NCT02895685

Brief Summary

The investigators have planned a randomized study, examining the effect of self-directed training in groups vs. individual training on trainees' acquisitions of open surgical skills. Eighty participants who signed up for a pre-existing simulation-based course in basic open surgical skills will be randomized to practice either in pairs or individually during the course. Participants open surgical skills will be tested on a simulated skin model before and after the course. The investigators hypothesis is that dyad training will enhance self-directed learning in open surgical skills.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 6, 2016

Last Update Submit

September 9, 2016

Conditions

Technical Skills Training

Keywords

SimulationSelf-regulated trainingEducationOpen surgeryDyad training

Outcome Measures

Primary Outcomes (1)

  • To examine the effect of off-site self-directed training in groups vs. individual training

    Differences between pre-test and post-test scores in basic tasks on a simulated model

    12 months

Secondary Outcomes (7)

  • To examine the effect of off-site self-directed training in groups vs. individual training

    12 months

  • To examine the effect of off-site self-directed training in groups vs. individual training

    12 months

  • To examine the effect of off-site self-directed training in groups vs. individual training

    12 months

  • To examine the effect of off-site self-directed training in groups vs. individual training

    12 months

  • To examine the effect of off-site self-directed training in groups vs. individual training

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Dyad training

EXPERIMENTAL

Participants randomized to train in pairs during the whole 6-week course

Other: Dyad training

Control group: individually training

NO INTERVENTION

If randomized to train individually, participants will be instructed to do all the training individually. Participants will be instructed not to practice with others when practising at home and will only receive feedback from the expert during the expert-guided self-training. At the training at CAMES, participants will sit at separate tables.

Interventions

Dyad trainingOTHER

Participants will be paired in teams at the introduction. Participants will be instructed to train and supervise each other in pairs and will receive information on how to give constructive feedback. Participants will practice in pairs during on-site classes and encouraged to train in pairs during the self-regulated training at home. At the on-site classes, participants will be instructed to practice with their partner, during the expert-guided self-training and receive all feedback in pairs. Participants will train at the same table with space for two people. Outside the classroom, participants will decide themselves when and how often they will meet to practise. Participants are instructed to actively observe his or her partner while practising and are encouraged to discuss their performance and any difficulties they encounter. Testing will be done individually. With the training log, the investigators will measure whether the participants train in pairs at home as instructed.

Dyad training

Eligibility Criteria

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

You may qualify if:

  • The participants may enter the study if any of the following apply:
  • Medical doctor from a department in the Capital Region and the region of Zeeland in Denmark.
  • Medical students employed in internships or research year in surgical departments in the Capital Region and the region of Zeeland in Denmark.
  • The participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

  • The participants may not enter the study if any of the following apply:
  • The participant have performed more than 50 open surgical procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Year Student

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 12, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

September 12, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)