- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350345
Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST) (SAFEST)
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 Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alicante
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San Juan De Alicante, Alicante, Spain, 03550
- Grupo ATENEA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Students with Clinical Practices.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 months
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Collaborators and Investigators
Publications and helpful links
General 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UGP-21-215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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