NCT03221153

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

August 25, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 29, 2016

Last Update Submit

July 14, 2017

Conditions

Keywords

Patient SafetyQualitySimulationUndergraduateMedical Student

Outcome Measures

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.

    One year

Secondary Outcomes (1)

  • Qualitative Evaluation of Attitudes and preferences towards patient safety

    One year

Study Arms (2)

No Intervention

NO INTERVENTION

This is the control group. Participants in this group will take the usual course without simulation techniques.

Simulation

EXPERIMENTAL

This is the intervention group. Participants in this group will to take the course with simulation techniques.

Procedure: Simulation techique

Interventions

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.

Simulation

Eligibility Criteria

Age21 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tecnologico de Monterrey School of Medicine

Monterrey, Nuevo León, 64710, Mexico

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Karla Pacheco, MD

    Instituto Tecnologico y de Estudios Superiores de Monterey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking only at the level of outcome assessor as this is an educational intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial of two educational interventions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2016

First Posted

July 18, 2017

Study Start

August 25, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations