NCT03650959

Brief Summary

Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. One method has yet to be identified as superior in terms of educational outcomes, resource utilization, and participant perspectives. Pre-clerkship medical students were randomized to: faculty, peer tutor, or computer augmented learning. Participants practiced suturing through their randomized method until they reached targeted proficiency defined using hand motion analysis (HMA). Proficiency was defined as a score of the average plus a standard deviation of five surgeons' HMA for two of three consecutive sutures using appropriate technique. The primary outcome was the number of stitches placed to achieve proficiency. The secondary outcomes were the number of sutures used, time, and costs incurred. Learning curves were constructed. Participants' perceptions were assessed using a follow-up survey.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2019

Completed
Last Updated

September 27, 2024

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

August 27, 2018

Last Update Submit

September 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of stitched laid to reach proficiency

    Five days

Secondary Outcomes (3)

  • Number of sutures used to reach proficiency

    Five days

  • Minutes to reach proficiency

    Five days

  • Individual costs to reach proficiency

    Five days

Other Outcomes (2)

  • Learning curves

    Five days

  • Student preferences

    Five days

Study Arms (3)

Faculty-led

EXPERIMENTAL
Other: Method of learning simple interrupted sutures with instrument tie

Peer tutor-led

EXPERIMENTAL
Other: Method of learning simple interrupted sutures with instrument tie

Computer augmented self-directed learning

EXPERIMENTAL
Other: Method of learning simple interrupted sutures with instrument tie

Interventions

Students will train to proficiency (defined by hand motion analysis) on simple interrupted sutures with an instrument tie via one of three different methods: faculty-led, peer tutor-led, or computer augmented self-directed learning.

Computer augmented self-directed learningFaculty-ledPeer tutor-led

Eligibility Criteria

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

You may qualify if:

  • Second year, pre-clerkship medical students

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's Unviersity

Kingston, Ontario, K7L 3N6, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor & Medical Education Scholar

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

June 4, 2018

Primary Completion

June 16, 2019

Study Completion

June 16, 2019

Last Updated

September 27, 2024

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations