Educational ProblemsNCT03050281
Simulation and Cadaver Workshop for Medical Students
A study testing Simulation/Cadaver lab and Lectures in people with Educational Problems, run by Mayo Clinic at 1 site in United States.
Trial summary
Background: The use of simulation and cadaveric laboratory training are highly beneficial for faculty and advanced trainees, but its usefulness for third-year medical students rotating through OB-GYN or general surgery is unknown. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Simulation/Cadaver lab and Lectures
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Jul 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
- All medical students in 2nd year
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility, Feasibility, and Cost-effectiveness of Using a Combined Cadaver and Simulation Laboratory Experience During the OB-GYN and Surgical Medical School Clerkships
Background: The use of simulation and cadaveric laboratory training are highly beneficial for faculty and advanced trainees, but its usefulness for third-year medical students rotating through OB-GYN or general surgery is unknown.
Objective: To determine if a two-day intensive, cost-effective review of procedural skills and anatomy using the simulation laboratory and cadaver-based dissection improves performance of third-year medical students on the National Board of Medical Examiners (NBME) Shelf and USMLE Step 2 board examination and during pre- and post-test demonstrations.
Read more
Significance: If proven effective, implementation of a short, inexpensive, and comprehensive course highlighting anatomical and procedural skills during the third year of medical school could be implemented.
Design Methods: The investigators will conduct a 1:1 randomization of third-year medical students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students will either participate in traditional education (N=20) as is currently taking place or traditional education plus cadaver-based/simulation-based learning (N=20). Third-year medical students rotating in OB-GYN or surgery will be eligible to enroll.
Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes will be improved and procedural skills and overall satisfaction will be increased.
Read the detailed description
The primary goals of the final two years of medical school are to provide an experience that develops the fundamental clinical skills necessary to succeed as a resident and to offer opportunities for medical students to explore career interests. Largely unchanged for many years, the final two years of medical school include a series of required third year clerkships that include obstetrics and gynecology (OB-GYN) and general surgery. Following the completion of the third year, many students may have already decided on a specialty, and thus use the final year for electives and rotations that hone their skills and prepare them for residency. For those students planning for a procedural-based career such as OB-GYN or surgery, a considerable amount of time may be spent learning advanced surgical techniques, such as knot-tying, suturing, or other such procedures. In addition to traditional learning through didactic experiences, texts, and 'hands-on' patient interaction, some programs have developed supplemental curricula using simulators and cadaveric dissection. While studies demonstrate that these methods enhance students' readiness for procedural-based residencies, these studies have only focused on surgical residents or select fourth-year medical students who have a specific interest in surgery.
No study has focused on a comprehensive, streamlined approach using these supplemental techniques for third-year medical students. A standardized curriculum using simulation and cadaveric laboratories in the third year may provide students with the necessary skills to succeed in their required OB-GYN and surgical clerkships, while hopefully improving their examination scores and overall experience. The investigators intend to utilize a 'hands-on' series of laboratory experiences using the simulation center and cadavers to enhance the traditional learning structure. The investigators believe that a two-day course design would provide the necessary information and experience without the use of excessive resources.
Typically, work using cadavers is relegated to the study of gross human anatomy in the first year of medical school. Students experience an in-depth review of human anatomy, while learning the basic skills for dissection. After the completion of this introductory course, few medical schools routinely use cadavers or a simulation laboratory, despite the well-documented benefits for advanced learners. The usefulness of such an experience was well demonstrated in a pilot study performed by Morgan et al, which provided an intensive 78-hour (4-week) multifaceted curriculum designed for fourth year medical students prior to entering an OB-GYN residency. The course included didactic lectures, simulation training, cadaver dissection, a knot and suture experience, and surgical procedures performed on cadavers and simulation equipment. The authors concluded that despite being time-consuming and expensive, students significantly enhanced surgical skills and readiness to begin residency. Similar results have also been demonstrated in courses focused on suturing, knot-tying, and procedure-based techniques for select fourth year students entering a surgical residency program; the intent of these courses was to enhance the necessary skills to achieve appropriate required milestones. While these elective rotation pilot programs were successful in achieving their primary outcome, the drawbacks were that they were performed in fourth year students only, relegated to a select few entering surgical fields, and were costly and time-consuming.
Accordingly, the primary goal is to utilize a comprehensive, streamlined, and cost-effective approach using simulation and cadaver experiences for all eligible third-year medical students. The investigators believe that this experience will enhance scores on the Shelf and USMLE examination and improve procedural skills and overall satisfaction while remaining inexpensive and efficient. To achieve this goal, this course will be offered while students are completing their OB-GYN or general surgery rotations, both of which are heavily procedure-based and require a similar skill set. This combined effort will also allow this course to be performed six times per year instead of up to 12 times per year, which will lower costs and lessen faculty workload. If this study proves to be successful, the hope is that this curriculum could be implemented at other medical schools. The study design is also unique because the investigators will be recruiting a large student population from a national medical school instead of having students serve as their own controls in a single-center experience. The students in this study will be randomized into one of two groups: a traditional learning experience or a traditional learning experience that also includes supplemental cadaver-based and simulation-based learning.
The primary focus of this study is to determine whether the use of a comprehensive, combined, and simplified approach of using cadavers and simulation laboratories to train third-year medical students will have a beneficial effect on student performance in the OB-GYN and surgical clerkships.
Aim 1: To determine if the combined use of a 'hands-on' cadaver and simulation laboratory course will improve performance, NBME Shelf and USMLE Step 2 examination scores, and the overall experience during the third year OB-GYN and surgical clerkships.
Aim 2: To assess whether this experience can be accomplished in an efficient, cost-effective manner that would make it generalizable to other medical school curricula.
- Conditions
- Educational Problems
- Being tested
- Simulation/Cadaver lab, Lectures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation/Cadaver labOther
The primary focus of this study is to determine whether the use of a comprehensive, combined, and simplified approach of using cadavers and simulation laboratories to train third-year medical students will have a beneficial effect on student performance in the OB-GYN and surgical clerkships.
LecturesOther
Standard Anatomy lectures were offered.
| Study group | Role | What they receive |
|---|---|---|
| Simulation/Cadaver Workshop | Experimental | 2-day workshop using the Simulation/Cadaver Lab Receives: Other: Simulation/Cadaver lab |
| Didactic Workshop | Placebo comparator | Lectures Receives: Other: Lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean shelf exam scores
A "shelf" exam is an exam that some medical schools purchase from the NBME that test materials presented in the third-year clerkships. For this study the rotation scores examined were for obstetrics and gynecology, and surgery.
Measured: 1 year
Secondary outcomes (1)
Mean grade on rotation evaluation
The rotation evaluation is a subjective grade by the course professor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startApr 2016
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Shapiro, Mayo Clinic
- Investigators
- Brian P Shapiro, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050281
- Sponsor's protocol ID
- 16-003385
- Status last verified
- Oct 2019
- First submitted
- 4 Nov 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility, Feasibility, and Cost-effectiveness of Using a Combined Cadaver and Simulation Laboratory Experience During the OB-GYN and Surgical Medical School Clerkships
- ClinicalTrials.gov ID
- NCT03050281
- Acronym / sponsor ID
- 16-003385
- Conditions
- Educational Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 10 Feb 2017 (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: The use of simulation and cadaveric laboratory training are highly beneficial for faculty and advanced trainees, but its usefulness for third-year medical students rotating through OB-GYN or general surgery is unknown.
Objective: To determine if a two-day intensive, cost-effective review of procedural skills and anatomy using the simulation laboratory and cadaver-based dissection improves performance of third-year medical students on the National Board of Medical Examiners (NBME) Shelf and USMLE Step 2 board examination and during pre- and post-test demonstrations.
Significance: If proven effective, implementation of a short, inexpensive, and comprehensive course highlighting anatomical and procedural skills during the third year of medical school could be implemented.
Design Methods: The investigators will conduct a 1:1 randomization of third-year medical students rotating at all Mayo sites (Jacksonville, Rochester, and Scottsdale). The students will either participate in traditional education (N=20) as is currently taking place or traditional education plus cadaver-based/simulation-based learning (N=20). Third-year medical students rotating in OB-GYN or surgery will be eligible to enroll.
Anticipated Outcomes: Knowledge-based examination results as well as performance outcomes will be improved and procedural skills and overall satisfaction will be increased.
Detailed description
The primary goals of the final two years of medical school are to provide an experience that develops the fundamental clinical skills necessary to succeed as a resident and to offer opportunities for medical students to explore career interests. Largely unchanged for many years, the final two years of medical school include a series of required third year clerkships that include obstetrics and gynecology (OB-GYN) and general surgery. Following the completion of the third year, many students may have already decided on a specialty, and thus use the final year for electives and rotations that hone their skills and prepare them for residency. For those students planning for a procedural-based career such as OB-GYN or surgery, a considerable amount of time may be spent learning advanced surgical techniques, such as knot-tying, suturing, or other such procedures. In addition to traditional learning through didactic experiences, texts, and 'hands-on' patient interaction, some programs have developed supplemental curricula using simulators and cadaveric dissection. While studies demonstrate that these methods enhance students' readiness for procedural-based residencies, these studies have only focused on surgical residents or select fourth-year medical students who have a specific interest in surgery.
No study has focused on a comprehensive, streamlined approach using these supplemental techniques for third-year medical students. A standardized curriculum using simulation and cadaveric laboratories in the third year may provide students with the necessary skills to succeed in their required OB-GYN and surgical clerkships, while hopefully improving their examination scores and overall experience. The investigators intend to utilize a 'hands-on' series of laboratory experiences using the simulation center and cadavers to enhance the traditional learning structure. The investigators believe that a two-day course design would provide the necessary information and experience without the use of excessive resources.
Typically, work using cadavers is relegated to the study of gross human anatomy in the first year of medical school. Students experience an in-depth review of human anatomy, while learning the basic skills for dissection. After the completion of this introductory course, few medical schools routinely use cadavers or a simulation laboratory, despite the well-documented benefits for advanced learners. The usefulness of such an experience was well demonstrated in a pilot study performed by Morgan et al, which provided an intensive 78-hour (4-week) multifaceted curriculum designed for fourth year medical students prior to entering an OB-GYN residency. The course included didactic lectures, simulation training, cadaver dissection, a knot and suture experience, and surgical procedures performed on cadavers and simulation equipment. The authors concluded that despite being time-consuming and expensive, students significantly enhanced surgical skills and readiness to begin residency. Similar results have also been demonstrated in courses focused on suturing, knot-tying, and procedure-based techniques for select fourth year students entering a surgical residency program; the intent of these courses was to enhance the necessary skills to achieve appropriate required milestones. While these elective rotation pilot programs were successful in achieving their primary outcome, the drawbacks were that they were performed in fourth year students only, relegated to a select few entering surgical fields, and were costly and time-consuming.
Accordingly, the primary goal is to utilize a comprehensive, streamlined, and cost-effective approach using simulation and cadaver experiences for all eligible third-year medical students. The investigators believe that this experience will enhance scores on the Shelf and USMLE examination and improve procedural skills and overall satisfaction while remaining inexpensive and efficient. To achieve this goal, this course will be offered while students are completing their OB-GYN or general surgery rotations, both of which are heavily procedure-based and require a similar skill set. This combined effort will also allow this course to be performed six times per year instead of up to 12 times per year, which will lower costs and lessen faculty workload. If this study proves to be successful, the hope is that this curriculum could be implemented at other medical schools. The study design is also unique because the investigators will be recruiting a large student population from a national medical school instead of having students serve as their own controls in a single-center experience. The students in this study will be randomized into one of two groups: a traditional learning experience or a traditional learning experience that also includes supplemental cadaver-based and simulation-based learning.
The primary focus of this study is to determine whether the use of a comprehensive, combined, and simplified approach of using cadavers and simulation laboratories to train third-year medical students will have a beneficial effect on student performance in the OB-GYN and surgical clerkships.
Aim 1: To determine if the combined use of a 'hands-on' cadaver and simulation laboratory course will improve performance, NBME Shelf and USMLE Step 2 examination scores, and the overall experience during the third year OB-GYN and surgical clerkships.
Aim 2: To assess whether this experience can be accomplished in an efficient, cost-effective manner that would make it generalizable to other medical school curricula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation/Cadaver Workshop | Experimental | Other: Simulation/Cadaver lab2-day workshop using the Simulation/Cadaver Lab |
| Didactic Workshop | Placebo comparator | Other: LecturesLectures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All medical students in 2nd year
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 |
|---|---|---|
| Simulation/Cadaver labThe primary focus of this study is to determine whether the use of a comprehensive, combined, and simplified approach of using cadavers and simulation laboratories to train third-year medical students will have a beneficial effect on student performance in the OB-GYN and surgical clerkships. | Other | Simulation/Cadaver Workshop |
| LecturesStandard Anatomy lectures were offered. | Other | Didactic Workshop |
Primary outcome
Mean shelf exam scores
Time frame: 1 year
A "shelf" exam is an exam that some medical schools purchase from the NBME that test materials presented in the third-year clerkships. For this study the rotation scores examined were for obstetrics and gynecology, and surgery.
1 secondary outcome
Mean grade on rotation evaluation
Time frame: 1 year
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 22 Oct 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Brian P Shapiro, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation/Cadaver lab and Lectures in people with Educational Problems, run by Mayo Clinic at 1 site in United States.
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 22 Oct 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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 shelf exam scores (time frame: 1 year). 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 22 Oct 2019.