Training for Transfer by Contextual Variation

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT05834374
Collaborator
(none)
110
1
3
6.7
16.4

Study Details

Study Description

Brief Summary

The goal of this randomized study is to investigate the effect of introducing contextual variation on transfer when learning a technical skill in a group of medical students. The main questions it aims to answer is: If context variation of specific affordance conditions enhance the learner's ability to transfer out? Participants will practice performing an invasive ultrasound guided procedure either on a fantom with maximum affordances or with contextual variation. Researchers will compare the maximum affordances group and the contextual variation group to see if its effects compared to the control group with minimal affordances.

Condition or Disease Intervention/Treatment Phase
  • Other: Contextual variation
  • Other: Maximum affordances
N/A

Detailed Description

Participants:

Participants are medical student from the University of Copenhagen. They are recruited by announcements on student fora on Facebook.

Randomization:

The participants are randomized to the intervention group contextual variation, the intervention group maximum affordances or control group minimum affordances in an 1:1:1 allocation ratio. In addition, the order of the four transfer tests (a, b, c and d) is randomly selected for each participant. The randomization was conducted by an independent research assistant at CAMES. Random permuted blocks are generated online for both the intervention and the transfer test.

Equiptment:

The training session is conducted on a ballistic gel cube. Three cavities are excavated corresponding to the points of a triangle at the bottom of the cube. Each cavity include a 5" latex balloon filled with 10ml water. The ballistic gel is coloured with graphite thus, the cavities can only be visualized by ultrasound. The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.

Intervention:

In the first learning session the participants are provided with an ultrasound probe and a needle and instructed to detect and aim at a fixed target in a cube made of ballistic gel. The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide. The maximum affordances group has half the surface model covered and a complete guide throughout the session. The control group has the whole surface uncovered and no guide throughout the session. The participants will have 60 minutes to complete the training.

Transfer test:

The groups are re-invited seven days after completed training for a transfer test. The transfer test include four cases (a, b, c, d) where the overall aim is to perform a CVS procedure on a CVS mannikin. In case a and b, the participant has the affordances of a guide on the ultrasound probe and the screen. In case c and d, there is a lack of affordances by not using a guide on the probe or screen. The placental position is anterior in case a and c, and posterior in case b and d. The transfer test measures both the transfer out, i.e. applying a skill learned in one context to a new context, and transfer in, how the learner learns with the acquired skills in the new context. The order of the transfer tests is randomized at inclusion. The participants receive a brief introduction to the chorionic villus sampling (CVS) procedure ahead of the transfer test by watching a video where the procedure is performed in a clinical setting.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Training for Transfer by Contextual Variation: A Randomized Study
Actual Study Start Date :
Mar 17, 2021
Actual Primary Completion Date :
Oct 7, 2021
Actual Study Completion Date :
Oct 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Contextual variation

The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide.

Other: Contextual variation
The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
Other Names:
  • Maximum affordances
  • Experimental: Maximum affordances

    The maximum affordances group has half the surface model covered and a complete guide throughout the session.

    Other: Maximum affordances
    The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.

    No Intervention: Minimum affordances

    The control group has the whole surface uncovered and no guide throughout the session.

    Outcome Measures

    Primary Outcome Measures

    1. Transfertest score [4*7 min (4 tests) 7-10 days after intervention]

      ExÄpert based performances scores using a 5 point likert scale rating 4 items. Higher scores indicate better performance.

    Secondary Outcome Measures

    1. Training [60 min (training session)]

      Quantitative analysis of use of movements (many movements indicate expert performance), number of emptied ballons (higher number indicates better perfomance), incisions/ballon (lower number indicates better performance)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Passed a general anatomy exam

    • Proficiency in Danish

    Exclusion Criteria:
    • Previous ultrasound experience except mandatory training as part of the medical curriculum

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Copenhagen Academy of Medical Education and Simulation Copenhagen Denmark

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Study Chair: Martin G Tolsgaard, Professor, Rigshospitalet, Denmark
    • Principal Investigator: Vilma L Johnsson, M.D., Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vilma Johnsson, Principal Investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05834374
    Other Study ID Numbers:
    • H-19039518
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vilma Johnsson, Principal Investigator, Rigshospitalet, Denmark

    Study Results

    No Results Posted as of Apr 28, 2023