Training for Transfer by Contextual Variation

April 17, 2023 updated by: Vilma Johnsson, Rigshospitalet, Denmark

Training for Transfer by Contextual Variation: A Randomized Study

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Copenhagen Academy of Medical Education and Simulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Passed a general anatomy exam
  • Proficiency in Danish

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfertest score
Time Frame: 4*7 min (4 tests) 7-10 days after intervention
Exåpert based performances scores using a 5 point likert scale rating 4 items. Higher scores indicate better performance.
4*7 min (4 tests) 7-10 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training
Time Frame: 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)
60 min (training session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared upon request. However, raw data includes non-anonymized video records that are incompatible with sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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