跳至主要内容
临床试验/NCT05110378
NCT05110378已完成不适用

Do Good Non-Technical Skills Correlate With Good Clinical Outcomes in Endoscopy?

University Hospital Plymouth NHS Trust0 个研究点目标入组 326 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
326
主要终点
Oxford NOTECHS II

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Endoscopy staff consenting to take part in the study
  • Staff work in Endoscopy as their main NHS job Patients
  • Patients consenting to be observed and complete a patient satisfaction survey
  • Male or Female, aged 18 years or above
  • Able (in the investigator's opinion) and wiling to comply with all study requirements

排除标准

  • Staff • Endoscopy staff not consenting to take part in the study
  • Patients not consenting to take part in the study
  • Patients unable to understand the information provided or give consent to participate
  • o This was determined by the researcher who in her role as surgical doctor has been trained to assess patients' capacity to give informed consent.
  • Aged less than 18 years

结局指标

主要结局

Oxford NOTECHS II

时间窗: 100 endoscopic procedures over a period of 4-5 weeks

A Modified Theatre Team Non-Technical Skills Scoring System

次要结局

未报告次要终点

研究者

发起方
University Hospital Plymouth NHS Trust
申办方类型
Other
责任方
Sponsor

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