Shared Mental ModelsNCT02999113
Shared Mental Models and Technical Assessment in Video Assisted Thoracoscopy Surgery Lobectomies
An observational study of Shared Mental Models and Video Assisted Thoracoscopic Surgery, run by Copenhagen Academy for Medical Education and Simulation at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Mental Models, Video Assisted Thoracoscopic Surgery, Lobectomy
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Jun 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Team members of the operating room team performing VATS lobectomies
Who may be able to join
- Team members of the operating room team performing VATS lobectomies
Who cannot join
- Not team members of the operating room team performing VATS lobectomies, e.g. observers or guests in the OR during VATS lobectomies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Academy for Medical Education and Simulation (CAMES), Capital Region of Denmark
Copenhagen, 2100
About this study
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
Read the detailed description
BACKGROUND The majority of errors in healthcare in general, and the operating theatre in particular, are caused by human factors1,2. Hindering of these errors can be accomplished by good non-technical skills (NTS), including good teamwork and efficient communication within the operating room (OR) team3,4. NTS are defined as 'the cognitive, social and personal resource skills that complement technical skills and contribute to safe and efficient task performance'5.
Previously, safety studies have analysed and measured adverse events as an indication of patient safety4,6. A new safety theory by Erik Hollnagel, named Safety II, argues that instead of only investigating adverse events as a 'measure' for safety, we should also be investigating what happens when these do not occur or when they are avoided as equally important7. This broader perspective on patient safety has also been advocated by others8-10.
In an explorative, interview-based study, we took a Safety-II perspective when examining which NTS were most important for ensuring safe and efficient video-assisted thoracoscopic surgery (VATS) lobectomy, a high risk minimally invasive surgery with complementary and overlapping scope of practice between the surgical and anaesthesia subteams. The multi-professional teams identified specific important NTS that served as the basis for shared mental models (SMMs) regarding the patient, the current situation or the resources within the team. These mental models were accomplished through communication and coordination, and enabled the team to anticipate problems and stay ahead of the situation11. These teams performing high-risk procedures emphasized the importance of the six identified NTS for them to be able to obtain an accurate SMM to enable them to be ahead which they viewed as most important for a successful and safe operation.
Some of the first to look at SMM as a requirement for effective team performance was Cannon-Bowers and Salas in the 1990s12. They defined SMMs as common or overlapping cognitive representations of task requirements, procedures, and role responsibilities. More recent, SMMs have been specified as a shared understanding of the task (including equipment), the situation and resources of other team members. In turn, this will enable them to understand and interpret the situation and what the other team members know, what they need to know and what they are doing12-14. Moreover, others have found identical or similar constructs to SMMs, i.e. team mental models/shared situation models/team knowledge/team situation awareness, and the importance of these constructs for patient safety is largely agreed upon15-21.
SMMs are more than the sum of individual mental models20,22. They need to be similar, accurate and shared within the team; however, what level of information sharing and team monitoring in the team will result in high team performance is less clear17,18,23.
In a recent methodology publication, different probe questions were used to establish team members' knowledge in order to measure the team's SMM and situation awareness13. The probe questions related to the task, the situation, and future predictions of the situation including possible outcomes. The teams in these experiments were at a second-line emergency centre where team members had distinct responsibilities. These teams differ from OR teams which work closely together in and with the same 'physical environment', namely in the OR with the patient, on a high-risk but at the same time rather standardized task, namely an operation, which in our case is an elective procedure of VATS lobectomy. One can speculate if the SMMs of OR teams are identical or differ to these emergency centre teams. So far, measurement of SMMs in OR teams has to our knowledge only been conducted in simulation settings17. To what extent this shared mental modelling occurs within the OR teams in the clinical setting is not known.
Moreover, the correlation between OR teams' NTS and technical skills (TS) has previously been investigated, however, there is still no clear picture of whether or not a correlation exists4,24-26. Additionally, some studies found a positive correlation27-29, whereas others found a negative correlation30. As the SMMs of the VATS teams seem to be enabled by the NTS perceived as important, it could be hypothesised that this relationship for SMMs and TS in the clinical setting is clearer than for NTS and TS. Yet, it is unknown whether the OR teams' SMMs are correlated to TS or other patient- and procedure-related measures.
The aims of this study are twofold. First, to explore to what extent SMM occur within the VATS teams in a cardiothoracic surgery setting. Second, to establish whether the VATS team's SMM is associated with the surgeons' TS, procedural specific times, per-operative bleeding, or patient characteristics (age, gender, FEV %, comorbidity, tumour size or location).
Research questions for the study
- To what extent are the individual team members' mental models in agreement within the VATS team?
- Pre-operatively?
- Post-operatively?
- Pre- and post-operative correlations?
- How is the team's shared mental model associated with
- The surgeon's TS assessed by VATS lobectomy assessment tool (VATSAT)?
- Procedural specific times (see later for description)?
- Amount of bleeding?
- Patient characteristics?
METHODS Design This study will be a case series study of VATS lobectomies purposefully sampled at all four cardiothoracic surgery centres in Denmark. Data will be gathered from 60 lobectomies performed by multi-professional VATS teams including both experienced and intermediate level surgeons. Gathering of data is planned to start in December 2016.
Data sampling Team members' mental models will be explored through two questionnaires handed out to all team members before and after the operation (see Appendix to protocol (in Danish)). The questionnaires were constructed using the probe questions from Sætrevik et al., adapted to fit VATS lobectomy settings11,13,14.
Specifically, 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.
Perceived technical and teamwork skills, familiarity, 'global' and 'global in view of the current team' risk assessments are rated on a Likert scale from 1-7, and risk assessment of specific possible challenging situations are rated on a Likert scale from 1-3. The remaining items are either yes/no-questions or open-ended questions.
The questionnaires will be handed out to each team member individually before and after the VATS lobectomy. Endoscopic video-recordings of all the VATS lobectomies will be collected from the thoracoscope using the recording device MedCapture. Using these video-recordings, the TS level of the VATS surgeon will be evaluated by two independent raters using a VATSAT assessment tool31. The VATSAT tool evaluates eight items on a five point Likert scale and produces a pass/fail score.
An observer will be present throughout all the operations to collect data on amount of bleeding (in ml) and procedural specific times. The procedural specific times will be both pre-specified times and a continuous registration of time for tasks. The pre-specified times will be from the time the patient enters the OR to anaesthesia begins, to the surgeon makes the first incision, to the surgeon finishes the last suture, to the patient wakes up from anaesthesia, and to the patient leaves the OR.
The observer will in addition take field notes for qualitative analysis with special focus on the six NTS identified in our previous study as important to safe and successful VATS lobectomies.
Ethics The Regional Ethics Committee of the Capital Region of Denmark has been applied, and a letter of exemption has been given according to Danish Law (H-16041772). The participants will receive oral and written information and will give informed consent on the day of the operation with the continuous option of retraction of consent and participation. The endoscopic recordings will not start until the thoracoscope is inside the patient. All video-recordings, physical examples of questionnaires and master sheets will be stored according to Danish Data Protection Law, and any written description in the final manuscript and article will be presented anonymously. Only the members of the research team will review the endoscopic video-recordings.
Statistical analyses Questionnaire data The preoperative questionnaire will have in all 24 items concerning risk assessment and team resources. The post-operative questionnaire contains 16 items. It will describe the risk, skills and teamwork as perceived by each team member as it unfolded during the procedure. For each item, percentage of answers 'I don't know' will be calculated. For the remaining answers of each specific item, Cronbach's α will be calculated thereby representing the agreement within the team. These two numbers (percentage however revised to a number between 0-1) will be multiplied, thereby giving a number between 0-1. This will be done for all items. For each questionnaire, all item scores can be added to give a total score, between 0-24 or 0-16. For the pre-operative questionnaire, 24 will represent total agreement within the team before the operation, indicating complete overlap in the team's SMM of team resources and risk assessment. For the post-operative questionnaire, 16 will represent total agreement within the team after the operation, indicating complete overlap in the team's view on team resources, teamwork and risk assessment.
The post-operative questionnaire will conclude with an open-ended question concerning challenges faced during the procedure by all the different team members. From these it will be possible to categorize each of these answers as either correct (given a score of 1) or wrong (including 'I don't know'; given a score of 0) when compared to the answer given by the person in question. An example of this could be if the scrub nurse answers that the surgeon did not have any challenges, and the surgeon himself answers that he did have challenges dissecting the lymph nodes, the scrub nurse will get a score of zero.
In all, this will result in the calculations of three scores for SMMs regarding team resources, risk assessment and awareness of challenges within the team.
Correlation calculations The items concerning team members' perceived technical skills, teamwork skills, and risk assessment ('global' and 'global in view of the current team') will be collected both before and after the procedure. This will enable analysis of how well each team member predict these items before the operation as compared to the assessment after. This will be done by calculating Pearson's correlation coefficient r for each team member and for the team.
The scores representing the total SMM in the team pre- and post-operatively can be correlated to the surgeon's technical skills (the VATSAT score), procedural specific times, bleeding and patient characteristics. Pearson's correlation coefficient r will be used if the data are normally distributed or Spearman's correlation coefficient (rho) if the data are non-parametrically distributed. Statistical analyses will be performed using IBM SPSS statistics 22; SPSS Inc., Chicago, IL, USA.
Order of authors Kirsten Gjeraa, Peter Dieckmann, Anna Sofie Mundt, Lene Spanager, René Horsleben Petersen, Henrik Jessen Hansen, Doris Østergaard, Lars Konge.
- Keywords
- non-technical skills, patient safety, medical education
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre- and post-operatively
Secondary outcomes (4)
Technical skills (TS)
Using video-recordings from the thoracoscope, the TS level of the VATS surgeon will be evaluated by two independent raters using a VATSAT assessment tool31. The VATSAT tool evaluates eight items on a five point Likert scale and produces a pass/fail score.
Measured: per-operatively
Procedural specific times
The procedural specific times will be both pre-specified times and a continuous registration of time for tasks. The pre-specified times will be from the time the patient enters the OR to anaesthesia begins, to the surgeon makes the first incision, to the surgeon finishes the last suture, to the patient wakes up from anaesthesia, and to the patient leaves the OR.
Measured: During the operation (VATS lobectomies)
Amount of bleeding
An observer will be present throughout all the operations to collect data on amount of bleeding (in ml).
Measured: During the operation (VATS lobectomies)
Patient characteristics
patient characteristics: age, gender, FEV %, comorbidity, tumour size or location
Measured: Pre-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shared Mental ModelsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Kirsten Gjeraa, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Lars Konge, Professor, Study director, Copenhagen Academy for Medical Education and Simulation, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999113
- Sponsor's protocol ID
- R100-A7167
- Status last verified
- Jul 2018
- First submitted
- 16 Dec 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35075526
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Mental Models and Technical Assessment in Video Assisted Thoracoscopy Surgery Lobectomies
- ClinicalTrials.gov ID
- NCT02999113
- Acronym / sponsor ID
- R100-A7167
- Keywords
- non-technical skills, patient safety, medical education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- Dec 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Dec 2016 (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.
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
Detailed description
BACKGROUND The majority of errors in healthcare in general, and the operating theatre in particular, are caused by human factors1,2. Hindering of these errors can be accomplished by good non-technical skills (NTS), including good teamwork and efficient communication within the operating room (OR) team3,4. NTS are defined as 'the cognitive, social and personal resource skills that complement technical skills and contribute to safe and efficient task performance'5.
Previously, safety studies have analysed and measured adverse events as an indication of patient safety4,6. A new safety theory by Erik Hollnagel, named Safety II, argues that instead of only investigating adverse events as a 'measure' for safety, we should also be investigating what happens when these do not occur or when they are avoided as equally important7. This broader perspective on patient safety has also been advocated by others8-10.
In an explorative, interview-based study, we took a Safety-II perspective when examining which NTS were most important for ensuring safe and efficient video-assisted thoracoscopic surgery (VATS) lobectomy, a high risk minimally invasive surgery with complementary and overlapping scope of practice between the surgical and anaesthesia subteams. The multi-professional teams identified specific important NTS that served as the basis for shared mental models (SMMs) regarding the patient, the current situation or the resources within the team. These mental models were accomplished through communication and coordination, and enabled the team to anticipate problems and stay ahead of the situation11. These teams performing high-risk procedures emphasized the importance of the six identified NTS for them to be able to obtain an accurate SMM to enable them to be ahead which they viewed as most important for a successful and safe operation.
Some of the first to look at SMM as a requirement for effective team performance was Cannon-Bowers and Salas in the 1990s12. They defined SMMs as common or overlapping cognitive representations of task requirements, procedures, and role responsibilities. More recent, SMMs have been specified as a shared understanding of the task (including equipment), the situation and resources of other team members. In turn, this will enable them to understand and interpret the situation and what the other team members know, what they need to know and what they are doing12-14. Moreover, others have found identical or similar constructs to SMMs, i.e. team mental models/shared situation models/team knowledge/team situation awareness, and the importance of these constructs for patient safety is largely agreed upon15-21.
SMMs are more than the sum of individual mental models20,22. They need to be similar, accurate and shared within the team; however, what level of information sharing and team monitoring in the team will result in high team performance is less clear17,18,23.
In a recent methodology publication, different probe questions were used to establish team members' knowledge in order to measure the team's SMM and situation awareness13. The probe questions related to the task, the situation, and future predictions of the situation including possible outcomes. The teams in these experiments were at a second-line emergency centre where team members had distinct responsibilities. These teams differ from OR teams which work closely together in and with the same 'physical environment', namely in the OR with the patient, on a high-risk but at the same time rather standardized task, namely an operation, which in our case is an elective procedure of VATS lobectomy. One can speculate if the SMMs of OR teams are identical or differ to these emergency centre teams. So far, measurement of SMMs in OR teams has to our knowledge only been conducted in simulation settings17. To what extent this shared mental modelling occurs within the OR teams in the clinical setting is not known.
Moreover, the correlation between OR teams' NTS and technical skills (TS) has previously been investigated, however, there is still no clear picture of whether or not a correlation exists4,24-26. Additionally, some studies found a positive correlation27-29, whereas others found a negative correlation30. As the SMMs of the VATS teams seem to be enabled by the NTS perceived as important, it could be hypothesised that this relationship for SMMs and TS in the clinical setting is clearer than for NTS and TS. Yet, it is unknown whether the OR teams' SMMs are correlated to TS or other patient- and procedure-related measures.
The aims of this study are twofold. First, to explore to what extent SMM occur within the VATS teams in a cardiothoracic surgery setting. Second, to establish whether the VATS team's SMM is associated with the surgeons' TS, procedural specific times, per-operative bleeding, or patient characteristics (age, gender, FEV %, comorbidity, tumour size or location).
Research questions for the study
- To what extent are the individual team members' mental models in agreement within the VATS team?
- Pre-operatively?
- Post-operatively?
- Pre- and post-operative correlations?
- How is the team's shared mental model associated with
- The surgeon's TS assessed by VATS lobectomy assessment tool (VATSAT)?
- Procedural specific times (see later for description)?
- Amount of bleeding?
- Patient characteristics?
METHODS Design This study will be a case series study of VATS lobectomies purposefully sampled at all four cardiothoracic surgery centres in Denmark. Data will be gathered from 60 lobectomies performed by multi-professional VATS teams including both experienced and intermediate level surgeons. Gathering of data is planned to start in December 2016.
Data sampling Team members' mental models will be explored through two questionnaires handed out to all team members before and after the operation (see Appendix to protocol (in Danish)). The questionnaires were constructed using the probe questions from Sætrevik et al., adapted to fit VATS lobectomy settings11,13,14.
Specifically, 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.
Perceived technical and teamwork skills, familiarity, 'global' and 'global in view of the current team' risk assessments are rated on a Likert scale from 1-7, and risk assessment of specific possible challenging situations are rated on a Likert scale from 1-3. The remaining items are either yes/no-questions or open-ended questions.
The questionnaires will be handed out to each team member individually before and after the VATS lobectomy. Endoscopic video-recordings of all the VATS lobectomies will be collected from the thoracoscope using the recording device MedCapture. Using these video-recordings, the TS level of the VATS surgeon will be evaluated by two independent raters using a VATSAT assessment tool31. The VATSAT tool evaluates eight items on a five point Likert scale and produces a pass/fail score.
An observer will be present throughout all the operations to collect data on amount of bleeding (in ml) and procedural specific times. The procedural specific times will be both pre-specified times and a continuous registration of time for tasks. The pre-specified times will be from the time the patient enters the OR to anaesthesia begins, to the surgeon makes the first incision, to the surgeon finishes the last suture, to the patient wakes up from anaesthesia, and to the patient leaves the OR.
The observer will in addition take field notes for qualitative analysis with special focus on the six NTS identified in our previous study as important to safe and successful VATS lobectomies.
Ethics The Regional Ethics Committee of the Capital Region of Denmark has been applied, and a letter of exemption has been given according to Danish Law (H-16041772). The participants will receive oral and written information and will give informed consent on the day of the operation with the continuous option of retraction of consent and participation. The endoscopic recordings will not start until the thoracoscope is inside the patient. All video-recordings, physical examples of questionnaires and master sheets will be stored according to Danish Data Protection Law, and any written description in the final manuscript and article will be presented anonymously. Only the members of the research team will review the endoscopic video-recordings.
Statistical analyses Questionnaire data The preoperative questionnaire will have in all 24 items concerning risk assessment and team resources. The post-operative questionnaire contains 16 items. It will describe the risk, skills and teamwork as perceived by each team member as it unfolded during the procedure. For each item, percentage of answers 'I don't know' will be calculated. For the remaining answers of each specific item, Cronbach's α will be calculated thereby representing the agreement within the team. These two numbers (percentage however revised to a number between 0-1) will be multiplied, thereby giving a number between 0-1. This will be done for all items. For each questionnaire, all item scores can be added to give a total score, between 0-24 or 0-16. For the pre-operative questionnaire, 24 will represent total agreement within the team before the operation, indicating complete overlap in the team's SMM of team resources and risk assessment. For the post-operative questionnaire, 16 will represent total agreement within the team after the operation, indicating complete overlap in the team's view on team resources, teamwork and risk assessment.
The post-operative questionnaire will conclude with an open-ended question concerning challenges faced during the procedure by all the different team members. From these it will be possible to categorize each of these answers as either correct (given a score of 1) or wrong (including 'I don't know'; given a score of 0) when compared to the answer given by the person in question. An example of this could be if the scrub nurse answers that the surgeon did not have any challenges, and the surgeon himself answers that he did have challenges dissecting the lymph nodes, the scrub nurse will get a score of zero.
In all, this will result in the calculations of three scores for SMMs regarding team resources, risk assessment and awareness of challenges within the team.
Correlation calculations The items concerning team members' perceived technical skills, teamwork skills, and risk assessment ('global' and 'global in view of the current team') will be collected both before and after the procedure. This will enable analysis of how well each team member predict these items before the operation as compared to the assessment after. This will be done by calculating Pearson's correlation coefficient r for each team member and for the team.
The scores representing the total SMM in the team pre- and post-operatively can be correlated to the surgeon's technical skills (the VATSAT score), procedural specific times, bleeding and patient characteristics. Pearson's correlation coefficient r will be used if the data are normally distributed or Spearman's correlation coefficient (rho) if the data are non-parametrically distributed. Statistical analyses will be performed using IBM SPSS statistics 22; SPSS Inc., Chicago, IL, USA.
Order of authors Kirsten Gjeraa, Peter Dieckmann, Anna Sofie Mundt, Lene Spanager, René Horsleben Petersen, Henrik Jessen Hansen, Doris Østergaard, Lars Konge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Team members of the operating room team performing VATS lobectomies
Key inclusion criteria (1 listed)
- Team members of the operating room team performing VATS lobectomies
Key exclusion criteria (1 listed)
- Not team members of the operating room team performing VATS lobectomies, e.g. observers or guests in the OR during VATS lobectomies
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
shared mental models (SMM)
Time frame: pre- and post-operatively
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
4 secondary outcomes
Technical skills (TS)
Time frame: per-operatively
Procedural specific times
Time frame: During the operation (VATS lobectomies)
Amount of bleeding
Time frame: During the operation (VATS lobectomies)
Patient characteristics
Time frame: Pre-operatively
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 18 Jul 2018.
- Derived from this study: PubMed 35075526Gjeraa 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.
- Individual participant dataSharing planned: No
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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.
Lars Konge, Professor study director
Copenhagen Academy for Medical Education and Simulation, Copenhagen, Denmark
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 Shared Mental Models and Video Assisted Thoracoscopic Surgery, run by Copenhagen Academy for Medical Education and Simulation 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 18 Jul 2018. 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?
shared mental models (SMM) (time frame: pre- and post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999113, which also lists 1 linked publication.
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 18 Jul 2018.