NCT03684720

Brief Summary

The study is a randomized experimental study comparing two forms of learning; guided-discovery-learning and traditional instructional learning. Recruiting sixty-four participants, the investigators plan on comparing these two groups through a procedural skill in the form of suturing. In the case of guided-discovery-learning, the group will be allowed a discovery phase before instruction. In contrast, the control group will receive traditional instruction-lead-learning, in which a teacher teaches the participants a skill, and afterwards the participants practice it. After the teaching session, both groups will undertake a post-test of skill-level. A week later both groups will undertake a test for the execution of the learned suturing skill to a more complex version of the original task (Near-transfer). They will also undergo a test for the ability to transfer their learning to a new skill (i.e. preparation for future learning), in this case a new suture (Far-transfer). By filming these tests and having a blinded expert rater score them, the investigators will be able to get a measurement of attained transfer of skill-level throughout the procedures. The investigators hypothesis is that, the participants in the Guided-discovery-group will have an equal score to that of the traditional-learning group in the ability to obtain a skill and transfer it to a more complex version. Furthermore, the investigators hypothesize that the Guided-discovery-group will score better than the traditional-learning group in the case of transferring the procedural knowledge to learning a new skill. As well as testing the efficacy of guided-discovery-learning on a procedural skill, the investigators wish to investigate how and why it works. By filming a subset of participants in each group, as well as using questionnaires, and focus-group interviews the investigators will explore how participants interact in this different learning-environment compared to the traditional instructional learning-environment.

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
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

August 24, 2018

Last Update Submit

February 5, 2019

Conditions

Keywords

Medical educationBasic ScienceProcedural skillsSimulationTransferInstructional designGuided Discovery LearningRetention

Outcome Measures

Primary Outcomes (1)

  • Effects of Guided-Discovery-Learning in the Far Transfer of Simple Surgical Skills.

    Comparison of far transfer-test between control and intervention group as assessed by OSATS: Global Rating Scale of Performance. OSATS is short for: Objective Structured Assessment of Technical Skills. It consists of 7 subsets of which 5 are relevant to the study. Each participant is rated from 1(minimum) to 5(maximum) in each subset, and all subsets are added together by simple summation. This gives the participants a total score of out of 25 points, where the higher the number the better the performance.

    Through study completion on average 12 months

Secondary Outcomes (3)

  • Effects of Guided-Discovery-Learning on the Near Transfer of Simple Surgical Skills.

    Through study completion on average 12 months

  • Effects of Guided-Discovery-Learning immediately after a training-session in simple surgical skills.

    Through study completion on average 12 months

  • Impact Difference on near and far transfer using Guided-Discovery-Learning

    Through study completion on average 10 months

Study Arms (2)

Discover followed by direct instruction [DD]

EXPERIMENTAL

The intervention group which will be taught suturing using guided-discovery-learning

Other: Discover followed by direct instruction [DD]

Instruction followed by practice [IP]

NO INTERVENTION

The control group which will be taught suturing using traditional instructional teaching.

Interventions

The intervention group will be taught suturing using the principles of guided-discovery-learning. In its simplest form, this means allowing the participants to practice placing a simple interrupted suture using the materials needed, as well as a picture of a finished suture. They must then draw from their own learning experiences, as well as discover for themselves how to do it. After a discovery period, an instructor will then teach them, how to place a simple interrupted suture, and will them guide them, as they begin to practice again.

Also known as: Guided-discovery-learning
Discover followed by direct instruction [DD]

Eligibility Criteria

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

You may qualify if:

  • Participant are students currently attending a Danish medical bachelor and who are willing and consent to participation in the study.

You may not qualify if:

  • Participants who have received prior suturing education are excluded from participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy of Medical Education and Simulation

Copenhagen, KBH Ă˜, 2100, Denmark

Location

Related Publications (13)

  • Reznick RK, MacRae H. Teaching surgical skills--changes in the wind. N Engl J Med. 2006 Dec 21;355(25):2664-9. doi: 10.1056/NEJMra054785. No abstract available.

    PMID: 17182991BACKGROUND
  • Dawe SR, Pena GN, Windsor JA, Broeders JA, Cregan PC, Hewett PJ, Maddern GJ. Systematic review of skills transfer after surgical simulation-based training. Br J Surg. 2014 Aug;101(9):1063-76. doi: 10.1002/bjs.9482. Epub 2014 May 15.

    PMID: 24827930BACKGROUND
  • Zendejas B, Brydges R, Hamstra SJ, Cook DA. State of the evidence on simulation-based training for laparoscopic surgery: a systematic review. Ann Surg. 2013 Apr;257(4):586-93. doi: 10.1097/SLA.0b013e318288c40b.

    PMID: 23407298BACKGROUND
  • Zendejas B, Cook DA. Reply to Letter: "Surgical Simulation: Seeing the Bigger Picture and Asking the Right Questions". Ann Surg. 2015 Aug;262(2):e51-2. doi: 10.1097/SLA.0000000000001138. No abstract available.

    PMID: 25607763BACKGROUND
  • Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.

    PMID: 22691145BACKGROUND
  • Brydges R, Dubrowski A, Regehr G. A new concept of unsupervised learning: directed self-guided learning in the health professions. Acad Med. 2010 Oct;85(10 Suppl):S49-55. doi: 10.1097/ACM.0b013e3181ed4c96.

    PMID: 20881703BACKGROUND
  • Lee HS, Anderson JR. Student learning: what has instruction got to do with it? Annu Rev Psychol. 2013;64:445-69. doi: 10.1146/annurev-psych-113011-143833. Epub 2012 Jul 12.

    PMID: 22804771BACKGROUND
  • Mylopoulos M, Brydges R, Woods NN, Manzone J, Schwartz DL. Preparation for future learning: a missing competency in health professions education? Med Educ. 2016 Jan;50(1):115-23. doi: 10.1111/medu.12893.

    PMID: 26695471BACKGROUND
  • DeCaro MS, Rittle-Johnson B. Exploring mathematics problems prepares children to learn from instruction. J Exp Child Psychol. 2012 Dec;113(4):552-68. doi: 10.1016/j.jecp.2012.06.009. Epub 2012 Jul 31.

    PMID: 22849809BACKGROUND
  • Grierson LE. Information processing, specificity of practice, and the transfer of learning: considerations for reconsidering fidelity. Adv Health Sci Educ Theory Pract. 2014 May;19(2):281-9. doi: 10.1007/s10459-014-9504-x. Epub 2014 Apr 2.

    PMID: 24691891BACKGROUND
  • Hatala R, Cook DA, Brydges R, Hawkins R. Constructing a validity argument for the Objective Structured Assessment of Technical Skills (OSATS): a systematic review of validity evidence. Adv Health Sci Educ Theory Pract. 2015 Dec;20(5):1149-75. doi: 10.1007/s10459-015-9593-1. Epub 2015 Feb 22.

    PMID: 25702196BACKGROUND
  • Devine LA, Donkers J, Brydges R, Perelman V, Cavalcanti RB, Issenberg SB. An Equivalence Trial Comparing Instructor-Regulated With Directed Self-Regulated Mastery Learning of Advanced Cardiac Life Support Skills. Simul Healthc. 2015 Aug;10(4):202-9. doi: 10.1097/SIH.0000000000000095.

    PMID: 26154249BACKGROUND
  • Brydges R, Manzone J, Shanks D, Hatala R, Hamstra SJ, Zendejas B, Cook DA. Self-regulated learning in simulation-based training: a systematic review and meta-analysis. Med Educ. 2015 Apr;49(4):368-78. doi: 10.1111/medu.12649.

    PMID: 25800297BACKGROUND

Study Officials

  • Andreas H Aagesen

    Copenhagen Academy for Medical Education and Simulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The groups will be masked, until the day of the teaching session, so the investigator won't know, which group he assigns participants to, when enrolling them. The raters who will score the participants, will have no knowledge of which group the participant belongs to.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study is a randomized experimental study comparing 2 groups, a control and an intervention. One group will receive traditional instructional teaching (control) and the other will receive guided-discovery-learning (intervention). Both groups will undertake the same tests after the teaching session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 24, 2018

First Posted

September 26, 2018

Study Start

October 2, 2018

Primary Completion

November 5, 2018

Study Completion

July 31, 2020

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations