Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02679872 |
| Other study ID # |
R100-A7166 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 4, 2016 |
| Last updated |
December 16, 2016 |
| Start date |
February 2016 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
December 2016 |
| Source |
Copenhagen Academy for Medical Education and Simulation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: National Board of Health |
| Study type |
Observational
|
Clinical Trial Summary
Good non-technical skills (NTS) have been shown to prevent adverse events and errors.
Improvements of NTS can be achieved by simulation based-team training.The NTS of the
operating theatre team performing video-assisted thoracoscopic surgery (VATS) is speculated
to differ fra open thoracic surgery, as is the case with technical skills; however, these
have not been investigated. The aim of this study is to explore which NTS the members of the
VATS team perceive to be most important to patient care and safety. Exploration will be done
through a deductive, qualitative analysis of semi-structured group and individual interviews
with VATS team members. A theoretical perspective of Hollnagels Safety-II will be taken
using the taxonomy of Oxford Non-Technical Skills (NOTECHS) system with the aim of informing
patient safety.
Description:
BACKGROUND:
Non-technical skills (NTS) can be defined as 'the cognitive, social and personal resource
skills that complement technical skills, and contribute to safe and efficient task
performance'. Human errors, such as communication breakdowns, lack of speaking up and of
good leadership, are known to contribute considerably to adverse events. Adverse events are
common in the operating theatre affecting patient safety. Adaptive behaviours have been
shown important as a response to the dynamic, complex world of the operating theatre to
prevent potential problems and adverse events.
As with technical skills, NTS can be taught by team training. Team training have been shown
to improve attitudes as well as NTS, and reduced technical errors. Large studies have
additionally shown that team training can reduce adverse events and improve patient outcome.
A training intervention targeted at operating theatre teams will need to start with an
assessment uncovering the learning needs of the team members.
In general minimally invasive surgery (MIS) is shown to be more complex, involve more
personnel and take longer time than open surgery. The technical skills are different, among
other things due to complex equipment and two-dimensional vision of a three-dimensional
operating space. In our systematic review (submitted), only few studies investigated the NTS
in MIS teams. The communication in MIS compared to open surgery were found to be different,
relating more to equipment and patient related topics. Working in fixed teams improved
teamwork climate in MIS teams.
Correspondingly, the NTS of the video-assisted thoracoscopic surgery (VATS) operating team
is speculated to differ from the NTS needed in open surgery as is the case with the
technical skills. However, no studies investigated the NTS of VATS teams.
The aim of this study is to explore, which NTS the members of the VATS team perceive to be
most important to high quality patient care and patient safety.
METHODS:
Frameworks/theory:
The theoretical conceptual framework for the study is the safety theory by Erik Hollnagel,
named Safety-I and Safety-II, arguing for a new view on safety: Safety-II. In Safety-I, the
ontology is that things either function or malfunction, that could be a piece of equipment
or healthcare professionals following procedures or guidelines. Consequently, the aetiology
of the outcomes can be explained by a cause-effect relationship, where the malfunction of
things linearly cause an unwanted effect. The resulting phenomenology then refers to
outcomes as adverse events / incidents/ accidents. Oppositely, in Safety-II, the ontology is
that in socio-technical systems, such as the healthcare system, performance adjustments is
needed to adjust work, that is the task and the tools, to the actual situation of the
complex world. Hence, as the technology only can vary to a limited extent, human performance
needs to vary. The aetiological explanation in Safety-II is therefore, that performance
variability resonate through both proactive and reactive adjustments into observed outcomes,
named emergent outcomes. The resulting phenomenology sees the performance variability as
both the basis of adverse events and of acceptable outcomes; that is everyday activities.
These performance adjustments can be categorised into three types of adjustments:
Maintaining/creating, compensating and avoiding, thereby characterising the performance
variability for a specific activity. In all, the starting point is turned around. In
Safety-II, the focus is on why and how things go right with the aim of understanding
everyday activities, termed 'Work-as-Done', in contrast to the less interesting written
procedure guidelines etc., termed 'Work-as-Imagined'.
Within non-technical skills research and education in healthcare, and especially within the
specialities working in the operating theatre, a taxonomy widely used is the framework of
behavioural markers adapted from the aviation industry, termed the Oxford Non-Technical
Skills (NOTECHS) system. This framework is structured around four categories, divided into
several elements each represented by examples of good or poor behavioural markers. This
system has been developed and evaluated for operating teams and assesses both the team and
each subteam's NTS. In this study, the taxonomy of the NOTECHS system in the perspective of
the conceptual theory of Safety-II will be used as framework for the data analysis as
described in detail below. In all, the behavioural markers representing good behaviours will
therefore be the focus of this study to explore how things go right as this is much often
the case than not. Interviewing the actual VATS team members themselves will explore their
own perception of the NTS used in their everyday activities including the needed adaptions
to situational requirements, found by others. This will represent 'Work-as-Done' rather than
'Work-as-Imagined' with the aim of informing the Safety-II perspective on patient safety.
Design:
The study will use the theories described above in an explorative semi-structured interview
study. The data collection and thereby sample size will be an iterative process until no new
data is revealed, hence saturation is met. This will include interviews of both
multi-professional teams and individuals depending on the data revealed during the
interviewing-analysing process. Interviews will be conducted by KG and ASM using a
semi-structured interview guide. The interview guide will be adjusted during the iterative
process of interviews and analysis. All interviews will be audio-recorded and transcribed
verbatim. The study will be reported in accordance with the Standards for Reporting
Qualitative Research (SRQR). Quality and rigour will be aimed for as suggested for
qualitative research.
Ethics:
The Regional Scientific Ethics Committee of the Capital Region will be applied; however, we
expect a letter of exemption due to Danish laws on educational studies not involving
patients. Participants will receive oral and written information and will have to give
informed consent with the continuous option of retracting their consent and participation.
Personal data will be stored according to Danish Data Protection Law, and will be presented
anonymously. The study protocol will be registered at www.clinicaltrials.gov.
Participants, setting and time:
Participants will be purposefully sampled as subject matter experts in terms of VATS
operating teams in conjunction with individuals. The teams will consist of one or two
surgeon(s) with VATS experience, one younger assisting surgeon, one anaesthesiologist, one
nurse anaesthetist, and one to two scrub nurses with experience as both assisting and
circulating nurse. The individuals will be relevant healthcare professionals of any of the
above. Participants will come from the four university hospitals performing VATS in Denmark
in collaboration with head of departments. Each person will only be included in one team
interview and/or one individual interview. The interviews are planned to be conducted in
February and March 2016.
The interview guide:
The interview guide will be semi-structured with a scripted introduction before each
interview setting the scene and the topic of the interview. The interview will try to
explore all four NOTECHS categories, namely leadership & management, teamwork &
co-operation, problem-solving & decision-making, and situation awareness in a Safety-II
perspective, focusing on the performance variability of the team members needed in their
daily work to adapt to situational requirements. Emphasis will be laid on allowing all team
members to give their perspective in order to explore views of the entire team. The
interviews will be semi-structured so probe questions will be used when necessary to obtain
additional information.
Prior to conducting the interviews, two authors (KG, ASM) will spend a number of hours
observing VATS procedures in order to become familiar with the procedures and with any
critical phases of the operations. This, along with input from experienced VATS surgeons
(RHP, HJH) and an experienced anaesthesiologist (DO), will inform the interview guide. The
interview guide will be internally reviewed by the authors consisting of surgeons, a scrub
nurse and an anaesthesiologist that are experienced qualitative and NTS researchers. It will
be pilot tested on healthcare professionals without specific NTS knowledge to avoid
misunderstanding and misinterpretation; however, these data will not be included in the
study.
Data collection and analysis:
The interviews will be conducted face-to-face in undisturbed rooms in relation to the
operating theatre in or just after normal working hours depending on working schedule. The
participants demographic data will be collected consisting of profession, age, gender, years
of clinical experience, years and type of experience with laparoscopic or VATS procedures
and previous experience with NTS training.
A deductive data analysis strategy will be applied in this study. With the taxonomy of the
NOTECHS framework we will use directed content analysis to analyse the interviews. Directed
content analysis can be applied when 'prior research exists about a phenomenon that is
incomplete/would benefit from further description'. As we approach the topic from a
Safety-II perspective, focus will be on which behaviours the VATS team members perceive as
important in insuring that things go right thereby insuring high quality patient care and
patient safety. Explicitly we will focus on performance variability in their everyday work,
categorising them as either maintaining/creating, compensating or avoiding.
The strategy is to use the categories of NOTECHS as well as categories of performance
variability, when reading the transcribed interviews. The text will then be coded into these
categories for condensation, adding new ones when extra text of interest is uncovered in
order to avoid missing important new information that could inform the theory on NTS in VATS
teams. The text coded will be marked to adhere to one of the categories, introducing new
categories if needed. The texts will then be paraphrased to condense the interview
quotations into observable behavioural examples.
The analyses will be conducted by KG and ASM. The first interviews will be coded by both KG
and ASM; the coding will be discussed between these two and LS/DO. When agreement is
satisfactorily, the two authors will split up and code the remaining interviews
independently. The results of the coding will be discussed with LS/DO and later the full
group of authors. The analysis will be conducted using NVivo (version 10).
Acknowledgements:
The authors will like to thanks the participating cardiothoracic departments in Denmark.
PROJECT ORGANISATION:
This study will be conducted at Copenhagen Academy for Medical Education and Simulation
(CAMES), at Rigshospitalet, Capital Region of Denmark and Copenhagen University.
Members of the research group:
Project leader, MD, PhD student Kirsten Gjeraa (KG) Interviewer and analyser, CRN Anna Sofie
Mundt (ASM) Co-supervisor, MD, PhD Lene Spanager (LS) Co-supervisor, MD Henrik Jessen Hansen
(HJH) Co-supervisor, MD René Horsleben Petersen (RHP) Co-supervisor, MD, PhD, associate
professor Lars Konge (LK) Supervisor, MD, DMSc, MHPE, professor Doris Østergaard (DO)
Publication:
The results will be published in an international journal.
Author list:
Kirsten Gjeraa, Anna Sofie Mundt, Lene Spanager, Lars Konge, René Horsleben Petersen, Henrik
Jessen Hansen, Doris Østergaard.
