NCT05110378

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

December 18, 2018

Last Update Submit

May 2, 2023

Conditions

Keywords

non-technical skillsgastrointestinal endoscopyqualitative researchtrainingassessment

Outcome Measures

Primary Outcomes (1)

  • Oxford NOTECHS II

    A Modified Theatre Team Non-Technical Skills Scoring System

    100 endoscopic procedures over a period of 4-5 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endoscopy staff (medical and non-medical) at Plymouth Hospitals NHS Trust and Torbay and South Devon NHS Foundation Trust. Patients attending the Endoscopy department during the study period were provided with written information explaining the study and inviting them to take part.

You may qualify if:

  • Staff
  • 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

You may not qualify if:

  • Staff • Endoscopy staff not consenting to take part in the study
  • Patients
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hitchins CR, Metzner M, Edworthy J, Ward C. Non-technical skills and gastrointestinal endoscopy: a review of the literature. Frontline Gastroenterol. 2018 Apr;9(2):129-134. doi: 10.1136/flgastro-2016-100800. Epub 2017 Mar 29.

    PMID: 29588841BACKGROUND

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal Diseases

Study Officials

  • Catherine Ward, BSc, MBBS, FRCA, PGCME

    University Hospitals Plymouth NHS Trust

    STUDY CHAIR
  • Charlotte Hitchins, BMedSci, BMBS, MRCS

    University Hospitals Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2018

First Posted

November 5, 2021

Study Start

October 1, 2015

Primary Completion

October 4, 2017

Study Completion

January 24, 2018

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share