TrainingNCT06101836
The Impact of Remote Training on Colonoscopy KPIs
A study testing Training intervention in people with Training and Colonoscopy, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Training, Colonoscopy, Colorectal Cancer
- What is being tested?
- Training intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Training, Colonoscopy, Colorectal Cancer
- Being tested
- Training intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Other | All participant trainees will undergo the educational intervention, therefore there is only one arm since all participants will undergo the intervention. The intervention is a day where participants (the trainees) will undergo a full day of training in colonoscopy. Comparison of key performance measures in colonoscopy is made before and after the intervention. Receives: Other: Training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2020
- Primary completion31 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrainingStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Tate, Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101836
- Sponsor's protocol ID
- BC-07318 E01
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06101836
- Acronym / sponsor ID
- BC-07318 E01
- Conditions
- Training, Colonoscopy, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Other | Other: Training interventionAll participant trainees will undergo the educational intervention, therefore there is only one arm since all participants will undergo the intervention. The intervention is a day where participants (the trainees) will undergo a full day of training in colonoscopy. Comparison of key performance measures in colonoscopy is made before and after the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training interventionTrainees 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. | Other | Interventional arm |
Primary outcome
Caecum Intubation rate
Time frame: 3 months
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
Colonoscopy withdrawal time
Time frame: 3 months
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
Patient comfort during colonoscopy - Visual analogue scale
Time frame: 3 months
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
Patient comfort during colonoscopy - Sedation
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Tate, Dr. principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training intervention in people with Training and Colonoscopy, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caecum Intubation rate (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.