Entrustable Professional ActivitiesNCT07107542
Exploring the Relationship Between Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) in Occupational Therapy Clinical Interns' Independent Competence
An observational study of Entrustable Professional Activities and Mini-clinical Evaluation Exercise, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational cross-sectional study is to evaluate whether the combined use of Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) can assess the independent clinical competence of occupational therapy interns at Far Eastern Memorial Hospital. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Entrustable Professional Activities, Mini-clinical Evaluation Exercise, Physical Occupational Therapy
- What is being tested?
- Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) Assessment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Oct 2025to 30 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study population consists of occupational therapy interns undergoing physical domain fieldwork at Far Eastern Memorial Hospital. Participants are typically fourth-year students engaged in clinical internship training.
Who may be able to join
- Occupational therapy interns in the physical domain at Far Eastern Memorial Hospital
- Provide informed consent to participate
Who cannot join
- None specified
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, 220
Chao Yi Cheng, MS, +886-2-8966-7000 ext. 1516, xero1118@gmail.com
About this study
Official title: Entrustable Professional Activities and Mini-Clinical Evaluation Exercise in a Simulated Workplace-based Assessment for Physical Occupational Therapist Intern
The goal of this observational cross-sectional study is to evaluate whether the combined use of Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) can assess the independent clinical competence of occupational therapy interns at Far Eastern Memorial Hospital. The main questions it aims to answer are:
- Does the performance on Mini-CEX correlate with the interns' ability to perform independently?
- Does the use of EPAs provide additional insight into interns' readiness for unsupervised clinical practice?
Read more
Participants will:
- Provide informed consent at the sixth week of their internship.
- Undergo assessment with Mini-CEX and EPAs during their eighth week of clinical training.
- Complete demographic questionnaires including age, gender, study habits, prior university experience, parental occupation, and residence area.
Read the detailed description
Medical graduates in the healthcare field apply theoretical knowledge gained during their education combined with clinical supervision to develop professional skills necessary for patient care. To comprehensively evaluate interns' professional competence during clinical training, workplace assessment tools such as the Mini-Clinical Evaluation Exercise (Mini-CEX) are commonly used. Mini-CEX, developed by the American Medical Association, assesses seven core clinical skills over a 20 to 30-minute observation period. However, Mini-CEX alone may not fully capture the interns' ability to perform independently.
Competency-Based Medical Education (CBME) emphasizes the development of core competencies, and Entrustable Professional Activities (EPAs) have been proposed as a framework to describe tasks that trainees should be entrusted to perform unsupervised at various training stages. EPAs assess the level of supervision required, reflecting the degree of trust clinical supervisors place in trainees. In Taiwan, EPAs tailored for occupational therapy have been developed and implemented under the guidance of the Occupational Therapy Association.
This study aims to explore the relationship between Mini-CEX and EPAs in evaluating occupational therapy interns' independent clinical competence. The study will recruit 50 interns from the physiological domain of occupational therapy at Far Eastern Memorial Hospital over four years. Participants will be recruited at the sixth week of their internship, provide informed consent, and be assessed at the eighth week using both Mini-CEX and EPAs. The assessments are part of routine clinical training evaluations and take approximately 20 minutes.
Data collected will include demographic information and assessment scores. Statistical analyses will involve descriptive statistics, Pearson correlation to examine relationships between variables, and multiple linear regression to identify predictors of clinical performance, including age, gender, study habits, prior university experience, parental occupation, and residence area. Participation is voluntary and will not affect interns' clinical training or evaluation outcomes.
This study seeks to provide evidence on whether combining Mini-CEX and EPAs offers a more reliable assessment of interns' readiness for independent clinical practice, potentially informing future educational strategies in occupational therapy training.
- Conditions
- Entrustable Professional Activities, Mini-clinical Evaluation Exercise, Physical Occupational Therapy, Occupational Therapy Education
- Being tested
- Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) AssessmentOther
Participants undergo standard fieldwork assessments using Mini-CEX and EPAs during their internship to evaluate fieldwork competence and readiness for independent practice. These are observational assessments without additional experimental interventions.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Fieldwork Interns | This group includes occupational therapy interns specializing in the physical domain who are undergoing fieldwork training at Far Eastern Memorial Hospital. Participants are recruited during their sixth week of internship and assessed at the eighth week. The study evaluates their fieldwork performance using Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) as standard assessment tools. Participation is voluntary with informed consent, and no additional interventions beyond routine fieldwork training are applied. Data collected will be used to analyze the relationship between these assessment tools and interns' readiness for independent practice. Receives: Other: Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Clinical Competence of Occupational Therapy Interns
The primary outcome is the assessment of occupational therapy interns' independent performance during fieldwork, measured by combined scores of the Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs). The Mini-CEX evaluates seven core clinical competencies, scored from 1 to 9 per item, with higher scores indicating better clinical performance. EPAs assess competence based on supervision levels, scored from 1 to 5, where higher scores reflect greater independence and readiness for unsupervised clinical practice. This combined assessment captures interns' clinical skills, decision-making, and preparedness for independent work.
Measured: Assessment conducted at the eighth week of internship fieldwork.
Secondary outcomes (1)
Correlation of Demographic Factors with fieldwork Competence
Analysis of demographic variables including age, gender, average study time, prior university experience, parental occupation, and residence area, to explore their association with interns' performance on Mini-CEX and EPAs assessments.
Measured: Data collected and analyzed at the eighth week of internship.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start8 Oct 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Yi Cheng, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107542
- Sponsor's protocol ID
- 114026-E
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data (IPD) due to considerations related to participant privacy and confidentiality. The data collected involve sensitive personal and demographic information of occupational therapy interns, and sharing such data could risk identification despite de-identification efforts. Additionally, the study was conducted under ethical approvals that restrict data sharing beyond the research team. Aggregate results and summary findings will be made publicly available through publications and ClinicalTrials.gov, ensuring transparency while protecting participant rights.
Publications
Ten Cate O, Chen HC, Hoff RG, Peters H, Bok H, van der Schaaf M. Curriculum development for the workplace using Entrustable Professional Activities (EPAs): AMEE Guide No. 99. Med Teach. 2015;37(11):983-1002. doi: 10.3109/0142159X.2015.1060308. Epub 2015 Jul 14.
PubMed 26172347Pinilla S, Kyrou A, Kloppel S, Strik W, Nissen C, Huwendiek S. Workplace-based assessments of entrustable professional activities in a psychiatry core clerkship: an observational study. BMC Med Educ. 2021 Apr 21;21(1):223. doi: 10.1186/s12909-021-02637-4.
PubMed 33882926Fu, C. P., Chiang, F. M., Lee, C. Y., Chi, H. Y., Wu, J. L., Lin, Y. J., Li, M. W., Chen, Y. J., Chang, W. Y., Chang, W. D., Huang, S. M., Liao, W. S., Yang, Y. C., Huang, C. K., Kuo, N. J., Liu, T. H., & Chen, Y. L. (2023). Developing the topics of entrustable professional activities in pediatric occupational therapy in Taiwan: A pilot study. Taiwan Journal of Occupational Therapy, 41(2), 91-110. https://doi.org/10.6594/tjot.202308_41(2).0001
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entrustable Professional Activities and Mini-Clinical Evaluation Exercise in a Simulated Workplace-based Assessment for Physical Occupational Therapist Intern
- ClinicalTrials.gov ID
- NCT07107542
- Acronym / sponsor ID
- 114026-E
- Conditions
- Entrustable Professional Activities, Mini-clinical Evaluation Exercise, Physical Occupational Therapy, Occupational Therapy Education
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 8 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 6 Aug 2025 (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.
The goal of this observational cross-sectional study is to evaluate whether the combined use of Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) can assess the independent clinical competence of occupational therapy interns at Far Eastern Memorial Hospital. The main questions it aims to answer are:
- Does the performance on Mini-CEX correlate with the interns' ability to perform independently?
- Does the use of EPAs provide additional insight into interns' readiness for unsupervised clinical practice?
Participants will:
- Provide informed consent at the sixth week of their internship.
- Undergo assessment with Mini-CEX and EPAs during their eighth week of clinical training.
- Complete demographic questionnaires including age, gender, study habits, prior university experience, parental occupation, and residence area.
Detailed description
Medical graduates in the healthcare field apply theoretical knowledge gained during their education combined with clinical supervision to develop professional skills necessary for patient care. To comprehensively evaluate interns' professional competence during clinical training, workplace assessment tools such as the Mini-Clinical Evaluation Exercise (Mini-CEX) are commonly used. Mini-CEX, developed by the American Medical Association, assesses seven core clinical skills over a 20 to 30-minute observation period. However, Mini-CEX alone may not fully capture the interns' ability to perform independently.
Competency-Based Medical Education (CBME) emphasizes the development of core competencies, and Entrustable Professional Activities (EPAs) have been proposed as a framework to describe tasks that trainees should be entrusted to perform unsupervised at various training stages. EPAs assess the level of supervision required, reflecting the degree of trust clinical supervisors place in trainees. In Taiwan, EPAs tailored for occupational therapy have been developed and implemented under the guidance of the Occupational Therapy Association.
This study aims to explore the relationship between Mini-CEX and EPAs in evaluating occupational therapy interns' independent clinical competence. The study will recruit 50 interns from the physiological domain of occupational therapy at Far Eastern Memorial Hospital over four years. Participants will be recruited at the sixth week of their internship, provide informed consent, and be assessed at the eighth week using both Mini-CEX and EPAs. The assessments are part of routine clinical training evaluations and take approximately 20 minutes.
Data collected will include demographic information and assessment scores. Statistical analyses will involve descriptive statistics, Pearson correlation to examine relationships between variables, and multiple linear regression to identify predictors of clinical performance, including age, gender, study habits, prior university experience, parental occupation, and residence area. Participation is voluntary and will not affect interns' clinical training or evaluation outcomes.
This study seeks to provide evidence on whether combining Mini-CEX and EPAs offers a more reliable assessment of interns' readiness for independent clinical practice, potentially informing future educational strategies in occupational therapy training.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy Fieldwork Interns | – | Other: Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) AssessmentThis group includes occupational therapy interns specializing in the physical domain who are undergoing fieldwork training at Far Eastern Memorial Hospital. Participants are recruited during their sixth week of internship and assessed at the eighth week. The study evaluates their fieldwork performance using Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) as standard assessment tools. Participation is voluntary with informed consent, and no additional interventions beyond routine fieldwork training are applied. Data collected will be used to analyze the relationship between these assessment tools and interns' readiness for independent practice. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study population consists of occupational therapy interns undergoing physical domain fieldwork at Far Eastern Memorial Hospital. Participants are typically fourth-year students engaged in clinical internship training.
Key inclusion criteria (2 listed)
- Occupational therapy interns in the physical domain at Far Eastern Memorial Hospital
- Provide informed consent to participate
Key exclusion criteria (1 listed)
- None specified
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 |
|---|---|---|
| Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) AssessmentParticipants undergo standard fieldwork assessments using Mini-CEX and EPAs during their internship to evaluate fieldwork competence and readiness for independent practice. These are observational assessments without additional experimental interventions. | Other | Occupational Therapy Fieldwork Interns |
Primary outcome
Independent Clinical Competence of Occupational Therapy Interns
Time frame: Assessment conducted at the eighth week of internship fieldwork.
The primary outcome is the assessment of occupational therapy interns' independent performance during fieldwork, measured by combined scores of the Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs). The Mini-CEX evaluates seven core clinical competencies, scored from 1 to 9 per item, with higher scores indicating better clinical performance. EPAs assess competence based on supervision levels, scored from 1 to 5, where higher scores reflect greater independence and readiness for unsupervised clinical practice. This combined assessment captures interns' clinical skills, decision-making, and preparedness for independent work.
1 secondary outcome
Correlation of Demographic Factors with fieldwork Competence
Time frame: Data collected and analyzed at the eighth week of internship.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 26172347Ten Cate O, Chen HC, Hoff RG, Peters H, Bok H, van der Schaaf M. Curriculum development for the workplace using Entrustable Professional Activities (EPAs): AMEE Guide No. 99. Med Teach. 2015;37(11):983-1002. doi: 10.3109/0142159X.2015.1060308. Epub 2015 Jul 14.
- Background: PubMed 33882926Pinilla S, Kyrou A, Kloppel S, Strik W, Nissen C, Huwendiek S. Workplace-based assessments of entrustable professional activities in a psychiatry core clerkship: an observational study. BMC Med Educ. 2021 Apr 21;21(1):223. doi: 10.1186/s12909-021-02637-4.
- BackgroundFu, C. P., Chiang, F. M., Lee, C. Y., Chi, H. Y., Wu, J. L., Lin, Y. J., Li, M. W., Chen, Y. J., Chang, W. Y., Chang, W. D., Huang, S. M., Liao, W. S., Yang, Y. C., Huang, C. K., Kuo, N. J., Liu, T. H., & Chen, Y. L. (2023). Developing the topics of entrustable professional activities in pediatric occupational therapy in Taiwan: A pilot study. Taiwan Journal of Occupational Therapy, 41(2), 91-110. https://doi.org/10.6594/tjot.202308_41(2).0001
- Official website of the rehabilitation research team. This site does not currently contain detailed information about this specific study. For study-related inquiries, please contact the research team directly.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This study will not share individual participant data (IPD) due to considerations related to participant privacy and confidentiality. The data collected involve sensitive personal and demographic information of occupational therapy interns, and sharing such data could risk identification despite de-identification efforts. Additionally, the study was conducted under ethical approvals that restrict data sharing beyond the research team. Aggregate results and summary findings will be made publicly available through publications and ClinicalTrials.gov, ensuring transparency while protecting participant rights.
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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.
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 and Mini-clinical Evaluation Exercise, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Aug 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Yi Cheng, MS (+886-2-8966-7000 ext. 1516, xero1118@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent Clinical Competence of Occupational Therapy Interns (time frame: Assessment conducted at the eighth week of internship fieldwork.). 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 NCT07107542, which also lists 3 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 6 Aug 2025.