- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03221153
Patient Safety Skills for Medical Students
Simulation for the Evaluation of General Skills in Patient Safety and Quality in Undergraduate Medical Students
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karla Pachecho, MD
- Phone Number: 9716 +528120339000
- Email: karla.pacheco@itesm.mx
Study Contact Backup
- Name: Ana Villalpando
- Phone Number: +5281 88882107
- Email: ana.villalpando@itesm.mx
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 64710
- Recruiting
- Tecnologico de Monterrey School of Medicine
-
Contact:
- Federico Ramos, PhD
- Phone Number: +528188882107
- Email: framos@itesm.mx
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative Evaluation of Attitudes and preferences towards patient safety
Time Frame: One year
|
Assessed by interview of individuals about their attitudes and behaviours
|
One year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karla Pacheco, MD, Instituto Tecnologico y de Estudios Superiores de Monterey
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EGSPQS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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