NCT03623009

Brief Summary

Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. In this study, we investigate how certain environmental factors can affect skill acquisition for the resident surgeon. Our trial tests whether psychosocial constructs affect task-performance. This study is a multi-center endeavor with the University of North Carolina-Chapel Hill, the University of Washington, and UPMC. Over an 12 month period, residents will be asked to complete surveys and a laparoscopic skills assessment, which will be administered after residents are randomized to an intervention or control arm. The intervention arm will be asked to read an article that is meant to trigger psychosocial constructs that we hypothesize will affect skill performance. The control arm will receive a neutral article prior to completing the laparoscopic skills assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

August 6, 2018

Last Update Submit

October 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score on laparoscopic skills assessment

    Score (continuous outcome) based on verified fundamentals of laparoscopic skills assessment grading rubric.

    12 months

Secondary Outcomes (1)

  • Changes in psychosocial constructs

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.

Behavioral: An article meant to trigger certain psychosocial behaviors

Control

SHAM COMPARATOR

The control arm will receive a neutral article prior to completing the assessment.

Behavioral: a neutral article

Interventions

An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.

Intervention

The control arm will receive a neutral article prior to completing the assessment.

Control

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15218, United States

Location

Related Publications (1)

  • Myers SP, Dasari M, Brown JB, Lumpkin ST, Neal MD, Abebe KZ, Chaumont N, Downs-Canner SM, Flanagan MR, Lee KK, Rosengart MR. Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial. JAMA Surg. 2020 Jul 1;155(7):552-560. doi: 10.1001/jamasurg.2020.1127.

MeSH Terms

Conditions

Sexism

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Sara P Myers, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
UPMC Resident/Fellow

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations