An interventional study investigating the effect of video feedback by the Mini-Clinical Evaluation Exercise (Mini-CEX) method compared to conventional directly observed feedback method by Mini-Clinical Evaluation Exercise (Mini-CEX) on final year medical (Internship Year) students’ clinical competence at Shiraz University of Medical Sciences, Iran

ISRCTN	ISRCTN47543844
DOI	https://doi.org/10.1186/ISRCTN47543844
Secondary identifying numbers	1234

Submission date: 16/02/2022
Registration date: 16/02/2022
Last edited: 17/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Video feedback (VF) patient encounter is a new approach that has been developed that involves videotaping doctor-patient consultations and an assessor watching the consultation and providing feedback. The aim of this study is to evaluate the effect of the Mini-Clinical Evaluation Exercise (Mini-CEX) by video feedback method on the clinical competency of final year medical (internship year) students at the Shiraz University of Medical Sciences, Iran.

Who can participate?
Medical internship year students at the Shiraz University of Medical Sciences

What does the study involve?
The participants are assessed using a checklist in order to measure their clinical competency. They are randomly allocated to two groups, a control group who undergo traditional directly observed Mini-CEX feedback and an intervention group who undergo video Mini-CEX feedback. Following the participation of interns in the feedback workshops, their clinical competency is assessed again.

What are the possible benefits and risks of participating?
Participating students will have an opportunity to improve their clinical and communications skills. Possible risks to participants are minimal. Participants may feel anxiety and stress during the assessment process. This is minimized by explaining that these assessments are for research purposes only and that assessment scores and identifying information will be kept confidential.

Where is the study run from?
Shiraz University of Medical Sciences (Iran)

When is the study starting and how long is it expected to run for?
October 2020 to January 2022

Who is funding the study?
Shiraz University of Medical Sciences (Iran)

Who is the main contact?
1. Dr Kaveh Taghipour, kaveh109@hotmail.com
2. Dr Seyyed-Esmaeil Managheb, managheba@sums.ac.ir

Contact information

Dr Seyyed-Esmaeil Managheb
Public

Shiraz University of Medical Sciences
Zand Avenue
Shiraz
1234
Iran

Phone	+98 (0)917 312 5037
Email	managheba@sums.ac.ir

Dr Kaveh Taghipour
Scientific

Shiraz University of Medical Sciences
Zand Avenue
Shiraz
1234
Iran

Phone	+98 (0)9177891008
Email	kaveh109@hotmail.com

Dr Seyyed-Esmaeil Managheb
Principal Investigator

Shiraz University of Medical Sciences
Zand Avenue
Shiraz
1234
Iran

Phone	+98 (0)917 312 5037
Email	managheba@sums.ac.ir

Study information

Study design	Double-blind randomized controlled interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	The effect of video feedback by the mini-clinical evaluation exercise (Mini-CEX) method compared to conventional methods by mini-clinical evaluation exercise (Mini-CEX) on medical interns' clinical competence at Shiraz University of Medical Sciences, Iran
Study objectives	1. There is no statistically significant difference between the OSLER 1 results of interns who have undergone video feedback compared to traditional feedback. 2. There is a statistically significant difference between the OSLER 2 results of the video feedback group compared to the traditional feedback group. 3. There is a statistically significant difference between the OSLER 1 and OSLER 2 results of both the video feedback group and traditional feedback group.
Ethics approval(s)	Approved 23/02/2021, Ethics Committee in Research Shiraz University of Medical Sciences (Zand Avenue, Shiraz, 12365, Iran; +98 (0)7132305410; info@sums.ac.ir), ref: IR.SUMS.REC.1399.619
Health condition(s) or problem(s) studied	Medical education - clinical skills and communication skills clinical competency
Intervention	Our study is a prospective randomized, controlled double-blinded interventional study that involves a total of 40 interns of Shiraz University of Medical Sciences. The 40 participants were randomly allocated to two equal groups of 20 students each, a control group who underwent traditional feedback and an intervention group who underwent video feedback. Random allocation was ensured by writing each participant's name in a sealed envelope and then randomly assigning participants to each of the study groups. The 40 participants were then assessed using an objective structured long examination record (OSLER) checklist in order to ascertain baseline clinical competency (OSLER1). Subsequently, following the participation of interns in the feedback workshops, a post-intervention assessment of clinical competency was undertaken (OSLER 2). The results prior to feedback (OSLER1) were compared to the OSLER checklist scores following feedback (OSLER 2). The OSLER checklist based on a questionnaire of 10 faculty members of the Shiraz University of Medical Sciences (clinical faculty members) and staff in the Educational Development Center of Shiraz University of Medical Sciences has been determined to have a content validity index (CVI) of 100% and a CVR of 93%.
Intervention type	Behavioural
Primary outcome measure	Clinical competency measured using the objective structured long examination record (OSLER) checklist score at baseline and 4 weeks
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	03/10/2020
Completion date	18/01/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	Both
Target number of participants	40
Total final enrolment	40
Key inclusion criteria	Medical internship students' currently undergoing a 1-month rotation/attachment to the Family Medicine Department of Shiraz University of Medical Sciences
Key exclusion criteria	Medical internship students who have previously undergone any previous 1-month rotation/attachment to the Family Medicine Department of Shiraz University of Medical Sciences
Date of first enrolment	21/04/2021
Date of final enrolment	22/05/2021

Locations

Countries of recruitment

Iran

Study participating centre

Family Medicine Clinic, Rasool Azam Clinic

Rasool Azam Boulevard
Shiraz
12334
Iran

Sponsor information

Shiraz University of Medical Sciences
University/education

Central building - seventh floor
Zand St.
Shiraz
1234
Iran

Phone	+98 (0)71 3235 7282
Email	vcrdep@sums.ac.ir
Website	sums.ac.ir
"ROR"	https://ror.org/01n3s4692

Funders

Funder type

University/education

Shiraz University of Medical Sciences
Government organisation / Local government

Alternative name(s): SUMS
Location: Iran

Results and Publications

Intention to publish date	01/03/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets used and/or analysed during the current study are not publicly available due to restrictions, but are available from Dr Kaveh Taghipour (kaveh109@hotmail.com) on reasonable request and with the permission of Shiraz University of Medical Sciences

Editorial Notes

17/02/2022: Contact details updated.
16/02/2022: Trial's existence confirmed by the Ethics Committee in Research Shiraz University of Medical Sciences.