NCT03050281

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

November 4, 2016

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Mean grade on rotation evaluation

    1 year

Study Arms (2)

Simulation/Cadaver Workshop

EXPERIMENTAL

2-day workshop using the Simulation/Cadaver Lab

Other: Simulation/Cadaver lab

Didactic Workshop

PLACEBO COMPARATOR

Lectures

Other: Lectures

Interventions

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.

Simulation/Cadaver Workshop

Standard Anatomy lectures were offered.

Didactic Workshop

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All medical students in 2nd year

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Brian P Shapiro, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 4, 2016

First Posted

February 10, 2017

Study Start

April 1, 2016

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 22, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations