Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05110378 |
| Other study ID # |
15/P/101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
January 24, 2018 |
Study information
| Verified date |
May 2023 |
| Source |
University Hospital Plymouth NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Failures in non-technical skills (NTS) contribute to adverse events in healthcare. Previous
research has explored the assessment and training of these skills, and yet there is a lack of
evidence for their impact on clinical outcomes. Gastrointestinal endoscopy is a high-pressure
specialty, but to date there is little on the role of NTS in this area, or a method for their
assessment.
This MD project aims to measure NTS in endoscopy, explore their relationship with clinical
outcomes, and identify those specific to this area of healthcare.
Methods An observational study of endoscopy teams in real time, using the Oxford NOTECHS II
assessment tool. Comparison of NTS performance with procedure outcomes and patient
satisfaction.
A qualitative interview study with staff members to establish the NTS specifically relevant
to working in gastrointestinal endoscopy.
Description:
Ten to fifteen percent of patients will experience some kind of adverse event during their
hospital stay. A significant proportion of these occur in surgery. The causes of such adverse
events often stem not from deficiencies in clinical or technical skills but from the
non-technical aspects of human and team performance).
Much of the early research in this field comes from the aviation industry where
"non-technical skills" are defined as "the cognitive and social skills of flight crew members
in the cockpit". Failures in teamwork in cockpit crews have been linked to half of adverse
events in aviation and further work within surgery has shown a significant reduction in
adverse events when teams perform well.
Behavioural ratings systems have been used in aviation and other high risk industries for
many years to facilitate assessment and training. "NOTECHS" was designed in the 1990s by a
collaboration of European aviation experts as a system to assess the non-technical skills of
individual pilots. Over recent years similar such tools or taxonomies have been developed in
healthcare. Within surgery some taxonomies assess individual team members such as
'Non-Technical Skills for Surgeons' (NOTSS), 'Anaesthetists' Non-Technical Skills' (ANTS) and
'Scrub Practitioners List of Intra-operative Non-Technical Skills' (SPLINTS), whilst others
aim to assess the whole team: 'revised NOTECHS', 'Oxford NOTECHS (II)' and 'Observational
Teamwork Assessment for Surgery' (OTAS). 'NOTSS', 'ANTS' and 'SPLINTS' were developed by a
group at the University of Aberdeen. Each provides a rating scale to assess the non-technical
skills of an individual practitioner within a surgical team. They can be used as an
observational assessment or a self-evaluation tool for reflection and professional
development. The "revised NOTECHS" scale developed by a team at Imperial College, adapted the
"NOTECHS" system to assess the non-technical skills of theatre teams. The "Oxford NOTECHS"
was similarly adapted from "NOTECHS" to assess theatre teams but with an additional
subdivision into three "sub-teams" (surgical, anaesthetic and nursing). The "Oxford NOTECHS"
has further been revised to the "Oxford NOTECHS II" scale to improve the discrimination
between levels of performance. "OTAS" combines a task checklist and a team behaviour
assessment in the pre- operative, operative and post-operative phases of a procedure.
Two studies using the Oxford NOTECHS system have shown an improvement in scores after a
training intervention. Mishra et al observed 65 laparoscopic cholecystectomies before and
after a Crew Resource Management (CRM) style training intervention applied to all staff
members (29 laparoscopic cholecystectomies before, 39 after). Oxford NOTECHS scores improved
significantly after the training intervention. Scores negatively correlated with technical
error rates and positively (but not significantly) with staff safety attitudes. Another study
observing laparoscopic cholecystectomy and carotid endarterectomy showed similar improvement
in Oxford NOTECHS scores after a training intervention (all staff trained). This was
associated with a concurrent decrease in technical errors, procedural errors and an increase
in Safety Attitude Questionnaire scores, but no significant change in clinical outcomes.
These findings are consistent with a number of other studies investigating the effect of
human factors team training within healthcare. Outcome measures vary between studies:
learning assessment questionnaires, observed teamwork behaviour, participant perception of
teamwork and staff attitudes have all been used as markers of performance and have all shown
to improve after team training interventions. Unfortunately only a few studies have linked
training interventions to clinical outcome improvements. The Veterans Health Administration
Medical Team Training (MTT) program was a multi-center quality improvement program in the
USA. This study showed a significant reduction in surgical morbidity after the introduction
of team training. This along with the Oxford NOTECHS studies demonstrates that improving
non-technical skills may improve clinical outcomes. Thus though there is a range of data on
the effect of training on reduction of non-technical error, and some data which demonstrates
a direct link between non-technical skills and successful outcomes, there is still much work
to be done in clarifying the three-way links between non-technical skills, successful
outcomes and the role of training.
Endoscopy units are akin to day-case theatre complexes. Endoscopic procedures vary in their
length and complexity. Diagnostic gastroscopy and colonoscopy with or without biopsy (removal
of tissue) are the commonest procedures performed. However, there are a wide range of
therapeutic procedures also undertaken including stenting, endoscopic resection of tumours,
endoscopic retrograde cholangio-pancreatography and feeding gastrostomy insertion. Patients
consent to undergo these procedures having been fully informed of the risks involved. They
are either awake, under sedation (56.4% of sedation in the Peninsula region occurs in
Endoscopy units), or under general anaesthetic depending on the complexity of the procedure
and their preference. The PHNT endoscopy unit performs more than 12,000 procedures per year
in a contained unit of 5 rooms, operating Monday to Saturday. Additional procedures requiring
x-ray screening occur within the radiology department supplemented by Endoscopists and
Nursing staff from the unit.
There are clear auditable outcome standards for technical performance and training in
Endoscopy provided by the British Society of Gastroenterology (BSG) and the Joint Advisory
Group on GI Endoscopy (JAG). These include markers of completion of procedures such as Caecal
Intubation Rate and Adenoma Detection Rate in Colonoscopy. Challand et al showed that good
clinical performance in Colonoscopy was associated with increased efficiency. They also found
that there was no negative effect of training on either of these outcomes.
Although adverse events are rare in Endoscopy, advances in technology and techniques have led
to an increase in risk. As therapeutic procedures become more advanced the more "surgical"
the specialty becomes. The National Confidential Enquiry into patient Outcomes and Death
Report 2004 investigated the death of 1818 patients within 30 days of therapeutic endoscopy
during April 2002 to March 2003. They found a wide variety of practice in different units
across the UK, particularly in areas such as sedation administration, patient monitoring and
planning of procedures: the non-technical aspects of endoscopy.
The Endoscopist, whether a Surgeon, Physician or Advanced Nurse Practitioner, is equivalent
to the operating surgeon and nursing staff perform very similar roles to theatre
nurses/practitioners. An anaesthetist is present only for those procedures performed under
general anaesthetic. Despite a similar team and technical set up to an operation room there
is a clear deficit in the literature with regards to non-technical skills and team
performance within Endoscopy. It is likely that there will be a three-way relationship
between non-technical skills, successful outcomes and training as there are for other
surgical areas.
Endoscopy units share many characteristics with theatre complexes and are pioneering
increasingly complex procedures and yet there is little literature relating to the assessment
or training of team performance in this area; even within other areas of healthcare there is
little correlation with clinical outcomes. Taxonomies for team performance and non-technical
skills assessment in surgery are now well established and yet there still is no published
evidence of their use in or adaptation for Endoscopy. There is therefore scope for:
1. The evaluation and development of a non-technical skills assessment tool within
Endoscopy (based on Oxford NOTECHS II - a well-established taxonomy with good
reliability and validity). Correlation of non-technical skills with clinical and other
outcomes. Our endoscopy unit has a large throughput of similar cases per annum
(>12,000). This means the face, construct and concurrent validity of the non-technical
skills assessment tool can be tested reliably with greater power. Scores could be
correlated easily with standardized quality and safety outcomes.
2. Development of a Human Factors Simulation team training intervention based on the
knowledge gained from. Training has yet to take place within the Endoscopy unit in our
Hospital.
The aims of the project are as follows:
To develop the measurement of non-technical skills in endoscopy (using the Oxford NOTECHS II
taxonomy); to delineate the relationship between successful clinical (and other) outcomes and
non-technical skills as measured by the tool.
Endoscopy units share many characteristics with theatre complexes and are pioneering
increasingly complex procedures and yet there is little literature relating to the assessment
or training of team performance in this area; even within other areas of healthcare there is
little correlation with clinical outcomes. Taxonomies for team performance and non-technical
skills assessment in surgery are now well established and yet there still is little evidence
of their use in or adaptation for Endoscopy. This project seeks to provide a firm basis for
future work by establishing the measurement of non-technical skills in endoscopy, relating
those skills to clinical outcomes, and identifying those features of non-technical skills
training likely to be of greatest importance in terms of successful clinical outcomes.
