Knowledge, Attitudes, PracticeNCT03221153
Patient Safety Skills for Medical Students
A study testing Simulation techique in people with Knowledge, Attitudes, Practice, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 21 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice
- What is being tested?
- Simulation techique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteMexico
- Study dates
- 25 Aug 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 5th year medical students enrolled in the course "Quality and Patient Safety" in the Tecnológico de Monterrey School of Medicine, Campus Monterrey.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Tecnologico de Monterrey School of Medicine
Monterrey, Nuevo León, 64710
Federico Ramos, PhD, +528188882107, framos@itesm.mx
About this study
Official title: Simulation for the Evaluation of General Skills in Patient Safety and Quality in Undergraduate Medical Students
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.
- Conditions
- Knowledge, Attitudes, Practice
- Being tested
- Simulation techique
- Keywords
- Patient Safety, Quality, Simulation, Undergraduate, Medical Student
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation techiqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Simulation techique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Qualitative Evaluation of Attitudes and preferences towards patient safety
Assessed by interview of individuals about their attitudes and behaviours
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start25 Aug 2016
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of two educational interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Patricia Pacheco Alvarado, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Karla Pacheco, MD, Principal investigator, Instituto Tecnologico y de Estudios Superiores de Monterey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221153
- Sponsor's protocol ID
- EGSPQS
- Status last verified
- Jul 2017
- First submitted
- 29 Jul 2016
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 2400509Sperling 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation for the Evaluation of General Skills in Patient Safety and Quality in Undergraduate Medical Students
- ClinicalTrials.gov ID
- NCT03221153
- Acronym / sponsor ID
- EGSPQS
- Conditions
- Knowledge, Attitudes, Practice
- Keywords
- Patient Safety, Quality, Simulation, Undergraduate, Medical Student
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- 25 Aug 2016
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Sep 2017 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of two educational interventions
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –This is the control group. Participants in this group will take the usual course without simulation techniques. |
| Simulation | Experimental | Procedure: Simulation techiqueThis is the intervention group. Participants in this group will to take the course with simulation techniques. |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 5th year medical students enrolled in the course "Quality and Patient Safety" in the Tecnológico de Monterrey School of Medicine, Campus Monterrey.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation techiqueThe 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. | Procedure or surgery | Simulation |
Primary outcome
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.
1 secondary outcome
Qualitative Evaluation of Attitudes and preferences towards patient safety
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Results publication: PubMed 2400509Miller 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.
- Results publication: PubMed 23561054Sperling 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.
- Individual participant dataSharing planned: Undecided
Related trials for Knowledge, Attitudes, Practice
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Pacheco, MD principal investigator
Instituto Tecnologico y de Estudios Superiores de Monterey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation techique in people with Knowledge, Attitudes, Practice, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karla Pachecho, MD (+528120339000 ext. 9716, karla.pacheco@itesm.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of skills and knowledge about quality and patient safety (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03221153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.