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Status unknownNCT03221153Updated Jul 18, 2017

Patient Safety Skills for Medical Students

An interventional study of Simulation techique in Knowledge, Attitudes, Practice, sponsored by Instituto Tecnologico y de Estudios Superiores de Monterey. Status unknown at 1 site in Mexico. Open to participants aged 21 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-18.

Sponsored by Instituto Tecnologico y de Estudios Superiores de Monterey · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
21 Years to 24 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knowledge, Attitudes, Practice

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Keywords

  • Patient Safety
  • Quality
  • Simulation
  • Undergraduate
  • Medical Student
03

In context

Behavior

409 studies on the registry are indexed under Behavior; 168 are open to participants now.

This study's planned enrollment of 140 is above the median of 120 across 321 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Instituto Tecnologico y de Estudios Superiores de Monterey is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 5th year medical students enrolled in the course "Quality and Patient Safety" in the Tecnológico de Monterrey School of Medicine, Campus Monterrey.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureSimulation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One year

Secondary outcomes

  1. Qualitative Evaluation of Attitudes and preferences towards patient safety

    Assessed by interview of individuals about their attitudes and behaviours

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Tecnologico de Monterrey School of Medicine
    Monterrey, Nuevo León 64710, Mexico
    Recruiting
08

References and documents

Publications

  • Miller GE. The assessment of clinical skills/competence/performance. Acad Med. 1990 Sep;65(9 Suppl):S63-7. doi: 10.1097/00001888-199009000-00045. No abstract available. PubMed 2400509 ↗
  • 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. PubMed 23561054 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03221153
Lead sponsor
Instituto Tecnologico y de Estudios Superiores de Monterey
Responsible party
Karla Patricia Pacheco Alvarado (MD, Instituto Tecnologico y de Estudios Superiores de Monterey) — Principal investigator
First posted
Jul 18, 2017
Start date
Aug 25, 2016
Primary completion
Sep 1, 2017 (estimated)
Completion
Sep 1, 2017 (estimated)
Last update
Jul 18, 2017

Study contacts

Karla Pachecho, MD
Contact
karla.pacheco@itesm.mx
+528120339000 ext. 9716
Ana Villalpando
Contact
ana.villalpando@itesm.mx
+5281 88882107
Karla Pacheco, MD
principal investigator · Instituto Tecnologico y de Estudios Superiores de Monterey

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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