Testing NOTSSdk in the Clinical Setting

August 23, 2013 updated by: Lene Spanager, Herlev Hospital
The purpose of this study is to test the use of a tool (NOTSSdk)to assess and provide feedback to trainee surgeons' non-technical skills. It focuses on two aspects: reliability of ratings of trainee surgeons using NOTSSdk; and the content and quality of feedback given to trainees based on observations using NOTSSdk.

Study Overview

Status

Completed

Conditions

Detailed Description

The specific research questions are:

  • How many situations (=operations) are necessary to assess using NOTSSdk, to get reliable ratings of trainee surgeons' NTS?
  • What is the impact of the NOTSSdk feedback tool on the content of feedback conversations regarding NTS?
  • How do trainees perceive the usefulness of the feedback session?
  • How do raters perceive the usefulness of the ratings and the feedback session?

Materials and methods

We aim for a sample of 15 trainees in one hospital.

Demographic data will be collected regarding: gender, age, postgraduate experience (years/months), surgical experience (years/months), specialist training level for both assessors and trainees.

Procedure The head of the surgical department will be informed about the project and will be asked permission to recruit trainees and assessors.

Participants will be informed about the project orally and in writing prior to commencement. Surgeon assessors and trainees will be given the NOTSSdk handbook to familiarize themselves with the system before the study.

The assessors will receive a short guidance on how to provide assessments and give feedback using NOTSSdk immediately before the first operation. After the first assessment and feedback session, the assessor will be offered a further short structured guidance on how to fill in the assessment form and how to provide structured feedback. It will also be allowed for the assessor to solve ambiguities, ask questions and to get further explanation of the categories and elements of NOTSSdk.

Eligible operations: laparoscopic cholecystectomy, hernia repair, laparoscopic appendectomy, small bowel obstruction, hemicolectomy - depending on the trainee's competence.

Reliability study Each trainee will be assessed by one surgeon assessor using NOTSSdk during an operation. Each trainee will be assessed on two occasions. Assessors will vary according to availability. This will produce app. 30 assessments in total.

Feedback study Data will be collected in connection with data gathering in the reliability study that is, data will be provided by the same assessors and the same trainees on the same occasions. After the operation the surgeon will provide feedback to the trainee based on his/her observations. This feedback session will be observed and audio recorded by the primary investigator. After each feedback session the trainee and the surgeon will be individually surveyed exploring their perception of the feedback session and its usefulness. After the last feedback session the assessors will be surveyed about their perceptions of NOTSSdk feasibility.

Data analysis

Reliability study Generalizability theory will be applied to analyze how many operations are necessary to observe for reliable assessment. First the different variance components (trainees, assessors, cases etc.) will be estimated (three facet, balanced design with trainees nested within assessors and nested within operations). These will be used to generate Generalizability coefficients to estimate overall reliability of the use of NOTSSdk depending on number of assessors and operations observed.

Feedback study

We will use qualitative content analysis of emergent themes to explore the contents of the feedback sessions with special focus on:

  • Frequency of NTS topics discussed over time
  • Frequency of TS topics discussed over time Descriptive statistics will be used to present trainees' perceptions of the usefulness of the feedback and to present assessors' perceptions of the usefulness and feasibility of the ratings and the feedback.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Trainee surgeons in one surgical department

Description

Inclusion Criteria:

  • trainees in surgical specialist training

Exclusion Criteria:

  • trainees not in surgical specialist training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reliability of ratings of surgeons' non-technical skills
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • NTS-2_LS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee Surgeons

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