Combining virtual patients with simulation-based education: does order matter? A quantitative multi-method study

ISRCTN	ISRCTN90696311
DOI	https://doi.org/10.1186/ISRCTN90696311
Sponsor	University of Bern
Funder	University of Bern

Submission date: 24/07/2026
Registration date: 30/07/2026
Last edited: 07/09/2026

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

Not provided at time of registration

Contact information

Prof Sören Huwendiek
Principal investigator

Mittelstrasse 43
Bern
3012
Switzerland

Phone	+31 6846218
Email	soeren.huwendiek@unibe.ch

Dr Anja Kéry-Candela
Scientific, Public

University of Bern
Institute for Medical Education (IML)
Master of Medical Education (MME)
Bühlstrasse 26
Bern
3012
Switzerland

Email	anja.kery@bluewin.ch

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Crossover
Purpose	To generate evidence on the optimal sequencing and implementation of a blended learning approach combining virtual patients and simulation-based education within a self-directed learning framework in undergraduate medical education.
Scientific title	Virtual patients combined with EPA 6 simulation training for medical students
Study objectives
Ethics approval(s)	Approved 31/01/2023, Cantonal Ethics Committee Bern (KEK) (Murtenstrasse 31, Bern, 3010, Switzerland; +41 31 633 70 70; info.kek@be.ch), ref: BASEC-No: Req-2023-00138
Health condition(s) or problem(s) studied	Blended learning with virtual patients and simulation-based education in undergraduate medical education.
Intervention	Intervention: Pre-existing student groups were randomized to one of two educational sequences: (1) completion of a virtual patient (VP) module before participation in simulation-based education (SBE) or (2) completion of the same VP module after SBE. The VP module consisted of three standardized virtual patient cases delivered through a digital learning platform. Upon completion of the module, the platform automatically recorded participants' learning analytics individually, including completion of all three cases, case success rates, and processing time. All participants completed the same face-to-face SBE course, consisting of three standardised team-based simulation scenarios, each assessed by one facilitator. The intervention differed only in the timing of the VP module relative to the SBE session. Primary outcomes included objective assessment of team performance during the simulation. Secondary outcomes included participants' self-assessed confidence and perceived competence regarding the learning objectives. Self- assessments were conducted before and after the educational intervention. The total duration of participation comprised completion of the VP module, participation in the SBE course, and pre- and post-intervention self-assessments, all completed within a single study period during the students' last study term. Originally, the study comprised the subsequent objective structured clinical examination ( OSCE), as part of the planned follow-up outcome. This analysis could not be conducted because the OSCE dataset was no longer available due to institutional reorganisation. Consequently, the present study is limited to the evaluation of immediate educational outcomes and cannot determine whether the observed effects translated into subsequent objective clinical performance.
Intervention type	Behavioural
Primary outcome measure(s)	Facilitator assessments measured using a study-specific questionnaire comprising items aligned with the nine predefined learning objectives of the virtual patient (VP) cases, with responses recorded on a 5-point Likert scale, at immediately after each of three simulation-based education session VP processing measured using automated recording of VP log data, including processing time, completion status and success rates. Log data were linked with simulation-based education participation dates to determine whether the VP cases were completed before or after the simulation session, and collected at the end of the study Self-assessments confidence measured using a study-specific standardized questionnaire: Students rated their expectations regarding the impact of the VP cases on their confidence and the extent to which these expectations were fulfilled using a 5-point Likert scale, at baseline (immediately before the intervention) and immediately after completion of both the three VP cases and the three simulation-based education sessions Self-assessment competencies measured using a study-specific standardized questionnaire. Students rated their expectations regarding the impact of the VP cases on achieving each of the nine predefined learning objectives and the extent to which these expectations were fulfilled using a 3-point Likert scale, at baseline, immediately before the blended learning intervention and the extent to which these expectations were fulfilled immediately after completion of both the three VP cases and the three simulation sessions Blended learning perception measured using a study-specific standardized questionnaire. Participants rated the overall blended learning format and the perceived impact of the VP cases within, on a 3-point Likert scale, at immediately after completion of both the VP cases and the simulation-based education session
Key secondary outcome measure(s)	Self-reported confidence related to the predefined learning objectives measured using a study-specific questionnaire assessing confidence regarding each of the nine learning objectives on a 5-point Likert scale, at baseline, immediately before the blended learning intervention and immediately after completion of both the VP cases and the simulation-based education session Perceived contribution of the VP cases to achieving the predefined learning objectives measured using a study-specific questionnaire assessing the perceived contribution of the VP cases to each learning objective on a 3-point ordinal scale, at completion of both the VP cases and the simulation-based education session VP engagement measured using automatically recorded VP processing data, including completion status, processing time, success rates, and completion before or after the simulation-based education session, determined by linking platform log data with simulation participation dates, at the end of the simulation-based education session
Completion date	30/06/2023

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	All
Target sample size at registration	240
Total final enrolment	240
Key inclusion criteria	1. Enrolled as an undergraduate medical student at the University of Bern 2. Enrolled in the sixth year of the undergraduate medical curriculum 3. Assigned to a pre-existing simulation group consisting of eight students for the scheduled simulation-based education session 4. Provision of written informed consent to participate in the study
Key exclusion criteria	1. Not enrolled as a sixth-year undergraduate medical student at the University of Bern 2. Not assigned to a scheduled simulation group
Date of first enrolment	19/03/2023
Date of final enrolment	24/04/2023

Locations

Countries of recruitment

Switzerland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			29/07/2026	No	No

Additional files

49989_Self-assessment Survey.pdf: Other files

Editorial Notes

07/09/2026: A study contact was updated.
29/07/2026: Study’s existence confirmed by the Cantonal Ethics Committee Bern (KEK), which deemed the research exempt from ethical review because it is not covered by the Human Research Act (HRA).