Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cross-sectional Analysis of Non-technical Attributes and Surgical Experience in Surgical Staff, Trainees and Applicants.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728088
Recruitment Status : Enrolling by invitation
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Ghent

Tracking Information
First Submitted Date October 23, 2018
First Posted Date November 1, 2018
Last Update Posted Date November 1, 2018
Actual Study Start Date September 1, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2018)
  • Participant communication styles [ Time Frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. ]
    Communication styles measured using the CSI-96 scale
  • Participant attitudes towards uncertainty [ Time Frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion ]
    Attitudes towards uncertainty measured using the PRU scale
  • Participant attitudes towards taking risks [ Time Frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion ]
    Attitudes towards taking risks measured using the PRA scale
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 31, 2018)
Participant perceived actual health status [ Time Frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. ]
Perceived health status measured using the SF-36 scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cross-sectional Analysis of Non-technical Attributes and Surgical Experience in Surgical Staff, Trainees and Applicants.
Official Title Non-technical Attributes and Surgical Experience: a Cross-sectional Study Comparing Communication Styles and Attitudes in Surgical Staff, Trainees and Applicants
Brief Summary

This study consists of an analysis of the communication styles and attitudes towards risk and uncertainty (i.e. non-technical attributes) in a surgical population with varying clinical experience.

The study aims to investigate the differences and specific patterns in non-technical attributes that may be discerned in these groups and how these non technical attributes develop throughout surgical training.

Detailed Description

This study evaluated the communication styles and attitudes towards risk and uncertainty in a population of surgical candidates (pre- and postgraduates), surgical trainees and surgical staff members, from the specialties of general surgery, orthopedics, urology and plastic surgery. After signing informed consent, participants complete an on-line questionnaire, which contains a set of validated tools.

Initially, a cross-sectional analysis of the non-technical attributes will be conducted, to identify any patters, similarities or differences between participant groups.

The study hypothesis is that significant differences can be observed in participant attributes, which relate to their clinical experience.

Additionally, surgical candidates who agree to participate in this study and are accepted for a surgical training in either general surgery, orthopaedics, urology or plastic surgery, will be invited to repeat the questionnaire at a 2-year interval, to investigate the evolution of their non-technical attributes throughout their training and to identify general patterns.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Candidates applying for a surgical specialty (general surgery, orthopaedics, urology, plastic surgery); trainees in one of these surgical specialties; staff members in one of these surgical specialties.
Condition Healthy Volunteers
Intervention Other: Rating scales concerning non-technical attributes
Other Names:
  • Communication styles inventory (CSI-96) rating scale
  • Physician's reactions towards uncertainty (PRU) rating scale
  • Physicians's risk attitudes (PRA) rating scale
Study Groups/Cohorts
  • Surgical Candidates

    Under- and postgraduate candidates applying for surgical training in general surgery, orthopedics, urology or plastic surgery at Ghent University Hospital.

    All candidates will complete the rating scales concerning non-technical attributes in the period prior to the surgical selections.

    Intervention: Other: Rating scales concerning non-technical attributes
  • Surgical trainees

    Surgical trainees active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital or an affiliated non-academic training hospital.

    All trainees will be invited to participate in the study. Trainees who agree to participate will complete the rating scales concerning non-technical attributes.

    Intervention: Other: Rating scales concerning non-technical attributes
  • Surgical staff

    Surgical staff members active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital.

    All surgical staff members will be invited to participate in the study. Surgical staff members who agree to participate will complete the rating scales concerning non-technical attributes.

    Intervention: Other: Rating scales concerning non-technical attributes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 31, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participant is part of any of the following groups:

    • Applicant for surgical training in general surgery, orthopedics, urology or plastic surgery.
    • Trainee in general surgery, orthopedics, urology, plastic surgery.
    • Staff in general surgery, orthopedics, urology, plastic surgery.
  • Participant is active at Ghent University Hospital or an affiliated training hospital.

No exclusion criteria apply to this study.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728088
Other Study ID Numbers B6702016287
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Research data will not be shared standard.
Responsible Party University Ghent
Study Sponsor University Ghent
Collaborators Not Provided
Investigators
Principal Investigator: Isabelle Van Herzeele, MD, PhD Vascular surgeon
PRS Account University Ghent
Verification Date October 2018