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Patient Safety Skills for Medical Students

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ClinicalTrials.gov Identifier: NCT03221153
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this project, the authors aim to evaluate the use of high fidelity simulation as a method of evaluation of general skills in fifth year medical students about patient quality and safety in a hospital setting.

Condition or disease Intervention/treatment
Knowledge, Attitudes, Practice Procedure: Simulation techique

Detailed Description:

Undergraduate training in patient safety and healthcare quality is often overlooked by medical curricula.

Simulation techniques have been used in different subjects as a support for learning invasive techniques in surgical areas, but it has not been used to improve knowledge and performance on patient quality domains that would be applied in real life scenarios.

This project is a randomized trial for medical students undertaking the course in "Quality and Patient Safety". The authors will randomized students at the beginning of each rotation into two groups: a) an intervention group (where students will take the simulation and will be evaluated by a final written exam); and b) a control group (where students will take only the usual teaching in classrooms and will be evaluated with the same written exam). Furthermore, students will be asked to fill a questionnaire to obtain their attitudes and knowledge about the topics in quality and safety in healthcare.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial of two educational interventions
Masking: Single (Outcomes Assessor)
Masking Description: Masking only at the level of outcome assessor as this is an educational intervention.
Primary Purpose: Other
Official Title: Simulation for the Evaluation of General Skills in Patient Safety and Quality in Undergraduate Medical Students
Study Start Date : August 25, 2016
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: No Intervention
This is the control group. Participants in this group will take the usual course without simulation techniques.
Experimental: Simulation
This is the intervention group. Participants in this group will to take the course with simulation techniques.
Procedure: Simulation techique
The intervention group will be in a simulated case with mock scenarios and interaction by 'acting out' the clinical situation where knowledge and attitudes about safety in hospitalized patients will be assessed.

Outcome Measures

Primary Outcome Measures :
  1. Mean score of skills and knowledge about quality and patient safety [ Time Frame: One year ]
    Assessed by questionnaire evaluation of knowledge in the area of patient safety and quality of healthcare using a multiple choice question examination and a survey. This outcome is measured in a scale from 0 to 100 individually and it will be averaged throughout each group.

Secondary Outcome Measures :
  1. Qualitative Evaluation of Attitudes and preferences towards patient safety [ Time Frame: One year ]
    Assessed by interview of individuals about their attitudes and behaviours

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 5th year medical students enrolled in the course "Quality and Patient Safety" in the Tecnológico de Monterrey School of Medicine, Campus Monterrey.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221153

Contact: Karla Pachecho, MD +528120339000 ext 9716 karla.pacheco@itesm.mx
Contact: Ana Villalpando +5281 88882107 ana.villalpando@itesm.mx

Tecnologico de Monterrey School of Medicine Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Contact: Federico Ramos, PhD    +528188882107    framos@itesm.mx   
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Principal Investigator: Karla Pacheco, MD Instituto Tecnologico y de Estudios Superiores de Monterey
More Information

Responsible Party: Karla Patricia Pacheco Alvarado, MD, Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT03221153     History of Changes
Other Study ID Numbers: EGSPQS
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karla Patricia Pacheco Alvarado, Instituto Tecnologico y de Estudios Superiores de Monterey:
Patient Safety
Medical Student