Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST)

Patient Safety Clinical Trial

— SAFEST  

Official title:

Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350345
• Other study ID #: UGP-21-215
• Status: Completed
• Start date: April 9, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: February 2024
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Students with Clinical Practices.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Patient Safety

Intervention

Other:
• Root-cause analysis
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.

Locations

Country	Name	City	State
Spain	Grupo ATENEA	San Juan De Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root-cause analysis	An analysis of the causes of the problem will be carried out to try to prevent its recurrence in the future.	5 months