Valvular Heart DiseaseNCT05895799
Whole-task Hybrid Simulation Improves Medical Student Competence in Cardiology Clerkship
A study testing Tuition from a expert clinical trainer in people with Valvular Heart Disease, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
The goal of this randomized controlled waitlist trial is to assess the utility of expert tuition with hybrid simulation and repeated peer grading on medical student learning and performance in cardiology long-case examinations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Tuition from a expert clinical trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2021to 6 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- were in either Year 2 of the Graduate Entry Medicine (GEM) program (equivalent to Year 3/5 of the Direct Entry Medical Degree Programme), or Year 1 of the Senior Cycle, i.e., Year 4/5 of the Direct Entry Medical Degree Programme, having completed Year 2 of the GEM program in the preceding year; and
- had successfully completed the standard RCSI module in Clinical Cardiology.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Utility of Hybrid Simulation With Wearable Technology and Repeated Peer Assessment on Medical Student Learning and Performance in Cardiology Long Case Examinations - the ASSIMILATE ExCELLENCE Study
The goal of this randomized controlled waitlist trial is to assess the utility of expert tuition with hybrid simulation and repeated peer grading on medical student learning and performance in cardiology long-case examinations. The primary aim of this research is to assess the effects of time, individual teaching with an expert trainer, and repeated peer assessment on students' performance scores in sequential formative long-case examinations in cardiology. The secondary aims are: (a) to assess to what degree performance scores change over time with respect to the intervention group, and (b) to assess for any change in the level of inter-observer variability over time.
Participants will be randomized into two groups and undertake three formative long-case examinations in cardiology with a hybrid patient. Each group will have tuition from an expert trainer in a randomized controlled waitlist design. The investigators will compare groups to see if the tuition from a clinical expert has an effect on participants' performance.
Read the detailed description
The long case examination in medicine is regarded as an authentic test of clinical competence; however, it has been shown to have low reliability and validity due to the variability in the patients used and subjective examiner grading. In this study, the investigators hypothesized that expert tuition with hybrid simulation using a standardized patient wearing a novel auscultation vest, i.e., a hybrid patient, and repeated peer grading would improve student learning and performance in sequential cardiology long case examinations. Furthermore, they hypothesized that the format's validity would improve through the use of less subjective quantitative scoring checklists.
Scripted histories and scoring checklists for three clinical scenarios in cardiology were co-created and refined through iterative consensus by a panel of clinical experts; these were then paired with recordings of auscultatory findings from three real patients with known valvular heart disease. A wearable vest with embedded pressure-sensitive panel speakers was developed to transmit these recordings when examined at the anatomically standard auscultation points. Students in the Graduate Entry Medicine degree program at RCSI were invited to enroll in the study and undertake a series of three long case examinations in cardiology (LC1 - LC3) using hybrid simulation. Each participant's performance was recorded and graded using the novel scoring checklist by two peer participants and two RCSI examiners. In addition, participants were randomized into two groups: Group 1 received individual and small-group teaching with a hybrid patient from an expert trainer between LC1 and LC2; those in Group 2 received the same intervention between LC2 and LC3 (a randomized controlled waitlist design). Participants completed a pre- and post-study questionnaire. Data are presented as number (%), mean ± standard deviation, or median (interquartile range). Group comparisons were made using either the unpaired t-test or the chi-squared (χ2) test. A p-value < .05 was considered statistically significant. Multivariate analysis was undertaken using general linear mixed modeling and multiple logistic regression. Inter-observer variability was assessed using the Intraclass Correlation Coefficient (ICC).
- Conditions
- Valvular Heart Disease
- Being tested
- Tuition from a expert clinical trainer
- Keywords
- Hybrid simulation, Cardiology clerkship, Peer assessment, Whole-task learning, Standardized patient, Wearable technology
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuition from a expert clinical trainerOther
Each group was initially provided with an online tutorial on the complete physical examination of the cardiovascular system as performed on a standardized patient by the trainer. At the beginning of each session, the trainer performed the examination on a hybrid patient wearing the auscultation vest and provided additional teaching, explanations, and rationale. Following the demonstration, each participant was invited to perform repeated physical examinations in front of their peers with real-time one-to-one feedback from the trainer. After each performance, the participant was encouraged to critique their own performance(s), peers were invited to provide some insights, and the trainer gave some overall feedback. At the end of the session and after each participant had had the opportunity to perform the complete examination at least once, the participants were taken through a range of abnormal signs using the auscultation vest with explanations provided by the trainer.
| Study group | Role | What they receive |
|---|---|---|
| Clinical teaching from an expert after LC1 | Active comparator | Medical students who had early intervention, i.e. teaching from an expert trainer, in the randomized controlled waitlist design. Receives: Other: Tuition from a expert clinical trainer |
| Clinical teaching from an expert after LC2 | Active comparator | Medical students who had a late intervention, i.e. teaching from an expert trainer, in the randomized controlled waitlist design. Receives: Other: Tuition from a expert clinical trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' total scores in sequential cardiology long case examinations
To assess the effects of time, individual teaching with an expert trainer, and repeated peer assessment on students' performance scores in sequential formative long case examinations in cardiology.
Students will undertake three long case examinations. Each participant's total score in each examination will be compared across time.
Measured: Within 6 months of study completion
Secondary outcomes (2)
Students' total scores categorized by intervention group in sequential cardiology long case examinations
To assess to what degree performance scores changed over time with respect to intervention group.
Measured: Within 6 months of study completion
Variability in students' performance scores in sequential cardiology long case examinations as assessed by peer and faculty graders
Each long case examination will be assessed by two peers and two faculty graders. To assess inter-observer variability over time using Intraclass Correlation Coefficients.
Measured: Within 6 months of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jan 2021
- Primary completion30 Nov 2021
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies 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
- Crossover
- Model description
- Randomized controlled waitlist design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Connolly Hospital Blanchardstown
- Responsible party
- Sponsor
- Investigators
- Claire Condron, PhD, Study director, RCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895799
- Sponsor's protocol ID
- AE280780
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daly M, Mulhall C, O'Neill J, Eppich W, Shpigelman J, Cahir C, Fraughen D, McElduff E, Uhomoibhi C, Condron C. Effectiveness of hybrid simulation training on medical student performance in whole-task consultation of cardiac patients: The ASSIMILATE EXCELLENCE randomized waitlist-controlled trial. Adv Simul (Lond). 2024 Oct 1;9(1):40. doi: 10.1186/s41077-024-00314-2.
PubMed 39354536
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Hybrid Simulation With Wearable Technology and Repeated Peer Assessment on Medical Student Learning and Performance in Cardiology Long Case Examinations - the ASSIMILATE ExCELLENCE Study
- ClinicalTrials.gov ID
- NCT05895799
- Acronym / sponsor ID
- AE280780
- Conditions
- Valvular Heart Disease
- Keywords
- Hybrid simulation, Cardiology clerkship, Peer assessment, Whole-task learning, Standardized patient, Wearable technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Connolly Hospital Blanchardstown
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 9 Jun 2023 (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.
The goal of this randomized controlled waitlist trial is to assess the utility of expert tuition with hybrid simulation and repeated peer grading on medical student learning and performance in cardiology long-case examinations. The primary aim of this research is to assess the effects of time, individual teaching with an expert trainer, and repeated peer assessment on students' performance scores in sequential formative long-case examinations in cardiology. The secondary aims are: (a) to assess to what degree performance scores change over time with respect to the intervention group, and (b) to assess for any change in the level of inter-observer variability over time.
Participants will be randomized into two groups and undertake three formative long-case examinations in cardiology with a hybrid patient. Each group will have tuition from an expert trainer in a randomized controlled waitlist design. The investigators will compare groups to see if the tuition from a clinical expert has an effect on participants' performance.
Detailed description
The long case examination in medicine is regarded as an authentic test of clinical competence; however, it has been shown to have low reliability and validity due to the variability in the patients used and subjective examiner grading. In this study, the investigators hypothesized that expert tuition with hybrid simulation using a standardized patient wearing a novel auscultation vest, i.e., a hybrid patient, and repeated peer grading would improve student learning and performance in sequential cardiology long case examinations. Furthermore, they hypothesized that the format's validity would improve through the use of less subjective quantitative scoring checklists.
Scripted histories and scoring checklists for three clinical scenarios in cardiology were co-created and refined through iterative consensus by a panel of clinical experts; these were then paired with recordings of auscultatory findings from three real patients with known valvular heart disease. A wearable vest with embedded pressure-sensitive panel speakers was developed to transmit these recordings when examined at the anatomically standard auscultation points. Students in the Graduate Entry Medicine degree program at RCSI were invited to enroll in the study and undertake a series of three long case examinations in cardiology (LC1 - LC3) using hybrid simulation. Each participant's performance was recorded and graded using the novel scoring checklist by two peer participants and two RCSI examiners. In addition, participants were randomized into two groups: Group 1 received individual and small-group teaching with a hybrid patient from an expert trainer between LC1 and LC2; those in Group 2 received the same intervention between LC2 and LC3 (a randomized controlled waitlist design). Participants completed a pre- and post-study questionnaire. Data are presented as number (%), mean ± standard deviation, or median (interquartile range). Group comparisons were made using either the unpaired t-test or the chi-squared (χ2) test. A p-value < .05 was considered statistically significant. Multivariate analysis was undertaken using general linear mixed modeling and multiple logistic regression. Inter-observer variability was assessed using the Intraclass Correlation Coefficient (ICC).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled waitlist design
| Arm | Type | Receives |
|---|---|---|
| Clinical teaching from an expert after LC1 | Active comparator | Other: Tuition from a expert clinical trainerMedical students who had early intervention, i.e. teaching from an expert trainer, in the randomized controlled waitlist design. |
| Clinical teaching from an expert after LC2 | Active comparator | Other: Tuition from a expert clinical trainerMedical students who had a late intervention, i.e. teaching from an expert trainer, in the randomized controlled waitlist design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- were in either Year 2 of the Graduate Entry Medicine (GEM) program (equivalent to Year 3/5 of the Direct Entry Medical Degree Programme), or Year 1 of the Senior Cycle, i.e., Year 4/5 of the Direct Entry Medical Degree Programme, having completed Year 2 of the GEM program in the preceding year; and
- had successfully completed the standard RCSI module in Clinical Cardiology.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Tuition from a expert clinical trainerEach group was initially provided with an online tutorial on the complete physical examination of the cardiovascular system as performed on a standardized patient by the trainer. At the beginning of each session, the trainer performed the examination on a hybrid patient wearing the auscultation vest and provided additional teaching, explanations, and rationale. Following the demonstration, each participant was invited to perform repeated physical examinations in front of their peers with real-time one-to-one feedback from the trainer. After each performance, the participant was encouraged to critique their own performance(s), peers were invited to provide some insights, and the trainer gave some overall feedback. At the end of the session and after each participant had had the opportunity to perform the complete examination at least once, the participants were taken through a range of abnormal signs using the auscultation vest with explanations provided by the trainer. | Other | Clinical teaching from an expert after LC1, Clinical teaching from an expert after LC2 |
Primary outcome
Students' total scores in sequential cardiology long case examinations
Time frame: Within 6 months of study completion
To assess the effects of time, individual teaching with an expert trainer, and repeated peer assessment on students' performance scores in sequential formative long case examinations in cardiology. Students will undertake three long case examinations. Each participant's total score in each examination will be compared across time.
2 secondary outcomes
Students' total scores categorized by intervention group in sequential cardiology long case examinations
Time frame: Within 6 months of study completion
Variability in students' performance scores in sequential cardiology long case examinations as assessed by peer and faculty graders
Time frame: Within 6 months of study completion
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 9 Jun 2023.
- Derived from this study: PubMed 39354536Daly M, Mulhall C, O'Neill J, Eppich W, Shpigelman J, Cahir C, Fraughen D, McElduff E, Uhomoibhi C, Condron C. Effectiveness of hybrid simulation training on medical student performance in whole-task consultation of cardiac patients: The ASSIMILATE EXCELLENCE randomized waitlist-controlled trial. Adv Simul (Lond). 2024 Oct 1;9(1):40. doi: 10.1186/s41077-024-00314-2.
- 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.
Claire Condron, PhD study director
RCSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuition from a expert clinical trainer in people with Valvular Heart Disease, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 2 inclusion and 1 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Students' total scores in sequential cardiology long case examinations (time frame: Within 6 months of study completion). 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 NCT05895799, which also lists 1 linked publication.
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 9 Jun 2023.