Do students learn more about physical examination of the shoulder if they attend a blended learning module compared to 'traditional' teaching methods?

ISRCTN ISRCTN13061552
DOI https://doi.org/10.1186/ISRCTN13061552
Submission date
24/09/2020
Registration date
02/11/2020
Last edited
09/09/2024
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
The study aims to create better evidence on the role of activating competency-based didactics in course development of physical examination skills in preclinical students. It will find out whether integrating clinical investigation techniques and professional posture in an activating competency-based training session will lead to a greater increase in student competence compared to traditional teaching methods 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 activating competency-based (intervention group) or traditional teaching curriculum (control group). The activating competency-based 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. Participants 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 may partake in a lottery drawing one iPad in each intervention and control group. 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 University of Tuebingen at the Tübingen University Hospital (Germany)

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

Study website

Contact information

Dr Roland Koch
Scientific

Institute for General Practice and Interprofessional Care
Osianderstr. 5
Tübingen
72076
Germany

ORCiD logoORCID ID 0000-0001-5748-8463
Phone +49 (0)1758065961
Email roland.koch@med.uni-tuebingen.de

Study information

Study designTwo-armed randomized observer-blinded interventional trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleTransfer 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
Study acronymTraceX
Study objectivesCurrent hypothesis as of 24/03/2021:
Preclinical medical students who have completed an activating competency-based 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 learning modules following traditional teaching methods.


Previous 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(s)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
Health condition(s) or problem(s) studiedEffect of activating competency-based learning on a complex shoulder examination requiring professional posture, transfer of anatomical knowledge and clinical examination skills
InterventionCurrent interventions as of 24/03/2021:
Participants (preclinical medical students) will be randomly assigned to either activating competency-based learning (intervention group) or traditional teaching methods.

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).


Previous interventions:
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 typeBehavioural
Primary outcome measureCompetency 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 measuresA 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 study start date01/12/2019
Completion date30/08/2021

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80 (40 per study arm)
Total final enrolment36
Key inclusion criteriaAll preclinical students aged >18 years enrolled at the Medical Faculty of the University of Tübingen
Key exclusion criteriaHealth status does not allow participation
Date of first enrolment03/05/2021
Date of final enrolment28/05/2021

Locations

Countries of recruitment

  • Germany

Study participating centres

Tübingen University Hospital
Institut für Allgemeinmedizin und Interprofessionelle Versorgung
Medizinische Fakultät
VITA Gebäude
Osianderstr. 5
Tübingen
72076
Germany
Eberhard-Karls University Tübingen
Institute of Clinical Anatomy and Cell Analysis
Oesterbergstrasse 3
Tübingen
72074
Germany

Sponsor information

Universitätsklinikum Tübingen
Hospital/treatment centre

Medical Faculty
Geissweg 5/1
Tübingen
72076
Germany

Phone +49 (0)7071 29 73884
Email forschung.allgemeinmedizin@med.uni-tuebingen.de
Website https://www.medizin.uni-tuebingen.de/en/Homepage.html
ROR logo "ROR" https://ror.org/00pjgxh97

Funders

Funder type

Hospital/treatment centre

Universitätsklinikum Tübingen

No information available

Results and Publications

Intention to publish date01/01/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned 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 planThe 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.

Editorial Notes

09/09/2024: The intention to publish date was changed from 31/03/2024 to 01/01/2025.
11/12/2023: The intention to publish date was changed from 31/12/2023 to 31/03/2024.
04/09/2023: The intention to publish date was changed from 30/08/2023 to 31/12/2023.
04/07/2023: The intention to publish date was changed from 31/01/2023 to 30/08/2023.
01/12/2022: The intention to publish date was changed from 30/09/2022 to 31/01/2023.
17/12/2021: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2021 to 30/09/2022.
2. The total final enrolment was added.
24/03/2021: The following changes were made to the trial record:
1. The condition was changed from "Effect of blended learning on a complex shoulder examination requiring professional posture, transfer of anatomical knowledge and clinical examination skills" to "Effect of activating competency-based learning on a complex shoulder examination requiring professional posture, transfer of anatomical knowledge and clinical examination skills".
2. The interventions were changed.
3. The recruitment end date was changed from 04/05/2021 to 28/05/2021.
4. The recruitment start date was changed from 12/04/2021 to 03/05/2021.
5. The hypothesis was changed.
6. The plain English summary was updated to reflect these changes.
25/09/2020: Trial’s existence confirmed by Ethics Committee of the Medical Faculty Universitätsklinikum Tübingen