Condition category
Not Applicable
Date applied
24/09/2020
Date assigned
02/11/2020
Last edited
02/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The study aims to create better evidence on the role of blended learning in course development of physical examination skills in preclinical students. It will find out whether integrating clinical investigation techniques and professional posture in a blended-learning training session will lead to a greater increase in student competence compared to a classical curriculum with lecture and case demonstrations. Competencies in the above-mentioned areas are assessed with an examination in which the student is asked to examine a patient with shoulder problems.

Who can participate?
All students of the preclinical semesters who are enrolled at the Medical Faculty of Tübingen University

What does the study involve?
Participants will be randomly allocated to either blended-learning (intervention group) or a face-to-face curriculum (control group). The blended learning intervention comprises a 1.5-hour e-learning module on professional posture and clinical examination as well as the functional anatomy of the shoulder. Next, students in the intervention group attend a 1.5-hour peer learning seminar in which they train examining their peers and give mutual feedback. Participants in the control group will receive a 1.5-hour lecture on shoulder anatomy combined with a patient demonstration by a GP. Next, students in the control group are offered 1.5 hours of free training where shoulder models are available. Partcipants take an exam after 8 weeks. The exam takes about 25 minutes. Participants are given questionnaires at the start of the study and after the exam. The questionnaires take about 15 minutes to complete.

What are the possible benefits and risks of participating?
There is no risk for the participants. A personal benefit for the participants is the learning opportunity (clinical elements for pre-clinicians). In order to compensate for any additional time expenditure, students who have participated in the study and passed the examination will receive a "go free" certificate for the curricular anatomy exam of the shoulder. Furthermore, all participants will receive two cinema vouchers.

Where is the study run from?
University of Tuebingen at the Tübingen University Hospital (Germany)

When is the study starting and how long is it expected to run for?
December 2019 to August 2021

Who is funding the study?
Faculty internal ProfilPlus funding

Who is the main contact?
Dr Roland Koch
roland.koch@med.uni-tuebingen.de

Trial website

https://www.medizin.uni-tuebingen.de/de/das-klinikum/einrichtungen/institute/allgemeinmedizin/forschung/aus-und-weiterbildungsforschung/trace-x

Contact information

Type

Scientific

Primary contact

Dr Roland Koch

ORCID ID

https://orcid.org/0000-0001-5748-8463

Contact details

Institute for General Practice and Interprofessional Care
Osianderstr. 5
Tübingen
72076
Germany
+49 (0)1758065961
roland.koch@med.uni-tuebingen.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Transfer of anatomical knowledge in the examination situation for pre-clinical medical students (TraceX): a randomized, controlled study comparing face-to-face teaching and blended learning

Acronym

TraceX

Study hypothesis

Preclinical medical students who have completed a blended learning unit on professional posture, clinical examination skills and basic anatomical knowledge achieve a higher competency score in a simulated shoulder examination than students who have completed the same amount of time in face-to-face learning modules.

Ethics approval

Assessed 04/05/2020, the study does not require ethic approval (Ethics Committee of the Medical Faculty, Gartenstraße 47, 72074 Tübingen, Germany; +49 7071 29 77661; ethik.kommission@med.uni-tuebingen.de), ref: 231/202BO1

Study design

Two-armed randomized observer-blinded interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Effect of blended learning on a complex shoulder examination requiring professional posture, transfer of anatomical knowledge and clinical examination skills

Intervention

Participants (preclinical medical students) will be randomly assigned to either blended-learning (intervention group) or a face-to-face curriculum.

The blended learning intervention comprises a 1.5-h e-learning module on professional posture and clinical examination as well as functional anatomy of the shoulder. Next, students in the intervention arm attend a 1.5-h peer learning seminar in which they train examining their peers and give mutual feedback.

Participants in the control arm will receive a 1.5 h lecture on shoulder anatomy combined with a patient demonstration by a GP. Next, students in the control arm are offered 1.5 h of free training where shoulder models are available.

Intervention and control at T2 (T0+6 weeks) run parallel and will last 2 weeks in total. They are followed by a 2-day formative exam at T3 (T0+ 8 weeks). For each participant, the exam takes about 25 minutes. In the exam, the effect of the intervention is measured. Participants are given questionnaires at allocation (T0) and after the exam (T4). The questionnaires take about 15 minutes to complete.

The randomization is provided using an open-source online randomization tool (RANDI).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Competency in professional posture, physical examination and anatomical knowledge measured as a combined score of maximum 45 points in an examination situation with an actor patient at T3 (8 weeks)

Secondary outcome measures

A newly developed and piloted questionnaire measures the following items at T0 and T4 and uses a pseudonym to measure pre-post development in the following domains:
1. Self-assessed competency level in the three domains (professional posture, anatomical knowledge and clinical examination skills)
2. German inventory on attitudes and assessment of blended learning at T0 and T4
3. Perceived stress questionnaire (PSYINDEX) at T0 and T4
4. Technology affinity (ATI) at T0 only
5. Sociodemographic characteristics at T0 only
6. Attitudes to e-learning and ways to improve the experience, assessed using focus groups with participants at T4

Overall trial start date

01/12/2019

Overall trial end date

30/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All preclinical students aged >18 years enrolled at the Medical Faculty of the University of Tübingen

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

80 (40 per study arm)

Participant exclusion criteria

Health status does not allow participation

Recruitment start date

12/04/2021

Recruitment end date

04/05/2021

Locations

Countries of recruitment

Germany

Trial participating centre

Tübingen University Hospital
Institut für Allgemeinmedizin und Interprofessionelle Versorgung Medizinische Fakultät VITA Gebäude Osianderstr. 5
Tübingen
72076
Germany

Trial participating centre

Eberhard-Karls University Tübingen
Institute of Clinical Anatomy and Cell Analysis Oesterbergstrasse 3
Tübingen
72074
Germany

Sponsor information

Organisation

Universitätsklinikum Tübingen

Sponsor details

Medical Faculty
Geissweg 5/1
Tübingen
72076
Germany
+49 (0)7071 29 73884
forschung.allgemeinmedizin@med.uni-tuebingen.de

Sponsor type

Hospital/treatment centre

Website

https://www.medizin.uni-tuebingen.de/en/Homepage.html

Funders

Funder type

Hospital/treatment centre

Funder name

Universitätsklinikum Tübingen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal on medical education. Aside from the main article, the researchers plan to publish a study protocol and a mixed-methods evaluation of the secondary outcomes.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy reasons of the participants. It can be made available upon resonable personal request. It will be saved on user-restricted, ISO27001 certified servers at UKT.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2020: Trial’s existence confirmed by Ethics Committee of the Medical Faculty Universitätsklinikum Tübingen