internships: Observational Study. JMIR Med Educ. 2024 Jul 18;10:e56879. doi: 10.2196/56879.
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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.
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 Patient Safety, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Root-cause analysis (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350345, which also lists 3 linked publications.
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 23 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.