NCT03341351

Brief Summary

This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Primary outcome will be measured as change in technical skills score as measured by change from baseline on a validated objective structured assessment of technical skills (OSTATS) for repair of fourth-degree laceration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 26, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

October 26, 2017

Last Update Submit

April 17, 2018

Conditions

Keywords

Fourth-degree lacerationBeef tongue model

Outcome Measures

Primary Outcomes (1)

  • Technical skills score

    The primary outcome will be change in technical skills score measured as change from baseline in a validated objective structured assessment of technical skills (OSATS) for repair of fourth degree obstetric laceration. This OSATS was described by Siddiqui et al and is based on a task-specific checklist for fourth-degree lacerations and has a maximum score of 20 and minimum score of 0. The higher the score the better the performance.

    up to 24 weeks

Secondary Outcomes (8)

  • Participant preference

    up to 24 weeks

  • Knowledge assessment

    up to 24 weeks

  • Participant confidence

    up to 24 weeks

  • Time of repair

    up to 24 weeks

  • Ease of use of model

    up to 24 weeks

  • +3 more secondary outcomes

Study Arms (2)

Instructional video

ACTIVE COMPARATOR

The modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration.

Other: Instructional video

Instructional workshop

ACTIVE COMPARATOR

The group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration.

Other: Instructional workshop

Interventions

Instructional video using the modified beef tongue model

Instructional video

Instructional workshop using the modified beef tongue model.

Instructional workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residents currently in training program at University of Alabama at Birmingham

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

  • Siddiqui NY, Stepp KJ, Lasch SJ, Mangel JM, Wu JM. Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations. Am J Obstet Gynecol. 2008 Dec;199(6):676.e1-6. doi: 10.1016/j.ajog.2008.07.054.

    PMID: 19084100BACKGROUND
  • Patel M, LaSala C, Tulikangas P, O'Sullivan DM, Steinberg AC. Use of a beef tongue model and instructional video for teaching residents fourth-degree laceration repair. Int Urogynecol J. 2010 Mar;21(3):353-8. doi: 10.1007/s00192-009-1042-3.

    PMID: 19924368BACKGROUND
  • Illston JD, Ballard AC, Ellington DR, Richter HE. Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation. Obstet Gynecol. 2017 Mar;129(3):491-496. doi: 10.1097/AOG.0000000000001908.

    PMID: 28178060BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesObstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Joseph Malek, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor performing the objective structured assessment of technical skills will be masked to the intervention of the participant.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor/Fellow

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 14, 2017

Study Start

November 14, 2017

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations