Impact of simulation training on communication skills in medical students

ISRCTN ISRCTN10251799
DOI https://doi.org/10.1186/ISRCTN10251799
Secondary identifying numbers LS-C-23-216-McCarrick-Cahill
Submission date
30/10/2024
Registration date
31/10/2024
Last edited
21/07/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
This study aims to see if a program focused on communication and consent in surgery can improve students' communication skills. The goal is to determine if this training should be a permanent part of the surgical curriculum.

Who can participate?
All surgical students can participate. Non-surgical students are excluded.

What does the study involve?
Participants will watch an actor and a tutor roleplay good and bad consent practices. Afterward, there will be a discussion about what makes good communication when getting patient consent. Students will also take part in a mock consent exercise at the start and end of the week to measure their communication skills.

What are the possible benefits and risks of participating?
Benefits include practicing communication skills, receiving feedback, and helping to improve the surgical curriculum. Risks are minimal but include the possibility that the tutorial may not improve communication skills.

Where is the study run from?
The study is conducted at UCD in the Mater Misericordiae site (Ireland)

When is the study starting and how long is it expected to run for?
October 2023 to October 2024

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
The main contact for the study is Cathleen McCarrick (cathleen.mccarrick@ucd.ie).

Contact information

Dr Cathleen McCarrick
Public, Scientific, Principal Investigator

Catherine McAuley Centre
21 Nelson Street
Dublin
D07 A8NN
Ireland

ORCiD logoORCID ID 0000-0002-9713-9038
Phone +353 879033513
Email cathleen.mccarrick@ucd.ie

Study information

Study designSingle center interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)University/medical school/dental school
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participation information sheet
Scientific titleImpact of simulation training on communication skills in medical students- a randomised controlled trial
Study acronymISTCSMS
Study objectivesThat dedicated communication simulation training has a significant effect on medical students' communication skills.
Ethics approval(s)

Approved 06/10/2023, Human Research Ethics Committee – Sciences (HREC-LS) (University College Dublin, Belfield, Dublin, -, Ireland; -; research.ethics@ucd.ie), ref: LS-C-23-216-McCarrick-Cahill

Health condition(s) or problem(s) studiedCommunication skills in a student population
InterventionCommunication Skills Training involved a workshop designed for this study adhering to the foundational structure of the Calgary Cambridge Communication Guide to Medical Interviews (CCCM) as adopted and utilized by the Royal College of Surgeons in Ireland (RCSI) in their Human Factors in Patient Safety training for postgraduate surgical trainees. This training incorporates sessions designed to cultivate communication skills in trainees in national core surgical training who are then tested on an annual basis utilising a scoring rubric designed with explicit reference to the CCCM to simultaneously assesses communication content and process skills. For this study, CST workshops comprised an actor and a surgical tutor roleplaying as simulated patient (SP) and doctor respectively. They acted out two scenarios in which the tutor obtained informed consent for an intervention (specifically laparoscopic cholecystectomy). Students were provided with the framework of the CCCM to refer to whilst observing these scenarios. The first scenario was designed to exemplify good communication skills; encapsulating positive aspects of verbal and non-verbal communication; initiating the session appropriately and allowing the patient to express their level of understanding of the procedure in question, empathetic open listening and clear concise communication of the risks in non-medical terminology. This exemplar was then contrasted with a role play demonstration of poor communication. This consent was performed in a rushed and coercive fashion with poor verbal and non-verbal communication coupled with deliberate avoidance of terminology that a patient would readily understand. Highlighting these extreme examples allows for the subsequent development of an in-depth group discussion on the important points of communication within the consent process whilst the tutor referenced the CCCM structural framework for exemplifying good communication and developing a frame of reference for students in constructing a shared mental model so they could self-critique against a common shared standard. Additionally, the actor gave feedback to each interaction lending authenticity as the voice of a patient to the process. Students then voluntarily roleplayed as patients/ doctors consenting each other allowing for the organic encouragement of peer-to-peer learning. The control group continued to receive standard clinical teaching.

Randomisation was done outside of the study by the school administration who randomly assigns students to surgical groups eg clustered randomisation. Following that process the groups were randomly assigned to either the intervention or control using a sealed envelope.
Intervention typeOther
Primary outcome measureData was collected via the UCD scoring OSCE rubric and the GCRS-Global communication rating scale. Prior to the intervention both groups were given scores by blinded examiners and then after the intervention both groups underwent this. UCD scale is a mark equating to grade e.g. A+, A, A-, B=, B, B-..GCRS is a mark out of 3 for each domain of communication e.g. initiation of session, non verbal communication.
Secondary outcome measuresStudents' confidence levels measured via anonymous survey before and after training.
Overall study start date06/10/2023
Completion date10/10/2024

Eligibility

Participant type(s)Learner/student
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants120-140
Total final enrolment122
Key inclusion criteriaStudents attached to surgical teaching
Key exclusion criteriaNot undergoing surgical teaching
Date of first enrolment07/10/2023
Date of final enrolment10/10/2024

Locations

Countries of recruitment

  • Ireland

Study participating centre

University College Dublin
Mater Misericordiae Hospital
Eccles Street
Dublin 7
D07 A8NN
Ireland

Sponsor information

University College Dublin
University/education

Department of surgery
School of Medicine
Dublin
-
Ireland

Email debbie.killeen@ucd.ie
Website http://www.ucd.ie/
ROR logo "ROR" https://ror.org/05m7pjf47

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date11/11/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer reviewed journal
IPD sharing planDatasets generated during and analyzed in this study will mainly be published and those that are not are avaiable upon request from Cathleen.mccarrick@ucd.ie

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 18/07/2025 21/07/2025 Yes No

Editorial Notes

21/07/2025: Publication reference added.
31/10/2024: Trial's existence confirmed by Human Research Ethics Committee – Sciences (HREC-LS)