UltrasonographySIGNATURENCT04114812
Near-peer Tutoring Compared With a Standard Faculty-led Course for Undergraduate Training in Abdominal Ultrasound.
A study testing Blended learning and Standard course in people with Ultrasonography and Educational Techniques, run by University of Bern at 3 sites in Switzerland.
Trial summary
Background: Ultrasound has become clinical skill widely used in most medical disciplines. Institutions are changing their curricula to implementing basic ultrasound knowledge, often supplementing traditional teaching with 'near-peer' tutoring through classes held by advanced peers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Educational Techniques
- What is being tested?
- Blended learning and Standard course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 17 Sep 2019to 21 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical students at three Swiss universities (Bern, Freiburg, Zurich) in the 3rd to 8th semester, who:
- are willing to participate in the study;
- are willing to pay the 200.- CHF course fees (partial reimbursement of tutors and administrative fee for the SGUM course certificate)
- fill out a baseline questionnaire
- signed informed consent sheet
Who cannot join
- Did not sign study agreement or pay the course fee
- More than 5 hours of previous formal ultrasound training
- Failure to fill out baseline questionnaire
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University of Bern
Bern, 3000
University of Fribourg
Fribourg, 1700
University of Zurich
Zurich, 8091
About this study
Official title: Student-centred Learning With Near-peer Tutoring Compared With a Standard Faculty-led Course for Undergraduate Training in Abdominal Ultrasound. A Multicentre Open-label Randomized Controlled Trial.
Background:
Ultrasound has become clinical skill widely used in most medical disciplines. Institutions are changing their curricula to implementing basic ultrasound knowledge, often supplementing traditional teaching with 'near-peer' tutoring through classes held by advanced peers. Near-peer tutoring has been found to be both effective and cost-effective.
Read more
In Switzerland the most popular course in postgraduate training is a resource-intensive 21-hour basic course for abdominal ultrasound. However, this is expensive, and may not be the best way to impart these skills to undergraduates, who need training more adapted to their needs.
Therefore a 21-hour blended-learning ultrasound course, comprising 5 hours of e-learning and 16 hours of near-peer tutoring has been developped. Students and their near-peer tutors autonomously organize individual practical teaching sessions within a 16 weeks time period.
Methods:
Medical students from second to fourth year at the Universities of Bern, Fribourg and Zurich will be included. Stratified by study site, students will be randomized to one of the two interventions. The blended-learning group will receive e-learning and near-peer tutoring over 16 weeks; the other group will receive 21 hours of teaching, from ultrasound experts, in a 2.5-day course. All participants will undergo a six-station OSCE directly after the course and 6 months later. Students will fill out online questionnaires at baseline, directly after the course and 6 months later. The mean scores of both groups will be compared at six months after the end of both courses. Secondary outcome measures will be students' ultrasound skills immediately after the courses, student satisfaction, multivariate regression exploring factors that affect outcome at 6 months and exploratory subgroup analysis.
Discussion:
This study is designed to compare the current way of ultrasound education in Switzerland with a new blended learning course. It aims to determine whether the blended learning course is as good as, or better than the existing 21-hour standard course. If this is found to be the case, blended learning could help to expand capacity to offer such courses to undergraduate medical students. It would eventually allow undergraduate Swiss medical students to acquire ultrasound skills before starting their residencies. This study also aims at improving the understanding of how to achieve effective student-centred learning supported by near-peer tutoring.
Read the detailed description
Background:
Over the last decades, ultrasound (US) examination has become commonly used in many medical specialties, including internal medicine and primary care. Young doctors often perform simple ultrasound investigations as residents in internal medicine or primary care especially in emergency care. Currently, 30% of Swiss primary care practices are equipped with an ultrasound machine.
The Swiss Society for Ultrasound in Medicine (SGUM/SSUM) is the accreditation body for ultrasound education in Switzerland. Doctors must obtain a certificate from the SGUM before they can bill ultrasound examinations for insurance payments. However, ultrasound courses are time-intensive (63 hours total, plus a final examination), and are offered in the postgraduate phase, when doctors often have few resources and little time. This may explain why only about half of General Practitioners who use ultrasound have the SGUM certificate. For the half without the certificate, not only can they not bill their ultrasound examination to an insurance company, but also the quality of the examination is less assured, as they have not demonstrated their competence in US skills in the SGUM examination. This may lead to insecurity for the patient and for the performing doctor. There is also a risk that this results in unnecessary examinations.
The SGUM certificate is achieved by passing three courses (basic/advanced/final; 21 hours each) as well as a summative final examination. Between courses, trainees must perform a certain number of US examinations on real patients, under direct and distant supervision. These courses are now being opened to undergraduates, and the 2017 revision of the Swiss learning objectives for medical studies (PROFILES) added basic US skills as mandatory learning goal.
In the past years US training courses at Swiss medical universities were mostly optional, and were quickly overbooked. This shortage of courses could be addressed by using near-peer tutors, which are increasingly used in faculty-organized US classes. Near-peer tutors are "trainees one or more years senior to trainees on the same level of medical education spectrum". Five randomized-controlled trials of ultrasound training have compared near-peer tutoring with faculty-led teaching and assessed students' practical ultrasound skills as a primary outcome measure. Four of these found peer-tutoring to be non-inferior and one found that students in the near-peer-tutoring group slightly underperformed.
Near-peer tutoring in undergraduate US training offers many potential advantages over traditional faculty-based teaching:
- Since mostly reciprocal US is being done by the participating medical students, perfect conditions for learning basic sonographic anatomy can be found. Medical students, in contrast to patients, are mostly slender, healthy and mobile.
- In near-peer tutoring settings, students are more likely to ask questions and participate actively. In addition, having ultrasound skills can help students feel more secure in their basic clinical examination skills.
- Near-peer tutoring relieves pressure on the university by alleviating the increasing teaching demand and by being cost-effective.
- There is evidence that students who work as tutors constantly improve their own skills.
In Autumn 2017, the Institute of Primary Health Care (BIHAM) at the University of Bern set up a working group of 24 US experts from all Swiss universities and of representatives of SGUM sections. The group decided on the "Swiss standard" for basic abdominal ultrasound examination after discussing it at two consensus-building meetings. In Spring 2018, videotapes of SGUM experts demonstrating the ultrasound examination of the various abdominal organs, based on that consensus, were recorded. These videos were integrated into interactive e-learning modules. They have been available to all Swiss medical students since the beginning of 2019.
In parallel, a formal system of training and continuous education for near-peer tutors was put in place by a collaboration of motivated students and faculty staff. Near-peer tutors receive at least 6 days of US training, including teaching on didactic techniques, and afterwards be registered as so-called 'junior-tutors' by SGUM. They must offer at least four hours of US class per semester, but can choose the times and dates. Tutors will be reimbursed for their teaching through course fees paid by course participants.
Methods:
The standard "Basic course in abdominal ultrasound", delivered over 2.5 consecutive days, contains 5 hours of theory and 16 hours of practical training. In contrast, our blended-learning course is more student-centred, in that it expects students to take the initiative to learn the theory from (A) the e-learning developed by the working group, and (B) 16 hours of near-peer tutoring in groups of two to four, at times that are mutually agreeable for tutors and students, without faculty involvement.
The e-learning is made up of five modules starting by an introductory e-learning module on technical basics in ultrasound, followed by four practical modules comprising the abdominal organs. For each of the four practical modules, students start by working through the e-learning module, followed by four hours of individual near-peer tutoring sessions.
Students decide the pace of their 16 hours of training, typically over a four-month period. When a student completes all five e-learning modules and has gathered 16 signatures from the peer-tutored classes, they can apply to take a summative final examination. If they pass the Objective Structured Clinical Examination (OSCE) validated by Hofer et al. (2011) and adapted to Swiss needs, they are accredited by SGUM, according to Swiss national accreditation guidelines, for the "Basic course in abdominal ultrasound" - the first of the three ultrasound courses within the SGUM curriculum.
The OSCE will be assessed twice for every participant. Once at the end of the course and once 6 months after the end of the course. The second OSCE will be the primary outcome, since it evaluates long-term retention of acquired US knowledge. Every student will be tested by six different examiners in each OSCE. Differences in difficulty of the four series of OSCE stations as well as difficulty of every station will be taken into account in the statistical analysis.
The blended-learning course offers several other advantages by implementing modern didactics: by distributing teaching sessions over 16 weeks instead of just 2.5 consecutive days, students benefit from "spaced repetition" which improves long term retention. In our programme, students can decide which session to choose next, and tutors and students arrange the teaching sessions according to their availability and needs, so learning is student-centred. These factors differentiate our study from the near-peer tutoring in ultrasound education reported in some studies, in which tutors engage in scheduled courses organized by university faculty.
Between randomization and the end of the training (t = 16 weeks), students will be instructed not to undergo any additional training (e-learning, practical sessions or other) other than those provided within the intervention. Additional training will be recorded directly after the end of the training by questionnaire and by going through e-learning logs. During the 6-month follow-up period, students in both groups will be equally encouraged to continue self-organised training and both will be granted access to ultrasound machines.
Adjusting to local curricula we will primarily recruit students in semester 7 in Bern (total medical student intake per year = 220) and in semester 6 in Zurich (240) and Fribourg (120). At each site, we will present the programme during a plenary session, assisted by our local co-investigators.
To avoid systematic differences in additional training during the follow-up period, the following rules will put in place:
- Students will only be told their test results from the first test after the end of the study
- Test performance in the follow-up test will have no effect on the accreditation
To reduce loss to follow-up, we will:
- Require all students who apply for the programme to sign a separate form confirming their availability and intention to complete the course and the examinations
- Reimburse participants 50.- CHF after they have taken the second OSCE.
- Reimburse travel costs for the second OSCE
- Hand out the test result and the course certificate only after the second OSCE
Students' motivation for ultrasound training is very high. The optional courses at Swiss universities are typically overbooked within minutes and many students are disappointed that they are unable to take part. Our study will give students the opportunity to get a certificate accredited by the SGUM for a course fee of 200.- CHF, regardless of the intervention they are assigned to. Postgraduate training for the same degree costs around 1200.- CHF.
We will use centralized computed randomization in blocks of 4 to allocate each of the participants to one of the two study arms, with allocation in a 1:1 ratio, stratified by study site. The reason for block randomisation is the requirement of the control group to comprise of exactly 24 or 28 students due to the maximum group size of 4 students per tutor. The randomization will be performed by a blinded external partner (Clinical Trials Unit in Bern).
Outcome assessors will be experienced sonographers who have not taught course participants of either group.
To ensure high interrater-reliability, faculty training for all assessors will be held immediately before the OSCE. In the first part of this training, the assessors discuss key aspects of the rating using videotaped examples of OSCE stations to achieve a common standard. At the end of the training, assessors will rate another video example, where the interrater-reliability will be assessed.
OSCE assessors will be blinded to group allocation. The assessments will be at the same time for each group. We will instruct students not to reveal their group allocation to the OSCE assessors.
Sample size calculation has been done as follows: Based on a pilot with 20 students we expect a mean score of 33/50 points per station with a standard deviation (SD) of 4 points. The study was powered for non-inferiority using a margin of a -1.5 points for the difference in mean OSCE scores between the intervention and control group in the practical exam at 6 months (primary outcome). 1.5 points difference would correspond to an effect size of 0.375 standard deviations (SD), which we would still consider as non-inferior. We calculated the sample size with the assumption that the intervention group will perform somewhat better (+0.5 in mean score) than the control group based on test results from previous pilots. We chose a 1-sided alpha-error of 0.05 and a power of 90% (138 participants). Allowing for a 9% dropout rate we decided to include 152 students.
Discussion:
If the new blended-learning format is shown to be at least as good as the existing standard course, we could quickly expand our capacity to offer such courses to undergraduate medical students, replacing resource-intensive faculty-led courses with peer-assisted learning programmes. This will eventually allow all undergraduate students to acquire ultrasound skills that will help them in their residencies. The national accreditation body fully supports this near-peer-tutoring-based course both financially and through full accreditation of a pilot project and has committed to continue its support if we find that this teaching format produces results that are just as good as, or better than, the usual faculty-led courses. Learning more about the advantages conferred by student-centred learning through near-peer teaching will enable us to design better peer-assisted learning programmes and to design new, similar programmes in other areas.
- Conditions
- Ultrasonography, Educational Techniques
- Being tested
- Blended learning, Standard course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended learningOther
In the intervention group, students will be given access to an e-learning platform that contains five e-learning modules. They will attend individual small group tutoring sessions, with a maximum of 4 students per group. They will be able to book these sessions at a dedicated web platform. They will have 16 weeks in which to complete the 5 e-learning modules and 16 hours of practical training. Progress will be monitored and supported by regular follow-up messages and calls by the study team. Students must hand in the logbook with tutors' signatures when they enter the exam. All students within the blended learning group that completed 5 hours of e-learning as well as 16 hours of peer-tutoring and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study.
Standard courseOther
In the standard course or control group, students will participate in a 2.5-day course in abdominal ultrasound, comprising 5 hours of lectures and 16 hours of ultrasound training in small groups, with a maximum of 4 students per group. The course will be held in an ultrasound training centre in Bern. All students within the standard course group that participated in the whole 2.5 day course and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Blended learning | Experimental | Participants in the blended learning group will be taught abdominal ultrasound by an e-learning platform and practical near-peer tutoring classes over 16 weeks, summing up to 5 hours of e-learning and 16 hours of near-peer tutoring classes. Receives: Other: Blended learning |
| Standard course | Active comparator | Participants in the standard course or control group will participate in a 2.5-day course in abdominal ultrasound, comprising 5 hours of lectures and 16 hours of ultrasound training. Receives: Other: Standard course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean participants' "Swiss Students' Ultrasound Skills Assessment" scores six months after the end of their courses (OSCE 2).
The investigators will assess the participants' ultrasound skills using the "Swiss Students' Ultrasound Skills Assessment". This uses a validated OSCE form (Hofer et al. 2011), which has been adapted to specific Swiss needs and revalidated. The total score can range from 0-300 points, a higher total representing a better performance. The OSCE assesses handling of the probe, explanation of the ultrasound image, examination skills and theoretical knowledge. Each station will assess a key topic that arises in both courses.
Measured: 10 months from enrollment at each site
Secondary outcomes (4)
Mean participants' "Swiss Students' Ultrasound Skills Assessment" scores immediately after the end of their courses (OSCE 1).
As above.
Measured: 16 weeks from enrollment at each site
Change in mean participants' "Swiss Students' Ultrasound Skills Assessment" scores (knowledge retention).
To evaluate knowledge retention, the investigators will analyse the change in mean "Swiss Students' Ultrasound Skills Assessment" scores between the end of the courses and 6 months later,
Measured: 10 months from enrollment at each site
Participants' satisfaction with allocated courses
Students will complete a "Ultrasound Course Satisfaction Rating Scale" questionnaire immediately before OSCE 1. This will assess participants' satisfaction with their respective courses, through their mean Likert scale scores (Possible scores for each question 1-5, where 1 = Very dissatisfied, 5 = Very satisfied).
Measured: 16 weeks from enrollment at each site
Multivariate regression exploring factors that affect outcome at six months after the end of their courses
The investigators will use multivariate regression to explore factors that affect the outcome at 6 months after the end of the courses (e.g. group allocation, additional hours of self-training, average group size during training, gender).
Measured: 10 months after enrollment at each site
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start17 Sep 2019
- Primary completion25 Sep 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will include 152 medical students at the Universities of Bern, Fribourg and Zurich. Stratified by study site, students will be randomized to one of the two interventions. The blended-learning group will receive e-learning and near-peer tutoring over 16 weeks; the other group will receive 21 hours of teaching, from ultrasound experts, in a 2.5-day course.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman Hari, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114812
- Sponsor's protocol ID
- UBern SIGNATURE
- Acronym
- SIGNATURE
- Status last verified
- Jan 2022
- First submitted
- 27 Sep 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bornemann P, Barreto T. Point-of-Care Ultrasonography in Family Medicine. Am Fam Physician. 2018 Aug 15;98(4):200-202. No abstract available.
PubMed 30215979Ultrasound Guidelines: Emergency, Point-of-Care and Clinical Ultrasound Guidelines in Medicine. Ann Emerg Med. 2017 May;69(5):e27-e54. doi: 10.1016/j.annemergmed.2016.08.457. No abstract available.
PubMed 28442101Ma IWY, Arishenkoff S, Wiseman J, Desy J, Ailon J, Martin L, Otremba M, Halman S, Willemot P, Blouw M; Canadian Internal Medicine Ultrasound (CIMUS) Group*. Internal Medicine Point-of-Care Ultrasound Curriculum: Consensus Recommendations from the Canadian Internal Medicine Ultrasound (CIMUS) Group. J Gen Intern Med. 2017 Sep;32(9):1052-1057. doi: 10.1007/s11606-017-4071-5. Epub 2017 May 11.
PubMed 28497416Rikley E, Boillat-Blanco N, Meuwly JY, Breuss E, Senn N. [Ultrasonography : an useful diagnostic tool for the general practitioner]. Rev Med Suisse. 2017 Mai 10;13(562):990-994. French.
PubMed 28627842Hoppmann RA, Rao VV, Bell F, Poston MB, Howe DB, Riffle S, Harris S, Riley R, McMahon C, Wilson LB, Blanck E, Richeson NA, Thomas LK, Hartman C, Neuffer FH, Keisler BD, Sims KM, Garber MD, Shuler CO, Blaivas M, Chillag SA, Wagner M, Barron K, Davis D, Wells JR, Kenney DJ, Hall JW, Bornemann PH, Schrift D, Hunt PS, Owens WB, Smith RS, Jackson AG, Hagon K, Wilson SP, Fowler SD, Catroppo JF, Rizvi AA, Powell CK, Cook T, Brown E, Navarro FA, Thornhill J, Burgis J, Jennings WR, McCallum JB, Nottingham JM, Kreiner J, Haddad R, Augustine JR, Pedigo NW, Catalana PV. The evolution of an integrated ultrasound curriculum (iUSC) for medical students: 9-year experience. Crit Ultrasound J. 2015 Dec;7(1):18. doi: 10.1186/s13089-015-0035-3. Epub 2015 Nov 21.
PubMed 26589313Education and Practical Standards Committee, European Federation of Societies for Ultrasound in Medicine and Biology. Minimum training recommendations for the practice of medical ultrasound. Ultraschall Med. 2006 Feb;27(1):79-105. doi: 10.1055/s-2006-933605. No abstract available.
PubMed 16508866Wakefield RJ, Weerasinghe A, Tung P, Smith L, Pickering J, Msimanga T, Arora M, Flood K, Gupta P, Bickerdike S, McLaughlan J, Uttley A, Wilson J, Evans T, Wolstenhulme S, Roberts TE. The development of a pragmatic, clinically driven ultrasound curriculum in a UK medical school. Med Teach. 2018 Jun;40(6):600-606. doi: 10.1080/0142159X.2018.1439579. Epub 2018 Feb 28.
PubMed 29490531Bulte C, Betts A, Garner K, Durning S. Student teaching: views of student near-peer teachers and learners. Med Teach. 2007 Sep;29(6):583-90. doi: 10.1080/01421590701583824.
PubMed 17922356Celebi N, Zwirner K, Lischner U, Bauder M, Ditthard K, Schurger S, Riessen R, Engel C, Balletshofer B, Weyrich P. Student tutors are able to teach basic sonographic anatomy effectively - a prospective randomized controlled trial. Ultraschall Med. 2012 Apr;33(2):141-5. doi: 10.1055/s-0029-1245837. Epub 2010 Nov 23.
PubMed 21104601Knobe M, Munker R, Sellei RM, Holschen M, Mooij SC, Schmidt-Rohlfing B, Niethard FU, Pape HC. Peer teaching: a randomised controlled trial using student-teachers to teach musculoskeletal ultrasound. Med Educ. 2010 Feb;44(2):148-55. doi: 10.1111/j.1365-2923.2009.03557.x. Epub 2009 Dec 21.
PubMed 20040056Knobe M, Sellei RM, Maus U, Mooij SC, Gradl G, Sopka S, Niethard FU, Pape HC. [Undergraduate curricular training in musculoskeletal ultrasound: the impact of preexisting anatomic knowledge]. Z Orthop Unfall. 2010 Dec;148(6):685-90. doi: 10.1055/s-0030-1250378. Epub 2010 Oct 12. German.
PubMed 20941690Kuhl M, Wagner R, Bauder M, Fenik Y, Riessen R, Lammerding-Koppel M, Gawaz M, Fateh-Moghadam S, Weyrich P, Celebi N. Student tutors for hands-on training in focused emergency echocardiography--a randomized controlled trial. BMC Med Educ. 2012 Oct 29;12:101. doi: 10.1186/1472-6920-12-101.
PubMed 23107588Garcia-Casasola G, Sanchez FJ, Luordo D, Zapata DF, Frias MC, Garrido VV, Martinez JV, de la Sotilla AF, Rojo JM, Macho JT. Basic Abdominal Point-of-Care Ultrasound Training in the Undergraduate: Students as Mentors. J Ultrasound Med. 2016 Nov;35(11):2483-2489. doi: 10.7863/ultra.15.11068. Epub 2016 Oct 13.
PubMed 27738292Ten Cate O, Durning S. Peer teaching in medical education: twelve reasons to move from theory to practice. Med Teach. 2007 Sep;29(6):591-9. doi: 10.1080/01421590701606799.
PubMed 17922354Garcia de Casasola Sanchez G, Gonzalez Peinado D, Sanchez Gollarte A, Munoz Aceituno E, Pena Vazquez I, Torres Macho J. Teaching of clinical ultrasonography to undergraduates: students as mentors. Rev Clin Esp (Barc). 2015 May;215(4):211-6. doi: 10.1016/j.rce.2014.11.023. Epub 2015 Jan 10. English, Spanish.
PubMed 25583252
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Student-centred Learning With Near-peer Tutoring Compared With a Standard Faculty-led Course for Undergraduate Training in Abdominal Ultrasound. A Multicentre Open-label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04114812
- Acronym / sponsor ID
- SIGNATURE / UBern SIGNATURE
- Conditions
- Ultrasonography, Educational Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Ultrasound has become clinical skill widely used in most medical disciplines. Institutions are changing their curricula to implementing basic ultrasound knowledge, often supplementing traditional teaching with 'near-peer' tutoring through classes held by advanced peers. Near-peer tutoring has been found to be both effective and cost-effective.
In Switzerland the most popular course in postgraduate training is a resource-intensive 21-hour basic course for abdominal ultrasound. However, this is expensive, and may not be the best way to impart these skills to undergraduates, who need training more adapted to their needs.
Therefore a 21-hour blended-learning ultrasound course, comprising 5 hours of e-learning and 16 hours of near-peer tutoring has been developped. Students and their near-peer tutors autonomously organize individual practical teaching sessions within a 16 weeks time period.
Methods:
Medical students from second to fourth year at the Universities of Bern, Fribourg and Zurich will be included. Stratified by study site, students will be randomized to one of the two interventions. The blended-learning group will receive e-learning and near-peer tutoring over 16 weeks; the other group will receive 21 hours of teaching, from ultrasound experts, in a 2.5-day course. All participants will undergo a six-station OSCE directly after the course and 6 months later. Students will fill out online questionnaires at baseline, directly after the course and 6 months later. The mean scores of both groups will be compared at six months after the end of both courses. Secondary outcome measures will be students' ultrasound skills immediately after the courses, student satisfaction, multivariate regression exploring factors that affect outcome at 6 months and exploratory subgroup analysis.
Discussion:
This study is designed to compare the current way of ultrasound education in Switzerland with a new blended learning course. It aims to determine whether the blended learning course is as good as, or better than the existing 21-hour standard course. If this is found to be the case, blended learning could help to expand capacity to offer such courses to undergraduate medical students. It would eventually allow undergraduate Swiss medical students to acquire ultrasound skills before starting their residencies. This study also aims at improving the understanding of how to achieve effective student-centred learning supported by near-peer tutoring.
Detailed description
Background:
Over the last decades, ultrasound (US) examination has become commonly used in many medical specialties, including internal medicine and primary care. Young doctors often perform simple ultrasound investigations as residents in internal medicine or primary care especially in emergency care. Currently, 30% of Swiss primary care practices are equipped with an ultrasound machine.
The Swiss Society for Ultrasound in Medicine (SGUM/SSUM) is the accreditation body for ultrasound education in Switzerland. Doctors must obtain a certificate from the SGUM before they can bill ultrasound examinations for insurance payments. However, ultrasound courses are time-intensive (63 hours total, plus a final examination), and are offered in the postgraduate phase, when doctors often have few resources and little time. This may explain why only about half of General Practitioners who use ultrasound have the SGUM certificate. For the half without the certificate, not only can they not bill their ultrasound examination to an insurance company, but also the quality of the examination is less assured, as they have not demonstrated their competence in US skills in the SGUM examination. This may lead to insecurity for the patient and for the performing doctor. There is also a risk that this results in unnecessary examinations.
The SGUM certificate is achieved by passing three courses (basic/advanced/final; 21 hours each) as well as a summative final examination. Between courses, trainees must perform a certain number of US examinations on real patients, under direct and distant supervision. These courses are now being opened to undergraduates, and the 2017 revision of the Swiss learning objectives for medical studies (PROFILES) added basic US skills as mandatory learning goal.
In the past years US training courses at Swiss medical universities were mostly optional, and were quickly overbooked. This shortage of courses could be addressed by using near-peer tutors, which are increasingly used in faculty-organized US classes. Near-peer tutors are "trainees one or more years senior to trainees on the same level of medical education spectrum". Five randomized-controlled trials of ultrasound training have compared near-peer tutoring with faculty-led teaching and assessed students' practical ultrasound skills as a primary outcome measure. Four of these found peer-tutoring to be non-inferior and one found that students in the near-peer-tutoring group slightly underperformed.
Near-peer tutoring in undergraduate US training offers many potential advantages over traditional faculty-based teaching:
- Since mostly reciprocal US is being done by the participating medical students, perfect conditions for learning basic sonographic anatomy can be found. Medical students, in contrast to patients, are mostly slender, healthy and mobile.
- In near-peer tutoring settings, students are more likely to ask questions and participate actively. In addition, having ultrasound skills can help students feel more secure in their basic clinical examination skills.
- Near-peer tutoring relieves pressure on the university by alleviating the increasing teaching demand and by being cost-effective.
- There is evidence that students who work as tutors constantly improve their own skills.
In Autumn 2017, the Institute of Primary Health Care (BIHAM) at the University of Bern set up a working group of 24 US experts from all Swiss universities and of representatives of SGUM sections. The group decided on the "Swiss standard" for basic abdominal ultrasound examination after discussing it at two consensus-building meetings. In Spring 2018, videotapes of SGUM experts demonstrating the ultrasound examination of the various abdominal organs, based on that consensus, were recorded. These videos were integrated into interactive e-learning modules. They have been available to all Swiss medical students since the beginning of 2019.
In parallel, a formal system of training and continuous education for near-peer tutors was put in place by a collaboration of motivated students and faculty staff. Near-peer tutors receive at least 6 days of US training, including teaching on didactic techniques, and afterwards be registered as so-called 'junior-tutors' by SGUM. They must offer at least four hours of US class per semester, but can choose the times and dates. Tutors will be reimbursed for their teaching through course fees paid by course participants.
Methods:
The standard "Basic course in abdominal ultrasound", delivered over 2.5 consecutive days, contains 5 hours of theory and 16 hours of practical training. In contrast, our blended-learning course is more student-centred, in that it expects students to take the initiative to learn the theory from (A) the e-learning developed by the working group, and (B) 16 hours of near-peer tutoring in groups of two to four, at times that are mutually agreeable for tutors and students, without faculty involvement.
The e-learning is made up of five modules starting by an introductory e-learning module on technical basics in ultrasound, followed by four practical modules comprising the abdominal organs. For each of the four practical modules, students start by working through the e-learning module, followed by four hours of individual near-peer tutoring sessions.
Students decide the pace of their 16 hours of training, typically over a four-month period. When a student completes all five e-learning modules and has gathered 16 signatures from the peer-tutored classes, they can apply to take a summative final examination. If they pass the Objective Structured Clinical Examination (OSCE) validated by Hofer et al. (2011) and adapted to Swiss needs, they are accredited by SGUM, according to Swiss national accreditation guidelines, for the "Basic course in abdominal ultrasound" - the first of the three ultrasound courses within the SGUM curriculum.
The OSCE will be assessed twice for every participant. Once at the end of the course and once 6 months after the end of the course. The second OSCE will be the primary outcome, since it evaluates long-term retention of acquired US knowledge. Every student will be tested by six different examiners in each OSCE. Differences in difficulty of the four series of OSCE stations as well as difficulty of every station will be taken into account in the statistical analysis.
The blended-learning course offers several other advantages by implementing modern didactics: by distributing teaching sessions over 16 weeks instead of just 2.5 consecutive days, students benefit from "spaced repetition" which improves long term retention. In our programme, students can decide which session to choose next, and tutors and students arrange the teaching sessions according to their availability and needs, so learning is student-centred. These factors differentiate our study from the near-peer tutoring in ultrasound education reported in some studies, in which tutors engage in scheduled courses organized by university faculty.
Between randomization and the end of the training (t = 16 weeks), students will be instructed not to undergo any additional training (e-learning, practical sessions or other) other than those provided within the intervention. Additional training will be recorded directly after the end of the training by questionnaire and by going through e-learning logs. During the 6-month follow-up period, students in both groups will be equally encouraged to continue self-organised training and both will be granted access to ultrasound machines.
Adjusting to local curricula we will primarily recruit students in semester 7 in Bern (total medical student intake per year = 220) and in semester 6 in Zurich (240) and Fribourg (120). At each site, we will present the programme during a plenary session, assisted by our local co-investigators.
To avoid systematic differences in additional training during the follow-up period, the following rules will put in place:
- Students will only be told their test results from the first test after the end of the study
- Test performance in the follow-up test will have no effect on the accreditation
To reduce loss to follow-up, we will:
- Require all students who apply for the programme to sign a separate form confirming their availability and intention to complete the course and the examinations
- Reimburse participants 50.- CHF after they have taken the second OSCE.
- Reimburse travel costs for the second OSCE
- Hand out the test result and the course certificate only after the second OSCE
Students' motivation for ultrasound training is very high. The optional courses at Swiss universities are typically overbooked within minutes and many students are disappointed that they are unable to take part. Our study will give students the opportunity to get a certificate accredited by the SGUM for a course fee of 200.- CHF, regardless of the intervention they are assigned to. Postgraduate training for the same degree costs around 1200.- CHF.
We will use centralized computed randomization in blocks of 4 to allocate each of the participants to one of the two study arms, with allocation in a 1:1 ratio, stratified by study site. The reason for block randomisation is the requirement of the control group to comprise of exactly 24 or 28 students due to the maximum group size of 4 students per tutor. The randomization will be performed by a blinded external partner (Clinical Trials Unit in Bern).
Outcome assessors will be experienced sonographers who have not taught course participants of either group.
To ensure high interrater-reliability, faculty training for all assessors will be held immediately before the OSCE. In the first part of this training, the assessors discuss key aspects of the rating using videotaped examples of OSCE stations to achieve a common standard. At the end of the training, assessors will rate another video example, where the interrater-reliability will be assessed.
OSCE assessors will be blinded to group allocation. The assessments will be at the same time for each group. We will instruct students not to reveal their group allocation to the OSCE assessors.
Sample size calculation has been done as follows: Based on a pilot with 20 students we expect a mean score of 33/50 points per station with a standard deviation (SD) of 4 points. The study was powered for non-inferiority using a margin of a -1.5 points for the difference in mean OSCE scores between the intervention and control group in the practical exam at 6 months (primary outcome). 1.5 points difference would correspond to an effect size of 0.375 standard deviations (SD), which we would still consider as non-inferior. We calculated the sample size with the assumption that the intervention group will perform somewhat better (+0.5 in mean score) than the control group based on test results from previous pilots. We chose a 1-sided alpha-error of 0.05 and a power of 90% (138 participants). Allowing for a 9% dropout rate we decided to include 152 students.
Discussion:
If the new blended-learning format is shown to be at least as good as the existing standard course, we could quickly expand our capacity to offer such courses to undergraduate medical students, replacing resource-intensive faculty-led courses with peer-assisted learning programmes. This will eventually allow all undergraduate students to acquire ultrasound skills that will help them in their residencies. The national accreditation body fully supports this near-peer-tutoring-based course both financially and through full accreditation of a pilot project and has committed to continue its support if we find that this teaching format produces results that are just as good as, or better than, the usual faculty-led courses. Learning more about the advantages conferred by student-centred learning through near-peer teaching will enable us to design better peer-assisted learning programmes and to design new, similar programmes in other areas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will include 152 medical students at the Universities of Bern, Fribourg and Zurich. Stratified by study site, students will be randomized to one of the two interventions. The blended-learning group will receive e-learning and near-peer tutoring over 16 weeks; the other group will receive 21 hours of teaching, from ultrasound experts, in a 2.5-day course.
| Arm | Type | Receives |
|---|---|---|
| Blended learning | Experimental | Other: Blended learningParticipants in the blended learning group will be taught abdominal ultrasound by an e-learning platform and practical near-peer tutoring classes over 16 weeks, summing up to 5 hours of e-learning and 16 hours of near-peer tutoring classes. |
| Standard course | Active comparator | Other: Standard courseParticipants in the standard course or control group will participate in a 2.5-day course in abdominal ultrasound, comprising 5 hours of lectures and 16 hours of ultrasound training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medical students at three Swiss universities (Bern, Freiburg, Zurich) in the 3rd to 8th semester, who:
- are willing to participate in the study;
- are willing to pay the 200.- CHF course fees (partial reimbursement of tutors and administrative fee for the SGUM course certificate)
- fill out a baseline questionnaire
- signed informed consent sheet
Key exclusion criteria (3 listed)
- Did not sign study agreement or pay the course fee
- More than 5 hours of previous formal ultrasound training
- Failure to fill out baseline questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended learningIn the intervention group, students will be given access to an e-learning platform that contains five e-learning modules. They will attend individual small group tutoring sessions, with a maximum of 4 students per group. They will be able to book these sessions at a dedicated web platform. They will have 16 weeks in which to complete the 5 e-learning modules and 16 hours of practical training. Progress will be monitored and supported by regular follow-up messages and calls by the study team. Students must hand in the logbook with tutors' signatures when they enter the exam. All students within the blended learning group that completed 5 hours of e-learning as well as 16 hours of peer-tutoring and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study. | Other | Blended learning |
| Standard courseIn the standard course or control group, students will participate in a 2.5-day course in abdominal ultrasound, comprising 5 hours of lectures and 16 hours of ultrasound training in small groups, with a maximum of 4 students per group. The course will be held in an ultrasound training centre in Bern. All students within the standard course group that participated in the whole 2.5 day course and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study. | Other | Standard course |
Primary outcome
Mean participants' "Swiss Students' Ultrasound Skills Assessment" scores six months after the end of their courses (OSCE 2).
Time frame: 10 months from enrollment at each site
The investigators will assess the participants' ultrasound skills using the "Swiss Students' Ultrasound Skills Assessment". This uses a validated OSCE form (Hofer et al. 2011), which has been adapted to specific Swiss needs and revalidated. The total score can range from 0-300 points, a higher total representing a better performance. The OSCE assesses handling of the probe, explanation of the ultrasound image, examination skills and theoretical knowledge. Each station will assess a key topic that arises in both courses.
4 secondary outcomes
Mean participants' "Swiss Students' Ultrasound Skills Assessment" scores immediately after the end of their courses (OSCE 1).
Time frame: 16 weeks from enrollment at each site
Change in mean participants' "Swiss Students' Ultrasound Skills Assessment" scores (knowledge retention).
Time frame: 10 months from enrollment at each site
Participants' satisfaction with allocated courses
Time frame: 16 weeks from enrollment at each site
Multivariate regression exploring factors that affect outcome at six months after the end of their courses
Time frame: 10 months after enrollment at each site
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Background: PubMed 30215979Bornemann P, Barreto T. Point-of-Care Ultrasonography in Family Medicine. Am Fam Physician. 2018 Aug 15;98(4):200-202. No abstract available.
- Background: PubMed 28442101Ultrasound Guidelines: Emergency, Point-of-Care and Clinical Ultrasound Guidelines in Medicine. Ann Emerg Med. 2017 May;69(5):e27-e54. doi: 10.1016/j.annemergmed.2016.08.457. No abstract available.
- Background: PubMed 28497416Ma IWY, Arishenkoff S, Wiseman J, Desy J, Ailon J, Martin L, Otremba M, Halman S, Willemot P, Blouw M; Canadian Internal Medicine Ultrasound (CIMUS) Group*. Internal Medicine Point-of-Care Ultrasound Curriculum: Consensus Recommendations from the Canadian Internal Medicine Ultrasound (CIMUS) Group. J Gen Intern Med. 2017 Sep;32(9):1052-1057. doi: 10.1007/s11606-017-4071-5. Epub 2017 May 11.
- Background: PubMed 28627842Rikley E, Boillat-Blanco N, Meuwly JY, Breuss E, Senn N. [Ultrasonography : an useful diagnostic tool for the general practitioner]. Rev Med Suisse. 2017 Mai 10;13(562):990-994. French.
- Background: PubMed 26589313Hoppmann RA, Rao VV, Bell F, Poston MB, Howe DB, Riffle S, Harris S, Riley R, McMahon C, Wilson LB, Blanck E, Richeson NA, Thomas LK, Hartman C, Neuffer FH, Keisler BD, Sims KM, Garber MD, Shuler CO, Blaivas M, Chillag SA, Wagner M, Barron K, Davis D, Wells JR, Kenney DJ, Hall JW, Bornemann PH, Schrift D, Hunt PS, Owens WB, Smith RS, Jackson AG, Hagon K, Wilson SP, Fowler SD, Catroppo JF, Rizvi AA, Powell CK, Cook T, Brown E, Navarro FA, Thornhill J, Burgis J, Jennings WR, McCallum JB, Nottingham JM, Kreiner J, Haddad R, Augustine JR, Pedigo NW, Catalana PV. The evolution of an integrated ultrasound curriculum (iUSC) for medical students: 9-year experience. Crit Ultrasound J. 2015 Dec;7(1):18. doi: 10.1186/s13089-015-0035-3. Epub 2015 Nov 21.
- Background: PubMed 16508866Education and Practical Standards Committee, European Federation of Societies for Ultrasound in Medicine and Biology. Minimum training recommendations for the practice of medical ultrasound. Ultraschall Med. 2006 Feb;27(1):79-105. doi: 10.1055/s-2006-933605. No abstract available.
- Background: PubMed 29490531Wakefield RJ, Weerasinghe A, Tung P, Smith L, Pickering J, Msimanga T, Arora M, Flood K, Gupta P, Bickerdike S, McLaughlan J, Uttley A, Wilson J, Evans T, Wolstenhulme S, Roberts TE. The development of a pragmatic, clinically driven ultrasound curriculum in a UK medical school. Med Teach. 2018 Jun;40(6):600-606. doi: 10.1080/0142159X.2018.1439579. Epub 2018 Feb 28.
- Background: PubMed 17922356Bulte C, Betts A, Garner K, Durning S. Student teaching: views of student near-peer teachers and learners. Med Teach. 2007 Sep;29(6):583-90. doi: 10.1080/01421590701583824.
- Background: PubMed 21104601Celebi N, Zwirner K, Lischner U, Bauder M, Ditthard K, Schurger S, Riessen R, Engel C, Balletshofer B, Weyrich P. Student tutors are able to teach basic sonographic anatomy effectively - a prospective randomized controlled trial. Ultraschall Med. 2012 Apr;33(2):141-5. doi: 10.1055/s-0029-1245837. Epub 2010 Nov 23.
- Background: PubMed 20040056Knobe M, Munker R, Sellei RM, Holschen M, Mooij SC, Schmidt-Rohlfing B, Niethard FU, Pape HC. Peer teaching: a randomised controlled trial using student-teachers to teach musculoskeletal ultrasound. Med Educ. 2010 Feb;44(2):148-55. doi: 10.1111/j.1365-2923.2009.03557.x. Epub 2009 Dec 21.
- Background: PubMed 20941690Knobe M, Sellei RM, Maus U, Mooij SC, Gradl G, Sopka S, Niethard FU, Pape HC. [Undergraduate curricular training in musculoskeletal ultrasound: the impact of preexisting anatomic knowledge]. Z Orthop Unfall. 2010 Dec;148(6):685-90. doi: 10.1055/s-0030-1250378. Epub 2010 Oct 12. German.
- Background: PubMed 23107588Kuhl M, Wagner R, Bauder M, Fenik Y, Riessen R, Lammerding-Koppel M, Gawaz M, Fateh-Moghadam S, Weyrich P, Celebi N. Student tutors for hands-on training in focused emergency echocardiography--a randomized controlled trial. BMC Med Educ. 2012 Oct 29;12:101. doi: 10.1186/1472-6920-12-101.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Hari, MD principal investigator
University of Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blended learning and Standard course in people with Ultrasonography and Educational Techniques, run by University of Bern at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean participants' "Swiss Students' Ultrasound Skills Assessment" scores six months after the end of their courses (OSCE 2). (time frame: 10 months from enrollment at each site). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114812, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.