The Impact of Remote Training on Colonoscopy KPIs

Colorectal Cancer Clinical Trial

Official title:

The Impact of a Short Training Course Focussed on the Acquisition of Conscious Competence on Nurse, Endoscopist and Patient Reported Comfort Scores During and After Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101836
• Other study ID #: BC-07318 E01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is a complex, highly operator dependent, practical skill. The consistent attainment of key performance indicators (KPIs) by endoscopists depends primarily upon training. Local factors can make training unstructured and contingent upon the observed practice of a small number of trainers. The investigators sought to demonstrate the feasibility and impact of a virtual-live one day colonoscopy-training course.

Description:

The investigators aim to conduct a prospective interventional single-center (University Hospital of Ghent, Belgium) study with trainees to evaluate their colonoscopy associated key performance indicators (KPIs)(Caecum intubation rate, adenoma detection rate, withdrawal time, serious complication rate and patient comfort score) between October and December 2020, prior and post a one-day virtual-live hybrid endoscopy training course.

Trainees and patients have to give their explicit consent for data acquisition and publication.

Consecutive patients undergoing a colonoscopy during the reported period who consent for the study can be included. Colonoscopies are performed with either high-definition or standard-definition white-light colonoscopes. Patients are prepared taking split dose of a polyethylene glycol solution (twice ½ liter) with 2 liters of additional water. During the procedure, patients are consciously sedated (midazolam and fentanyl). All patients receive standard of care endoscopic procedures and therapy.

After each colonoscopy, patients will be asked to fill a questionnaire regarding their comfort during the colonoscopy, using the Global Visual Analog Scale (VAS). Assisting nurses will be asked to note the patient's Gloucester Comfort Score (GCS), a validated comfort score for lower endoscopy. GCS>3 was defined as significant discomfort of the patient. The endoscopist-assessed GCS, and other KPIs of colonoscopy will be extracted from the colonoscopy report. Inclusion of patients starts 3 weeks prior to the planned endoscopy training intervention and continues for another 4 weeks thereafter. Online surveys will be sent to the trainees and trainers after the course, requesting their feedback.

The intervention: a one-day (8 hour) colonoscopy course in the trainees' local (Ghent, Belgium) endoscopy unit, involving virtual-live training by remote (Cheltenham, UK) experts trainers, renowned as consciously competent in colonoscopy technique. Sessions will be a mixture of didactic instruction, interactive discussion and live cases. Every included trainee will perform a live colonoscopy where they are accompanied by a local consultant who acts as a liaison for safety purposes. Live training is delivered via a second television-monitor positioned next to the endoscopic image via teleconference call (Zoom, San Jose, USA). The trainers have access to the real-time image of the endoscopy, as well as the magnetic endoscope imager (scope guide - Olympus, Tokyo Japan). The entire procedure will be recorded allowing the non-participating trainees to follow the course live on their computer. The course will also be available via live-stream (Vimeo, city, USA) external participants, and later for catch-up on the educational endoscopy platform GIEQs.com.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• trainees: trainees in endoscopy who work at the University Hospital of Ghent who want to participate and who consent for the study

• patients: all patients presenting for a colonoscopy between October and December 2020 and who consent to participate

Exclusion Criteria:

• trainees: trainees in endoscopy who work at the University Hospital of Ghent who do not want to participate and who don't consent for the study

• patients: all patients presenting for a colonoscopy between October and December 2020 and who do not consent to participate

Related Conditions & MeSH terms

• Colonoscopy
• Colorectal Cancer
• Colorectal Neoplasms
• Training

Intervention

Other:
• Training intervention
Trainees underwent a one-day training course (intervention) by consciously competent endoscopists who were physically remote consisting of interactive theoretical sessions and live sessions, where trainees performed colonoscopy in their local endoscopy unit receiving real-time instructions via a tele-conference monitor. Trainers and trainees not doing the colonoscopy, followed the procedure in real-time. KPIs were assessed on trainee-performed colonoscopies for 3 weeks prior and 4 weeks after the intervention.

Locations

Country	Name	City	State
Belgium	University Hospital of Ghent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caecum Intubation rate	Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: caecum intubation (intubated YES or No) after the training intervention	3 months
Primary	Colonoscopy withdrawal time	Trend in measurable colonoscopy key performance indicators pre- and post intervention. What is the withdrawal time (in minutes)? Is there a favourable trend in key performance indicator: colonoscopy withdrawal time (in minutes) after the training intervention	3 months
Primary	Patient comfort during colonoscopy - Visual analogue scale	Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: patient comfort (Visual analogue scale-number between 0-10, with 0=no pain and 10=worse pain possible) after the training intervention	3 months
Primary	Patient comfort during colonoscopy - Sedation	Trend in measurable colonoscopy key performance indicators pre- and post intervention. Is there a favourable trend in key performance indicator: patient comfort (amount of sedation necessary/used: midazolam (mg) and/or fentanyl (micrograms)) after the training intervention	3 months