Entrustable Professional ActivitiesNCT05179980
Comprehensive Model for Evaluation of Surgical EPAs
An observational study of Entrustable Professional Activities, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo at 1 site in Mexico.
Trial summary
Introduction. Competency-based medical education (CBME) frameworks have become increasingly prevalent among surgical education accreditation bodies. Medical schools, postgraduate training programs, and licensing bodies conduct assessments to certify the competence of future practitioners, and judge the adequacy of… Read more about this study
- Who is it for?
- Ages 23 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Entrustable Professional Activities
- What is being tested?
- Assessment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2020to 30 Jun 2020
- Phase
- Observational
- 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 23 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of the general surgery program at a secondary care, public medical institution.
Who may be able to join
- Residents in an universitary general surgery program
Who cannot join
- Staff surgeons
- Residents from another universitary program
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
Chihuahua City, 31000
About this study
Official title: Design of a Comprehensive Model for the Evaluation of Trustable Professional Activities in the General Surgery Setting
Introduction. Competency-based medical education (CBME) frameworks have become increasingly prevalent among surgical education accreditation bodies. Medical schools, postgraduate training programs, and licensing bodies conduct assessments to certify the competence of future practitioners, and judge the adequacy of training programs.
Methods. A prospective cohort study was designed to evaluate clinical-surgical competencies in all residents of a general surgery program. All medical residents of the general surgery program of the Faculty of Medicine and Biomedical Sciences at the Autonomous University of Chihuahua, were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom), for posterior evaluation by the professors of the program with electronic rubrics made with Google forms.
Read the detailed description
A prospective cohort study was designed to evaluate clinical-surgical competencies in residents of the general surgery program during the 2020-2021 academic year at a single, secondary care, public medical institution.
For this purpose a previously validated instrument for the comprehensive evaluation of clinical-surgical competencies was used (9), which considered five dimensions, derived from the Single Plan for Medical Specialties in terms of 1-3) Clinical-surgical care (preoperative, transoperative and postoperative management), 4) Search and transfer of knowledge, and 5) Research proficiency. Each instrument was composed of 6 to 7 items, graduated in four levels of achievement; a) responsive, b) resolutive, c) autonomous, and d) strategic.
All surgery residents were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom) for posterior self-evaluation, co-evaluation and hetero-evaluation with electronic rubrics made with Google forms.
- Conditions
- Entrustable Professional Activities
- Being tested
- Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called Evaluation
Evaluation of clinical-surgical competencies with a previously validated instrument.
What is being measured
The primary outcome is the main question the study is designed to answer.
Entrustable Professional Activities
Important work tasks that trainees need to be able to perform with supervision at a distance by the end of Basic Training
Measured: 2020-2024 academic years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Mar 2020
- Primary completion29 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Entrustable Professional ActivitiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Carlos R Cervantes-Sánchez, MD, MSc, Principal investigator, Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179980
- Sponsor's protocol ID
- 00189
- Status last verified
- Nov 2024
- First submitted
- 17 Dec 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Comprehensive Model for the Evaluation of Trustable Professional Activities in the General Surgery Setting
- ClinicalTrials.gov ID
- NCT05179980
- Acronym / sponsor ID
- 00189
- Conditions
- Entrustable Professional Activities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital General de Chihuahua - Dr. Salvador Zubirán AnchondoOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jan 2022 (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.
Introduction. Competency-based medical education (CBME) frameworks have become increasingly prevalent among surgical education accreditation bodies. Medical schools, postgraduate training programs, and licensing bodies conduct assessments to certify the competence of future practitioners, and judge the adequacy of training programs.
Methods. A prospective cohort study was designed to evaluate clinical-surgical competencies in all residents of a general surgery program. All medical residents of the general surgery program of the Faculty of Medicine and Biomedical Sciences at the Autonomous University of Chihuahua, were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom), for posterior evaluation by the professors of the program with electronic rubrics made with Google forms.
Detailed description
A prospective cohort study was designed to evaluate clinical-surgical competencies in residents of the general surgery program during the 2020-2021 academic year at a single, secondary care, public medical institution.
For this purpose a previously validated instrument for the comprehensive evaluation of clinical-surgical competencies was used (9), which considered five dimensions, derived from the Single Plan for Medical Specialties in terms of 1-3) Clinical-surgical care (preoperative, transoperative and postoperative management), 4) Search and transfer of knowledge, and 5) Research proficiency. Each instrument was composed of 6 to 7 items, graduated in four levels of achievement; a) responsive, b) resolutive, c) autonomous, and d) strategic.
All surgery residents were video recorded with consent, in the field (Outpatient consultation, Surgical ward, Inpatient room, Classroom) for posterior self-evaluation, co-evaluation and hetero-evaluation with electronic rubrics made with Google forms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of the general surgery program at a secondary care, public medical institution.
Key inclusion criteria (1 listed)
- Residents in an universitary general surgery program
Key exclusion criteria (2 listed)
- Staff surgeons
- Residents from another universitary program
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 |
|---|---|---|
| AssessmentAlso: EvaluationEvaluation of clinical-surgical competencies with a previously validated instrument. | Other | – |
Primary outcome
Entrustable Professional Activities
Time frame: 2020-2024 academic years
Important work tasks that trainees need to be able to perform with supervision at a distance by the end of Basic Training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Carlos R Cervantes-Sánchez, MD, MSc principal investigator
Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Entrustable Professional Activities, run by Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo 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 2 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: finished, as of the sponsor's last update on 22 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entrustable Professional Activities (time frame: 2020-2024 academic years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.