Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee SurgeonsNCT01773525
Testing NOTSSdk in the Clinical Setting
An observational study of Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee Surgeons, run by Herlev Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee Surgeons
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Trainee surgeons in one surgical department
Who may be able to join
- trainees in surgical specialist training
Who cannot join
- trainees not in surgical specialist training
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of ratings of surgeons' non-technical skills
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee SurgeonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Spanager, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773525
- Sponsor's protocol ID
- NTS-2_LS
- Status last verified
- Aug 2013
- First submitted
- 14 Jan 2013
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing NOTSSdk in the Clinical Setting
- ClinicalTrials.gov ID
- NCT01773525
- Acronym / sponsor ID
- NTS-2_LS
- Conditions
- Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee Surgeons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Trainee surgeons in one surgical department
Key inclusion criteria (1 listed)
- trainees in surgical specialist training
Key exclusion criteria (1 listed)
- trainees not in surgical specialist training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of ratings of surgeons' non-technical skills
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study: Usability of a Tool for Structured Assessment of and Feedback to Trainee Surgeons, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of ratings of surgeons' non-technical skills (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.