Education, MedicalNCT03650959
Optimizing Resource Utilization During Proficiency-based Training of Suturing Skills to Medical Students
A study testing Method of learning simple interrupted sutures with instrument tie in people with Education, Medical and Sutures, run by Queen's University at 1 site in Canada.
Trial summary
Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Sutures
- What is being tested?
- Method of learning simple interrupted sutures with instrument tie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2018to 16 Jun 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Second year, pre-clerkship medical students
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Resource Utilization During Proficiency-Based Training of Suturing Skills to Medical Students: a Randomized Controlled Trial of Faculty-Led, Peer Tutor-Led, and Computer Augmented Methods of Teaching
Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. One method has yet to be identified as superior in terms of educational outcomes, resource utilization, and participant perspectives.
Pre-clerkship medical students were randomized to: faculty, peer tutor, or computer augmented learning. Participants practiced suturing through their randomized method until they reached targeted proficiency defined using hand motion analysis (HMA). Proficiency was defined as a score of the average plus a standard deviation of five surgeons' HMA for two of three consecutive sutures using appropriate technique.
The primary outcome was the number of stitches placed to achieve proficiency. The secondary outcomes were the number of sutures used, time, and costs incurred. Learning curves were constructed. Participants' perceptions were assessed using a follow-up survey.
- Conditions
- Education, Medical, Sutures
- Being tested
- Method of learning simple interrupted sutures with instrument tie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Method of learning simple interrupted sutures with instrument tieOther
Students will train to proficiency (defined by hand motion analysis) on simple interrupted sutures with an instrument tie via one of three different methods: faculty-led, peer tutor-led, or computer augmented self-directed learning.
| Study group | Role | What they receive |
|---|---|---|
| Faculty-led | Experimental | Not described Receives: Other: Method of learning simple interrupted sutures with instrument tie |
| Peer tutor-led | Experimental | Not described Receives: Other: Method of learning simple interrupted sutures with instrument tie |
| Computer augmented self-directed learning | Experimental | Not described Receives: Other: Method of learning simple interrupted sutures with instrument tie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stitched laid to reach proficiency
Measured: Five days
Secondary outcomes (3)
Number of sutures used to reach proficiency
Measured: Five days
Minutes to reach proficiency
Measured: Five days
Individual costs to reach proficiency
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start4 Jun 2018
- Primary completion16 Jun 2019
- Study completion16 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boris Zevin, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650959
- Sponsor's protocol ID
- SURG-422-18
- Status last verified
- Aug 2018
- First submitted
- 27 Aug 2018
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Resource Utilization During Proficiency-Based Training of Suturing Skills to Medical Students: a Randomized Controlled Trial of Faculty-Led, Peer Tutor-Led, and Computer Augmented Methods of Teaching
- ClinicalTrials.gov ID
- NCT03650959
- Acronym / sponsor ID
- SURG-422-18
- Conditions
- Education, Medical, Sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 16 Jun 2019 (actual)
- First posted
- 29 Aug 2018 (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.
Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. One method has yet to be identified as superior in terms of educational outcomes, resource utilization, and participant perspectives.
Pre-clerkship medical students were randomized to: faculty, peer tutor, or computer augmented learning. Participants practiced suturing through their randomized method until they reached targeted proficiency defined using hand motion analysis (HMA). Proficiency was defined as a score of the average plus a standard deviation of five surgeons' HMA for two of three consecutive sutures using appropriate technique.
The primary outcome was the number of stitches placed to achieve proficiency. The secondary outcomes were the number of sutures used, time, and costs incurred. Learning curves were constructed. Participants' perceptions were assessed using a follow-up survey.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Faculty-led | Experimental | Other: Method of learning simple interrupted sutures with instrument tie |
| Peer tutor-led | Experimental | Other: Method of learning simple interrupted sutures with instrument tie |
| Computer augmented self-directed learning | Experimental | Other: Method of learning simple interrupted sutures with instrument tie |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Second year, pre-clerkship medical students
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 |
|---|---|---|
| Method of learning simple interrupted sutures with instrument tieStudents will train to proficiency (defined by hand motion analysis) on simple interrupted sutures with an instrument tie via one of three different methods: faculty-led, peer tutor-led, or computer augmented self-directed learning. | Other | Computer augmented self-directed learning, Faculty-led, Peer tutor-led |
Primary outcome
Number of stitched laid to reach proficiency
Time frame: Five days
3 secondary outcomes
Number of sutures used to reach proficiency
Time frame: Five days
Minutes to reach proficiency
Time frame: Five days
Individual costs to reach proficiency
Time frame: Five days
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 27 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Method of learning simple interrupted sutures with instrument tie in people with Education, Medical and Sutures, run by Queen's University at 1 site in Canada.
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 1 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 27 Sep 2024. 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 Canada. 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?
Number of stitched laid to reach proficiency (time frame: Five days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024.