NCT05350345

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

April 22, 2022

Last Update Submit

February 22, 2024

Conditions

Keywords

Patient SafetySafety IncidentStudentReport System

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Also known as: Gamification

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All students during their clinical internship can participate in this study.

You may qualify if:

  • Students with Clinical Practices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo ATENEA

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (3)

  • Donal, L. (2020). Patient Safety Incident Reporting and Learning Systems: Technical report and guidance. In World Health Organization.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Interventions

Root Cause Analysis

Intervention Hierarchy (Ancestors)

Health Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor (2012) with a position as Clinical Psychologist (1984) in Primary Care

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

April 9, 2022

Primary Completion

November 8, 2023

Study Completion

November 8, 2023

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations