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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03221153
Other study ID # EGSPQS
Secondary ID
Status Recruiting
Phase N/A
First received July 29, 2016
Last updated July 14, 2017
Start date August 25, 2016
Est. completion date September 1, 2017

Study information

Verified date July 2017
Source Instituto Tecnologico y de Estudios Superiores de Monterey
Contact Karla Pachecho, MD
Phone +528120339000
Email karla.pacheco@itesm.mx
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 24 Years
Eligibility Inclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mexico Tecnologico de Monterrey School of Medicine Monterrey Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Instituto Tecnologico y de Estudios Superiores de Monterey

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Miller GE. The assessment of clinical skills/competence/performance. Acad Med. 1990 Sep;65(9 Suppl):S63-7. — View Citation

Sperling JD, Clark S, Kang Y. Teaching medical students a clinical approach to altered mental status: simulation enhances traditional curriculum. Med Educ Online. 2013 Apr 3;18:1-8. doi: 10.3402/meo.v18i0.19775. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean score of skills and knowledge about quality and patient safety 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. One year
Secondary Qualitative Evaluation of Attitudes and preferences towards patient safety Assessed by interview of individuals about their attitudes and behaviours One year
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