NCT07107542

Brief 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. The main questions it aims to answer are:

  1. 1.Does the performance on Mini-CEX correlate with the interns' ability to perform independently?
  2. 2.Does the use of EPAs provide additional insight into interns' readiness for unsupervised clinical practice?
  3. 3.Provide informed consent at the sixth week of their internship.
  4. 4.Undergo assessment with Mini-CEX and EPAs during their eighth week of clinical training.
  5. 5.Complete demographic questionnaires including age, gender, study habits, prior university experience, parental occupation, and residence area.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
35mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Oct 2025Mar 2029

First Submitted

Initial submission to the registry

July 11, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

July 11, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessment conducted at the eighth week of internship fieldwork.

Secondary Outcomes (1)

  • Correlation of Demographic Factors with fieldwork Competence

    Data collected and analyzed at the eighth week of internship.

Study Arms (1)

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.

Other: Mini-Clinical Evaluation Exercise (Mini-CEX) and Entrustable Professional Activities (EPAs) Assessment

Interventions

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.

Occupational Therapy Fieldwork Interns

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Occupational therapy interns in the physical domain at Far Eastern Memorial Hospital
  • Provide informed consent to participate

You may not qualify if:

  • None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 26172347BACKGROUND
  • Pinilla 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.

    PMID: 33882926BACKGROUND
  • Fu, 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

    BACKGROUND

Related Links

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist, Department of Rehabilitation, Far Eastern Memorial Hospital

Study Record Dates

First Submitted

July 11, 2025

First Posted

August 6, 2025

Study Start

October 8, 2025

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Available IPD Datasets

Study Protocol Access

Locations