NCT02999113

Brief Summary

To explore to what extent shared mental models (SMM) occur within the Video-Assisted Thoracoscopic Surgery (VATS) teams in a cardiothoracic surgery setting. Additionally, to establish whether the VATS team's SMM is associated with the surgeons' technical skills, procedural specific times, per-operative bleeding, or patient characteristics

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

December 16, 2016

Last Update Submit

July 17, 2018

Conditions

Keywords

non-technical skillspatient safetymedical education

Outcome Measures

Primary Outcomes (1)

  • shared mental models (SMM)

    Questionnaires. The pre-operative questions concern team members' perceived technical skills, teamwork skills and familiarity; risk assessment ('global' and 'global in view of the current team'); and risk assessment of specific tasks. The post-operative questions concern team members' perceived technical skills and teamwork skills; risk assessment ('global' and 'global in view of the current team'), leadership and teamwork during the procedure, and knowledge of challenges experienced during the procedure

    pre- and post-operatively

Secondary Outcomes (4)

  • Technical skills (TS)

    per-operatively

  • Procedural specific times

    During the operation (VATS lobectomies)

  • Amount of bleeding

    During the operation (VATS lobectomies)

  • Patient characteristics

    Pre-operatively

Other Outcomes (1)

  • Experience level of surgeon

    Pre-operatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Team members of the operating room team performing VATS lobectomies

You may qualify if:

  • Team members of the operating room team performing VATS lobectomies

You may not qualify if:

  • Not team members of the operating room team performing VATS lobectomies, e.g. observers or guests in the OR during VATS lobectomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Gjeraa K, Dieckmann P, Jensen K, Moller LB, Petersen RH, Ostergaard D, Ersboll AK, Konge L. Effects of shared mental models in teams performing video-assisted thoracoscopic surgery lobectomy. Surg Endosc. 2022 Aug;36(8):6007-6015. doi: 10.1007/s00464-021-08972-3. Epub 2022 Jan 24.

Study Officials

  • Lars Konge, Professor

    Copenhagen Academy for Medical Education and Simulation, Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 21, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

June 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations